NRC: Home Page - 0303g/!.tJL U;S -o · 2019-12-12 · SIEMENS Kathy Modes Senior Health Physicist...

SIEMENS

Kathy Modes Senior Health Physicist US NRC Region I DNMS

Health care

Tuesday, August 12, 2014

(3 0303g/!.tJL

3 :z- 3 S I U;S -o I Dear Ms. Modes, L L 35/{pfJ Please find enclosed our application for a NRC license. If you have any questions regarding this application please forward them to Matthew Daut at m<.tJlht;_\_\~,_Q,l_tH.£L~lcn1~ll,<;_,co_!D. I am also available to answer questions if needed at Skoncr_th.yAmhg,nc_t.

Sincerely,

Sandy Konerth, DABR, DABMP

Siemens Medical Solutions USA, Inc. 221 Gregson Drive Cary, NC 27511 USA

NMSS/RGN1 MATERIALS-002

Tel.: +1-919-319-2900 www.usa.siemens.com/healthcare

NRC FORM 313 (03-2014)

U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-{1120 EXPIRES: 05/31/2015

10 CFR 30, 32, 33, 34 35, 36, 37, 39, and 40

~C.,p-R litEG(t(-f~

{~"+l APPLICATION FOR MATERIALS \~l LICENSE .... .., +0 ..........

Estimated burden per response to comply with this mandatory collection request: 4.3 hours. Submittal of the application is necessary to detenmine that the applicant is qualified and that adequate procedures exist to

protect the public health and safety. Send comments regarding burden estimate to the FOIA, Privacy, and

Information Collections Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,

or by internet e-mail to [email protected], and to the Desk Officer, Office of Information and

Regulatory Affairs, NEOB-1 0202, (3150-0120), Office of Management and Budget, Washington, DC 20503. If a

means used to impose an information collection does not display a currently 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. *AMENDMENTS/RENEWALS THAT INCREASE THE SCOPE OF THE EXISTING LICENSE TO A NEW OR HIGHER FEE CATEGORY WILL REQUIRE A FEE.

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH:

OFFICE OF FEDERAL & STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555-0001

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS:

IF YOU ARE LOCATED IN:

ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, KENTUCKY, MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH CAROLINA, TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA,

SEND APPLICATIONS TO:

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY U.S NUCLEAR REGULATORY COMMISSION, REGION I 2100 RENAISSANCE BOULEVARD, SUITE 100 KING OF PRUSSIA, PA 19406-2713

IF YOU ARE LOCATED IN:

ILLINOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, SEND APPLICATIONS TO:

MATERIALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION, REGION Ill 2443 WARRENVILLE ROAD, SUITE 210 LISLE, IL 60532-4352

ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS, LOUISIANA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO, NORTH DAKOTA, OKLAHOMA, OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS, UTAH, WASHINGTON, OR WYOMING,

SEND APPLICATIONS TO:

NUCLEAR MATERIALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION, REGION IV 1600 E. LAMAR BOULEVARD ARLINGTON, TX 76011-4511

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

1. THIS IS AN APPLICATION FOR (Check appropriate item)

0 A. NEW LICENSE

D B. AMENDMENT TO LICENSE NUMBER

D C. RENEWAL OF LICENSE NUMBER

3. ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Various see Item 3

12. LICENSE FEES (Fees required only for new applications, with few exceptions") (See 10 CFR 170 and Section 170.31)

NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)

Siemens Medical Solutions USA, Inc. c/o Matthew Daut 221 Gregson Drive Cary, NC 27511

NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

BUSINESS CELLULAR TELEPHONE NUMBER

(91 9) 208-3026

FEE CATEGORY 3P AMOUNT I ENCLOSED $ 2,000.00

13 CERTIFICATION. (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICA T/ON 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, 36, 37, 39, AND 40, AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF. WARNING: 18 U.S C. SECTION 1001 ACT OF JUNE 25, 1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.

OFFICER-- TYPED/PRINTED NAME AND TITLE DATE

NRC FORM 313 (03-2014)

Appendix D

Checklist for License Application

APPENDIXD

SERVICE PROVIDER APPLICATION REVIEW CHECKLIST

Date:----------------

CONTENTS OF APPLICATION

ITEM 8.1 TYPE OF APPLICANT/LICENSEE

T_ype of Action License No.

7 A. New License Not Applicable

B. Amendment

nc. Renewal

ITEM8.2 NAME OF APPLICANT/LICENSEE

LEGAL NAME: Siemens Medical Soultions USA Inc.

MAILING ADDRESS: 221 Gregson Drive, Cary NC 27511

ITEM8.3 LOCATION OF USE

[]Address listed above.

0Facilities that must be speeitlcally identified on the license (Street Address, City, State, and Zip Code): 0 ______________________ _

0----------------0 _____________________ _

[{J'femporary Job Sites.

ITEM8.4 CONTACT PERSON

NAME: Matthew D. Daut

TELEPHONBNUMB~R: (919) 319-2952

D-l NURE0-1556, Vol.l8

APPENDIXD

ITEMS 8.5 • 8.6 RADIOACTIVE MATERIAL TO BE POSSESSED/*REQUESTE.O USE OF MATERIALS

BROAD SCOPE LICENSE AUTHORIZATION

0TypeA

DTypeB

OTypeC

SEALED SOURCES AND DEVICES

l.f I Identify each radionuclide (element name and mass number) that will be used in each sealed source.

l.f I Provide the manufacturer's (distributor's) name and model number for each sealed source and, if applicable, device requested.

l.f I Confum that the activity per source and maximum activity in each device will not exceed the maximum activity listed on the approved certificate of registration issued by NRC or by an Agreement State.

D Confum that each sealed source, device, and source/device combination is registered as an approved sealed source or device by NRC or an Agreement State.

UNSEALED MATERIALS (Volatile and Nonvolatile)

l.f I Provide element name with mass number, chemical and/or physical form, and maximum requested possession limit.

D Provide information for volatile materials, if known, on the anticipated rate of volatility or dispersion. This information may be obtained from the material vendor, supplier, or manufacturer.

SEALED SOURCES

Radioisotope Mfg./Model No. Quantity Use SSD Certificate No. (CurJesiMBq/GBq)

See Attachements

NUREO- 1556, Vol. 18 D-2

APPENDIXD

UNSEALED MATERIALS

Radioisotope Chemic:ai/Physlcal Form Quantity Use Volatility/Dispersion (CurleB/MBq/GBq)

See Attachments

SOURCE MATERIALS

Radioisotope Chemical/Physical Form Quantity Use (Curles/MBq/GBq) Klloarams

SPECIAL NUCLEAR MATERIALS (LFSS THAN CRITICAL MASS)

Radioisotope Chemfc:a~byslcal Form Quantity Use (CurfuiMBqiGBq)

. MATERIAL USE LEGEND

L=Lealc Test Analysis E=Environmental C=Calibration of NL-Nuclear Laundry Sample AnalySis radiaiion protection

equipment

. CC•CommercJal CNL=Commerclal CL=Commercial Leak Ea=Commercial Calibration of radiation Nuclear Laundry Test Analysis Environmental Sample protection equipment Analysis

Incineration Compaction/Super Decontamination Site Characterization Compaction

D-3 NUREO - I S:S6, Vol.l8

APPBNDIXD

MATERIAL USE LEGEND

O=Other Services Not Included Excluding Critical Mass Quantities of SNM

PSI=Possesslon of Sealed Sources Incident to Performing Services

~Installation Into devices or equlpmentQadlatlon Survey@emovalf71 Relocation ~epalr Source Exchange[{] Routine Malntenance[{]Preventive Malntenancc:£:Z]N'on-routine ~ntenance Source Retrleva0Transportatior0Packaging0Leak Test Same AcqulsitionOCustomer Training Other Services not Included,

Other Services Explanation:

CW::Commercial Waste Manaaement Services

0Inclneratio~ Compaction/Super Compaction 0SolidiRcatlonNitrification0Packaglna, Repackaging, and Transportation . 0Decontamlnation D Decommissioning OSUc Characterization OOthcr Services not included, excluding critical mass quantities of SNM

Other Commercial Services Explanation:

FINANCIAL ASSURANCE

[{] Financial Assurance not required.

D Financial Assurance required and Financial Assurance Documents submitted for review.

D Decommissioning Records File established.

NUREG • JSS6, Vol. 18 D-4

ITEM8.7

[Z]Name

RESPONSIBLE INDIVIDUALS

Corporate OrganiZation Chart Submitted. l.f I Radiation Safety Organizational Chart Submitted.!./ I Name(s) of responsible individual(s):

l.f I Title(s) of individual(s)

l.f I Training of individual(s)

l.f I Experience.

Radiation Safety Offtcer Information:

(Z]Bxperience [lJ:rraining -Include specffic dates

APPENDIXD

Wndependent L.Jw\hority to stop unsafe operations

[{l>rganizational Chart (Day-to-Day Radiation Safety Positions) provided

llJSee Item 8. 7.1 for a list of typical RSO duties and responsibilities

AUTHORIZED USERS/ANCILLARY PERSONNEL

l.f I Classroom training:

[{]Lecture

D Videotape

[Z] Self-study that emphasizes practical subject matter important to the safe handling of licensed materials

[l] All types of training conunensurate with the expected hazards encountered during routine and emergency conditions.

l.f I Frequency of Training:

l.f I Before assuming duties with, or in the vicinity of, radioactive materials

(Z]wbenever there Is a significant change in duties, regulations, or the terms and conditions of the license

l.f I Annually for refresher training.

