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p o.sg) U.S. NUCLE AR REGULATORY COMMISSION .Amendment No. 13 y

! MATERIALS LICENSE g l'

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] >|[ Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, i

3 Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35, 39,40 and 70, and in reliance on statements and representations heretoforej 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 f.1 to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions

speciGed 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'N Regulatory Commission now or hereafter in effect and to any conditions specined below.

, |bLY | ,,

.i Licensee

j In accordance with application datedFebruary 23 1994 ;

.

1. Westview Osteopathic 3. Ucense number ,13-18543-01 is renewed injj Medical Hospital its entirety to read as follows: ! '

:f . 3630 Guion Road'

|

1 2Ji Indianapolis, IN 46222 4. Expiration date December 31, 1999 _

i

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i5. Docket or1

!j'. Reference No 030-13850l 6. Byproduct, source. and/or s) 7. Chemical and/or physical 8. Maximum amount that licensee3 special nuclear material e ..may possess at any one timeform %

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_' ,A. Any radiopharmaceutical A N As neededj A. Any byproduct W r-

1 material identifNd ' ' sidentified in 10;CFR'-

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j in 10 CFR 35.100 % g35.100 [fp >,

1 B. Any byproduct <f" B.i Any radiopharmaceutical B. =dsneeded |

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3 materialidentif,ijd n h(identified in 10!CFR ' , 7 '

g; , M35'.200 (exclu"diiig'j in 10 CFR 35.20d ,'

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f(.b 9 generators);,.*: '

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j C. Prepackage"diKits ~ LC. Any byproduct . , C. 200 microcuries= material identified, E' '' I |

@ in 10 CFR 31.11~

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jl#9. Authorized Use:

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i i,g.g A. Medica'l use described in 10 CFR'35.100, i

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8. Medical use described in 10 CFR 35.200 (excluding generators). | |

| C. In vitro studies,

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1 CONDITIONS II,

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10. Location of Use: 3630 Guion Road, Indianapolis, Indiana.

| |11. Radiation Safety Officer: David C. Williams, D.0. j, o$ 9412270147 941213 1 l '

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| MATERIALS LICENSE 13.-18513-01 ('

*" "'*"#* *4 SUPPLEMENTARY SHEET >1 03D-13850 yi ki Amendment No. 13 Eq tI > ,

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i >I Ri 12. Authorized Users: Fi L

| A. David C. Williams, D.0., for material in 10 CFR 35.100, 35.200 (y (excluding generators) and 31.11. p1 P1 B. Thomas N. Murphy, M.D., for material in 10 CFR 35.100, 35.200 gI (excluding generators) and 31.11. II e ,

f 13. This license is based on the licensee's statements and representations listed below: [!

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.

'! A. Application dated February 23, 1994 with attachments',(excluding items 8, 9.4 g,

I and attachment 10 4). (,) t'

'

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I 8 B. Application dated N'ovember 18, 1988, only items-8,T(training), 9.4 (personnel I '

! monitoring) and'10.4-A'( QGeneral Rules for safetuse of ridioactive material).Il

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I i! FOR THE U.S. NUCLEAR REGULATORY COMMISSION | )i ,

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gy a /42 b. M !Date DEC 131994q Materials Licensing Section, Region III |< ii I-s ,m -

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3 (FOR LFMS USE)O : INFORMATION FROM LTSBETWEEN I --------------------

1

LICENSE FEE MANAGEMENT BRANCH. ARM PROGRAM CODE 021200 AND STATUS CODE 2REGIONAL LICENSING SECTIONS FEE CATECORY: 7C

EXP. DATE: 19940331: FEE COMMENTS:O I DECOM FIN ASSUR REEDT R------------3 ::::::::::::::::::::::::::::::::::::

LICENSE FEE TRANSMITTALO

A. REGION

1. APPLICATION ATTACHEDO APPLICANT / LICENSEE: WESTVIEW OSTEOPATHIC MEDICAL

RECEIVED DATE: 940228DOCKET NO: 3013850CONTROL NO. 396528O LICENSE NO. 13-18543-01ACTION TYPE: RENEWAL

2. FEE ATTACHEDO AMOUNT: ###.c o'

CHECK NO. , p_Z 7p p

3. COMMENTS

D6::EZ_Q2T. _'_;(;,,/: ::_-SIGNED

| DATE_

O B. LICENSE FEE MANAGEMENT BRANCH (CHECK WHEN MILESTONE 03 IS ENTERED / /)1. FEECATECORYAhDAMOUNT: kkO_5. ______________,,___________

O 2. CORRECT FEE PAID. APPLICATION MAY BE PROCESSED FOR: 53$hNT _,__ g _,__ -

LICENSE ::::_: - : -- UO3. OTHER i

__________________________________ y___________________ ________ _

Z ___- ::_ N % ,[[ : : :_~ gDATE__

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ORECEIVED

OMAR 10 m94

O REGION III

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WeSwiew' ~

Hosais| m arruemhE mnn nos

3630 Guion RoadP.O. Box 22650

i Indianapolis, Indiana| 46222-0650

317/924-6661

Fax: 317/924-3073

February 23, 1994

Meterialm Licensing SectionU. S. Nuclear Regulatory Commission, Region III831 Warrenv111e RoadLisle, Illinois 66532-4351

Gentlemen

Attached please find an original and one copy of a completed NRCForm 313 for renewal of byproduct material 11 cense 13-18543-01. Acheck in the amount of $1400.00 for the renewal fee is also attachedoc required.

