Department of Justice, License Renewal Application dated ...Radiology Department - Nuclear Medicine...

43
February 20 th , 2013 Mr. Hector Bermudez Health Physicist - Medical Branch Division of Nuclear Materials Safety US Nuclear Regulatory Commission NRC Region 1 2100 Renaissance Boulevard, Suite 100 King of Prussia, PA 19406-2713 Subject: Renewal of NRC Radioactive Material License No. 32-25613-01 Federal Medical Center (FMC) Butner, NC - Bureau of Prisons (BOP) Department of Justice (DOJ) Dear Mr. Bermudez; The Federal Medical Center (FMC) of the Bureau of Prisons {BOP)/Department of Justice (DOJ) in Butner, North Carolina, wishes to fully renew NRC Radioactive Material License No. 32- 25613-01 in its entirety. Basically all items and conditions on the current license will remain in effect with only slight modifications as outlined below and in this renewal application. NUREG -1556, Vol.9, Rev.2 including the Checklists of Appendix C - Applicability Table C.1, Radioactive Material Use Table C.2, and Training & Experience, Facilities & Equipment, Radiation Protection Program, and Waste Disposal Table C.3 were used in the preparation of this license renewal application. The information and attached documents relating to this License Renewal Application (NRC #32-25613-01) do not include or contain security-related sensitive information. The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public. Under the renewal application, the Radionuclides Used, Maximum Quantity, and the Purposes of Use will all remain exactly the same with no modification. Daniel D. Sprau, DrPH will continue on as the Radiation Safety Officer listed on the license and as described in the recent amendment (Dec.6 th , 2012 - Amendment No.6) and the accompanying documentation. For Authorized Users, all of the physicians listed on the license will remain same with the exceptions of Drs. Thompson, Wiener, and Coughlin, who have been removed. All Materials and designations will remain the same. In addition, under the Radiatign Protection program, the Occupational Dosimetry Program now uses the Landauer Co. for all of the Radiation Workers, General Public, and Area Monitors, covered by the license. Monitors are now issued either on a monthly or quarterly basis. r- 6Yft6IA& NMSSlRGN1 MAtERIALS.002

Transcript of Department of Justice, License Renewal Application dated ...Radiology Department - Nuclear Medicine...

February 20th 2013

Mr Hector Bermudez Health Physicist - Medical Branch Division of Nuclear Materials Safety US Nuclear Regulatory Commission NRC Region 1 2100 Renaissance Boulevard Suite 100 King of Prussia PA 19406-2713 030~11~ Subject Renewal of NRC Radioactive Material License No 32-25613-01

Federal Medical Center (FMC) Butner NC - Bureau of Prisons (BOP) Department of Justice (DOJ)

Dear Mr Bermudez

The Federal Medical Center (FMC) of the Bureau of Prisons BOP)Department of Justice (DOJ) in Butner North Carolina wishes to fully renew NRC Radioactive Material License No 32shy25613-01 in its entirety Basically all items and conditions on the current license will remain in effect with only slight modifications as outlined below and in this renewal application

NUREG -1556 Vol9 Rev2 including the Checklists of Appendix C - Applicability Table C1 Radioactive Material Use Table C2 and Training ampExperience Facilities ampEquipment Radiation Protection Program and Waste Disposal Table C3 were used in the preparation of this license renewal application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Under the renewal application the Radionuclides Used Maximum Quantity and the Purposes of Use will all remain exactly the same with no modification Daniel D Sprau DrPH will continue on as the Radiation Safety Officer listed on the license and as described in the recent amendment (Dec6th

2012 - Amendment No6) and the accompanying documentation

For Authorized Users all of the physicians listed on the license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Uj~ designations will remain the same

In addition under the Radiatign Protection program the Occupational Dosimetry Program now uses the Landauer Co for all of the Radiation Workers General Public and Area Monitors covered by the license Monitors are now issued either on a monthly or quarterly basis

rshy 6Yft6IAamp NMSSlRGN1 MAtERIALS002

Please let us know if you have any questions This license renewal application request was approved today by the Federal Medical Center (FMC) - Bureau of Prisons (BOP) Radiation Safety Committee

Daniel D Sprau DrPH Radiological Health Consultant 2522580716 ~Qr~~I~1lIuI]9C9-l1 Radiation Safety Officer 9195753900 ext 5172 Dspraubopgov Federal Medical Center Federal Bureau of Prisons Department of Justice PO Box 1500 Butner NC 27509

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION APPROVED SY OMS NO 3150-0120 EXPIRES (0513112015) (05-2012) Estimated buman per response to comply with this mandatory collection request 43 hours Submittal of 10 CFR 30 32 33 the application is necessary to determine that the applicant is qualified and that adequate procedures exist34 35 36 39 and 40

to protect the public heanh and satety Send commanlS regarding burden estimate to the Information Services Bnanch (T-5 F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by

APPLICATION FOR MATERIALS LICENSE Inlemal amall to InfocoliectsResourcenrcgov and to the Desk Officer Office of Information and Regulatory Affairs NEOB-10202 (3150-0120) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a cumenUy valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAliON FOR DISTRlBUll0N OF EXEMPT PRODUCTS FILE APPLICATIONS WITH IF YOU ARE LOCATED IN

OFFICE OF FEDERAL amp STATE MATERIALS AND ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN ENVIRONMENTAL MANAGEMENT PROGRAMS SEND APPLICAll0NS TO DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION MATERIALS LICENSING BRANCH WASHINGTON DC 20555-0001 US NUCLEAR REGULATORY COMMISSION REGION III

2443 WARRENVILLE ROAD SUITE 210 ALL OTHER PERSONS FILE APPLlCA nONS AS FOLLOWS LISLE IL 605324352

IF YOU ARE LOCATED IN

ALABAMA CONNECTICUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH NEW YORK NORTH CAROLINA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS CAROLINA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA UTAH WASHINGTON OR WYOMING

SEND APPLICATIONS TO SEND APPLICATIONS TO

LICENSING ASSISTANCE TEAM NUCLEAR MATERIALS LICENSING BRANCH DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION IV US NUCLEAR REGULATORY COMMISSION REGION I 1600 E LAMAR BOULEVARD 2100 RENAISSANCE BOULEVARD SUITE 100 ARLINGTON TX 760114511 KING OF PRUSSIA PA 19406-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)1 THIS IS AN APPLICATION FOR (Checkappropnate item)

A NEW LICENSE Dept of Justice - Federal Bureau of Prisons Federal Medical Center - Radiology

B AMENDMENT TO LICENSE NUMBER ~-~ ----~ -~ PO Box 1600 32-25613-01C RENEWAL OF LICENSE NUMBER Butner NC 27509 ZJ

3 ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

Daniel D Sprau DrPH - HealthMedical Physics Consultant Dept of Justice - Federal Bureau of Prisons

BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER Federal Medical Center (FMC)

(919) 575-3900 (252) 258-0716 Radiology Department - Nuclear Medicine

BUSINESS EMAIL ADDRESSButner NC 27509 dspraubopgov or spraustrahlungcom

SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIOE

5 RADIOACTNE MATERIAL a Element and mass number b chemical andior physical form and C maixlmum amount 6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS TRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10 CFR 170 and Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY Renewal $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STA TEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULATIONS PARTS 30 32 33 34 35 bull 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEOGE AND BELIEF 7 WARNING 18 USC SECTION 1001 ACT OF JUNE 25 1948 62 STAT 749 MAKES IT A C RIMINAL O~ -=- Fj A WlLLFU FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER lJVjTHIN ITS JURISDI

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

(~AT~poundTony Hiscocks Associate Warden

77~ ~5jj FOR NRC USE~titY

TYPE OF FEE IFEE LOG IFEE ur AMOUNT RECEIVED bullCHECK NUM~ COMMENTS

$i

APPROVED BY DATE

NRC FORM 313 (05-2012)

UNITED STATES

NUCLEAR REGULATORY COMMISSION REGION

2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PENNSYLVANIA 19406-2713

December 14 2012

Docket No 03036175 License No 32-25613-01 Control No 579472

Daniel D Sprau DrPH Radiation Safety Officer Department of Justice Federal Bureau of Prisons Federal Medical Center PO Box 1500 Butner NC 27509

SUBJECT DEPARTMENT OF JUSTICE LICENSE AMENDMENT CONTROL NO 579472

Dear Dr Sprau

This refers to your license amendment request Enclosed with this letter is the amended license

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license If there are any errors or questions please notify the US Nuclear Regulatory Commission Region I Office Licensing Assistance Team (610) 337-5239 so that we can provide appropriate corrections and answers

An environmental assessment for this action is not required since this action is categorically excluded under 10 CFR 5122( c)( 14)

Current NRC regulations and guidance are included on the NRCs website at wwwnrcgov select Nuclear Materials Med Ind amp Academic Uses then Licensee Toolkits see our toolkit index page You may also obtain these documents by contacting the Government Printing Office (GPO) toll-free at 1-866-512-1800 The GPO is open from 800 am to 530 pm EST Monday through Friday (except Federal holidays)

Thank you for your cooperation

~IIY middotlHector-e=-rmgtltUdez - J - Health Physicist

Medical Branch Division of Nuclear Materials Safety

Enclosure Amendment No 6

6 NRC FORM 374 PAGE _1_0F _3_PAGES

US NUCLEAR REGULATORY COMMISSION Amendment No

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954 as amended the Energy Reorganization Act of 1974 (Public Law 93-438) and Title 10 Code of Federal Regulations Chapter I Parts 30 31 32 33 34 35 36 39 40 and 70 and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer byproduct source and special nuclear material designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations ofthe applicable Partes) This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954 as amended and is subject to all applicable rules regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below

Licensee I n accordance with the letter dated

November 282012

1 Department of Justice 3 License number 32-25613-01 is amended in

Federal Bureau of Prisons itsentirety to read as follows

Federal Medical Center

2 PO Box 1500 4 Expiratiol1idatE_ February 28 2013

Butner North Carolina 27509 __ middot 5 Docket No 030lt~6175 -~

Reference No

6 Byproduct source andor sp~Cial 8 Maximum amount that licensee may nuclear material possess at anyone time under this

license Lbullbullbullbull

A Any byproduct material~ A AsOeeded permitted by 10 CFR 35pOp

B Any byproduct material -- B Asneeded permitted by 1 0 CFR 35200

-~

C Any byproduct material C~ ioo millicuries permitted by 10 CFR 35300

9 Authorized use

A Any uptake dilution and excretion study permitted by 10 CFR 35100 B Any imaging and localization study permitted by 10 CFR 35200 C Any diagnostic study or therapy procedure permitted by 10 CFR 35300