NUREO- 1556, Vol. IS

APPENDIXD

I./ I Suggested Radiation Safety Topics:

NUREG- ISS6, Vol. 18

I./ I Fundamentals of Radiation Safety:

I./ I Characteristics of radiation

I./ I Units of radiation dose and quantity of radioactivity

I./ I Hazards of exposure to radiation

I./ !Levels of radiation from licensed material

I./ !Methods of controlling radiation dose (time, distance, and shielding)

I./ IALARA concept.

I./ I Radiation Detection Instruments:

I./ I Operation

I./ I Calibration

I./ I Limitations of radiation survey instruments

I./ I Radiation survey techniques for measur.ing radiation field

I./ I Radiation survey techniques for measuring removable/fixed contamination

I./ I Handling and proper use of personnel monitoring equipment.

~diation Protection Equipment and Use:

----rlJ Proper use of protective equipment

D Decontamination of contaminated protection equipment.

I./ I Applicable NRC regulations (10 CFR 19, 20, 21, 31, 32, 34, 35, 36, 39, 40, 70, and 71) as applicable

I./ I Case histories relevant to operations

I./ I Course Examination (Didactic):

I./ I Successful completion of closed-book written/oral examination depending on the complexity and hazards of authorized activities

I./ I Review of incorrect answers with student.

I./ I On-the Job Training and Examination (Practical):

I./ I on-the-job training done under the supervision of a qualified individual (AU, RSO, or manufacturer's representative authorized by NRC or an Agreement State) that includes supervised hands-on experience performing the task authorized on the license that are commensurate with the expected hazards during routine and emergency conditions.

D-6

ITEM8.8

ITEM8.9

APPENDJXD

l.f I Practical examination consisting of an assessment by the RSO to ensure that each proposed AU is qualified to work independently and that each individual is knowledgeable of the radiation safety aspects of licensed activities. This may be demonstrated by observing the proposed AU perform licensed activities.

l.f I Discussion ancVor drill on emergency procedures

l.f I Retraining on areas found to be deficient in both the practical and didactic areas.

l.f I Classroom Course Instructor Qualifications:

l.f I Qualified individual (e.g., a person who me~ts the· qualifications for RSO or authorized user on the license and is familiar with the licensee's program).

l.f I Instructors who provide classroom training to individuals in the principles of radiation and radia~ion safety should have knowledge and understanding of these principles beyond those obtainable in a course similar to the one given to prospective authorized users.

l.f I Individuals viho provide instruction in the hands-on use of licensed materials should have training and experience that would qualify them to be authorized users, or should possess a thorough understanding of the licensee operations. ·

TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS

l.f I See Item 8. 7 for suggested topics, frequency of training, etc.

l.f I Elements of training program identified.

FACILITIES AND E9UIPMENT N 1-J..

Commercial Leak Test or Env~onmental Sample Analysis. (No response req~ired)

Commercial Instrument. Calibration. (No response required)

Services Involving Handling of Sealed Sources Inside Shielded Containers. (No response required)

0-7 NUREG- 1556, Vol.l8

APPENOIXD

Services Involving Handling of Sealed Sources Outside Shielded Containers

D Sketch/drawing to scale of the facility and all work areas where materials will be used or stored.

D Identify the following, where applicable:

0Areas where explosive, flammable or other hazardous materials stored

0Buildings

0Boundary lines

Osecurity fences

0Local storage areas

Grawn to specifaed scale

osketch/drawing of:

locked storage container

security of licensed materials.

Other services that involve handling of unsealed radioactive material:

D Describe the permanent facilities and equipment to be made available at each location.

D Include a description of the area(s} assigned for the receipt, storage, security, preparation, handling, waste storage and measurement of radioactive materials.

D Submit a facility diagram showing the proximity of licensed materials to unrestricted areas.

D Drawings, sketches, diagrams, etc. should indicate the scale, or include dimensions on each drawing or sketch.

D Submit a diagram, sketch, or drawing, when applicable, that identiftes areas where radioactive materials may become airborne. The diagram should contain descriptions of the ventilation systems, with pertinent airflow rates, filtration equipment, sample collection points, and monitoring systems.

D Submit a diagram of radioactive waste handling equipment that includes incinerators.

D Describe proposed laundry facilities, if applicable, used for contaminated protective equipment and clothing. Specify how the contaminated waste water from the laundry machines or sinks is disposed. Operating and emergency procedures should address decontamination of the laundry area and equipment.

NUREO - ISS6, Vol. 18 D-8

APPENDIXD

Doescribe protective clothing (such as rubber gloves, coveraUs, respirators, and face shields), auxiUary shielding, absorbent materials, secondary containers for waste water storage for decontamination purposes, plastic bags for storbtg contaminated items, etc., that will be available.

Drdentify specialized handling tools. facility safety mterlocks designed to prevent operation of radiological safety systemS in the event that operation of a system could result in accidental exposure or release of material (e.g., HEPA ftlters, ventilation system, safety door interlocks, etc.) or equipment.

Facility: For Authorization for Unsealed Materials Other than Leak Test m· Environmental Sample Analysis, Provide:

D Describe, if applicable:

0Hoods

0Hood fdters

Osinks

D Trays with absorbent materials

0Remote handling tools

I./ I Rubber gloves.

D Storage provisions:

Dnescribe and provide a drawing of storage facilities

Ostorage of waste materials included

osecurity provisions

DAdequate shielding.

D Noncommercial LaundryFacility for contaminated clothing, etc.

D Noncommercial Decontamination Facilities.

Temporary Job Site Facility:

I./ I Sealed Sources General:

I./ I No facility description is required

D Specialized handling tools or equipment.

D-9 NUREG- 1556, Vol.l8

APPENDIXD

ITEM 8.10

ITEM 8.10.1

ITEM8.10.2

l.f I Unsealed Material:

l.f I Describe protective clothing (such as rubber gloves, coveralls, respirators, and face shields}, auxiliary shielding, absorbent materials, secondary containers for waste water storage for decontamination purposes, plastic bags for storing contaminated items, etc., that will be available.

l.f I Describe available radiation safety equipment.

RADIATION SAFETY PROGRAM

AUDIT PROGRAM

l.f I Reviewed on an ~nnual basis:

[{]ALARA l.f I NRC/DOT regulations and License

l.f I Occupational/Public Doses.

l.f I Audit program not submitted, but available for inspection by NRC.

l.f I Appendix I reviewed.

RADIATION MONITORING INSTRUMENTS

D Type of instruments (OM, Ion chamber, scintillation).

D Type of radiation detected (a, p, 'Y· neutron).

l.f I Availability of survey instruments.

NUREG- 1556, Vol. 18 D-10

Survey instrument Instrument Probes Range

• Manufacturer • Model No. • CPM

• Model No. • DPM

• #Available • mR/hr

•Type • mr/hr

- OMI on-chamber

- Scintillation

Counting Equipment For: Calibration Standards

• Analysis of Contamination Swipes

• Analysis of Bioassay Samples

Special Equipment #Available

• • •

Air Samplers

Direct Reading Dosimeters

Condenser R meter

CALffiRATION OF RADIATION DETECTION INSTRUMENTS N A D Calibration frequency specified.

DIn-house.

D By manufacturer.

D By outside ftrm:

Name ----------------------------~------License No. ---------------

0 Calibration procedures in Appendix J adopted.

APPENDIXD

Radiation Detected

• a

• p • y

• neutron

Minimum Detectable Activity

Description

D Alternative calibration procedures for radiation detection instruments provided for NRC review.

· D-ll NUREO- 1556, VoJ.18

APPBNDIXD

ITEM 8.10.3

ITEM8.10.4

MATERIAL RECEIPT AND ACCOUNTABILITY PHYSICAL INVENTORY

D Semiannual frequency.

D Maintain records or receipt, transfer, and disposal.

D Information:

D Quantity and kind of licensed material (Sealed Sources)

D Location of licensed material

Onate of inventory

0Name of individual conducting inventory

0Inventory records for sealed sources may be.combined with leak test records.

0Appendix K ·Ordering/Receiving Materials Reviewed.

OCCUPATIONAL DOSE

I ,f I Evaluation Completed for occupationally exposed individuals.

[Z] Dosimetry:

[Z]TLD

0Fibn OosL I ,f I Neutron capability

I ,f I NV LAP-approved

I ,f !Exchange frequency:

[Z]Monthly

[Zpuarterly

Other lnstadose read quarterly

BIOASSAYS N 11 D Procedures in RG 8.20, Rev. 1, adopted for conducting bioassays.

OAitemate Procedure to RG 8.20, Rev. 1, provided for conducting bioassays.

NUREO • 1556. Vol. 18 ().12

ITEM 8.10.5

ITEM 8.10.6

D Collll)lercial Service:

D Name-------

0 License No.-------

PUBLIC DOSE

l.f I No response required.

l.f I Dose evaluation maintained for inspection.

l.f I Appendix M reviewed.

APPENDIXD

SAFE USE OF RADIONUCLIDES ANI> EMERGENCY PROCEDURES

l.f I Procedure for obtaining an agreement with customers outlining the responsibilities of both the customer and service provider, when performing service operations at a customer's facility.

[Z] Instructions for handling and using licensed materials .

D Instructions for maintaining secudty during storage and transportation.

I./ I Instructions to keep licensed material under control and immediate surveillance during use.

l.f I Steps to take to keep radiation exposures ALAR A.

l.f I Steps to maintain accountability during use.

l.f I Steps to control access to work sites.

I./ I Steps to take and whom to contact when an emergency occurs.

D Instructions for using remote handling tools when handting sealed sources, except low-activity calibration sources.

l.f I Methods and occasions for conducting radiation surveys, including surveys for detecting contamination.

l.f I Procedures to minimize personnel exposure during routine use artd in the event of an incident, including exposures from inhalation and ingestion of licensed unsealed matedals.

l.f I Methods and occasions for locking and securing stored licensed materials.

l.f I Procedures for personnel monitoring, including bioassays, and the use of personnel monitoring equipment.