Upon review you will note that the information contained in thisrenewal application is almost identical to our previous renewaloubmission. Minor changes have been made to reflect the revisions1n 10 CFR 20. This renewal application was prepared with theecoistance of our Health Physica Consultant, - Mr. Mack L. Richard.Should you have any questions regarding the content of thiscpplication, please contact either myself at (317) 920-7183,Mo. Yvonne Lewis at (317) 920-7184, or Mr. Richard at (327) 274-0330.

Sincerely,

1 ^

David C. Williams, D. O.Radiation Safety Officer

DCW mbAttachments

CC: Y. L.e w i s, CNMT, ARRT

y{D g {AM. Richard, M. S.

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unenarmimmaa ggcoN 1%Ella 3 96528on APPbuh, n

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.

NRC FORM 313 U. S. NUCLEAR REWLATORY COMMISSION ' APPROVED BY OMB. NO.31504120EXPIT.E$ S.3046

ESTIMATED BURDEN PER RESPONSE TO COMPLY WITH THl$R 30,32. 33 INFORMATON COLLECTION REQUEST 9 HOURS SUBMITTAL OF THE

34. 35. 36, 39 and 40 APPLCATON IS NECESSARY TO DETERMINE THAT THE APPLICANT l$QUALIFIED AND THAT ADEOUATE PROCEDURES EXIST TO PROTECTTHE PUBLC HEALTH AND SAFETY FORW ARD COMMENTS

APPLICATION FOR MATERIAL LICENSE REGARDNG BURDEN ESTiuATE TO THe iNrORMAfiON AND RECORDSMANAGEMENT BRANCH (MNBB T714), U S NUCLEAR REGULATORYCOMM'SSON. WASHINGTON, DC 20555 0001 AND TO THEPAPERWORK REDUCTON PROJECT (3160 0120) OFFCE OFMANAGEMENT ANDilUDGFT WASHINGTON DC 20%03

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.

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH. IF YOU ARE LOCATED IN.

DVISION OF INDUSTRIAL AND MEDCAL NUCLE AR SAFETY ILLINOIS, INDLANA, CWA MICHtOAN, MINN" SOT A. M4SSOURI, OHto, OR WibCONSIN,

OFFCE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS SEND APPLICATIONS TO:U S NUCLEAR REGULATORY COMMISSONWASHINGTON DC 205554001 MATERIALS LCE NSNG SECTON

U S NUC'. EAR REGULATORY COMMISSON. REGCN lilALL OTHER PERSONS FILE APPLICAT.ONS AS FOLLOWS: 799 ROOSEVELT ROAD

GLEN ELLYN. lL 00137-5927IF YC0 ARE LOCATEDIN-

CONNECTICUT, DELAWARE, Dl3TRCT OF COLUMBLA. MAINE MARYLAND, ARKANSAS, COLORADO, IDAHO, KANSAS, LOUISLANA. MONT ANA, NEBRASKA, CW

MASSACHUSETTS, NEW HAMPSHIRE, N"W JERSEY, NEW YORK, PENNSYLVANIA, MEKICO, NORTH DAKOTA, OKLAHOMA, SOUTH DAKOT 4, TEXAS, UT AM, OR WYOMINO,

RHODE ISLA*'D, OR VERMONT, SEND APPLICATCNS TO' SEND APJLICATCNS 70;

LICENSING ASSISTANT SECTON NUCLEAR MATERLALS LICENSING SECTONNUCLEAR MATERIALS SAFETY BRANCH U S NUCLEAR tEGULATORY COMMtSSON. REGION IVU S NUCLEAR REGULATORY COMMISSON REGON I 811 RYAN PLAZ A DRIVE. SUITE 400475 ALLENDALE ROAD ARLNGTON TA 76011 4064KING OF PRUSSA PA 19A0&141$

ALADAMA. FLORCA, GEOR0lA. KENTUCKY, MIS $t$$1PPI, NORTH CAROLMA. PUERTO ALASKA, ARIZONA, CALIFORNIA HAWAll, NEVADA, OREGON, WASHINGTON, AND U S.

KlCO, SOUTH CAROLINA TENNESSEE, VIRGINLA, VIRQlN ISLANDS, OR WEST VIROINtA, TERRITORIES AND POSSESSIONS IN THE PACIFIC, SEND APPLICATONS TO.

SEND APPLICAflONS 70.

NUCLEAR MATER 4ALS LCENSNG SECTON RADCACTIVE M ATERI ALS SAFETY BRANCH

U S NUCLEAR REGULATORY COMutSSON. REGON N U S NUCLEAR REGULATORY COMMISSON, REGION V

101 MARIETTA STREET. NW. SUITE 2930 1450 MARIA LANE

ATLANTA. GA 3C3234199 W ALNUT CREEK, CA 94596 5368

PERSONS LOCATED IN AGREEMENT ST ATES SEND APPtsCATCNS TO THF U S. NUCLEAR REOULATORY COMMIS$CN ONLY IF THEY WISH TO POSSESS AND USE LICENSEDMATERIAL IN STATES SUBJECT TO U $ NUCLEAR REGULATORY MVMI JURIEDICTONS.