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at Old North Carolina Highway 75 Butner North Carolina

11 The Radiation Safety Officer for this license is Daniel D Sprau DrPh

12 Licensed material is only authorized for use by or under the supervision of

A Individuals permitted to work as an authorized user in accordance with 10 CFR 3513 and 3514

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Please let us know if you have any questions This license renewal application request was approved today by the Federal Medical Center (FMC) - Bureau of Prisons (BOP) Radiation Safety Committee

Daniel D Sprau DrPH Radiological Health Consultant 2522580716 ~Qr~~I~1lIuI]9C9-l1 Radiation Safety Officer 9195753900 ext 5172 Dspraubopgov Federal Medical Center Federal Bureau of Prisons Department of Justice PO Box 1500 Butner NC 27509

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION APPROVED SY OMS NO 3150-0120 EXPIRES (0513112015) (05-2012) Estimated buman per response to comply with this mandatory collection request 43 hours Submittal of 10 CFR 30 32 33 the application is necessary to determine that the applicant is qualified and that adequate procedures exist34 35 36 39 and 40

to protect the public heanh and satety Send commanlS regarding burden estimate to the Information Services Bnanch (T-5 F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by

APPLICATION FOR MATERIALS LICENSE Inlemal amall to InfocoliectsResourcenrcgov and to the Desk Officer Office of Information and Regulatory Affairs NEOB-10202 (3150-0120) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a cumenUy valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAliON FOR DISTRlBUll0N OF EXEMPT PRODUCTS FILE APPLICATIONS WITH IF YOU ARE LOCATED IN

OFFICE OF FEDERAL amp STATE MATERIALS AND ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN ENVIRONMENTAL MANAGEMENT PROGRAMS SEND APPLICAll0NS TO DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION MATERIALS LICENSING BRANCH WASHINGTON DC 20555-0001 US NUCLEAR REGULATORY COMMISSION REGION III

2443 WARRENVILLE ROAD SUITE 210 ALL OTHER PERSONS FILE APPLlCA nONS AS FOLLOWS LISLE IL 605324352

IF YOU ARE LOCATED IN

ALABAMA CONNECTICUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH NEW YORK NORTH CAROLINA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS CAROLINA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA UTAH WASHINGTON OR WYOMING

SEND APPLICATIONS TO SEND APPLICATIONS TO

LICENSING ASSISTANCE TEAM NUCLEAR MATERIALS LICENSING BRANCH DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION IV US NUCLEAR REGULATORY COMMISSION REGION I 1600 E LAMAR BOULEVARD 2100 RENAISSANCE BOULEVARD SUITE 100 ARLINGTON TX 760114511 KING OF PRUSSIA PA 19406-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)1 THIS IS AN APPLICATION FOR (Checkappropnate item)

A NEW LICENSE Dept of Justice - Federal Bureau of Prisons Federal Medical Center - Radiology

B AMENDMENT TO LICENSE NUMBER ~-~ ----~ -~ PO Box 1600 32-25613-01C RENEWAL OF LICENSE NUMBER Butner NC 27509 ZJ

3 ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

Daniel D Sprau DrPH - HealthMedical Physics Consultant Dept of Justice - Federal Bureau of Prisons

BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER Federal Medical Center (FMC)

(919) 575-3900 (252) 258-0716 Radiology Department - Nuclear Medicine

BUSINESS EMAIL ADDRESSButner NC 27509 dspraubopgov or spraustrahlungcom

SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIOE

5 RADIOACTNE MATERIAL a Element and mass number b chemical andior physical form and C maixlmum amount 6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS TRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10 CFR 170 and Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY Renewal $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STA TEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULATIONS PARTS 30 32 33 34 35 bull 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEOGE AND BELIEF 7 WARNING 18 USC SECTION 1001 ACT OF JUNE 25 1948 62 STAT 749 MAKES IT A C RIMINAL O~ -=- Fj A WlLLFU FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER lJVjTHIN ITS JURISDI

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

(~AT~poundTony Hiscocks Associate Warden

77~ ~5jj FOR NRC USE~titY

TYPE OF FEE IFEE LOG IFEE ur AMOUNT RECEIVED bullCHECK NUM~ COMMENTS

$i

APPROVED BY DATE

NRC FORM 313 (05-2012)

UNITED STATES

NUCLEAR REGULATORY COMMISSION REGION

2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PENNSYLVANIA 19406-2713

December 14 2012

Docket No 03036175 License No 32-25613-01 Control No 579472

Daniel D Sprau DrPH Radiation Safety Officer Department of Justice Federal Bureau of Prisons Federal Medical Center PO Box 1500 Butner NC 27509

SUBJECT DEPARTMENT OF JUSTICE LICENSE AMENDMENT CONTROL NO 579472

Dear Dr Sprau

This refers to your license amendment request Enclosed with this letter is the amended license

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license If there are any errors or questions please notify the US Nuclear Regulatory Commission Region I Office Licensing Assistance Team (610) 337-5239 so that we can provide appropriate corrections and answers

An environmental assessment for this action is not required since this action is categorically excluded under 10 CFR 5122( c)( 14)

Current NRC regulations and guidance are included on the NRCs website at wwwnrcgov select Nuclear Materials Med Ind amp Academic Uses then Licensee Toolkits see our toolkit index page You may also obtain these documents by contacting the Government Printing Office (GPO) toll-free at 1-866-512-1800 The GPO is open from 800 am to 530 pm EST Monday through Friday (except Federal holidays)

Thank you for your cooperation

~IIY middotlHector-e=-rmgtltUdez - J - Health Physicist

Medical Branch Division of Nuclear Materials Safety

Enclosure Amendment No 6

6 NRC FORM 374 PAGE _1_0F _3_PAGES

US NUCLEAR REGULATORY COMMISSION Amendment No

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954 as amended the Energy Reorganization Act of 1974 (Public Law 93-438) and Title 10 Code of Federal Regulations Chapter I Parts 30 31 32 33 34 35 36 39 40 and 70 and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer byproduct source and special nuclear material designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations ofthe applicable Partes) This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954 as amended and is subject to all applicable rules regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below

Licensee I n accordance with the letter dated

November 282012

1 Department of Justice 3 License number 32-25613-01 is amended in

Federal Bureau of Prisons itsentirety to read as follows

Federal Medical Center

2 PO Box 1500 4 Expiratiol1idatE_ February 28 2013

Butner North Carolina 27509 __ middot 5 Docket No 030lt~6175 -~

Reference No

6 Byproduct source andor sp~Cial 8 Maximum amount that licensee may nuclear material possess at anyone time under this

license Lbullbullbullbull

A Any byproduct material~ A AsOeeded permitted by 10 CFR 35pOp

B Any byproduct material -- B Asneeded permitted by 1 0 CFR 35200

-~

C Any byproduct material C~ ioo millicuries permitted by 10 CFR 35300

9 Authorized use

A Any uptake dilution and excretion study permitted by 10 CFR 35100 B Any imaging and localization study permitted by 10 CFR 35200 C Any diagnostic study or therapy procedure permitted by 10 CFR 35300

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at Old North Carolina Highway 75 Butner North Carolina

11 The Radiation Safety Officer for this license is Daniel D Sprau DrPh

12 Licensed material is only authorized for use by or under the supervision of

A Individuals permitted to work as an authorized user in accordance with 10 CFR 3513 and 3514

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION APPROVED SY OMS NO 3150-0120 EXPIRES (0513112015) (05-2012) Estimated buman per response to comply with this mandatory collection request 43 hours Submittal of 10 CFR 30 32 33 the application is necessary to determine that the applicant is qualified and that adequate procedures exist34 35 36 39 and 40

to protect the public heanh and satety Send commanlS regarding burden estimate to the Information Services Bnanch (T-5 F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by

APPLICATION FOR MATERIALS LICENSE Inlemal amall to InfocoliectsResourcenrcgov and to the Desk Officer Office of Information and Regulatory Affairs NEOB-10202 (3150-0120) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a cumenUy valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAliON FOR DISTRlBUll0N OF EXEMPT PRODUCTS FILE APPLICATIONS WITH IF YOU ARE LOCATED IN

OFFICE OF FEDERAL amp STATE MATERIALS AND ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN ENVIRONMENTAL MANAGEMENT PROGRAMS SEND APPLICAll0NS TO DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION MATERIALS LICENSING BRANCH WASHINGTON DC 20555-0001 US NUCLEAR REGULATORY COMMISSION REGION III

2443 WARRENVILLE ROAD SUITE 210 ALL OTHER PERSONS FILE APPLlCA nONS AS FOLLOWS LISLE IL 605324352

IF YOU ARE LOCATED IN

ALABAMA CONNECTICUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH NEW YORK NORTH CAROLINA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS CAROLINA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA UTAH WASHINGTON OR WYOMING

SEND APPLICATIONS TO SEND APPLICATIONS TO

LICENSING ASSISTANCE TEAM NUCLEAR MATERIALS LICENSING BRANCH DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION IV US NUCLEAR REGULATORY COMMISSION REGION I 1600 E LAMAR BOULEVARD 2100 RENAISSANCE BOULEVARD SUITE 100 ARLINGTON TX 760114511 KING OF PRUSSIA PA 19406-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)1 THIS IS AN APPLICATION FOR (Checkappropnate item)

A NEW LICENSE Dept of Justice - Federal Bureau of Prisons Federal Medical Center - Radiology

B AMENDMENT TO LICENSE NUMBER ~-~ ----~ -~ PO Box 1600 32-25613-01C RENEWAL OF LICENSE NUMBER Butner NC 27509 ZJ

3 ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

Daniel D Sprau DrPH - HealthMedical Physics Consultant Dept of Justice - Federal Bureau of Prisons

BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER Federal Medical Center (FMC)

(919) 575-3900 (252) 258-0716 Radiology Department - Nuclear Medicine

BUSINESS EMAIL ADDRESSButner NC 27509 dspraubopgov or spraustrahlungcom

SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIOE

5 RADIOACTNE MATERIAL a Element and mass number b chemical andior physical form and C maixlmum amount 6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS TRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10 CFR 170 and Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY Renewal $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STA TEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULATIONS PARTS 30 32 33 34 35 bull 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEOGE AND BELIEF 7 WARNING 18 USC SECTION 1001 ACT OF JUNE 25 1948 62 STAT 749 MAKES IT A C RIMINAL O~ -=- Fj A WlLLFU FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER lJVjTHIN ITS JURISDI