D-13 NURBO-JSS6, Voi.J8

APPENDIXD

D Procedures for transporting licensed matedals to temporary job sites, ' packaging of licensed materials for transport in vehicles (private or

conunon carrier), placarding of vehicles when needed, and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal.

0Procedures for picking up, receiving, and opening packages containing licensed materials, in accordance with 10 CPR 20.1906:

I ,f I Instructions for maintaining records in accordance with the regulations and the license conditions.

0Procedures for identifying and re~rting to NRC defects and noncompliance as required by 10 CFR 2l.2l(a) of this chapter.

I ,f I Procedures and actions to be taken if a sealed source is ruptured, including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments.

D1nstructions ror the proper storage and disposal or radioactive waste.

0Procedures to be followed in the e~t of uncontrolled release of radioactive unsealed licensed material to the environment, including notification of the RSO, NRC, and other Federal and state agencies.

I ,f !Procedures for identifying and reporting to NRC defects and noncompliance, see Table 8.4 that describes the typical incident notifications required by NRC regulations.

I ,f !Procedures for the implementation and adh~rence to good health physics ~ctices while performing service operations:

l.{JMinimization of distance to areas, to the extent practicable, where licensed materials are used and stored

DMaxirnization of survey frequency, within reason, to enhance detection of contamination

Dsegregation of radioactive material in waste storage areas

Qegregation of sealed sources and tracer materials to prevent crosscontamination

D Separation of radioactive material from explosives

D Separation of potentially contaminated .areas from clean areas by barriers or other controls.

NA 0 Service Provider Requesting Authorization to Perform Major Decontamination Activities:

0Instructions to personnel how to determine presence through survey

NUREO- 1556, Vol. 18 D-14

ITEM 8.10.7

D Levels of contamination

D Decontamination procedures

D Decontamination equipment

APPENDIXD

D Prevention of contamination or"personnel during decontamination

·0 How to handle contaminated waste materials

D Re-survey of contaminated area to determine effectiveness

0Records of survey:

Osefore

DAfter

D Contact persOn.

I./ I Decontamination activities will only be conducted by outside sources licensed by NRC or an Agreement State to conduct these activities.

SURVEYS

D Facilities.

D Equipment.

D Personnel.

D Restricted Areas.

0 Unrestricted Areas.

0 Types of Surveys: .

D Surveys for radioactive contamination that could be present on surfaces of floors, waDs, laboratory furniture, and equipment.

D Measurements of radioactive material concentrations in air for areas '. where radioactive materials are handled or processed in unsealed form

and where operations. could expose workers to the inhalation of radioactive material or where licensed material is or could be released to unrestricted area.

D Measurements of radioactive material concentrations in water that is released to the environment or to the sanitary sewer.

D Bioassays to determine the kinds, quantities or concentration, and in some cases, the location of radioactive material in the human body. A bioassay can be made by direct measurement (in vivo counting) or by analysis and evaluation of material excreted or removed from the human body.

D-15 NUREO- 1556, Vol.l8

APPBNDJXD

D Surveys of external radiation exposure levels in both restricted and unrestricted areas.

~ntamination Survey Frequency:

U Table 8.5 adopted

D Alternate contamination survey frequencies provided.

D Contamination in Unrestricted Area:

0Table 8.6 adopted

0Atternate contamination survey frequencies provided.

D Survey Record Requirements:

D A diagram of the area surveyed

D A list of items and equipment surveyed

D Specific locations on the survey diagram where wipe test was taken

D Ambient radiation levels with appropriate units

D Contamination levels with appropriate units

0Make and model number of instruments used

0Background levels

0Name of the person making the evaluation and recording the results and date.

D Air Monitoring:

D Determine whether the confinement of radioactive materials is effective

D Measure airborne radioactive material concentrations in the workplace

0 Estimate worker intakes of radioactive material

Onetermine posting requirements

Onetermine what protective equipment and measures are appropriate

0 Warn of signiftcantly elevated levels of airborne radioactive materials.

D Effluent Release Monitoring:

DAirborne

D Liquid (See Appendix N).

NURBO- JSS6, Vol. 18 D-16

ITEM 8.10.8

ITEM8.10.9

LEAK TESTING

D Vendor(s) Name:-----------

Address:--------------

Agreement State/NRC License No.:-----

0 Leak test kit.

APPENDIX D

D Leak testing conducted in-house using Appendix 0 procedures.

D Alternative leak testing procedures submitted for NRC review.

MAINTENANCE

I./ I Are specifically authorized by your license to perform the specific activity.

l./ I Follow the Irul~tufacturer's procedures describing the activity.

l./ I Have individuals qualifled by their training and experience to perform the activity.

I./ I use approved parts and components.

I./ I Have specialized equipment to perform these activities.

I./ I Test the device before it is returned to routine use to ensure that it functions as designed.

I./ I Test the device before it is returned to routine use to ensure that it functions as designed.

0 See Appendix P.

REMOVAL OR MAINTENANCE ON A SEALED SOURCE OR HOLDER

I./ I Services performed by Irumufacturer.

I./ I Performed by individual licensed by Agreement State or NRC.

D Performed by Jicensee.

I./ 1 Detailed procedures for each task provided for NRC review. Radiation safety precautions outlined in O&B procedures.

SEALED SOURCES STUCK IN A SOURCE HOLDER

I./ I Performed by licensed equipment rnanufacturel'.

I./ I Performed by individual licensed by Agreement State or NRC.

D-17 NUREO- JSS6, Vo1.18

APPENDIXD

I./ I Performed by licensee:

I./ I Detailed procedures for each task provided for NRC review

I./ I Radiation safety precautions outlined in O&E procedures.

OPENING, REPAIR, OR MODIFICATION OF SEALED SOURCES

D Performed by Agreement State/NRC licensed firm.

0 Performed by licensee:

D Detailed procedures for each task provided for NRC review

D Radiation safety precautions outlined in O&E procedures.

ITEM 8.10.10 MINIMIZATION OF CONTAMINATION

I./ I Imple~ntation of and adherence to good health physics practices in operatiOns.

0Minim.ization of areas, to the extent practicable, where licensed materials are used and stored.

0Maximization of the frequency of surveys, within reason, to minimize spread of contamination.

0Appropriate filtration of eftluent streams.

Ouse of non-porous materials for laboratory bench tops, flooring, etc.

oventilation stacks and duct work with minimal lengths and minimal abrupt changes in direction.

Ouse of appropriate plumbing materials with minimal pipe lengths and traps.

OMinimization of the number of disposal sites (sinks) where liquid waste is disposed.

ITEM8.10.11 TRANSPORTATION .fVft D No response required, DOT regulations will be followed.

D Appendix Q reviewed.

NUREO • IS56, Vol. 18 D-18

APPENDIXD

ITEM8.11 WASTE MANAGEMENT [10 CFR Part 20, Subpart K]

tJ A- D Decay-in-storage disposal for radioactive materials with half-lives less than or equal to 120 days:

ITEM 8.12

ITEM8.13

0When a container is transferred to the waste storage area, mark the container with an identiftcation label that includes the date sealed, the isotope in the container, and the initials of the person sealing the container

D <120 day T~ material

D Held for decay a minimum of 10 T~

D Confrrm that prior to disposal as in-house waste, you will monitor each container, as follows:

Check radiation detection survey meter for proper operation

Monitor container in a low-level area (less than 0.05mrem/hr)

Remove any shielding from container

Monitor all surfaces -

Discard only those containers that caMot be distinguished from background

Container that can be distinguished from background must be returned to storage area for further decay or transferred to person licensed to receive such waste.

D Return to manufacturer.

D Extended Interim Storage of materials pending disposal or transfer to authorized recipient.

D Licensed company.

D Disposal by release into sanitary sewerage (10 CFR 20.2003).

0 Appendix N reviewed.

FEES

I~ I Fee, if any required, attached.

CERTIFICATION

I~ ~ndividual signing an application authorized to make binding commitments and to sign official documents on behalf of the legal entity or applicant.

D-19 NUREO -1556, Vol.18

SIEMENS Healthcare

Explanation of Items Listed in NRC Form 313

ITEM 3- Address Where Licensed Material will be Used or Processed

Siemens employees will only use licensed materials in designated areas of use in facilities with a current NRC license. Siemens employees will be subject to the facility license tie-down requirements with regard to use and handling of licensed materials. Siemens employees will ensure compliance with all license conditions.

ITEM 5 - Radioactive Material

Siemens Customer Service Engineers may use both sealed and unsealed sources of licensed materials. Potential unsealed source use is described in Attachment 5-A and potential sealed source use is included in Attachment 5-B. All source use will occur at temporary job sites from customers with a current NRC License.

ITEM 6- Purpose(s) for Which Licensed Material Will Be Used

Siemens employees will use unsealed and sealed radioactive sources for installation, testing, repair, routine and non-routine maintenance, source exchange and calibration services for diagnostic imaging equipment. This may be performed at temporary work sites for customers with valid radioactive materials NRC license.

Radioactive materials will be used by Siemens employees under the following conditions:

• The radioactive materials are licensed by the customer. • The facility's personnel prepare sealed containers of the radioactive

chemicals/pharmaceuticals and provide them to the Siemens Medical Solutions USA, Inc. personnel for use in the servicing of the facility's imaging systems.

• When the servicing is completed, the Siemens Medical Solutions USA, Inc. personnel return these sealed containers to the facility's personnel for disposition.

• Siemens Medical Solutions USA, Inc. never takes possession of or removes any of the radioactive material from the facility.

• All service work takes place under the direction of the facility's radiation safety program and the facility's Radiation Safety Officer (RSO).