1 THIS IS AN APPLCATION FOR (CAsca apprognese ssem) 2 NAME AND MAILNG ADDRESS OF APPLCANT Oncludelap code)

^ "'*'***** Westview Osteopathic Medical HospitalB AMENDuENT TO tCENSE NUuBER 3g g gg

_

RENEve AL OF LCENSE NUMBER !3-18543-01X C- Indianapolis, IN 46222

3 ADDRESS {ES) WHERE LCENSED MATERAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THis

APPLCATION

Ms. N nne W sSatne as Item #2

TELEPHONE NUMBER

(317) 920-7184SUBMr' ITEMS 5 THROUGH 11 ON & 1/2 X 11" P APER THE TYPE AND SCOPE OF NFORM ATON TO BE PROVIDED IS DESCRIBED IN THE LCEN$E APPLCATON GUtDE

g RADCACTIVE MATERIALa Element and mass numt.or e chem. cal andrar physcal form, and s rr.hmmum amount 6 PURPOSE (S) FOR WHICH LCENSED MATERIAL WILL BE USED

whch ell be possessed at any one time

7 INDfVIDUAL(E;'tEspoNSifwE FOR RAD 6ATON SAFETY PROGRAM AND THEIR6 TR AINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRCTED AREAS

TR ANING EXPERIENCE

9 F ACIL:sYl. *ND EQUIPMENT 10 R ADIATON SAFETY PROGR AM

12 LCENSEE FE ES (See to CFR f 70 and Sechon f10 31)

rE E CAreGORY 7.C | AMOUNT 1400.0011 WASm MANAGEMENTENCtosED ,

13 CERTIFCATION (Mssf be compsefod by appicenf) THE APPLCANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENT ATIONS MADE IN THis APPLCATON ARE BINDINGUPON THE APPLCANT

THE APPLCANT AND ANY OF FC6AL EJECUTING THis CERTIFICATION ON BEHALF OF THE APPLCANT, N AMED IN ITEM 2. CERTIFY THAT THIS APPLCATION (S PRLPARED INCONFORMfTY WTTH Tf7LE 10. CODE OF FEDERAL REGULATONS PARTS 30, 32. 33. 34 35. 36. 39 AND 40. AND THAT ALL INFORM ATON CONT AINED HEREIN IS TRUE ANDCORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF

W ARNING 18 U S C SECTION 1001 ACT OFJUNE 25.19A8 62 ST AT 749 MAKES IT A CR' MIN AL OF F ENSE TO M AKE A WILLFULLY F ALSE ST ATEMLNT OR REPRESENT AflON TOANY DEPARTMENT CR AGENCY OF THE UNrTED ST ATES AS TO ANY MATTER WITHIN ITS JURISOCTION [g ,9 M V 17 T" Dn n

/ 1*- CAIE Su A * R ^#CERTIFYING OFFCE R - TYPED / PRINTED NAME AND TITLE SIGN f~E JDavid C. Dvar. President and Aaministrator . YM 2/23/94

-_

FOR NRC USE bNLY ' / LLn t m'

'to E 70 C TEGDRY AMOUNT RECEI ED

CHECK NUMBFfC E NTS

~]udrFdkg TOG 5 4F M00 % 10276D / 6E~: .nmon 111/

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'NRC FORM 313 (e 931 / /hrk N t) O

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'ITEM 5 / ITEM 6-

|- RADIOACTIVE MATERIAL / AUTHORIZED USE l

! Byproduct material: Any byproduct material specified in 10 CFR 35.100 and 10 CFR 35.200 (excluding,

generators). j

Amount utilized: As needed.

Authorized use: Medical diagnosis as specified in 10 CFR 35.100 & 35.200.

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ITEM 7. -

INDIVIDUA14S) RESPONSIBLE FOR RADIATION SAFETY PROGRAMAND THEIR TRAINING AND EXPERIENCE

Item 7.1 - The following individuals are to be considered " Authorized Users" under this license:

1. David C. Williams, D.O. - currently authorized under this license2. Thomas Murphy, M.D. - documentation of training and experience currently being reviewed by ,

the NRC under a separate license amendment dated 2/22/94

Item 7.2 - NA1

Item 7.3 - Radiation Safety Officer: David C. Williams, D.O. (named as the RSO under the current !

license). |

.

|

|

i

- - - - - ~ - - _ . . - - . - - - -

oo- -

.

ITEM 8*-

TRAINING FOR INDIVIDUALS WORKING INOR FREQUENTING RESTRICTED AREAS t

I. Item 8.1 - Training program for individuals who directly handle byproduct material: -

A. All individuals who directly handle byproduct material are required to review the following ,,

documents:

1. 10 CFR 192. 10 CFR 203. Nuclear Medicine Procedures Manual4. The radiation safety procedures specified in this license application.

B. The RSO or his designee will conduct a tour of the nuclear medicine facilities for all newnuclear medicine personnel with special emphasis on radiation safety, equipment, and procedures.

C. All new employees shall have ample opportunity to ask questions on radiation safety facilities ,

| and procedures. i

t

| D. New employee training is documented utilizing the attached form entitled "WESTVIEW !! OSTEOPATHIC MEDICAL HOSPITAL RADIATION SAFETY TRAINING" (ATTACHMENT

| 8.1 A).

| II. Training program for ar.cillary personnel: ;

I|

| A. The document entitled " INSTRUCTIONS TO INDIVIDUALS WHO FREQUENT AREASCONTAINING RADIOACTIVE MATERIALS" (ATTACHMENT 8.2A) is posted in the nuclear!