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

(~AT~poundTony Hiscocks Associate Warden

77~ ~5jj FOR NRC USE~titY

TYPE OF FEE IFEE LOG IFEE ur AMOUNT RECEIVED bullCHECK NUM~ COMMENTS

$i

APPROVED BY DATE

NRC FORM 313 (05-2012)

UNITED STATES

NUCLEAR REGULATORY COMMISSION REGION

2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PENNSYLVANIA 19406-2713

December 14 2012

Docket No 03036175 License No 32-25613-01 Control No 579472

Daniel D Sprau DrPH Radiation Safety Officer Department of Justice Federal Bureau of Prisons Federal Medical Center PO Box 1500 Butner NC 27509

SUBJECT DEPARTMENT OF JUSTICE LICENSE AMENDMENT CONTROL NO 579472

Dear Dr Sprau

This refers to your license amendment request Enclosed with this letter is the amended license

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license If there are any errors or questions please notify the US Nuclear Regulatory Commission Region I Office Licensing Assistance Team (610) 337-5239 so that we can provide appropriate corrections and answers

An environmental assessment for this action is not required since this action is categorically excluded under 10 CFR 5122( c)( 14)

Current NRC regulations and guidance are included on the NRCs website at wwwnrcgov select Nuclear Materials Med Ind amp Academic Uses then Licensee Toolkits see our toolkit index page You may also obtain these documents by contacting the Government Printing Office (GPO) toll-free at 1-866-512-1800 The GPO is open from 800 am to 530 pm EST Monday through Friday (except Federal holidays)

Thank you for your cooperation

~IIY middotlHector-e=-rmgtltUdez - J - Health Physicist

Medical Branch Division of Nuclear Materials Safety

Enclosure Amendment No 6

6 NRC FORM 374 PAGE _1_0F _3_PAGES

US NUCLEAR REGULATORY COMMISSION Amendment No

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954 as amended the Energy Reorganization Act of 1974 (Public Law 93-438) and Title 10 Code of Federal Regulations Chapter I Parts 30 31 32 33 34 35 36 39 40 and 70 and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer byproduct source and special nuclear material designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations ofthe applicable Partes) This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954 as amended and is subject to all applicable rules regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below

Licensee I n accordance with the letter dated

November 282012

1 Department of Justice 3 License number 32-25613-01 is amended in

Federal Bureau of Prisons itsentirety to read as follows

Federal Medical Center

2 PO Box 1500 4 Expiratiol1idatE_ February 28 2013

Butner North Carolina 27509 __ middot 5 Docket No 030lt~6175 -~

Reference No

6 Byproduct source andor sp~Cial 8 Maximum amount that licensee may nuclear material possess at anyone time under this

license Lbullbullbullbull

A Any byproduct material~ A AsOeeded permitted by 10 CFR 35pOp

B Any byproduct material -- B Asneeded permitted by 1 0 CFR 35200

-~

C Any byproduct material C~ ioo millicuries permitted by 10 CFR 35300

9 Authorized use

A Any uptake dilution and excretion study permitted by 10 CFR 35100 B Any imaging and localization study permitted by 10 CFR 35200 C Any diagnostic study or therapy procedure permitted by 10 CFR 35300

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at Old North Carolina Highway 75 Butner North Carolina

11 The Radiation Safety Officer for this license is Daniel D Sprau DrPh

12 Licensed material is only authorized for use by or under the supervision of

A Individuals permitted to work as an authorized user in accordance with 10 CFR 3513 and 3514

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

UNITED STATES

NUCLEAR REGULATORY COMMISSION REGION

2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PENNSYLVANIA 19406-2713

December 14 2012

Docket No 03036175 License No 32-25613-01 Control No 579472

Daniel D Sprau DrPH Radiation Safety Officer Department of Justice Federal Bureau of Prisons Federal Medical Center PO Box 1500 Butner NC 27509

SUBJECT DEPARTMENT OF JUSTICE LICENSE AMENDMENT CONTROL NO 579472

Dear Dr Sprau

This refers to your license amendment request Enclosed with this letter is the amended license

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license If there are any errors or questions please notify the US Nuclear Regulatory Commission Region I Office Licensing Assistance Team (610) 337-5239 so that we can provide appropriate corrections and answers

An environmental assessment for this action is not required since this action is categorically excluded under 10 CFR 5122( c)( 14)

Current NRC regulations and guidance are included on the NRCs website at wwwnrcgov select Nuclear Materials Med Ind amp Academic Uses then Licensee Toolkits see our toolkit index page You may also obtain these documents by contacting the Government Printing Office (GPO) toll-free at 1-866-512-1800 The GPO is open from 800 am to 530 pm EST Monday through Friday (except Federal holidays)

Thank you for your cooperation

~IIY middotlHector-e=-rmgtltUdez - J - Health Physicist

Medical Branch Division of Nuclear Materials Safety

Enclosure Amendment No 6

6 NRC FORM 374 PAGE _1_0F _3_PAGES

US NUCLEAR REGULATORY COMMISSION Amendment No

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954 as amended the Energy Reorganization Act of 1974 (Public Law 93-438) and Title 10 Code of Federal Regulations Chapter I Parts 30 31 32 33 34 35 36 39 40 and 70 and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer byproduct source and special nuclear material designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations ofthe applicable Partes) This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954 as amended and is subject to all applicable rules regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below

Licensee I n accordance with the letter dated

November 282012

1 Department of Justice 3 License number 32-25613-01 is amended in

Federal Bureau of Prisons itsentirety to read as follows

Federal Medical Center

2 PO Box 1500 4 Expiratiol1idatE_ February 28 2013

Butner North Carolina 27509 __ middot 5 Docket No 030lt~6175 -~

Reference No

6 Byproduct source andor sp~Cial 8 Maximum amount that licensee may nuclear material possess at anyone time under this

license Lbullbullbullbull

A Any byproduct material~ A AsOeeded permitted by 10 CFR 35pOp

B Any byproduct material -- B Asneeded permitted by 1 0 CFR 35200

-~

C Any byproduct material C~ ioo millicuries permitted by 10 CFR 35300

9 Authorized use

A Any uptake dilution and excretion study permitted by 10 CFR 35100 B Any imaging and localization study permitted by 10 CFR 35200 C Any diagnostic study or therapy procedure permitted by 10 CFR 35300

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at Old North Carolina Highway 75 Butner North Carolina

11 The Radiation Safety Officer for this license is Daniel D Sprau DrPh

12 Licensed material is only authorized for use by or under the supervision of

A Individuals permitted to work as an authorized user in accordance with 10 CFR 3513 and 3514

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

6 NRC FORM 374 PAGE _1_0F _3_PAGES

US NUCLEAR REGULATORY COMMISSION Amendment No

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954 as amended the Energy Reorganization Act of 1974 (Public Law 93-438) and Title 10 Code of Federal Regulations Chapter I Parts 30 31 32 33 34 35 36 39 40 and 70 and in reliance on statements and representations heretofore made by the licensee a license is hereby issued authorizing the licensee to receive acquire possess and transfer byproduct source and special nuclear material designated below to use such material for the purpose(s) and at the place(s) designated below to deliver or transfer such material to persons authorized to receive it in accordance with the regulations ofthe applicable Partes) This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954 as amended and is subject to all applicable rules regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below

Licensee I n accordance with the letter dated

November 282012

1 Department of Justice 3 License number 32-25613-01 is amended in

Federal Bureau of Prisons itsentirety to read as follows

Federal Medical Center

2 PO Box 1500 4 Expiratiol1idatE_ February 28 2013

Butner North Carolina 27509 __ middot 5 Docket No 030lt~6175 -~

Reference No

6 Byproduct source andor sp~Cial 8 Maximum amount that licensee may nuclear material possess at anyone time under this

license Lbullbullbullbull

A Any byproduct material~ A AsOeeded permitted by 10 CFR 35pOp

B Any byproduct material -- B Asneeded permitted by 1 0 CFR 35200

-~

C Any byproduct material C~ ioo millicuries permitted by 10 CFR 35300

9 Authorized use

A Any uptake dilution and excretion study permitted by 10 CFR 35100 B Any imaging and localization study permitted by 10 CFR 35200 C Any diagnostic study or therapy procedure permitted by 10 CFR 35300

CONDITIONS

10 Licensed material may be used or stored only at the licensees facilities located at Old North Carolina Highway 75 Butner North Carolina

11 The Radiation Safety Officer for this license is Daniel D Sprau DrPh

12 Licensed material is only authorized for use by or under the supervision of

A Individuals permitted to work as an authorized user in accordance with 10 CFR 3513 and 3514

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

NRC FORM 374A

MATERIALS LICENSE SUPPLEMENTARY SHEET

PAGE 2 OF 3 PAGES

i License Number

32-25613-01 IDocket or Reference Number

030-36175

IAmendment No 6

8 The following individuals are authorized users for medical use as indicated

Authorized Users

Donn Kirk Beeson MD

Samuel Bone III MD

Andrew Choi MD

Randy Cruell MO

Hector Hidalg~ MD

James W Lester Jr

Ashley Grantfv1~rritt VLL1Cmiddot

Hemang PathakIMD

Hal Safrit MD

deAF TlgeFfl~8ef MOj

middotmiddot

81 II i~topl lei T COUglllill MD

Christopher M Cepeda MD

Daniel O Cuscela DO

Material and Use

35100 35200 Oral administration of sodium iodide 1-131 in quantities less than or equal to 33

~mililcuries L

351 00 35middot2()O~

35100 35200

35100 35200J)ral administration of sodium iodide 1-1 ~Jimiddotmiddotmiddotmiddot bull

middotmiddot~middot351 0035200 ~

middotmiddotmiddotmiddot95100 95206

e5eoo

35100 35200

35300

13 In addition to the possession limits in Item 8 the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 3035( d) for establishing decommissioning financi1 assurance

14 The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71 Packaging and Transportation of Radioactive Material

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

NRC FORM 374A PAGE 3 OF 3 PAGES

License Number 32-25613-01 Docket or Reference Number MATERIALS LICENSE 030-36175SUPPLEMENTARY SHEET

Amendment NO6

15 Except as specifically provided otherwise in this license the licensee shaH conduct its program in accordance with the statements representations and procedures contained in the documents including any enclosures listed below This license condition applies only to those procedures that are required to be submitted in accordance with the regulations Additionally this license condition does not limit the licensees ability to make changes to the radiation protection program as provided for in 10 CFR 3526 The US Nuclear Regulatory Commissions regulations shall govern unless the statements representations and procedures in the licen~~esapp[ication and correspondence are more restrictive than the regulations G i