Siemens Medical Solutions USA Inc., employees do not possess any sources. No leak testing or inventories will be performed by employees at customer sites.

Siemens Medical Solutions USA Inc., employees will not package or prepare shipping documents for radioactive material. Transportation of radioactive material by Siemens employees will occur only within the confines of the licensed facility. Siemens Medical Solutions USA, Inc. Tel.: +1-919-319-2900 221 Gregson Drive

Cary, NC 27511 USA

www.usa.siemens.com/healthcare

Page 11

SIEMENS Health care


ITEM 7 -lndividual(s) Responsible for Radiation Safety Program and Their Training Experience.

Chief Radiation Safety Officer: The Chief Radiation Safety Officer is designated as Matthew D. Daut; his Delegation of Authority, related training, experience, and organization chart is included as Attachment 7-A. The duties and responsibilities of the Chief Radiation Safety Officer are detailed as follows:

The Chief Radiation Safety Officer for Siemens Medical Solutions USA (Service) is responsible to evaluate radiation exposure situations for SMS Service personnel and ensure that:

1. Training and dosimetry is available to personnel as needed. 2. A legal vehicle (license or registration) for conducting work in each state or territory of

the United States is in place and functional if required. 3. Personnel monitoring information is maintained to demonstrate compliance

with State or Federal limits for exposure to radiation. 4. Surveys and evaluations are conducted to demonstrate compliance with Federal and

State regulations for radiation protection. 5. Reports of personnel dose in excess of ALARA control levels or Legal exposure

limits are investigated immediately. 6. Training for personnel is conducted as required to ensure that personnel are familiar

with the situations where they may be exposed to radiation and with the knowledge necessary to protect themselves and others.

7. Procedures are available to personnel that indicate appropriate measures to be taken to monitor personnel, train personnel, and do work while keeping radiation exposure As Low As Reasonably Achievable.

8. The Radiation Protection Program is evaluated at least annually and is effective in demonstrating compliance with State and Federal Regulations.

ITEM 8 -Training for Individuals Working in or Frequenting Restricted Areas.

All Siemens personnel working with or handing sources will complete modality specific training and shall have successfully completed the Siemens Medical Solutions USA, Inc. 8-hour Basic Radiation Safety course - Radiation Safety for Nuclear/PET Engineers (Course /0: XX1 RADSAF). The 8 hour training course will be completed prior to working with sources and every three years thereafter. Successful completion of this course is determined by testing of the individual taking the course. Upon successful completion of a course, employees will be issued a wallet card that should be kept with them at all times during working hours.

Training outlines for the 8 hour Radiation Safety Course is included as Attachment 8-A. In addition, each user shall have successfully completed the following modality specific training course(s) prior to being allowed to work on or service imaging devices of that modality:



Page 12

SIEMENS Healthcare


• Nuclear Basics Radiation Safety (Course 10: NM1 NMBASIC) • PET Basics for PET and Biograph Engineers (Course 10: NM1 PETBAS)

Both of the courses above include additional radiation safety techniques as well as practical demonstration of incorporated radiation safety practices. Training Outlines for both classes are included as Attachment 8-B.

All personnel working in areas where radioactive materials are used will complete web based refresher Radiation Safety training annually.

Qualifications for Instructors: Radiation Safety Instructors will have the knowledge and understanding of the principals of radiation and radiation safety that exceed those delivered during the 8 hour course listed above. Additionally, individuals who provide hands on instruction will have the training and experience that would allow them to handle radioactive sources as detailed in Item 5 and 6. Specific information for instructors is available upon request.

ITEM 9 Facilities and Equipment

Siemens employees will only work at temporary job site locations where a customer has an existing radioactive materials license with the NRC. All work performed in accordance with this license is conducted at licensed customer facilities.

ITEM 10 Radiation Safety Program

Audit Program: An audit of this license and corresponding states will be performed at least annually. The Siemens Radiation Safety Program Audit Guide is available upon request.

RSO Organization Chart: Included with Attachment 7-A.



Page 13

SIEMENS Healthcare


RSO Duties and Responsibilities: The Chief Radiation Safety Officer for Siemens Medical Solutions USA (Service) is responsible to evaluate radiation exposure situations for SMS Service personnel and ensure that:

1. Training and dosimetry is available to personnel as needed. 2. A legal vehicle (license or registration) for conducting work in each state or territory of the

United States is in place and functional if required. 3. Personnel monitoring information is maintained to demonstrate compliance with State or

Federal limits for exposure to radiation. 4. Surveys and evaluations are conducted to demonstrate compliance with Federal and

State regulations for radiation protection. 5. Reports of personnel dose in excess of ALARA control levels or Legal exposure limits are

investigated immediately. 6. Training for personnel is conducted as required to ensure that personnel are familiar with

the situations where they may be exposed to radiation and with the knowledge necessary to protect themselves and others.

7. Procedures are available to personnel that indicate appropriate measures to be taken to monitor personnel, train personnel, and do work while keeping radiation exposure As Low As Reasonably Achievable.

8. The Radiation Protection Program is evaluated at least annually and is effective in demonstrating compliance with State and Federal Regulations.

Operating Procedures: Radiation safety, contamination control techniques, radioactive source accountability are integrated into the CX RC-US Working with Radioactive Calibration Sources and Radiation Generating Machines SOP and also outlined in the memorandum of understanding (MOU) between Siemens and the licensee. Attachment 1 0-A and 1 0-B is submitted for review. Radiation safety (ALARA), contamination control practices, control of sources and emergency procedures are integral parts of specific equipment procedures involving installation, repair, calibration and source exchange. Specific equipment instructions are available upon request.

The MOU between Siemens and the licensee contains language that specifies the conditions and limitations with respect to how radioactive material will be used by Siemens employees. This MOU is designed for existing customers and will be sent to all applicable customers. Siemens will include the language contained in the MOU as part of purchase agreements for new customers as applicable.

Radioactive Material Accountability: Siemens Customer Service Engineers shall ensure that the sources are protected from damage, theft, or loss while they are being used and ensure that sources are returned to the customer.

Emergency Procedures: CX RC-US Working with Radioactive Calibration Sources and Radiation Generating Machines SOP (Attachment 1 0-A) contains emergency procedures and communications required in the event of a spill of radioactive liquids. Siemens maintains



Page\4

SIEMENS Healthcare


procedures and actions required for ruptured sources for specific equipment. Procedures that contain emergency actions for stuck source, spill of radioactive liquid and ruptured source are included for review as Attachment 1 0-C. Siemens will follow NUREG- 1556 Vol. 18 Table 8.4 for identifying and reporting defects and incidents to the NRC.

Radiation Monitoring Instruments: All radiation detection instruments used by Siemens employees will be provided and maintained by the licensee.

Surveys: Siemens' Customer Service Employees will comply with good contamination control practices and immediately contact the facility RSO or their representative if they find contamination is present at their temporary work site. Surveys performed will be at the discretion of the customer; Siemens Medical Solutions USA, Inc., Customer Service Engineers will not normally perform surveys. Siemens encourages all customers to perform radiological assessments at any time during maintenance or repair work involving sealed or unsealed radioactive sources.

Material Receipt: Siemens Medical Solutions USA Inc., personnel will not order, receive, ship or package any licensed material.

Occupational Dosimetry: Personnel dosimetry policies are detailed in ex Re- US Personnel Dose Monitoring SOP and Siemens' ex RC-US Declaration of Pregnancy Declared Pregnancy Policy 0733-1 (PROPOSED). These items are submitted for review as Attachment 1 0-D and Attachment 1 0-E respectively.

Bioassays: Bioassay procedures for Siemens Medical Solutions USA Inc., personnel will not normally be required. However Siemens employees at temporary job sites will comply with the customer's bioassays procedures.

Leak Checks: Siemens does not possess or own any radioactive sources under this license. Siemens does not conduct leak check for our customers.

Radiation Detection Instruments: All radiation detection instruments are provided and maintained by the licensed organization (customer). Siemens employees will not maintain radiation detection instruments.

Waste Management: All customer-owned radioactive material used by Siemens personnel is returned to the customer for disposition in accordance their radioactive material license.



Page 15

SIEMENS Health care

Attachment 5-A: Sealed Licensed Material

Manufacturer: Siemens Modality PET I Pre-Clinical

Model LS-Accel x3 LS-HR+ x3 LS-Exactx3 LS-LAx2 Ls-MPS-0.5 x1 Ls-MR PETx4 LS-30 x1 LS-La_inveon x1 CS-6-14 x1 CS-6-9 x1 CS-10-14 x1 CS-10-9 x1 CS-20-3 x1 CS-20-2 x1 CS-20-1 x1 CS-27 x1 CS-MR-PET x1

SSRN TN-237 -S-1 03-S TN-237 -S-1 03-S TN-237 -S-1 03-S TN-237-S-103-S TN-237-S-103-S TN-237-S-103-S TN-237-S-103-S TN-237 -S-1 03-S TN-237 -S-1 04-S TN-237 -S-1 04-S TN-237-S-104-S TN-237 -S-1 04-S TN-237 -S-1 04-S TN-237 -S-1 04-S TN-237 -S-1 04-S TN-23 7 -S-1 04-S TN-237-S-104-S

Manufacturer: Sanders Modality PET I Pre-Clinical

Model PET -168-5 x3 PET 168-3.8 x3 PET-168-3.3 x3 PET -180-1 x1 PET -20C19-1 x1 PET -20C19-2 x1 PET -20C19-3 x1 PET -20C27 -2 x1 Pet-0.1-0.5 x1 PET -180-0.8 x1 PET -6C9-1 x1 PET -1 OC1 0-1 PET-6C14-.05 x1 PET -1 OC14-0.5

SSRN TN-0241-S-101-S TN-0241-S-101-S TN-0241-S-101-S TN-0241-S-1 01-S TN-0241-S-1 02-S TN-0241-S-102-S TN-0241-S-102-S TN-0241-S-1 02-S TN-0241-S-101-S TN-0241-S-1 01-S TN-0241-S-1 02-S TN-0241-S-1 02-S TN-0241-S-102-S TN-0241-S-1 02-S

Siemens Medical Solutions USA, Inc.