! medicine area.

B. The document listed above is also included in the information packet distributed to all new i

hospital employees.

C. New or revised policies, procedures, and/or regulations regarding radiation safety as it appliesto ancillary, personnel shall be provided in writing to the appropriate department (s) at the time thenew or revised policy, procedure, or regulation goes into effect.

!

|I

|

|

. __ _ - - . . - _ _ _ _ _-

oo- -

.

ATTACHMENT 8.1 AWESTVIEW OSTEOPATHIC MEDICAL HOSPITAL

RADIATION SAFETY TRAINING

The undersigned individual hereby verifies that he/she has received training in all itemschecked below and that all relevant questions have been adequated addressed:

[] 1. Review of 10 CFR 19 and 10 CFR 20.

[] 2. Review of the Nuclear Medicine Procedures Manual.

[] 3. Review of all radiation safety procedures.

[] 4. Tour of nuclear medicine area with emphasis on radiation safety facilities,equipment, and procedures.

[] 5. Other:

Signature of Employee:

Signature of Individual Providing Training:

Date Training was Completed:

o o-

.

ATTACHMENT 8.2A

INSTRUCTIONS TO INDIVIDUALS WHO FREQUENTAREAS CONTAINING RADIOACTIVE MATERIALS

As part of your routine job duties, you may be required to enter an area of the hospitalcontaining radioactive material. The areas in which this material is stored are primarily locatedin the Nuclear Medicine Department. These areas are required to be posted with the radiationwarning symbol. The actual containers holding radioactive material will also be labeled withthis symbol (an illustration of the radiation symbol is found below). It is important that you do |

not handle any object with a radiation symbol on it or remove it from the area in which it is

stored. Although levels of radiation exposure expected in these restricted areas are low, goodradiation safety measures should be taken. In order to minimize your exposure to radioactivematerials, the safety principles of time and distance should be applied - that is:

1. Keep the time of exposure to radiation to a minimum while performing your assignedtask, and

2. Maintain a reasonable distance between the source of radiation and yourself.

If you observe any condition in a restricted area that appears to be unsafe, leave the areaimmediately and notify your supervisor. Your supervisor will then notify a member of theNuclear Medicine Department. If you have any questions regarding radiation safety,regulations, hospital policies, or Nuclear Regulatory Commission license conditions, pleasecontact the Nuclear Medicine Department.

|

>

kg CAUTION

g RADIOACTIVEMATERIALS

(RED OR BLACK SYMBOL & LETTERING ON YELLOW BACKGROUND)

. -- - - - - - - _ . - .-

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.

! ITEM 9.

| FACILITIES AND EQUIPMENT

I. Item 9.1 - Ancotated drawing (see A*ITACHMENT 9.1A)i

! II. Item 9.2 - Survey instrument calibration is performed by a consultant who is licensed to performsurvey instrument calibrations.

| III. Item 9.3 - Dose calibrator calibration:t

A. Instrument constancy: A long-lived source ('"Cs) is assayed cally in the dose calibrator. Themeasured activity on the appropriate setting is compared to the measured activity from the previousday on the same setting. Any variation of greater than 10% indicates the need for repair oradjustment. Constancy is also checked using the same long-lived source on the other commonlyused settings on a weekly basis. Documentation as required in 10 CFR 35.50 is maintained (see

'

A'ITACHMENT 9.3A).

B. Instrument accuracy: Tests are mode of the instrument accuracy annually and/or after repair or .

adjustment. The test consists of assayi,ng NIST traceable standards (currently '"Cs, '"Ba, and "Co) !

on the appropriate settings and compannt; the decay corrected activities to the measured activities.Variation of greater than 10% indicates tie need for repair or adjustment. Documentation ismaintained as required in 10 CFR 35.50 (see A'ITACHMENT 9.3B).

assayed in the dose calibrator in the most commonly used geometries (e. pharmaceutical supplier andC. Geometrical variation: Calibrated doses are obtained from the radio

g. syringes and vials). Forvials, the activity provided in a given volume is assayed and that is then used as a reference point.The volume is increased in given increments (e.g. 3 ml) and reassayed each time. If the measuredactivity varies from the reference activity by more than 10%, a correction factor or alternate settingadjustment is recorded and employed for that given configuration. The similar methodology isutilized with syringes. Geometrical variation tests are performed at dose calibrator installation andafter repair or adjustment. Documentation is maintained as required in 10 CFR 35.50.

'

Approximately 50 mCis of""Tc is obtained fmm the radiopharmaceuticalD. Instrument linearity: initially assayed on the appropriate dose calibrator setting and this value issupplier. The activity isused as the reference activity (i.e. at time = "0"). At selected time intervals after the initialactivity is measured, another measurement is taken and compared with the decay corrected activityfrom the initial measurement. These measurements will be carried out until the decay correctedactivity corresponds to the lowest activity routinely measured in the dose calibrator. Variations ofgreater than 10% indicate the need for repair or adjustment. These tests will be conducted atinstallation, quarterly, and after repair or adjustment. Documentation is maintained as required in10 CFR 35.50 (see A'ITACHMENT 9.3C). Alternatively, a commercially available shield kit (e.g."Calicheck") specifically designed for performing dose calibrator linearity tests may be utilized.The instructions included with this commercially available kit will be followed. ;

IV. Item 9.4 - Personnel monitoring program:

A. Based upon a review of personnel monitoring data over the past several years, it has beendetermined that personnel monitoring is not required as specified in 10 CFR 20.1502 (i.e. !individuals are not likely to exceed 10% of the limits specified in 10 CFR ~20.1201).

i

IB. The licensee intends to continue utilizing personnel monitoring to assure that all exposures toindividuals are maintained "ALARA" and to document that personnel exposures do not reach levelswhich would require personnel monitoring under 10 CFR 20.1502.