A Application dated Oecernbe~ 92003 [ML03051 0218] B Letter dated January 282003 [ML030510198] C Letter dated FebruarY 7 2003 [ML03051 0180] O Letter dated OecefTiber 14 2007 [ML080090385]

Date __--Oecem_be_r_14--2_0_1-2____

Friday Oecember 14 2012 154735

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

--

--

APPENDIXCmiddot

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifus ing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

This response includes security-related sensitive infcmnation (see Section 52) which is included in ~es No Attachment __ and marked Security-related information - withhold under 10 CFR 2390

Form or Manufacturer MaximumYes Radionuclide Purpose of Use

Model No Quantity

Any byproduct Any As needed Any uptake dilution and V material permitted by excretion study pennitted

10 CFR 35100 by 10 CFR 35100 ~-

Any byproduct Any As needed Any imaging and material permitted by localization study 10 CFR 35200 peniutted by

10 CPR 35200 ~-

F-18 Any -_ curies Production of PET radioactive drugs under 10 CFR 3032U)

~-0-15 Any Production of PET

-_ curies radioactive drugs under 10 CFR 30320)

r C-ll Any curies Production of PET-_

radioactive drugs under 10 CPR 30320)

Any byproduct Any ~millicuries Any radiopharmaceutical material permitted by therapy procedure V 10 CPR 35300 permitted by

10 CFR 35300

Iodine-I31 Any _millicuries Administration ofI-131 sodium iodide

Byproduct material Sealed ~ource or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

-- )

Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

) ~

Byproduct material Sealed source or device milJicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CPR 35400 (Radionuclide Model No )

)_ Byproduct material Sealed source or device _millicuries Any brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35400 10 CFR 35400 (Radionuclide Model No )

)

C-5 NUREG - 1556 Vol 9 Rev 2

~ lP 1~

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

JPPENDIX C

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (Ifusing this checkist check applicable rows and fill in details and

attach copy ofchecklist to the application)

Yes Radionuclide Form or Manufacturerl Model No

Maximum Quantity

Purpose or Use

Strontiummiddot90 Sealed source or device _millicuries Treatment ofsuperficial (Manufacturer eye conditions using an applicator distributed Model No ) pursuant to 10 CFR 3274

and permitted by 10 CFR 35400

Byproduct material Sealed source or device _curies per source and Diagnostic medical use permitted by (Manufacturer _curies total ofsealed sources 10 CFR 35500 permitted by Check all that apply Model No ) 10 CFR 35500 in (j Gd-IS3 compatible devices (j 1-125 registered pursuant to (j Other describe 10 CFR 3032(g)

lridium-192 Sealed source or device _curies pr source and One source for medical (Manufacturer _curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No ____ remote afterloading brachytherapy device One source in its shipping container as ne~essary for replacement of the source in the remote afterloader device

Cobalt-60 Sealed source or device _curies pcr source and One source for medical (Manufacturer __curies total use permitted by

10 CFR 35600 in a Model No ) Manufacturer

l

Model No teletherapy unit One source in its shipping container as necessary fOl replacement of the source in the teletherapy unit

Cobalt-60 Sealed source or device _curies per source and For medical use (Manufacturer _curies total permitted by

10 CFR 35600 in a Model No ) Manufacturer

Model No stereotactic radiosurgery device Sources in the shipping container as necessary for replacement of the sources in the stereotactic

NUREG - 1556 Vol 9 Rev2 C-6

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

Table C2 Items 5 and 6 on NRC Form 313 Radioactive Material and Use (lfusing this checklist check applicable rows andfill in details and

attach copy ofchecklist to the application)

Yes RadionucUde Form or Manufacturerl Maximum Purpose of Use Model No~ Quantity

~-----+-----------------~----------------~-----~--~-------+--------------~~radiosurgery device

Any byproduct Prepackaged kits _millicuries In vitro studies material under 10 CFR 3111

------+-------------~---r----------------------~---------------~------------------~IDepleted uranium Metal _kilograms Shielding in a teletherapy

Depleted uranium

Any radionuclide in excess of30 millicuries for use in calibration transmission and reference sources (List radionuclide

)

Americjum~241

Plutonium (principal radionuclide Pumiddot238)

Metal _kilograms

Sealed source or device _millicuries (Manufacturer

Model No )

Sealed source or device _millicuries per source (Manufacturer

Model No Seale4 sources

and _millicuries total

) _miJlicuries per source and ~tota1

unit

Shielding in a linear accelerator

PorUse ina Manufacturer

Model No ~---_ for calibration and checking of licensees survey instruments

Use as an anatomical marker

As a component of Manufacturer

Model No _---~ nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturerS protocol dated __ This authorization includes follow-up explantation recovery

disposal and implantation

middot---~+-----------------r-----------------~----------------~~--------------ilOther Ponn or _millicuries Purpose ofuse ManufacturerlModel No

C~7 NUREOmiddotlSS6 Vol 9 Rev 2 ~

t~O)j

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

ITable C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andflll in details and attach a copy ofthe checklist to the application or provide information separately)

Cbeck box to indicateItem Number

Suggested Response materialand Title included in application

item 7 Radiation For an individual previously identified as an RSO on an NRC or Safety Officer Agreement State license or permit

Name Previous license number (ifissued by the NRC) or a copy ora license (if D4~Elt D issued by an Agreement State) or a copy ofa permit (ifissued by an NRC

C orA ~~ master materials licensee) on which the individual was specifically named ~~~~~~J~~ as the RSO 32 - Z 5( 3 b ~Rc

For an individual qualifying under 10 CFR 3557(a)(3)

Documentation that the individual was bull the RSO for only the medical uses ofaccelerator-produced radioactive

material or discrete sources ofRamiddot226 included in the definition of byproduct material as a result of the EPAct

bull the RSO for the medical uses of these materials before or during the effective period ofNRCs waiver of August 31 2005 f-----=-----------=---------+

For an individual qualifying under 10 CFR 3550(0)

Copy of certification by a specialty board whose certification process has CJ been recognized1o by NRC or an Agreement State under 10 CFR 3550(a)

AND ~R ~ bull _ _ _ _ _ ~ w

Description of the training and ~xperience specified in 10 CFR 3SS0(e) CJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND u _ bull _ _ bullbullbullbullbullbull __ bullbullbull bullbullbullbullbullbull_ ~

Written attestation signed by a preceptor RSO that the individual has 0 satisfactorily completed training in and experience required for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

i ANDtmiddotbullmiddot ~ ~ middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotbullmiddotmiddotmiddotmiddotmiddot bull u - ~~~_

If applicable description ofrecent related continuing education and CJ experience as required by 10 CFR 3559- ~n ~

IOUle names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwJlfcgovmaterialsmiauJmed-use-toolkithtm

C-9 NUREGmiddot 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

Table C3 Items 7 throughmiddot 11 on NRC Form 313 Training amp EXperience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or

u u u bullbullbull bullbull bull

provide information separately)

Checkbox to indicate

Item Number and Title Suggested Response material

included in application

For an individual qualifYing under 10 CFR 3550(b)

Description of the training and experience specified in 10 CPR 3SS0(b) [j demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO

AND ~ ~

Description of the training and experience specified in 10 CPR 3SS0(e) _

[j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issuell and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ ___ Written attestation signed by a preceptor RSO that the individual has [j

satisfactorily completed the required training and experience specified in 10 CPR 35S0(b) as well as the training in radiation safety regulatory issues and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

For an individual qualifYing under J0 CFR 3550(c)(1)

Copy of the certification(s)as a medical physicist by a board whose (j

certification process has been recognizedll by the NRC or an Agreement State under 10 CPR 3551(a) and description of the experience specified in 10 CPR 3550(c)(l) demonstraiing that the proposed RSO is q~lified by experience as applicable to the types ofuse for which the applicant seeks approval ofan individual to serve as RSO

AND

Description of the training and experience specified in 10 CPR 3S50(e) [j demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND~ _ bull t

~tp7 liThe names ofboard certifications that have been recognized by the NRC or an Agreement State are 2shy

posted on the NRCs Web site httpwwwnrcgovimaterialsmiaulmed-use-toQlkithtml

NUREG - 1556 Vol 9 Rev 2 C-lO

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

-------------~-----------~----~------~--~~------------_r--------_ilCheckbox to indicateItem Number

Suggested Response materialand Title included In appUeation

Written attestation signed by a preceptor RSO that the individual has satisfactorily completed the required training and experience specified for certification as well as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO

AND UU~l bullbull ~I wmiddot U u

If applicable description of recent related continuing education and LJ bull t-e_xp_er_ie_n_c_e_as_requ_i_re_d_by_l_O_C_F_R_35__59___________---+ +-F_o_7_an_in_d_iv_id_u_Q_lqu_alify~middot_ingu_n_de__1_O_C_F_R_3_5_5_0(c~(2)_____--+

Copy of the licensees license indicating that the individual is an AU LJ AMP or ANP identified on the licensees license and has experience with radiation safety aspects ofsimilar types ofuse ofbyproduct material for which the applicant seeks approval ofan individual to serve as RSO

AND u ~ bullbullbullbullbullbullbullbullu ~_ bullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbull ~

Description of the training and experience specified in 10 CFR 3550(e) LJ demonstrating that the proposed RSO is qualified by training in radiation safety regulatory issues and emergency procedures as applicable to the types ofuse for which the applicant seeks approval of an individual to serve as RSO

AND ~ - ~- bull

Written attestation signed by a preceptor RSO that the individual has LJ satisfactorily completed the requirements in 10 CFR 35S0(c)(2) as wen as training in radiation safety regulatory issues and emergency procedures for the types ofuse for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as ail RSO

AND middot ~I u u ~ bullbull~_

If applicable description ofrecent related continuing education and LJ experience as required by lO CFR 3559

C-ll NUREG - 1556 Vol 9 Rev 2

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDlXC

Table Co3 Items 7 through 11 on NRC Form 313 Training amp Experience i=acilltle~ amp Equipment Radiation Protection Program and Waste Disposal

(Check qll applicable ~ows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

Item 7 Authorized For an individual preViously identified as an AU on an NRC or Agreement Users for medical State license or permit _ uses

Name(s) (including Previous license number (ifissued by the NRC) or a copy ofth license license number (if issued by an Agreement State) or a copy of a permit issued by an NRC authorizing practice master materials licensee or a copy of a permit issued by an NRC or of medicine Agreement State broad-scope licensee or a copy of a permit issued by an podiatry or NRC Master Matetials Lictnse broad-scope permittee on which lhe dentistry if not physician dentist or podiatrist was specifically named as an AU for the provided previously uses requested or in attachment) Requested uses for each individual t--------------------------t