Isotope I Activity GaiGe-68- 6.25 mCi 231.25 MBq ea GaiGe-68 = 4.68 mCi 173.16 MBq ea GaiGe-68 = 3.75 mCi 1150.22 MBq ea GaiGe-68 = 1.25 mCi- 55.5 MBq GaiGe-68 = 0.5 mCi 19 MbB GaiGe-68 1.5 mCi 55.5 MBq GaiGe-68 1.25 mCi 44 MBq GaiGe-68 0.8 mCi29.6 MBq GaiGe-68 .55.mCi 20.35 MBq GaiGe-68 1.25 mCi 46.25 MBq GaiGe-68 0.55 mCi 20.35 Mbq GaiGe-68 1.25 mCi 46.25 Mbq GaiGe-68 4.06 mCi 150.22MBq GaiGe-68 2.5 mCi 92.5MBq GaiGe-68 1.5 mCi 55.5 MBq GaiGe-68 2.5 mCi 92.5 MBq GaiGe-68 3.0 mCi 111 MBg

Isotope I Activity GaiGe-68 = 5 mCi 185 MBq ea GaiGe-68 = 3.8 mCi 141 MBq ea GaiGe-68 = 3.3 mCi 1122 MBq ea GaiGe-68 = 1.2 mCi - 44 MBq GaiGe-68 = 1.2 mCi 44 MbB GaiGe-68 2 mCi 74 MBq GaiGe-68 3.2 mCi 120 MBq GaiGe-68 2 mCi 74 MBq GaiGe-68 .0.5.mCi 18.5 MBq GaiGe-68 0.8 mCi 30 MBq GaiGe-68 1 mCi 37 Mbq GaiGe-68 1 mCi 37 Mbq GaiGe-68 0.5 mCi 18.5 MBq GaiGe-68 0.5 mCi 18.5MBq

221 Gregson Drive Cary, NC 27511 USA

Total Activity 30mCi 23mCi 18mCi 4mCi 1 mCi 9mCi 2mCi 1.2 mCi .8mCi 2mCi .8mCi 2mCi 6mCi 4mCi 2.25 mCi 4mCi 5mCi

Total Activity 23mCi 20mCi 20mCi 2mCi 2mCi 3mCi 5mCi 3mCi 1 mCi 2mCi 2mCi 2mCi 1 mCi 1 mCi


SIEMENS Health care


Manufacturer: Eckert and Ziegler Modality PET I Pre-Clinical

Model EG-0317-3.3M x1 EG-0317 -1.2M x1 EG-0317-2M x1 EG-0318 x1 HEGL-0080-SM x3 HEGL-0080-4M x3 HEGL-008-3M x3 HEGL-0080-1M x2 HEGL-0800 x1 PHI-0089 x1 USM01 x1 USM02 x1 PHI-0119 x2

SSRN CA0406S 1845 CA0406S184S CA0406S184S CA0406S 184S CA0406S 185S CA0406S185S CA0406S 185S CA0406S 185S CA0406S 185S CA0406S 118S CA0406S235S CA0406S235S CA0406S118S

Manufacturer: Eckert and Ziegler Modality SPECT Model NES8426-28 NES8426-4 HEGL-0133 x1 PHI-0124 x1

SSRN CA0406S204S CA0406S204S CA0406S165S CA0406S 118S

NES8426- 28 Individual Source Breakdown Item Model Total Number 1 NES8426-28 4 2 NES8426-28 4 3 NES8426-28 4 4 NES8426-28 4 5 NES8426-28 4 6 NES8426-28 4 7 NES8426-28 4


Isotope I Activity GaiGe-68 = 3.3 mCi 122 MBq ea GaiGe-68 = 1.2 mCi 44 MBq ea GaiGe-68 = 2 mCi 7 4 MBq ea GaiGe-68 = 2.5 mCi 92.5 MBq ea GaiGe-68 = 5 mCi 185 MBq ea GaiGe-68 = 5 mCi 1185 MBq ea GaiGe-68 = 3 mCi - 111 MBq GaiGe-68 = 1 mCi 37 MBq GaiGe-68 = 1.2 mCi 44.4 MBq Cs-137 = 15 mCi 555 MBq GaiGe-68 = 500uCi 18.5 MBq Co-57 = 5 mCi 185 MBq Co-57= 5 mCi 185 MBq

Isotope I Activity Gd-153 = 192 mCi 740 MBq Gd-153 = 20 mCi 740 MBq GD-153 = 10 mCi 370 MBq Co-57 = 0.05 mCi 1.85 MBq

Activity Each 20 mCi 7 40 MBq 11.9 mCi 440 MBq 7.0 mCi 259 MBq 4.2 mCi 155 MBq 2.5 mCi 93 MBq 1.5 mCi 56 MBq 0.9 mCi 33 MBg


Total Activity 5mCi 2mCi 4mCi 4.5mCi 25mCi 25mCi 19mCi 4mCi 2mCi 15mCi 750 uCi 8mCi 8mCi

Total Activity 192 mCi 80mCi 17 mCi 0.1 mCi


SIEMENS Healthcare


Manufacturer: Eckert and Ziegler Modality SPECT- Flood Source Specified for Siemens Camera's Model 55RN Isotope I Activity PF24R-057-10M CA040651805 Co-57= 10mCi- 370 MBq MED3709 CA040651205 Co-57= 10mCi- 370 MBq NES8400 CA040651805 Co-57= 10mCi- 370 MBq CTRF10000 MA-1059-5-359-5 Co-57= 10mCi- 370 MBq

Manufacturer: RADQual Modality SPECT - Flood Source Specified for Siemens Camera's Model BM01-10 BM02-10 BM04-10 BM07-10 BM07-99 BM04-99 BM04-15

55RN NR-1235-5-1045 NR-1235-5-1045 NR-1235-5-1045 NR-1235-5-1045 NR-1235-5-1045 NR-1235-5-1045 NR-1235-5-1045


Isotope I Activity Co-57 = 1 OmCi - 370 MBq Co-57 = 1 OmCi - 370 MBq Co-57 = 1 OmCi - 370 MBq Co-57 = 1 OmCi - 370 MBq Co-57 = 5mCi - 185 MBq Co-57= 5mCi -185 MBq Co-57 = 15mCi 555 MBq


Total Activity 10mCi 10 mCi 10mCi 10 mCi

Total Activity 10mCi 10mCi 10mCi 10mCi 5mCi 5mCi 15mCi


SIEMENS Attachment 5-B List of Unsealed Sources:

F-18 liquid

Ga-67 liquid

Tc-99m liquid

1-131 liquid

Tl-201 liquid

ln-111 liquid


Healthcare

10 mCI

500 uCi

10 mCi

2mCi

10 mCi

2mCi


10 mCi

500 uCi

50 mCi

2mCi

50 mCi

2mCi


Hans Beinke VP, US Country Head of Quality &

EH&S Officer

I Dea Dougherty EH&S Director

All District Radiatio and Local Radiatio report dotted lin

Safety Officer (CRSO

I

Robert Verburgt Dir Quality for Service

I Matthew Daut

CRSO

Safety and Protection. Updated 06/25/2014

I

Ron Larkins West Zone VP

I John Goossens

DRSO- CA, NV, AZ, NM, UT

I Nader Khoury

LRSO- CA North

I John Simmons

DRSO- AK, WA, OR, ID, WY, CO

Mike Guin Sr, VP of National Service

I I

Ron Pellegrini Midwest Zone VP

I Henri Poche

DRSO

I Steve Cantrell LRSO-LA, MS

I Rick Vanemon

LRSO- KY

I Christian Rude

LRSO- TX

I Matt Clark LRSO- OK

I I j_

Mark Huerter Larry Came Ia Michael Parella Central Zone VP Southeast Zone VP Northeast Zone VP

I I I Seth Maniscalco Randolph Wilson Richard Longo

DRSO DRSO-GA, AL DRSO- NY

I I I !

Tim Morris Steven Stasel Dennis Buckley I LRSO- OH LRSO-GA DRSO- NE & MA J

I I I Jeff Grischow Dan Sobeck Ray Plesnarski

LRSO- IL LRSO- FL DRSO- NJ

I I Joseph Ostrowski Tridib Borkakoty

LRSO- PA Local RSO- DC, MD

I Steve Tole

DRSO-NC,SC

I Jack Finney

Local RSO- TN

I EMENS

Date: Tuesday, June 24, 2014

Memo To: Matthew Daut

Healthcare

From: Mike Guin, Vice President for Service, Siemens Medical Solutions USA, Inc.

Subject: Delegation of Authority to the Radiation Safety Officer

You have been appointed Radiation Safety Officer for the Siemens Medical Solutions USA, Inc radioactive material program. You are responsible for ensuring the safe use of radiation. You are responsible for managing the radiation safety program; identifying radiation safety problems; initiating, recommending, or providing corrective actions; verifying Implementation of corrective actions; stopping unsafe activities; and ensuring compliance with the regulations and compliance with the terms and conditions of the license and commitments contained therein.

You are hereby delegated the authority necessary to meet those responsibilities, including prohibiting the use of radioactive material by employees who do not meet the necessary requirements and shutting down operations where It Is justified by radiation safety concerns. You are required to notify management of situations where staff are not cooperating and not addressing radiation safety issues. In addition, you are free to raise Issues with the Radiation Control Bureau.