C. In the event that a woman " declares" pregnancy, the results of previous personnel monitoringfor that individual in addition to other pertinent information shall be reviewed by the RadiationSafety Committee (RSC) in order to determine if personnel monitoring is required under 10 CFR1502(b)(2). Such reviews shall be documented in the RSC meeting minutes.

V. Item 9.5 and 9.6 - NA

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Equipment

| Syringe. Shields -

| Vial Shields,

"L" Shi' eld;

| Lead Bricks! Forceps! Gloves

Lab Coats or " Scrubs"| Lead Apron ,

|

!

|

|

. ._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ __-____ __ _ __ -_-____ _ __--____ __ -_ ___

|

; ATTACHMENT 9.3ADOSE CAllBRATOR CONSTANCY CHECK

'''

Source: "'Cs

DATE BKG Cs-137 Tc-99m I-131 I-123 Xe-133 Ga-67 T1-201- In-111 Init.

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_ _ _ _ _ _ _ _ _ _ ._ ~ _ _ _ --_ - .-- _ . _ _ _ _ . .. . -. . - . _ _ _ _-

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ATTACHMENT 9.3BDOSE CAllBRATOR ACCURACY TEST

CAPINTEC MODEL CRC-5, SER # 51218

Nuclide --->

Orig. Act.mCis

|

Assay Date'

i

DK CorrectedAct. - mCis

.

'

Mnasured Act.mCis

Upper Limit(+10% mCis)

Lower Limit(-10% mCis)

10% Y/N Y/N Y/N

|

If any values were not within 10%, describe what action was taken:|

'

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|Test Performed By: Date:

RSO Signature:

|,

,

||

|

|

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_ _ . - . . _ - - _ _.

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.

.

ATTACHMENT 9.3CDOSE CALIBRATOR LINEARITY TEST

CAPINTEC MODEL CRC-5, SER # 51218

Mgasurement

Date

MaasurementTime

ElapsedTime

Calc. Act.mCis

Mnas. Act.mCis

-10% ofCalc. Act.

+10% ofCalc. Act.

Maas. Act.10% Y/N Y/N Y/N Y/N Y/N Y/N

Comments:

Test Performed By: Date:

RSO Signature:

. _ _ _ _ _ _ _ _ _ _ _ _

. . . _. -. __ - . . - - . .

. --|.

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.

ITEM 101-

! RADIATION SAFETY PROGRAM!

I. Item 10.1 - Radiation Safety Committee (RSC)/ Radiation Safety Officer (RSO): The licensee will ,

'

issue the model Radiation Safety Committee Charter and the Radiation Safety Officer Delegation ofAuthority published in Appendix F of NRC Regulatory Guide 10.8, Revision 2. -

II. Item 10.2 - ALARA Program (see ATTACHMENT 10.2A) |

III. Item 10.3 - 12ak tests: For all sealed sources'not exempt from leak testing per 10 CFR 35.59(f), thelicensee will establish and implement the model procedure for leak testing scaled sources published inAppendix H of NRC Regulatory Guide 10.8, Revision 2.

IV. Item 10.4 - Safe Use of Radiopharmaceuticals (see ATTACHMENT 10.4A for currently approved iprocedures) |

.

V. Item 10.5 - Spill procedures: The licensee will establish and implement the model spill procedures. i

published in Appendix J of NRC Regulatory Guide 10.8, Revision 2. :

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VI. Item 10.6 - Ordering and receiving:,

A. All orders for byproduct material will be placed by a member of the Nuclear MedicineDepartment or a designee of the RSO. License conditions regarding type and quantity of byproduct ;

material being ordered shall be considered prior to placing orders. i

B. Incoming shipments of byproduct material will be delivered to the Nuclear MedicineDepartment unless it is closed, in which case shipments will be delivered to the Radiology !'Department. The attached document entitled " INSTRUCTIONS FOR RECEIVING -RADIOACTIVE PACKAGES" (A*ITACHMENT 10.6A) is posted in both the Nuclear Medicineand Radiology Departments.

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C. All packages received in the Radiology Department shall be transported and secured in theNuclear Medicine Department following the initial receipt and inspection of such packages.

! VII. Item 10.7 - Opening of radioactive packages:

A. The currently approved procedures for opening radioactive shipments are described in -

ATTACHMENT 10.7A. !