For an A U requesting authorizationor an additional medical use

Description of the additional training and experience to demQnstrate the (J AU is also qualified for the new medical uses requested (eg training and experience needed to meet the requirements in 10 CFR 35290 (b) 35396 35390(b)(1 )(ii)(G) or 35690(~raquo

AND

A preceptor attestation if required (eg attestation is required to meet the requirements in 10 CFR 35396 35390(b)(I)(ii)(G) or 35690(craquo

t--------~--~--~-_+

For an individual qualifying under 10 CFR 3557(b)(3)

Documentation that the physician podiatrist or dentist o bull used only accelerator-produced radioactive materials or discrete

sources of Ra-226 or both for medical uses before or during the effective period ofNRCs waiver of August 31 2005 and

bull used these materials for the same medical uses requested

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is board-certified

Copy of the certification(s) by a specialty board(s) whose certification 0 process has been recognizedl2 by the NRC under 10 CFR Part 35 Subpart 0 E F G or H as applicable to the use requested

AND u u

12The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialsmiaulmed-use-toolkithtml

NU~EG -1556 Vol 9 Rev 2 C-12

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

AFPENDIXC F=~7=~~======~====================~============~~=======~~~~=1Table C3 Items 7 through 11 on NRC Formmiddot313 Training amp Experience Facilities

amp Equipment Radiation Protection Program and WastemiddotDisposal (Check all applicable rows andfill in details and attach a copy ofthe checklist 10 the application or

provide tnormation separately)

Check box tomiddot indic=-teHem Number

Suggested Response materialand Title

included in applilati~n

For an individual with a board certification recognized under 10 CFR 35390 a description of the supervised work experience administering dosages ofradioactive drugs required in 10 CFR 3S390(b)(I)(iiXG) demonstrating that the proposed Au is qualified for the types ofadministrations for which authorization is sought _

AND

For an individual with a board certification recognized under 10 CFR 35390 for medical uses described in 10 CFR 35200 a description of the supervised work experience eluting generatorsyste11S required in 10 CPR 3S290(c)(l)(iiXG) demonstrating the proposed AU is also qualified for imaging and localization medical uses

AND

For an individual with a board certification recognized under CJ 10 CFR 35490 or 35690 seeking authorization under IOCFR 35396(d) a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations ofunsealed byproduct material requiring a written directive

AND For im individual seeking authorization under io CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690(c) demonstrating that the proposed AU is qualifiedfor the type(s) of use for which authorization is sought

AND - ~bullbullbullbull _ middotmiddotmiddotmiddot t bullbull~ ~ _

Written attestation signed by a preceptor physician AU that thetraining and experience specified for certificlltion as well as the cJi~ical casework or training and experience required by 10 CFR 35396(d) or training for 10 CFR 35600 types of use if appropriate have been satisfactorily completed and that a level ofcompetency sufficient to function independently as an AU for the medicaluses authorized has been achieved

AND

Ifapplicable description of recent related continuing education and le_xp_en_middote_D_ce_as_requ_ire_d--by=---1O_C_FR_3_S_S9___----_______L

C-13 NUREG - 1556 Vol 9 Rev 2

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

__

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experlei1ce Facilities amp Equipment Radiation Protection Program an WasteDlsposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist o the middotapplication or

l~__--________~__________p~ro_v_id_e__i~~o_nna_t_w_n_s~ep~a~_a_re_l~~~)--------------~---------1I Checkbox

Item Number and Title Suggested Response

to Indicate material

Included In application I

~-

For an individual qualifying under 10 CFR Part 35 Subparts D E F G andor H who is not board-certified

A description of the training and experience identified in 10 CFR Part 35 C1 Subparts 0 E F G and H demonstrating that the proposed AU is qualified by training and experience for the use(s) requested

AND ~

For an individual seeking authorization under 10 CFR Part 35 Subpart H CJ description of the training specified in 10 CFR 35690 (c) demonstrating that the proposed AU is qualified for the type(s) ofuse for which authorization is sought

AND Written attestation signed by a preceptor physician AU th8t the above C1 training and experience have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has beenmiddotachieved

AND

If applicable description of recent related continuing education and experience as required by 10 CFR 3559

Item 7 Authorized For an individual previously identified 01 an ANP on an NRC or Nuclear Pharmacists Agreement State license or permit

Name(s) and license Previous license number (if issued by the NRC) or a copy of the license CJ to practice (if issued by an Agreement State) or a copy of a pennit issued by an NRC phannacy master materials licensee or a copy of a pennit issued by an NRC or

Agreement State broad-scope licensee or a copy ofa permit issued by anryenAshyNRC Master Materials License broad-scope pennittee on which the individual was sp~cifically named ANp +-----------------------------------------+ For an individual qualifying under 10 CFR 3557(0)(3)

Documentation that the nuclear phannacist

bull used only accelerator-produced radioactive materials or discrete sources of Ra-226 or both in the practice of nuclear phannacy before or during the effective period ofNRCs waiver ofAugust 31 2005 and

bull used these materials for the same uses requested ----~----------------------------------------I

NUREG - 1556 Vol 9 Rev 2 C-14

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

__ __

APPENDIXC

iTable C~ Item~7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist ~o the application or provide information separately)

Checkbox

[Item Number and Title l

Suggested Response to fndicat~ material

included in application

For an individual qualifying under 10 CFR 3555(0)

Copy of the certification(s) of the specialty board whose certification (J

proCess has been recognizedll under 10 CPR 3555(8)

AND u ~bullbullbull~ t _ _ _ bull ~11 _

Written attestation signed by a preceptor ANP that training and (J

experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved

AND

Ifapplicable description of recent related continuing education and a experience as required by 10 CFR 3559 +------------------------+ For an individual qualifying under 0 CFR 3555(b)

Description ofthe training and experience specified in 10 cFR 3555(b) (J demonstrating that the proposed ANP is qualified by training and experience

AND

Written attestation signed by a preceptor ANP that the above training and CJ experience have been satisfactorily completed and that a level of competency sufficient to timcti9n independently as ail ANP has been achieved

AND

Ifapplicable description ofrecent related continuing education and (J

experience as required by 10 CFR 3559

Item 7 Authorized For an individualpreyiousy identified as anAMP on op NRC or Medical Physicists Agreement Slate license orpermit

Name(s)

Previous license number (if iSsued by the NRC) or a copy of the license CJ I (if issued by an Agreement State) or a copy ofa pennit issued by an NRC

master materials licensee Of a copy of a permit issued by ap NRC Of Agreement State broad-scope licensee or a copy ofa pennit issued by an NRC Master Materials License broad-scope pennittee on which the

Jl_middotn_dl_middotv_id_u_al_w_as_s-pe_c_ifi_ca1_Iy_n_atn_ed_Bo_AMP fi_o_f_th_e_uscs re_qu_c_st_ed___--a

13The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httplwwwnrgiWvmaterialslmiaulmed-use-t901kithtml

C-lS NUREG - 1556 Vol 9 Rev 2

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

AP~ENDlXC

TsbleC3 I~em$ 7 ~hrough 11 on NRC Form 313 Training amp experience Facilities amp Eqllipment~ Radiation Protection Program and Waste Disposal

(Check all applicabe rows andfillindetails and attach a copy ofthe checklist to the application or

middotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotmiddotr------------------=---------+

provide information separately)

Check box

Item Number and Title

Suggested Response to indicate material

included in application

shy I bull shy

For an individual qualifying under JO CFR 3557(a)(3)

Documentation that the medical physicist

bull used only acceleratof-produced radioactive material discrete sources ofRa-226 or both for medical uses before Of during the effective period of NRCs waiver of Agust 312005 and

bull used these materials for the same medical uses requested

For an individualquafifying under 0 CFR 355(a)

Copy of the certification(s) oftbe specialty ooard(s) whose certification process has been recognizedl4 under 10 CFR 3551(a)

AND ~ ~- - -- - - ~

Description of the training and experience specified in 10 CPR 3551(c) o demonstratil18 that the propOsed AMp is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on qevice op~atiorr safety procedures clinical use and operation ofa treatment planning system

AND ___ __ Written attestation signed by a prec~tor AMP that the required training o and experience requir~d for certification as well as the training and

experience specifie~ in 10 CPR 3551(c) have been satisfactorily completed and that a level ofcompetency sufficient to function

independently as an AMP has been achieved

AND

If applicable description ofrecent related 90ntinuing education and experience as required by 10 CPR 3559 ~ ~

For an individlal qualifying under 10 CFR 3551(b)

Description of the training and experience demonstrating that the proposed o AMP is qualified by training and experience identified in 10 CFR 3551(b)(l) for the uses requested

AND

1

14The names ofboard certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site httpwwwnrcgovmaterialslmiaulmed-use-toolkithtml

NUREG- 1556~Vol 9 Rlv 2

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APmiddotPENDIXC

Table C3middot Items7through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Checkmiddotall applicable rowsandfill in details and attach a copy ofthe checklisllO the applicationor provide information separately)

Checkbox to indicate

Item Number Suggested Response materialand Title

included jn apppcatio~

-----------~------------------------------------------_+--~----_ilDescription of the trainingmiddotand experience specified in 10 CFRmiddot3SS1(c) CJ demonstrating that the proposed AMP is qualified by training in the types ofuse for which he or she is requesting AMP status including hands-on device operation safety procedures clinical use and operation ofa treatment planning system

AND ~ ~ _

Written attestation signed by a preceptor AMP that the required training CJ and experience have been satisfactorily completed and that a level of comp~tency sufficient to function independently as an AMP has been achieved

AND ltI bullbull J bullbullbullbullbullbull bullbullbullbull bullbullbull bullbulln _ bull bullbullbullbullbullbullbullbull J bullbullbullbullbullbullbullbull

If applicable description of recent related continuing education and CJ experience as required by 10 CPR 3559

Item 7 Authorized Note For purposes of this section of the table the term authorized user User for nonmedical is used to mean individuals authorized for the nonmedical uses described uses See Sections 811 and 812

For an individual previously authorizedor nonmedical use on an NRC or Agreement State license or permit

Name(s) Previous license number (if issued by the NRC) or a copy of the license CJ (if issued by an Agreement State) or acopy ofa pennit issued by an NRCRequested types master materials licensee or a copy ofa permit issued by an NRC or quantities and Agreement State broad-scope licensee or a copy ofa permit issued by annonmedical usesmiddotfor NRC Master Materials License broad-scope permittee on which theclach individual individual was specifically named an AU for the types quantities and uses requested - ~1-------------------------f-- shy Por individuals qualifYing under 10 CPR 3033(0)(3)