Signature and Title of Management: __ ___.,t7·t-:-:-'~..,.~ Jr?::..tSJ1"""'-=-'_"-_ ~-<~~~~--~ ~·· =-?-_t-::--1_·--=-1 <.~f ____ _ Mike~n. Vtce Prestdent for Servtce


Tel.: +1-919-319-2900 W\V.Y.usa.slemens.comihealthcare

QCertifitate of \ltraintng Awarded To

Matthew· Daut Recognizing completion of 5 days of s.Pecialized instruction in

Medical Radiation Safety Officer

November 5, 2010

Presented By Dade Moeller Radiation Safety Academ.v

431 N. Frederick Avenuo, Suite 220, OalthcnburJ, MD 20177

www.mocllerinc.comiiCidomy- 301-9.90-6006

ABIH has awarded this cours.e.,6.01 CM Points, CM Approval #09-4751 AAHP has awarded this cours~J~_}ontlnulng Education CreditS, 2009·00-076 ARRT and SNMT has awarded tfi(s course up to 40.5 CEH's, 024551·024555

Ray Johnson, MS, PE, FHPS, CHP Vice President, Training Programs

Enclosure ()) page (3) of ( q

0

0

0

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Naval Hospital Oldnawa, Radiation Safety

Certificate of Completion

is hereby granted to

LCDR MATTHEW DAUT · .. to certify that she has been trained and tested in accordance with

49 CFR 172.704 in. DOT Regulations and Radiation Safety Procedures

Granted: ·17 June 2011

.I. PARRY, LC Racfiation Saf,

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ARMED FORCES RADIOBIOLOGY RESEARCH INSTITUTE (AFRRI) 8901 Wisconsin Avenue, Bethesda, :MD 20889-5603

http://<vV\vw.atm.usuhs.miJ

The Armed Forces Radiobiology Research Institute (AFRRI) certifies that

Matthew D. Daut has participated in the educational activity entitled

Medical Effects of Ionizing Radiation (MEIR) Scientific Update Course

n·

atthe ·

Navy Medical Center Portsmouth (NMCP) Portsmouth, VA

John R. Mercier, MS, USA 1r, Military Training and Doctrin~

January 30-31,2007

0iltt~b~ Patricia K.. Lillis-Hearne, :MD

COL, MC, U.S. Anny

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,...OPN-AVJN_s_T_64

_70

·_3 __ NAVAL RADIOACTIVE MATERIALS PERM/1---------,

·.· .. ]

.J

Pursuant to the authority stated in OPNAVINST 6470.3A, Naval Ra.diatlon Safety Committee, and In reliance on statements made by th~ applicant, permission Is hereby granted for the acquisition, receipt, possession, use, storage and disposal of radioactive materials listed below subject to the condltiohs listed In this permit.

1-COMMAND

COMMANDING OFFICER U S NAVAL HOSPITAL PSC 482 APO AP 96362-1600

6 - RADIOACTIVE MATERIAL

· A. Any byproduct material permitted by 10 CFR 35.100.

B. Any byproduct material permitted by 10.CFR 35.200.

C. I-131 for diagnostic studies and outpatient hyperthyroid therapy permitted by 10 CFR 35.300.

D. Any byproduct material permitted by 10 CFR 35.65.

.E. Plutonium-239

OPNAV 6470/1 supplement (4-86)

In accordance with the letters dated 22 June and 01 August 2011

(OKINAWJ\) 2 ·PERMIT NO. 63-68470-11NP is amended in its entirety to read as follows:

3 - AMENDMENT NO. 33

4 • DOCKET NO.

5 • EXPIRATION DATE

28 February 2016 7-CHEMICAU

PHYSICAL FORM

A. Any

8 • MAXIMUM QUANTITY AUTHORIZED

A. As needed

B. Any B. As needed excluding gases and aerosols

C. Capsule Form

D. Any

E. Check source electroplated on polished Stainless Steel

C. As needed, . not to exceed 150 millicuries, (5550 megabecquerels) of I-131

D. No si~gle source to exceed the maximum activity specified in 10 CFR 35.65

E. One source not to exceed 0.008 miGrocuries (296 becquerels)

.---....._

_)

P.age ...2.. of Lpages OPNAVINST 6470.3

SUPPLEMENTARY SHEET------------------~ United States Naval Radiation Safety Committee

F. Americium-241

G. Thorium-230

9. Authorized Use:

Radioactive Materials Pernilt

F. Check source electroplated on polished Stainless Steel or Nickel

.G. Check source electroplated on polished Stainless Steel or Nickel

PERMIT NO. 63-68470-11NP AMENDMENT NO.

33

F. One source not to exceed 0.617 microcuries (226 ·kilobecq~erels)

G. No single source to exceed 0.005 microcuries (185 becquerels)

A. Any uptake, dilution and excretion study permitted by 10 CFR 35.100 for which a written directive ·is not required.

B. Any imaging and localization study permitted by 10 CFR 35.200 for which a written directive is not required.

C. Iodine-131 in capsule form for use in.any diagnostic study or outpatient hyperthyroid therapy permitted by 10 CFR 35.300 for which a written directive is required.

D. Any source~ of byproduct material to be used as calibration, transmission and reference sources as described in 10 CFR 35. 65·.

E - G. For receipt and storage only until authorized for transfer or disposal.

PERMIT CONDITIONS

10. Radioactive material. authorized by this Permit shall be stored and used only at u. s. Naval Hospital, Okinawa, Japan in Buildings 6000 (main hospital), 1321 (storage only), or other designated (storage only) building at the hospital._·

11. The Radiati9n Safety Officer for the use of radioactive material authorized by this Permit is LCDR Matthew Daut_, MSC, USN.

OPNAV 6470/1 supplement (4·88)

...............

, .. ~ .... ,

J

OPNAVINST 6470.3 Page~ of .Lpages

SUPPLEMENTARY SHEET------------------~ United Sta~es Naval ~adlatlon Safety Committee

Radioactive Materials Permit PERMIT NO. 63-68470-llNP AMENDMENT NO.

33

12. Radioactive material listed in Item 6 is also authorized for · use by, or under the supervision of:

A. Individuals permitted to work as an authorized user, and/or authorized medical physicist in accordance with 10 CFR 35.13 and 35.14.

B. The following individuals are authorized users for medical use:

Authorized Users

Christina J. Gondusky, (LCDR, MC, USN)

William K. Carson, M.D. (LCDR, MC, USN)

Hasan A. Hobbs, M.D. (LCDR, MC I USN)

Material and Use

M.D. 10 CFR 35.100, 35.200, and outpatient I-131 hyperthyroid therapy and diagnostic studies

,permitted by 10 CFR 35.392.

10 CFR 35.100, 35.200 and outpatient I-131 hyperthyroid therapy and diagnostic studies permitted by 10 CFR 35.392.

10 CFR 35.100, 35.200 and .. outpatient I-131 hyperthyr!)id

therapy and diagnostic studies pe~mitted by 10 CFR 35.392.

C. Radioactive material shall be used by, or under the supervision of, individuals designated by the Command's Radiation Safety Committee. ·

13. The Command shall. conduct a physical inventory of all sealed sources every six months to account for all sealed sources and devices, received and possessed under this permit per 10 CFR 35.67. In addition, waste shall be inventoried ev~ry six months. Records of the inventory shall be maintained for five years from the date of the inventory .. Records shall include the quantities and kinds of radioactive material, manufacturer's name and model/lot number, location of use or storage, and the date of the inventory and shall be signed by the Radiation Safety Officer.

OPNAV 647011 supplement (4·86)

.--......

· ... J

OPNAVINST 8470.3. Page ..!. of .l_pages


Rad/oacUve Materials Permit PERMIT NO. 63-68470-llNP AMENDMENT NO.

33

14. Sealed ·sources or detector cells containing permitted material shall not be opened or sources removed from source holders by the permittee.

15. The permittee shall not acquire radioactive material in a sealed source or device unless the source or device has been registered with the Nuclear Regulatory Commission pursuant to 10 CFR·32.210 or equivalent regulations of an Agreement State.

16. The·permittee is authorized rec~ipt of any permitted material in accordance with the provisions of lO CFR Part 20 and 10 CFR Part 71. Transfer of radioactive material is not authorized except for RADIAC instruments.

17. The Radiation Safety Officer or a qualified designee will personally approve all.transfers of radioactive material covered by this Permit. This includes a review of the packaging, labeling, and documentation of each outgoing shipment as well as the receipt process for each incoming shipment. ·

18. All personnel involved in the receipt, handling, preparation or transfer/shipment of radioactive material shall be trained in accordance with 49 CFR 172 Subpart H.· Documentation of training and testing shall be maintained for three years.

19. The Command shall comply·with and maintain current copies of the following:

A. Title 10, Code of Federal Regulations, Parts 19, 20,· 21, · 30, 35 and 711 and 49 CFR Parts 171-178.

B. BUMEDINST 6470.20.

C. OPNAVINST 6470.3A.

D. NAVMED P-5055.

E. NAVMCPUBHLTHCEN/OPNAV Information Notices and Bulletins.

20. Except as specifically provided otherwise by this Permit, the Command shall posses~ and use radioactive material described in this Permit in.accordance with statements, representations, and procedures contained in the following correspondence:


_)

OPNAVINST 6470.3 Page..§.. of .I.Pages


Radioactive Materials Permit PERMIT NO. 63-68470-11NP AMENDMENT NO.

33

A. NAVHOSP Okinawa ltr 6470 Ser 054/01632 of 12 Jun 06. (Am. 24: Renewal application).

B. NAVHOSP Okinawa ltr 6470 Ser 064/054/02100 of 21 Jul 06. (Delete M. S. Valade, M.D. (LCDR, MC, USN))

C. NAVENVIRHLTHCEN ltr 6470 Ser OEM/000961 of 18 Aug 06. (Extension of NRMP expiration date from 28 February 2006 to 28 February 2016, Item 5).