B. Documentation of all incoming shipments is maintained via the form entitled " RADIOACTIVEMATERIAL RECEIPT / SURVEY" (see ATTACHMENT 10.7B). |

VIII. Item 10.8 - Unit dosage records: The licensee will establish and implement the model procedure,

for a unit dosage record system published in Appendix M.1 of NRC Regulatory Guide 10.8, Revision 2. '

IX. Item 10.9 - NA (multi-dose vials are not used).

X. Item 10.10 - NA (*Tc generators or not used) !,

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! IX. Item 10.11 - NA (no brachytherapy sources are used)'

XII. Item 10.12 - Area survey procedures:

| A. A direct radiation survey will be performed daily in radiopharmaceutical preparation andadministration areas with a low-range survey instrument. documentation of these daily surveys is I

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maintained on the form entitled " DAILY AREA SURVEY" (see ATTACHMENT 10.12A) |

B. Contamination (wipe) surveys shall be performed in the aforementioned areas on a weekly Ibasis. These surveys consist of a series of wipe tests (approximately 100 cm' each) which will be ;

counted with an instrument capable of htecting at least 2000 dpm/100 cm'. Documentation of

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contamination surveys)h)all be maintained on the form entitled " WEEKLY WIPE AND AREA( <

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SURVEY" (see ATI'ACHMENT 10.12B). This form is also utilized to document a weekly directradiation survey which includes the radiopharmaceutical and radioactive waste storage areas.

XIII. Item 10.13 - Air concentration control:

A. The maximum amount of noble gas (i.e. *Xe) which can be utilized over a given time period |

and worker dose has been calculated utilizing the model procedure specified in Appendix O.1 oflNRC Regulatory Guide 10.8, Revision 2.

B. A charcoal trap is utilized to minimize the release of radioactive gases. The model procedurespecified in Appendix 0.3 of NRC Regulatory Guide 10.8, Revision 2 is utilized to assure airborne !releases are controlled.

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C. The licensee will follow the model procedure for calculating spilled gas clearance timespublished in Appendix O.4 of NRC Regulatory Guide 10.8, Revision 2.

D. Where applicable, Appendix X (issued June,1992) to NRC Regulatory Guide 10.8, Revision 2was also utilized for these calculations.

XIV. Items 10.14,10.15, and 10.16 - NA

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ATTACHMENT 10.2APROGRAM FOR MAINTAINING RADIATION EXPOSURES

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AS LOW AS REASONABLY ACHIEVABLE (ALARA)

The administration of Westview Osteopathic Medical Hospital is aware of the ALARAphilosophy and strives to maintain the radiation exposures of all personnel ALARA. In aneffort to maintain occupational radiation exposures ALARA, the following " investigationalLevels" have been established:

Total effective dose equivalent (TEDE):

Level 1 = 125 mrem /qtr.Level 2 = 375 mrem /qtr.

The sum of the deep dose equivalent and the committed dose equivalent to anyindividual organ (other than the lens of the eye) or the shallow dose equivalent to theskin or to any extremity:

Level 1 = 1250 mrem /qtr.Level 2 = 3750 mrem /qtr.

Eye dose equivalent:

Level 1 = 375 mrem /qtr.Level 2 = 1125 mrem /qtr.

In general, the exposure reports provided by the personnel monitoring vendor will be utilized todetermine compliance with the ALARA Program; however, other types of measurements (e.g.direct radiation surveys and calculated exposures) may also be used if necessary. If anypersonnel exceed investigational Level 1, the Radiation Safety Committee (RSC) will beinformed of that fact. |

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If a personnel exposure exceeds Investigational Level ll, the RSO will investigate the probablecause of that exposure and attempt to implement reasonable methods to reduce thatexposure. A detailed report of the cause of the exposure as well as the recommendations to |

reduce same will be provided to the RSC. The minutes of the RSC meetings will reflect anyreports submitted by the RSO and any subsequent action taken.

During an annual review of the entire radiation safety program, the RSC will consider anyadditional policies, procedures, equipment, etc. which could enhance the ALARA philosophyand make appropriate recommendations to the hospital administration.

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ATTACHMENT 10.4AGENERAL RULES FOR THE SAFE USE

OF RADIOACTIVE MATERIALS

1. Laboratory coats, " scrubs", or other suitable protective clothing shall be worn at all timeswhen handling radioactive material.

2. Disposable gloves shall be worn at all times while handling radioactive materials. Attimes, it may be necessary to administer radiopharmaceuticals without protective glovesto adequately locate the vein at the injection site. In this case, the individualadministering such a dose shall survey his/her hands immediately following injection anddecontaminate as necessary. |

3. All individuals who handle radioactive material shall monito their hands and clothingroutinely and specifically when leaving the restricted area (3.g. at lunch time and at theend of the day). I

4. Syringe shields shall be used for dose preparation and administration when in the opinionof the person administering the dose, such use does not compromise the well-being of thepatient.

5. Eating, drinking, smoking, and/or applying cosmetics if forbidden an any areas whereradioactive materials are used or stored. Storage of consummables is also prohibited inthe same location (e.g. cabinets or refrigerators) with radioactive materials.

6. Each patient dose shall be assayed in the dose calibrator prior to administration to thepatient. Doses which vary from the prescribed dose (specified by either the AuthorizedUser or the procedures manual) shall not be administered without specific approval by anAuthorized User.

7. In issued, personnel monitoring devices (whole body and extremity monitors) shall be1

worn at all times radioactive material is being handled. These devices shall be stored in a i

| low background area when not in use.

8. Radioactive waste shall be disposed only in containers which are appropriately labeled forthat purpose.

| 9. Pipetting by mouth is prohibited.!! 10. Any container (e.g. vial, syringe, etc.) of radioactive material shall always be plainlyl labeled in accordance with its intended use.|

! 11. Radioactive materials shall always be transported in shielded containers to minimize,

exposure. Consideration shall also be given to prevent contamination during transport. '

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ATTACHMENT 10.6AINSTRUCTIONS FOR RECEIVING RADIOACTIVE PACKAGES

1. Verify that the number of packages to be signed for corresponds to the number of -packages delivered.

2. Visually inspect the package (s) for damage and/or leakage..

3. If the package is in satisfactory condition, it should be placed on a cart, transported to theNuclear Medicine Department, and secured in the designated area.