Documentation of the individuals training and experience demonstrating CJ that the individual is qualified to use the types and quantities of licensed materials for the requested uses

Item 9 Facility A diagram is enclosed that describes the facilIties and identifies activities Diagram conducted in all contiguous areas surrounding the area(s) of use The

following information is included middot~middotmiddotQid~~i~middotsti~middots2middotmiddoti~dmiddotdmiddot~~i~dmiddot~i~middot ii7

information provided is marked accordingly

bull Drawings should be to scale indicating the scale used [It ~ ut bull__n

NUREO 1556 Vol 9 Rev 2

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

Table C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows andfill in details and attach a copy ofthe checklist to the application or provide information separately)

Check box to indicate

Item Number Suggested Response material

and Title included in application

bull Location room numbers and principal use ofeach room or area where ampf byproduct material is prepared used or stored location ofdirect transfer delivery tubes from a PET radionuclidelradioactive drug production facility or production area ofPET radioactive drugs under 10 CFR 30320) and areas where higher energy gamma- emitting radionuclides (eg PET radionuclides) are used

bull Location room numbers and principal use ofeach adjacent room rr (eg office file toilet closet hallway) including areas above beside and below therapy treatment rooms indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 201003 and

bull Provide shielding calculations and include information about the type o thickness and density of any necessary shielding to enable independent verification ofshielding calculations including a description ofany portable shields used (eg shielding ofproposed patient rooms used for implant therapy including the dimensions of any portable shield if one is used source storage safe)

In addition to the above for teletherapy and GSR facilities applicants a should provide the directions ofprimary beam usage for teletherapy units and in the case of an isocentric unit the plane ofbeam rotation

Item 9 Radiation A statement that Radiation monitoring instruments will be calibrated by Monitoring a person qualified to perform survey meter calibrations Instruments

ANDOR

A statement that We have developed and will implement and maintain 0 written survey meter calibration procedures in accordance with the requirements in 1 0 CFR 201501 and that meet the requirements of 10 CFR 3561

AND U ~ R n ~ bull

A description of the instrumentation (eg gamma counter solid state detector portable or stationary count rate meter portable or stationary dose rate or exposure rate meter single or multichannel analyzer liquid scintillation counter proportional counter) that will be used to perform required surveys

AND Amiddot~~~~~middot~middotmiddotmiddotmiddotwmiddot~middotilimiddotri~hmiddot~~middot~~d~middot~~middot~~~middotmiddoti~~middot~middot 7 as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose A statement that Equipment used to measure dosages will be calibrated Calibrator and Other in accordance with nationally recognized standards or the manufacturers Dosage Measuring instructions Equipment It~u a ~ u bullbullbullbull _ _ t~

NUREG - 1556 Vol 9 Rev 2 C-18

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

-able C3 Items 7 through 11 on NRC Form 313 Training amp Experience Facilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide information separately)

Checkbox to indicate

Ite~ Number Suggested Response material

lln~ Title included in appUeatfon

-----------~~-----------------------------------------+--~----~IWhen administering dosages of alpba-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 3272 or 10 CFR 30320)

bull A statement that Dosages will be determined by relying on the Cl provi~ers dose label for measurement of the radioactivity and a combination ofvolumetric measurement and mathematical calculation

OR _______-_ -middotmiddotmiddotmiddot~-middotmiddotmiddot~~~i~i=5=~~=imiddotmiddot-middotmiddotmiddotmiddot-middotmiddot middot_middotmiddot--middot-0middotmiddotmiddotmiddotmiddotmiddotmiddot_shy

I manufacturers calibration instructions) and dosage measurement procedures

Item 9 Therapy We are providing the procedures rcquired by 10 CFR 35642 CJ Unit - Cali~ation 10 CFR 35643 and 10 CFR 35645 ifapplicable to the license land Use tvftr application

tern 9 Other Guidance in Section 52 was reviewed and security-related information rf Equipment and provided is marked accordingly Facilities middotA~hdmiddotimiddotmiddotd~~riti~~middotmiddotidtifi~middotmiddotA~~~94~fmiddot~di~imiddotmiddot 7HO

facilities and equipment bullbullbullbullbullbullbullbull u _ bull _ _ bull

For manual brachytherapy facilities we are providing a description of the Cl emergency response equipment middotF~middotPETmiddot~d~~~~iidmiddot~middotPETmiddotdi~~~ti~middot~~~~ti~middotd 57 radiopharmaceutical therapy programs we are providing a description of the additional facilities and equipment for these uses

~ u _ _ _ bull ~ u ~

For teletherapy GSR and remote afterloader facilities we are providing a description of the following

bull Warning systems and restricted area controls (eg locks signs o warning lights and alarms interlock systems) for each therapymiddot treatment room

bull Area radiation monitoring equipment CJ

bull Viewing and intercom systems (except for LDR units) o bull Steps that will be taken to ensure that no two units can be operated Cl

simultaneously ifother radiation-producirig equipment (eg linear accelerator X-ray machine) is in the treatment room

bull Methods to ensure that whenever the device is not in use or is o unattended the console keys will be inaccessible to unauthorized persons and

L_______ ---_----I-~~____ middot middot Emergency response equipmentIC-19 NUREG - 15$6 Vol 9 Rev 2~bullbullZo

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXt

iTabHfC3middot Items 7 through 11 on NRC Form 313 Training amp Experience FacUlties amp Equipment Radiation Protection Program and Waste Disposal

(Check all applicable rows and fill in details and attach a copy ofthe checklist to the application or provide info~tion separately)