D. NAVHOS'P Okinawa ltr 6470 Ser 054/02286 of 10 Aug 07. (Delete F. R. ·Brandon, M.D. {LCDR, MC, USN) and J. T. Buratto, M.D. (LCDR, MC, USN) as authorized users.

B. NAVHOSP Okinawa ltr.6470 Ser 054/02488 of 22 Aug 07. (Am. 25: Addition of rooms C425 (MOR#3), C419 (MOR#1), 440 (MOR storage), and C212E (Histology specimen storage} as new areas of use for sentinel node biopsy procedures) .

F. NAVHOSP Okinawa ltr 6470 Ser 054/02904 of 26 Sep 07. (Am. 26: Addition of CDR Pelletier as AU under 35.100 & 200 and. outpatient hyperthyroid therapy under 35.392).

G. NAVHOSP Okinawa ltr 6470 Ser 054/01751 of 3 Jul 08. (Temporary appointment of LCDR Pa~ry, MSC as RSO for 60 days)

H. NAVHOS~ Okinawa ltr 6470 Ser 054/01818 of 3 Jul 08. (Am. 27: Approve LCDR Parry, M~C as RSO, delete LT Fairchild, MSC as RSO). Also removal of "accelerator produced" from permit conditions due to NARM rule, and change of name of NEHC to NAVMCPUBHLTHCEN.

I. NAVHOSP Okinawa ltr 6470 Ser 054/02733 of 26 Sep 08. (Remove CDR Chen as AU due to tranQfer from the command.)

J. NAVHOSP Okinawa ltr 6470 Ser 054/02749 of 29 Sep 08. (Am. 28: Add LCDR McFarland, MC as AU for diagnostic studies under 10 CPR 3S.100 & 35.200 uses.)

K. NAVHOSP Okinawa ltr 6470 Ser 054/03118 of 30 Oct 08. (Am. 28: Add LCDR Carson, MC as AU for diagnostic studies under 10 CFR 35.100 & 35.200 uses.)


..... . .

.· --·~

_j

OPNAYINST 6470.3 Page ..§.. of _l.pages


~adloacUve Materials Permit PERMIT NO. 63-68470-11NP AMENDMENT NO.

33

L. NAVHOSP Okinawa ltr 6470 Ser 054/03166 of 5 Nov 08. (Am. 29: Add LCDR Carson, MC as AU for outpatient hyperthyroid therapy and diagnostic studies under 10 CFR 35.392 uses.) ·

M. NAVHOSP Okinawa ltr 6470 Ser 054/02936 of 17 Sep 09. (Am. 30: Add LCDR Gondusky, MC as AU for diagnostic studies under 10 CPR 35.100 & 35.200)

N. NAVHOSP Okinawa ltr 6470 Ser 054/02940 of 17 Sep 09 .. (Am. 30: remove CDR Pelletier as AU.)

o. NAVHOSP Okinawa ltr 6470 Ser 054/02947 of.l8 Sep 09. (Am. 30: Add LCDR Gondusky~ MC as AU for outpatient hyperthyroid therapy and diagnostic studies under 10 CFR 35.392 uses.) ·

P. NAVHOSP Okinawa ltr 6470 Ser 054/06814 of 02 Aug 10. (Am. 31: Remove LCDR Joel T. McFarland, MC, USN, as AU for diagnostic studies under 10 CFR 35.100 & 35.200 due to his transfer on 02 Aug 10. Add Permit Conditions 6, ?,.and 8 for items E, F and G to authorize receipt and storage of additional check. sources.)

Q. NAVHOSP Okinawa ltr 6470 Ser 054/07017 of 19 Aug 10. (Notification to add LCDR H. A. Hobbs, MC as AU for diagnostic studies under 10 CFR 35.100 & 35.200.)

R. NAVHOSP Okinawa ltr 6470 Ser OQF0/07016 of 31 Aug 10. (Am. 3~: Add LCDR H. A. Hobos, MC as AU for outpatient hyperthyroid therapy and diagnostic studies under 10 CFR 35.392 uses.)

s. NAVHOSP Okinawa ltr 6470 Ser Ser OOF0/11226 of 22 Jun 11. (Temporary 60 day appointment of LCDR Matthew D. Daut, MSC as RSO from 17 June to 16 August 2011.)

T. NAVHOSP Okinawa ltr 6~70 Ser 064/11852 of 01 Aug 11. (Am. 33: Approve LCDR Daut, MSC as RSO, delete LCDR Parry,

MSC as RSO due to transfer.)


I • ./

Page :L of :/_pages OPNAVINST 6470.3

SUPPLEMENTARY SHEET------------------~

United States Naval Radiation Safety Committee

Radioactive Materials P9rmit PERMIT NO. 63-68470-llNP AMENDMENT NO.

33

21. The Command shall maintain records tor review by the Naval Radiation Safety Committee sufficient to document operational compliance with the above requirements and other conditions of this Permit.

DATB: /:2 AU&- cJ1) I I


Matthew David Daut Radiation Safety Officer, Physicist Naval Hospital Okinawa

Phone: (276)-250-3242 .......... lt"Jork: [email protected]

Detail orientated US Navy Radiation Health Officer with an eight year track record of superb radiation safety program management and leadership in a medical facility. Solid foundation and firsthand experience with diagnostic, therapeutic and palliative nuclear medicine administrations, high and low dose brachytherapy, permanent seed implants and NRC implementation for quantities of concern.

EDUCATION AND TRAINING: Bachelors of Science Nuclear Engineering Technology Thomas Edison State College••• Bachelors of Science Education, Valdosta State University, .. GPA: 3.82 Dade Moeller Medical Radiation Safety Officer Course, May 2011 X-Ray Performance Evaluation Course, Uniformed Services University of Health Sciences, February 2001 Radiation Health Officer, Naval Undersea Medical Institute, December 2000

PROFESSIONAl EXPERIENCE: US Navy Medical Service Corps Officer- Navy Lieutenant Commander

Radiation Safety Officer/Physicist June 2011- Present US Naval Hospital Okinawa, Japan Designated in writing by senior leadership to establish, maintain, enforce and control the only US Navy medical radioactive material license in Japan. lead, supervise and inspire 45 professionals in the safe use of radioactive material and radiation producing equipment for the Radiology Department. Continually review regulatory guidelines and maintain facility license current by use of amendments and notifications. Develop, facilitate and maintain training as detailed by facility license conditions and sustain As Low As Reasonably Achievable (ALARA) principals in clinical settings. Set agenda, coordinate and lead quarterly radiation safety committee meetings; keep senior management current on radiation safety program strengths, dosimetry results, issues and plans for improvement via committee minutes. Perform acceptance and periodic testing of all x-ray producing equipment for DoD facilities on Okinawa. • Recognized high risk radioactive material delivery procedure for material shipped from the United

States, analyzed, restructured and amended license to utilize host nation supplier. New process implemented local nationals for delivery eliminating Hospital liability and the need for a dedicated vehicle; saved $35k in annual radiopharmaceutical costs.

• Initiated and reengineered nuclear medicine documents and records for clarity and accuracy; implemented comprehensive review process that virtually eliminated administrative errors; changes cited by inspecting authorities as a major program improvement.

• Successfully completed 12 minor radiation safety program and dosimetry inspections with zero findings of concern.

• Trained seven Authorized Users, seven technicians, 45 emergency responders, 220 ancillary personnel and 1200 hospital staff using educational methods and detail commensurate with license conditions and audience.

• Maintain $15M capital equipment portfolio (including Symbia SPECT CT, Axiom Luminous suites,

Magnetom Espree MRI, Somatom Definition AS 64 Slice CT, Modularis, Uroskop, and Acuson ultrasounds) for the main hospital and six remote clinics; verify safe, continuous operation.

• Conducted and recorded eight semi-annual physical inventories of all radioactive material. • Served as technical expert to provide individualized education and risk analysis for local families and

teachers due to environmental concerns inherent to Okinawa. Demeanor and expertise proved invaluable during town-hall meetings.

PERSOI.JAL INFORMATION WAS REMOVED OY NRC. NO COPY OF THIS INFORMATION WM> RET AI NED BY THE NRC.

Assistant Radiation Safety Officer/Physicist March 2006- June 2011 US Naval Medical Center Portsmouth, Virginia Supervised safe handing and administration of radioactive material for a clinical and teaching nuclear medicine clinic specializing in diagnostic, therapeutic and palliative administrations and written directives. Trained, led and motivated 15 highly diverse and professional technicians in the safe storage, use and control of radioactive material. Directed radioactive material training, safety and control for permanent seed implant and brachytherapy operations. Managed dosimetry, medical screenings, ALARA practices for radiology, main operating room, interventional radiology, cardiac catheterization, and complex pain management clinics. Assisted Radiation Safety Officer in filing license amendments and submitting program notifications. Developed, facilitated and maintained radiation safety and radioactive material training. Coordinated regulatory agency inspections and served as point of contact. • Presented Navy and Marine Corps Commendation Medal for superb radiation safety program

oversight and deficiency free audits for five continuous years. • Awarded Navy Achievement Medal for filling a five-week critical manning shortage and saving

thousands in outsourcing costs by recertifying a inoperable x-ray suite for northeastern Navy medical facility.

• Trained three Authorized Users, 23 technicians, 33 emergency responders, 300 ancillary personnel and 3600 hospital staff using educational methods and detail commensurate with license conditions and audience. Training program cited by inspecting agency as best in Navy Medicine.

• Served as clinic coordinator for two Siemens Symbia nuclear medicine camera installations, ensured smooth, on time installation.