4. If the package is severely damaged and appears to be leaking, immediately implement thefollowing procedures, in order:

a. Avoid handling a leaking package if possible. If it is necessary to contain anyleaking material, put on disposable gloves, place the leaking package in a plastic bag,and twist and tape the bag closed - be careful not to contaminate the outside of thebag Remember, the disposable gloves may also be contaminated. Carefully removethose gloves (turn them inside out), place them in a plastic bag, and thoroughlywash your hands.

b. To avoid significant external contamination from a leaking package, all personnelshould remain at least 15 feet away from that package.

c. Request that the driver of the delivery vehicle remain there until it can beascertained that no significant contamination hazard is present.

d. If you should get any liquid from a leaking package on your hands, simply washyour hands thoroughly with soap and water - be careful not to break the skin.Contaminated (or potentially contaminated) clothing should be removed, placed in aplastic bag, and checked by a member of the Nuclear Medicine Staff.

e. Call one of the individuals listed below for assistance.

Emeraency fati Lhtt

David Williams, D.O. - 920-7183 (work), 844-6929 (home)M. Yvonne Lewis, CNMT, ARRT - 920-7184, 291-5066 (home)Mack L. Richard, M.S., Heelth Physics Consultant - 274-0330 (work), 745-6915 (home)

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ATTACHMENT 10.7APROCEDURES FOR OPENING RADIOACTIVE SHIPMENTS

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1. Radioactive shipments will be inspected and opened as soon as possible after receipt. |

l2. Disposable gloves and protective clothing will be worn when opening packages.

3. If there are vendor instructions for opening or unpacking the radioactive materials, they '

will be followed in addition to the procedures listed here.

4. The package is visually inspected for any sign of damage. if damage is present, details ofthe package's condition will be recorded.

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5. If contamination (wipe) testing is required per 10 CFR 20.1906(b)(1), a wipe test will beperformed over approximately 100 cm' of the package surface. A wipe test will also beperformed on any package which appears to be damaged and/or leaking.

6. If required under 10 CFR 20.1906(b)(2), direct radiation surveys of the external surfacesof the package and at 1 meter from the package shall be conducted. Furthermore, adirect radiation survey shall be performed on any package which appears to be damagedand/or leaking. |

7. If the exposure rate at any package surface exceeds 200 mR/hr or 10 mR/hr at 1 meter,or if the removable contamination exceeds 2200 dpm/100 cm', the NRC Region til office jand the delivering carrier shall be notified by telephone immediately.

8. Once opened, the package contents will be compared with the packing slip and theoriginal order. |

| 9. If damage to the inner container is evident, a wipe test will be performed to ascertain the| presence and/or extent of any contamination of the inner container, inner containers are| always assumed to be contaminated and handled with disposable gloves unless proven

otherwise.|

10. Packaging material will be monitored with a low level survey instrument and treated ascontaminated should levels above background be detected. if the packaging is free fromcontamination, all radioactive labels will be removed or defaced prior to disposal or returnto the radiopharmaceutical vendor. )

11. Written records will be maintained for all receipts of radioactive materials on the form |i entitled " RADIOACTIVE MATERIAL RECElPT/ SURVEY" (see ATTACHMENT 10.78). ]| I

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ATTACHMENT 10.78~

RADIOACTIVE SHIPMENT RECEIPT / SURVEYCounting Efficiency: .

DATE PKG. ACT. PKG.* MR/HR** WIPE TEST |RECEIVED I.D.# NUCLIDE(S) MCI (S) CHEMICAL FORM (S) SUPPLIER COND. SRFC 11 M DPM*** INIT.

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* VJ indicates the package condition is O.K.** Notify the RSO if exposure rate exceeds 200 mR/hr @ package surface or 10 mR/hr @ 1 meter.*** Notify RSO if contamination (wipe test) survey indicates removable contamination in excess of 200 dpm/100 cm'.

Comments:

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ATTACHMENT 10.12B

WEEKLY SWIPE AND AREA SURVEYWESTVIEW HOSPITAL revised 2-1-91

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ITEM 11-

RADIOACTIVE WASTE MANAGEMENT

I. Item 11.1 - Radiopharmaceutical radwaste:

A. In some cases, used vials and syringes are returned to the centralized radiopharmacy supplierfor disposal. These materials are prepared for transport in accordance with Department ofTransportation regulations and 10 CFR 71.

B. Most radiopharmaceutical radwaste is allowed to decay to background levels (at least 10 half-lives) as measured with a low-range survey instrument with all shielding removed. If the measuredradiation level is equivalent to background, all radiation labels are defaced or tremoved and thedecayed waste is disposed as non-radioactive. Should measurable readings be present even after 10half-lives, the waste will be placed back into storage for further decay and resurveyed at a laterdate. Documentation of all radwaste surveys is maintained on the form entitled " WASTEDISPOSAL RECORD". (see ATTACHMENT 11.1 A).