Check box

Item Number and Tit)emiddot ~

Suggested Response to Indicate material

included in appllcatlon

Item 10 Safety Attached are procedures required by 10 CFR~O o Procedures and

~~~~~~~ffi~ m _ bull bullbullbullbullbullbullbullbullbullHO

Guidance in Section 52 was reviewed and security-reiated sensitive 0 infortnlltion provided is marked accordingly

Item 10 A statement that Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive in 1

year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements

IIsted under Criteria in NUREG~lSS6 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

OR bullbull _ ~~ l _ u bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull n bullbullbull

A description ofan alternative method for demonstrating compliance with o the referenced regulations

Item 10 Area A statement that We have developed and wiIl implement and maintain Surveys written procedures for area surveys in accordance with 10 CFR 201101

that meet the requirements of 10 CFR 201501 and 10 CFR 3510

Item 10 Safe Use A statement that We have developed and will implement and maintain of Unsealed procedures for safe use ofunsealed byproduct material that meet the Licensed Material requirements of 10 CFR 201101 and 10 CFR 201301

]tern 10 A statement that We have developed and will implement and maintain ~ SpillContamination written procedures for safe response to spills of licensed material in Procedures accordance with 10 CFR 201101

Item 10 Name of the proposed employee and types ofactivities requested o Installation Maintenance Adjustment Repair AND

Inspection of Description ofthe training and experience demonstrating that the proposed 0 erapy Devices employee is qualified by training and experience for the use requestedContaining Sealed Sources AND

Copy of the manufacturers training certification and an outline of the o training in procedures to be followed

Item 10 Aresponse is not required Wlder the following oondition the NRC will NA Minimization of consider that the above criteria have been met if the information provided Contamination in applicants responses satisfy the criteria in Sections 815816821

825 827 and 829 on the topics facilities and equipment facility diagram Radiation Protection Program safety program and waste management

NUREG - 1556 Vol 9 Rev 2 C-20

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

APPENDIXC

rable C~ Items 7 through 11 on NRC Form313 Training amp Experience Fscilities amp Equipment Radiation Protection Program and Waste Disposal

(Check all qpplicable rows andfill in details and attach a copy ofthe checklist to theapplication or provide information separately)

Cbeekbox to indicate

Item Number Suggested Response material

and Title included in application

Item 11 Waste A statement that We have developed and will implement and maintain LV Management written waste disposal procedures for licensed material in accordance with

10 CFR 201 0 I that also meet the requirements of the applicable section of 10 CFR Part 20 Subpart K and of 10 CFR 3592 bull _ bullbullbullbullbullbullbullbullbullbullbullbullbull_iO bullbullbull_u u -~

Attached is a deSCription of the radioactive waste incinerator facility and 0 related portions of the Radiation Safety Program (10 CFR 202004) ~ ~- ~ _ _ 9 bullbullbullbullbullbull~ _ _ ~_ ~ -~ ~

Attached is arequest to receive potentially ~ontaminated radiation CJ transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 3032(i) authorization

C-2i NUREG - 1556 VoL 9 Rev 2 2 _20 V

J P

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Federal Medical Center (FMC) NRC 32-25613-01 Renewal Application

The information and attached documents relating to this License Renewal Application (NRC 32-25613-01) do not include or contain security-related sensitive information The Federal Medical Center (FMC) is part of a Federal Bureau of Prisons Facility that maintains high security at all times with no access to members of the general public

Item 7 Radiation Safety Officer

The Radiation Safety Officer is Daniel D Sprau DrPH Previously listed on this license - NRC 32-25613-01 and North Carolina Radioactive Material Licenseshy074-296-03

Item 7 Authorized Users for Medical Use

For Authorized Users all of the physicians listed on the current license will remain same with the exceptions of Drs Thompson Wiener and Coughlin who have been removed All Materials and Use designations will remain the same

Donn Kirk Beeson MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Samuel Bone III MD 35100 35200

Christopher M Cepeda MD 35100 35200

Andrew Choi MD 35100 35200

Randy Cruell MD 35100 35200 Oral administration of sodium Iodide 1-131 ~33 millicuries

Daniel O Cuscela DO 35300

Hector Hidalgo MD 35100 35200

James W Lester Jr MD 35100 35200

Ashley Grant Merritt MD 35100 35200

Hemang Pathak MD 35100 35200

Hal Safrit MD 35100 35200

NRC 32-25613-01 Renewal 1

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Item 9 Facili

Notes

Fume Hoo L Shape Lead Brick

bull Lead Safe Radioactiv Counter s

iagram (General Nuclear Medicine Room and Hot Lab

i ding Corridor and Ultrasound surround Hot Lab i ding Corridor and CT Room surround General Area

o above and below (unoccupied areas)

d Prep Area in Hot Lab rage Area for Unit Doses

r heckCalibration Sources M terial brought to Hot Lab by Nuclear Medicine Technologists

are stainless steel and floors seamless vinyl

f nstruments ) Model 14C GM End Window Survey Meter SN139666

vision) Model 451P Internal Ion Chamber Survey Meter SN6061 Advanced Survey Meter (ASM) External Nal Detector SN379 BioMed Model 451 Internal Ion Chamber Survey Meter SN3294 e Calibrator Nal Chamber SN1440051 Display SN1443004

Well Counter Nal SN900212

NRC 32-25613-01 Renewal 2

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Notes Record Storage Equ pI ent Storage Corridor and Control Room surrou PET Scan Room Concrete Floors abo~~ nd below (unoccupied areas) Former Cardiac Cath L ~~ ~~ Quiet Room adjace t ~ross corriqor Counter surfaces are iSt inless steel and floors seamless vinyl

Description of instrulTle ~ available Ludlum (BIODEX) Mcd 14C GMEnd Window Survey Meter SN1396~

Victoreen (Innovision ~Pdirmli54ll6iflterffi v~ftiiWI4tyenM8er~lsectooI======~ yfl=tv~I1~~YHnm

Isotopes used I F-18 Fluorine

Do

D r

nn

NRC 32-25613-01 Renewal 3

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Item 9 Radiation Monitoring Instruments

All Radiation monitoring instruments will be calibrated by a person qualified to perform survey meter calibrations

Description of all Survey Instruments

1 Ludlum (BIODEX) Model 14C GM End Window Survey Meter SN139666

2 Victoreen (Innovision) Model 451 P Internal Ion Chamber Survey Meter SN6061

3 Fluke Victoreen Advanced Survey Meter (ASM) External Nal Detector SN379

4 Victoreen Fluke BioMed Model 451 Internal Ion Chamber Survey Meter SN3294

5 Fluke Model4S1 Internal Ion Chamber Survey Meter SN1825

6 Bicron Surveyor 2000 - SNC381G 7 Atomlab 200 Dose Calibrator Nal Chamber SN1440051 Display

SN1443004 8 CAPTUS 3000 Well Counter Nal SN900212

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used

Item 9 Dose Calibrator and Other Dosage Measuring Equipment

Dose Calibrator equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions

NRC 32-25613-01 Renewal 4

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

=l i Il

Item 9 I ~eqUlpment and Facilities (1-131 Therapy ~~nll~ent Room)_J I 11 Notesmiddot ~+-=- j

Non-occupied areas surround 1-131 Treatment Room i I I Concrete Floors above and below (unoccupied areas) j

lodine-131 Safety and Sanitation Procedures Attached I I Counter surfaces are stainless steel and floors seamless vinyl I i o middotption of instruments j I FI ke Model 451 Intemallon Chamber Survey Meter SN1825 I I Bi ro Surveyor 2000 - SNC381 G I Is to es-~d~-==n _J 10 in-131 I) I 1-----------------1

I IL________~

n

NRC 32-25613-01 Renewal 5

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Item 10 Occupational Dose

Either we will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive in one (1) year a radiation dose in excess of 10 of the allowable limits in 10CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556 Vol 9 Rev 1 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses

Item 10 Area Surveys

We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 201101 that meet the requirements of 10 CFR 201101 and 1 OCFR 201301

Item 10 Safe Use ofUnsealed Licensed Material

We have developed and will implement and maintain written procedures for the safe use of unsealed byproduct material that meet the requirements of 10 CFR 201101 and 10CFR201301

Item 10 SpillContamination Procedures

We have developed and will implement and maintain written procedures for the safe response to spills of licensed material in accordance with 10 CFR 201101

Item 11 Waste Management

We have developed and will implement and maintain written disposal procedures for licensed material in accordance with 10 CFR 201101 that also meet the requirements of the applicable sections of 10CFR Part 20 Subpart K and of 10CFR 3592

NRC 32-25613-01 Renewal 6

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

FEDERAL CORRECTIONAL COMPLEX POLICY AND PROCEDURE BUITNERNC SAFETY MANAGEMENT POLICY

EFFECTIVE DATE July 1 2011 SUBJECT Iodinemiddot 131 Safety and Sanitation Procedules

I POLICY

It is the policy of the Federal Correctional Complex (FCC) to use radioactive materials in the safest possible manner

II PROCEDURES

A Introduction

Radiation is energy that travels in the form of waves or particles When WE~ hear the word Aradiation we generally think of nuclear power plants nuclear weapons or radiation treatments for cancer We would also be correct to add Amicrowaves radar electrical power lines cellular phones and sunshine to the list There are many different types of radiation that have a range of energy forming an electromagnetic spectrum When we hear the words radiation exposure we generally think of radiation from a source beaming out and striking the exterior of a body However radioactive particles can also become lodged inside the body and expose internal organs as the radionuclides decay As a result health physicists consider not only the type of radiation emitted from a source but also the routes by which people are likely to come in contact with it There are three main routes of exposure or exposure pathways

Inhalation Exposure by the inhalation pathway occurs when people breathe radioactive materials into the lungs The chief concerns are radioactively contaminated dust smoke or gaseous radionuclides such as radon Radioactive particles can lodge in the lungs and remain for a long time As long as it remains and continues to decay the exposure continues For radionuclides that decay slowly the exposure continues over a very long time Inhalation is of most concern for radionuclides that are alpha or beta particle emitters Alpha and beta particles can transfer large amounts of energy to surrounding tissue damaging DNA or other cellular material This damage can eventually lead to cancer or other diseases and mutations

Ingestion Exposure by the ingestion pathway occurs when someone swallows radioactive materials Alpha and beta emitting radionuclides are of most concern for ingested radioactive materials They release large amounts of energy directly to tissue causing DNA and other cell damage Ingested radio nuclides can expose the entire digestive system Some radionuclides can also be absorbed and expose the kidneys and other organs as well as the bones Radionuclides that are eliminated by the body fairly quickly are of limited concern These radionuclides have a short

1

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

biological half-life

Humans living in an environment that is naturally radioactive are exposed to low levels of ionizing radiation every day The sources of this natural radiation include cosmic rays from the sun and even the earth itself Man also receives exposures from manufactured sources of ionizing and non-ionizing radiation such as medical x-rays fallout from nuclear weapons testing and radio frequency and microwave radiation Since each of us is already being irradiated by these means it is then generally difficult to detect any additional detrimental effects that may occur due to any occupational radiation exposures

Although the amount of risk associated with low-level ionizing radiation exposures is a subject of great debate certain fundamental conclusions can be drawn from the data collected

Low level background radiation has been a part of mans environment since the beginning of time Any man-made radiation exposure merely adds to that already being received

The average individual in the United States receives approximately 200 millirem of radiation exposure per year from a variety of sources collectively referred to as background radiation

B Definitions

BACKGROUND RADIATION Ionizing radiation arising from radioactive material other than the one directly under consideration Background radiation due to cosmic rays and natural radioactivity is always present There may also be background radiation due to the presence of radioactive substances in other parts of the building in the building material itself etc

HALF-LIFE RADIOACTIVE Time required for a radioactive substance to lose 50 percent of its activity by decay Each radionuclide has a unique half-life

HALF-LIFE EFFECTIVE Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination

Effective half-life=Bioloqical half-life Radioactive half-life Biological half-life + Radioactive half-life

HIGH RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 100 millirems High Radiation Areas must be posted and must be equipped with specified control devices alarms etc

IONIZING RADIATION Any electromagnetic or particulate radiation capable of producing ions directly or indirectly in its passage through matter

ISOTOPES Nuclides having the same number of protons in their nuclei and hence

2

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

having the same atomic number but differing in the number of neutrons and therefore in the mass number Almost identical chemical properties exist between isotopes of a particular element

OCCUPATIONAL DOSE The dose received by an individual in a restricted area or in the course of employment the individuals assigned duties involved exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation whether in the possession of the licensee or other person Occupational dose does not include dose received from background radiation as a patient from medical practices from voluntary partiCipation in medical research programs or as a member of the general public

RADIATION AREA Any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in anyone hour a dose in excess of 5 millirem or in any 5 consecutive days a dose in excess of 100 millirems

SEALED SOURCE Radioactive material permanently enclosed inside a capsule or other holder such that there is no contact between the radioactive material and the open air Sealed sources must he tested for leakage at intervals specified in the NRC license

WASTE RADIOACTIVE Solid liquid and gaseous materials from nuclear operations that are radioactive or become radioactive and there is no further use Wastes are generally classified as high level (having radioactivity concentrations of hundreds of thousands of curies per gallon or cubic foot) low or intermediate (between these extremes)

C Iodine Therapy -131

Prenatal Radiation Exposure

The federal regulations state The licensee or registrant shall ensure that the dose to an embryofetus during the entire pregnancy due to occupational exposure of a declared pregnant woman does not exceed 05 rem (500 millirem) Escort and unit staff will be made aware of the potential for radiation exposure Declared pregnant women will not be authorized to escort the patient for treatment Pregnant or possibly pregnant staff shall not be involved with the patients care A ARadiation Area sign will be posted on the patient room door when the patient is secured inside

Dose Administration and Initial Survey

1 Prior to the dose administration talk with the patient to determine if there

3

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

are any special circumstances to explain the use of the three different waste boxes and to explain the daily survey Refer any unusual circumstances to the Radiation Safety Officer Obtain consent

2 Nuclear Medicine personnel should dress in protective clothing (gown gloves and shoe covers) to dose the patient Other personnel present during the administration should also dress out the observation can be done from the doorway if the Nuclear Medicine Technologist positions the cart at the foot of the bed A thyroid bioassay should be performed on the technologist administering the dose and any other personnel in the room at the time the patient is dosed Every attempt should be made to perform the bioassay approximately 24 hours after the patient is dosed but no later than 72 hours

3 The technologist and any other personnel participating in the dose administration should be surveyed before exiting the patient room Equipment used to dose the patient should be confined to the cart and the cart should be covered with an absorbent pad

4 Exposure rate measurements are performed at 1 meter using an ion chamber The initial measurement is made at the level of the umbilicus Subsequent measurements are made at the level of the thyroid

5 Remove protective garments when exiting the room in the following order Outer gloves Gown First shoe cover stepping with clean shoe onto step-off pad Second shoe cover stepping with clean shoe onto step-off pad Inner gloves Contaminated protective clothing is discarded in the waste box for disposable items

6 Finish the radiological survey in the clean area Note these measurements in the patient=s chart

7 Use the following equation for measurements

Da X 30 mCi = Dr MCi where

8 Da=Dose rate at 1 meter at administration of 1-131 in mRemshr MCi=Quantity of 1-131 administered Dr=Dose rate at 1 meter at time of release 5 30 mCi

9 Complete the survey form sketch the room make notes and enter

4

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

measurements

Patient Chart

bull Place radioactive warning tape on the spine and the front cover of the chart

bull Complete a Radiation Isolation Sign and place it at the front of the chart

Patient Room Preparation

bull The patients room will be prepared prior to treatment to help prevent contamination of the room and surrounding areas This will also facilitate the decontamination of the room after the patients discharge

bull All unnecessary furniture will be removed Any remaining furniture will be covered in plastic

bull As much of the floor as possible will be covered in absorbent paper to prevent the contamination of the floor tiles This paper will be collected and held for ten half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first befon disposal as regular trash

bull The nurse call switch will also be covered in plastic All wall switches sink handles doorknob and any other items that the patient might touch will be covered in plastic

bull The toilet seat fasteners will be loosened to facilitate removal during decontamination

bull Two radioactive waste containers will be provided One will be for disposable items and the other for reusable materials

bull No waste shall be removed from the room by unauthorized personnel All disposable materials should be placed into the appropriate container

bull A containment area with step off pads will be established at the entrance to the room

bull Isolation techniques will be carried out during the patient=s treatment by the nursing staff and any personnel that enter the room Dietary and housekeeping staff will not be permitted in the room until the room hias been decontaminated and cleared for other patients

5

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

bull The outside of the room door should be posted with a Radiation sign

bull Set up a step-off pad at the door using two absorbent pads All edges should be taped securely to the floor to reduce the risk of tripping

bull Place two pieces of tape on the floor marking one meter this will ensure a consistent exposure rate measurement from day to day

bull Only disposable dietary trays shall be delivered to the patient No reusable trays shall be taken into the room

For patients receiving a dose of 30 mCi or more

bull An isolation cart with disposable gowns gloves masks and booties will be positioned outside the room

bull Signs will be placed on the door requiring the use of Personal Protective Equipment (PPE) when entering the room

Patient Instruction

The patient should be given instruction for waste disposal instructed to drink plenty of fluids and instructed to shower and change hisher gown and linen before the daily survey The RadiologistNuclear Medicine Technologist should explain to the patient the benefits of contamination control The patient should understand that they are not to have visitors The RSO andor his designee should be notified of any unusual circumstances or patient requests Every attempt should be made to answer patient questions concerning radiation safety

Dailv Patient Survey

The patient is to be surveyed on a daily basis measurements are made at 1 meter The I meter exposure rate should be entered in the chart and on the door

Patient Room Procedures

Patients placed on isolation for (1-131) treatment will not be allowed to have personal items commissary or use the phone unless approved by the Radiation Safety Officer and the Correctional Services Supervisor

Patients will not be allowed to leave the room or have visitors until approved by the Radiation Safety Officer and the Correctional Services Supervisor The normal stay for (1-131) treatment is 48 to 96 hours

Staff entering a room requiring PPE must put on protective equipment prior to entering

6

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

the room

Remove garments when exiting the room in the following order

A Outer gloves B Gown C First shoe cover B stepping with clean shoe onto step-off pad D Second shoe cover B stepping with clean shoe onto step-off pad E Inner gloves F Place contaminated PPE in the waste bin located inside the room

Staff will limit time spent with the patient External irradiation may be reduced by contrOlling the distance and time spent close to the patients who have received therapeutic doses For additional information see Appendix Band C

Patient Room Decontamination

bull The patients room will be surveyed and decontaminated before being released for use with other patients This task will be completed under the direction of the Radiation Safety Officer

bull All disposable trash including the plastic and paper coverings will be removed and held for decay for 10 half-lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever i~i first and then disposed of as regular trash

bull All non-disposable items that cannot be decontaminated will be held for 10 half -lives (1-131) or until the level of radiation is indistinguishable from background radiation whichever is first before being returned to the hospital The telephone if authorized and toilet seat are items that are normally held

bull The patients clothes will be double bagged using the same procedures for infectious clothing and sent to the laundry The patient will be provided with a new set of institution clothing The patient will be escorted out of the Unit by a member of the radiation safety staff

bull The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe The exceptions are the sink bathroom floor tiles and inside the toilet where the target activity is 500 counts per minute

bull The decontamination process will be completed by the Radiation Safety Officer or other qualified member of the Radiology or Safety department

7

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

bull After the decontamination is completed the nursing and custody staff will be notified that the room has been cleared for further use

Patient Release

Listed below are the guidelines for the release of patients who are in isolation for (1-131) treatment

A The patient will be surveyed immediately after ingestion of the dose of radioiodine The patient shall be surveyed at a point equal to the length of their outstretched anTIS (arms in front of body with fingers extended) The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to 30 millicuries or less of (1-131) remaining in the patient

or

B The patient will be surveyed for release by measuring the dose rate at 1 meter The highest exposure rate at this distance shall be recorded The patient will not be released until the exposure rate has decreased to a rate that corresponds to (007 mSvhr) or (7 mremhr) The licensee must maintain a record as required by 10 CFR 3575(c) because the measurement includes shielding by tissue

Release will be approved by the Radiation Safety Officer (RSO) andor his designee

Radioactive Waste Radioactive waste will be collected by the Radiation Safety Officer or qualified member of the Radiology or Safety department

Radioactive Spills

Notify the Radiation Safety Officer and the Safety department in the event of a spill

Escort Procedures

Listed below are escort procedures for inmates who receive radioiodine therapy at an outside facility and return to the medical center

bull The patient contains unusual radiation levels only on the return trip from the hospital where the (1-131) is administered

bull Contact with the patient should be minimal until the body level of radioiodine drops below 30 millicuries Usually the high radiation levels last about 48 hours

8

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

bull Transporting officers should maintain necessary distance to the patient to provide required security precautions based on the patient=s custody level See Appendix A

bull Staff should wear disposable gloves during the return trip

bull The patient should be placed in the rear seat of the secure van when returning from treatment at the outside hospital

bull The patient should be moved directly from the secure van to the designated isolation room after returning to FMC Butner Transporting officers should be relieved at the Control Center by institution staff to limit the time escort staff are with the patient Institution movement by staff and inmates should be secured prior to transporting to the designated isolation room

bull Restraints used during transport procedures must be surveyed by a qualified member of the Radiology or Safety department (usually the Nuclear Medicine Technician) before they are returned to the Control Center The target activity level for decontamination is 100 counts per minute above background with a G-M survey meter with a pancake probe Restraints that cannot be decontaminated will be held for 10 half-lives

(1-131) or until the activity level is 100cpm above background whichever is first Escort officers will notify a member of the Radiology or Safety department (usually the Nuclear Medicine Technician) which secure van was used for patient transport It will be surveyed before being released for further use

bull Patients will be placed in the designated hospital room upon returning from (1-131) treatment The patient room or rooms adjacent to the designated isolation room must be unoccupied

9

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

Appendix A

Principles of Protection

Skin contamination ingestion or inhalation of radioactive material can be avoided by practicing good housekeeping clean work habits and frequent hand washing

Radioactive materials should not be allowed to come in contact with the skin Gloves should be worn whenever such contact is possible

Personnel should not smoke or eat when there is any possibility that the hands are contaminated

External irradiation may be reduced by controlling the distance and time spent close to the patients who have received therapeutic doses

Appropriate instructions will be posted on the patients door

Appendix B

NursingCustodial Care of Patients with Radioactive Material

Although the following guidelines are directed toward the care of Radioiodine Therapy patients the procedures apply to all patients containing unsealed radioactive materials

Time spent close to patients should be regulated If the hazard potential is high the Radiation Safety Officer or physician in charge will issue special instructions

Hands should be washed after contact with the patient particular attention being given to the fingernails

Disposable items that are contaminated should be put in the radioactive waste containers provided by Radiation Safety

Articles or utensils suspected of being contaminated should be monitored prior to final disposition

No special precautions are necessary for dishes instruments or utensils unless

10

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

contact with any body fluid has occurred

Instructions are provided for all hospital personnel who may come in contact with patients who have received diagnostic or therapeutic doses of radioisotopes

Appendix C

General Nursing Care

Equipment

A laundry bag should be provided to collect linen where there is danger of contamination by vomiting incontinence profuse perspiration or any contact with any other body fluids

Items such as bedpans urinals and basins should be thoroughly washed with soap and running water The same items should be used for an individual patient until his treatment terminates

Heavy rubber gloves should be used while cleaning possibly contaminated equipment These gloves should be washed while on the hands with soap and water and dried before removal

8ath

Unless specifically ordered by the physician staff should not give the patient a bath for the first 48 hours Patients who are physically capable are encouraged to shower or bathe

Excretions

Gloves should be worn whenever handling excreta of patients or contaminated material such as soiled bedding

Stools

Usually there is very little radioactivity in stools Stools may be disposed of in the usual way unless collection is specifically requested

Sputum Vomitus and Perspiration

11

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

If the radioactive isotope has been administered by mouth any vomitus expelled during the first 24 hours should be collected in a waterproof container For 1-131 therapy patients excessive sputum should be collected in a similar manner for the first 24 hours For intravenous administration no precautions are necessary except with 1-131 during the first 24 hours If there is excessive perspiration the bed sheets should be monitored for contamination

Soiled Tissues and Sponges

All such soiled material should be placed in a nonporous plastic bag attached to the patients bed and later reported to the Radiation Safety Officer

Urine

Accurate urine collections are sometime desired by the laboratory or physician in charge Great care should be taken not to lose any part of the specimen In the case of iodine therapy the urine collection bottles will be provided by Nuclear Medicine The patient should be encouraged to take care of his own urine collection if possible until collected by Nuclear Medicine If the urine is not to be collected it may be disposed of in the usual way upon approval of the Radiation Safety Officer If there is a large spill of urine with an (1-131) patient notify the Radiation Safety Officer Safety Department or Nuclear Medicine immediately

Appendix D

Emergencies

Emergencies involving radiation should be treated as any other emergency with respect to bodily injuries fires and explosions Any radiation exposures and contamination will be addressed after the physical hazards are contained DO NOT PANIC - when properly handled almost any accident or emergency occurring at FMC Butner involving radiation will add little or no immediate danger to the situation

bull Request assistance

bull Give life-saving assistance regardless of the radiological condition of the patient

bull Contain and monitor the emergency in order to prevent the spread of contamination and the possibility of exposure

12

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

bull Notify the Radiation Safety Officer and the Safety department immediately

13

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader

------------------pound---_---_ and to inform you that the initial processing which

includ~n~~strtvr~iw~rj~lmed [lJ There were no administrative omissions Your ~Plication was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

D Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number 55r DO~G When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RI) Sincerely (6middot96) licensing Assistance Team Leader