II. Item 11.2 - Sealed source disposal: Any disposal of sealed sources shall be performed in accordancewith 10 CFR 20.

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ATTACHMENT 11.1 ADECAY-IN-STORAGE DISPOSAL RECORD .

Storage Description of Contents Isotope (s) Disposal Survey Results Init.Date Date Bkg. Waste

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All radwaste shall be held for 10 half-lives and the unshielded exposure rate shall be equivalent tobackground prior to ultimate disposal.

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| DEC 1319941

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Westview OsteopathicMedical Hospital

ATTN: David C. Williams, D.O.Radiation Safety Officer i

3630 Guion Road |

Indianapolis, IN 46222 -

Dear Dr. Williams:

Enclosed is Amendment No. 13 renewing your NRC Material LicenseNo. 13-18543-01 in accordance with your request.

Please review the enclosed document carefully and be sure that you understandall conditions. If there are any errors or questions, please notify the U.S.Nuclear Regulatory Commission, Region III office so that we can provideappropriate corrections and answers.

Please note: the renewal application dated February 23, 1994 containedseveral procedures that lacked sufficient detail. Therefore, we havetied down those procedures that were submitted with your previous renewalapplication because these procedures contained sufficient detail.The procedures discussed above are for training, personnel monitoring and

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jgeneral rules for safe use of radiopharmaceuticals. j

Please be advised that your license expires at the end of the day, in |the month, and year stated in the license. Unless your license has beenterminated, you must conduct your program itvolving byproduct materials inaccordance with the conditions of your NRC license, representations made inyour license application, and NRC regulations. In particular, note that youmust:

1. Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, ;

Instructions and Reports to Workers; Inspections," 10 CFR Part 20, '

" Standards for Protection Against Radiation," and other applicableregulations.

2. Notify NRC, in writing, within 30 days:

a. When an authorized user, Radiation Safety Officer, or TeletherapyPhysicist permanently discontinues performance of duties under thelicense or has a name change; or

b. When the licensee's mailing address changes (no fee is required ifthe location of byproduct material remains the same).

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Westview Osteopathic -2- DEC 131994Medical Hospital

|3. In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC,promptly, in writing, and request termination of the license:

a. When you decide to terminate all activities involving materialsauthorized under the license; or

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b. If you decide not to complete the facility, acquire equipment, orpossess and use authorized material. .

4. Request and obtain a license amendment before you:

a. Receive or use byproduct material for a clinical procedurepermitted under Part 35 but not permitted by your license |issued pursuant to this Part; <

b. Permit anyone, except a visiting authorized user described in10 CFR 35.27, to work as an authorized user under the license;

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c. Change Radiation Safety Officers or Teletherapy Physicists; '

d. Order byprodr,t material in excess of the amount, or radionuclide,or form different than authorized on the license;

e. Add or change the areas of use or address or addresses of useidentified in the license application or on the license; or

f. Change ownership of your organization.

5. Submit a complete renewal application with proper fee or terminationrequest at least 30 days before the expiration date of your license.You will receive a reminder notice approximately 90 days before theexpiration date. - Possession of byproduct material after your license l

expires is a violation of NRC regulations. A license will not normallybe renewed, except on a case-by-case basis, in instances where licensed

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material has never been possessed or used, i

In addition, please note that NRC Form 313 requires the applicant, by his/hersignature, to verify that the applicant understands that all statementscontained in the application are true and correct to the best of the |

applicant's knowledge. The signatory for the application should be the llicensee or certifying official rather than a consultant. '

You will be periodically inspected by NRC. Failure to conduct your program inaccordance with NRC regulations, license conditions, and representations madein your license application and supplemental correspondence with NRC willresult in enforcement action against you. This could include issuance of anotice of violation, or imposition of a civil penalty, or an order suspending,

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Westview Osteopathic -3-Medical Hospital DEC 131994

modifying or revoking your license as specified in the General Policy andProcedures for NRC Enforcement Actions, 10 CFR Part 2, Appendix C. Sinceserious consequences to employees and the public can result from failure tocomply with NRC requirements, prompt and vigorous enforcement action will be

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taken when dealing with licensees who do not achieve the necessary meticulous' attention to detail and the high standard of compliance which NRC expects of

its licensees.

Sincerely,,

Original Signed By,

| Patricia M. VacherlonNuclear Materials Licensing Section

License No.: 13-18543-01Docket No.: 030-13850

Enclosure: Amendment No. 13

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DOCUMENT NAME: M:\03013850.CL4T. -*. . ,, ., m m. m m. w .c. c.,, .n %ne. w .c . c.,, .. .n %,u. %,. . . . u. ,,

OFFICE DRSS/RIII |NAME PMVACHERLON: Jaw -DATE 12/;3/94 //77/V

0FFICIAL RECORD COPY

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MAR 0 41994

Westview Osteopathic Nedical Hospital License No. 13-18543-01ATTN: David C. Williams, D.0. Control No. 396528

Radiation Safety Officer! 3630 Guion Road

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Indianapolis, IN 46222 |

Dear Dr. Williams:

SUBJECT: LICENSE RENEWAL APPLICATION

This is to acknowledge receipt of your application for renewal of thematerial (s) license identified above. Your application is deemed timelyfiled, and accordingly, the license will not expire until final actionhas been taken by this office.

Any correspondence regarding the renewal application should reference thecontrol number specified and your license number.

Sincerely,

Original Signed ByMarianne Meenan, ChiefNuclear Materials Support Section

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