• Issued, collected and mailed 330 dosimeters for personnel and area monitoring every six weeks; identified personnel of concern and implemented additional controls. Ensured personnel was maintained within federal limits; results reported to senior management.

Radiation Health Program Manager/Medical Department Division USS Frank Cable (AS 40}, Agana, Guam

October 2004- March 2006

Supervised issuing, collecting, on-site processing and recording of dosimetry required for nuclear repair divisions, non-destructive testing teams, divers and medical personnel on a deployable submarine repair platform. Managed exposure recording and reporting and medical screening for assigned and visiting radiation workers. Facilitated audit and program evaluations from external regulatory agencies and was designated as point of contact. • Awarded Navy and Marine Corps Commendation Medal for sustained flawless program

management. • Facilitated training with local medical facilities to improve response for industrial casualties;

significant improvements recognized by external agency inspectors.

Radiation Health Program Manager February 2001- March 2004 Naval Intermediate Repair Facility, Washington Managed dosimetry and medical screening programs for six divisions for an industrial repair. Facilitated external agency inspections and served as point of contact. Served as liaison with Puget Sound Naval Shipyard regarding exposure reporting, bioassays and regulatory concerns. • Earned Navy and Marine Corps Commendation Medal for sustained superior program management

and dosimetry operations for three years. • Issued, collected and mailed dosimetry for over 400 personnel distributed over seven divisions every

six weeks to the Naval Dosimetry Center; processed, reported and filed results.

ADDITIONAL INFORMATION: Highly proficient with MS Office, advanced programmer in Access, certifications in quality assurance, hazardous materials transportation, Lean Six Sigma (Green Belt), and Root Cause Analysis. Advanced diver certified, enjoy mountain biking and most sports.

Page2of2

SIEMENS XX1 RADSAF 8 Hour Radiation Safety Course Outline

Healthcare

Radiation Safety Course Description: Radiation Safety is for Field Service Engineers training to handle Radioactive Sources including those for standard Nuclear Medicine and PET cameras. This is an 8 hour Instructor Led course covering Radiation Safety Training for Radiation Workers. Lecture topics include Liquid and Sealed Source safety, ALARA rules and Work Practices. There is a test at the end of the day. There will be a photo badge for Siemens Employees stating that the individual has been trained and is allowed to work with Radioactive Sources. This badge certification validation will be good for 3 years from the date of the training.

Target Group: This is an entry-level class for those servicing Molecular Imaging Systems. Learning Target: • Understand principles of ALARA and RAD Safety • Understand what is involved in using Radioactive Source • Understand the basic principles of Radioactive Materials • Know rules regarding transport of Radioactive Source • Safety around and handling of sources National, State and Siemens rules on dosimetry • Understand do's and don'ts • Know the governing body over Radioactive Source • Use R=6CE(f)/r2 rule to determine dose limits • Know limits regarding Dosimetry • Understand the basic principles of Radioactive Materials • Know rules regarding transport of Radioactive Source, Safety and handling sources • National, State and Siemens rules on dosimetry • Know the governing body over Radioactive Source • Know limits regarding Dosimetry

Prerequisites: None

Contents:

• Risks and Biological Effects • Principles and practices of radiation protection. • Radioactivity measurement standardization and monitoring techniques and instruments. • Mathematics and calculations basic to the use and measurement of radioactivity. • Biological effects of radiation. • Safety Practices and Procedures • Natural and Man-Made Sources • Radiation Contamination • Atomic Structure • Radiation Measurement and Monitoring Techniques and Instruments • X-Ray Fundamentals, Calculations and Mathematics to Determine Radioactivity. • Source Descriptions Radionuclides • Test and Review



SIEMENS Health care

Notice: Please note this is required training for USA employees and Dealers of Siemens prior to attending Ml training. Our North Carolina RAM license requires that attendees must have 8+ hrs of Instructor Led Radiation Safety training. This must have been done within the last 3 yrs.

Duration: 8.00 hours



SIEMENS Healthcare

NM1 PETBAS Course Outine

Course Description: This course is designed to give a Service engineer the basic knowledge of Positron Emission Tomography and to supply the basic knowledge needed to safely engage in service evolutions of PET systems. Supply the common basic technical and service applications information need to attend system specific training.

Target Group: Customer Service Engineer, Installation Service Engineers,Technical Support Engineer and Inhouse Service Engineers who will be responsible for the installation, troubleshooting, repair, and calibration of Siemens Positron Emission Tomography systems.

Learning Target:

• Introduction in PET basics and Technology. • Generation of fundamental physical-technical understanding of PET. • Understanding of basic measurement and evaluations technique used in PET. • Performing basic PET system operations in customer and service mode. • Knowledge and basic experience of PET Service Manager. • Test and Adjustment software packages.

Contents:

• Introduction into Service Documentation • Safety/Radiation Protection • Essentials Nuclear Medicine Physics • PET Basics • PET Image Calculation and Reconstruction • PET Calibration • Overview of the different Biograph-Systems • Daily PET/CT Quality Check

PET Service Tools and Diagnostics

Notice: Designed as one of the modules required to complete the Biograph System Training.

Duration: 5.00 days


Tel.. +1-919-319-2900 www.usa.siemens.com/healthcare

SIEMENS Health care

NM1 NMBASIC Course Outline

Course Description: This course is designed to give a Service engineer the basic knowledge of Nuclear Medicine imaging and to supply the basic knowledge needed to safely engage in service evolutions of Nuclear Medicine systems. Supply the common basic technical and service applications information need to attend system specific training.

Target Group: Customer Service Engineer, Installation Service Engineers,Technical Support Engineer and Inhouse Service Engineers who will be responsible for the installation, troubleshooting, repair, and calibration of Siemens Nuclear Medicine imaging systems.

Learning Target:

• Introduction in Nuclear Imaging basics and Technology • Generation of fundamental physical-technical understanding of Nuclear Medicine

Imaging • Understanding of basic measurement and evaluations technique used in Nuclear

Medicine Imaging • Performing basic Nuclear Medicine system operations in customer and service mode • Knowledge and basic experience of Nuclear Medicine Imaging Systems Test and

Adjustment software packages

Contents:

• Principles of a Gamma Camera • Radiation Safety • Principles in Nuclear Medicine • Siemens Ml Product Line • What is Tuning and peaking • Principles in calibrating an NM Detector • How to acquire an Image and check the Quality • Principles in operating a Gamma Camera • Applications of Nuclear Medicine

Notice: **FOR THOSE ATTENDING THIS TRAINING IN THE USA ONLY: Our North Carolina RAM license requires that attendees have 8+hrs of instructor led Radiation Safety training within the last 3 yrs in order to attend Ml training in Cary, NC. USA only: Upon successful completion of this course, the Siemens employee is a "Qualified Electrical Safety Worker" and is authorized for Lock Out Tag Out, as long as they stay current on the EH&S training listed in the prerequisites. FDA Regulation 820.25 (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Duration: 5.00 days



Siemens Medical Solutions USA, Inc. Copyright© Siemens AG 2013 All rights reserved

~ CX RC-US Working with Radioactive Calibration Sources and Radiation E190-3

Generating Machines SOP

Restricted

Table of Contents

Change History ..................................................................................................... 2 Document Support ................................................................................................ 3

Purpose ............................................................................................................. 3 Scope ................................................................................................................ 3 Reference ......................................................................................................... 3 Definitions/ ........................................................................................................ 3 Acronyms .......................................................................................................... 3 Prerequisites ..................................................................................................... 4 Responsibilities ................................................................................................. 4

Radiation Exposure Monitoring (REM) Badges .................................................... 9 Radioactive Spill Procedures and Emergencies ................................................. 12 Records and Attachments .................................................................................. 15

Records ........................................................................................................... 15 Electronic File ............................................................................................................ 15

Attachments .................................................................................................... 15

Uncontrolled Document when printed. Signature on file. Page 1 of 15 Verify current revision prior to use.

Bob Verburgt Process Owner Signature/ Date

Dea Dougherty - Director EH&S QA Rep. Signature/ Date

2041-6

CX RC-US Working with Radioactive Calibration Sources and Radiation Generating Machines SOP

E190-3

Change History

Revision Effective Page Description of Change Level Date

00 01/15/04 all Initial Release B 04/1/05 10 Changes to 7.11 and removal of order form (no longer

needed) 1 10/18/07 All Initial release to new document management system.

Changed document number from SSG/SVC SOP 5.0/159 to 0159. No training required for this version.

2 3/27/09 3 Updated reference doc from WI 5.0/54 to Livelink # 0411, QP 4.19/09 to Livelink # 2002

2 3/27/09 5 Updated doc QP 4.19/09 to Livelink # 2002 2 3/27/09 No training required 3 3/24/14 All Changed document number from 0159 to E190. . Added

emergency response procedures, updated process and responsibilities based on organization changes and dosimetry provider changes and removal of radioactive materials from the field. The 8-Hour Radiation Safe Worker Training will be updated to include these changes. In addition, a "read and understand" task will be created via Learn@ Siemens.

Uncontrolled Document when printed. Please verify current revision prior to use.

Page 2 of 15

2041-6


E190-3

Document Support

Purpose

Scope

Reference

Definitions/ Acronyms

The purpose of this SOP is to describe how to work with a sealed radioactive calibration source for Radioactvie Material Handlers and how to install, repair, sell radiation generating machines

This SOP applies to CX-RC US employees within Siemens Medical Solutions USA, Inc. who are designated and qualified to handle radioactive materials or generate x-ray.

The reference section lists any other documents supporting, having impact, or are necessary for the execution of the document.

Document Number Document Title E131 Environmental Health and Safety Guide 2002 FDA Report of Assembly of Diagnostic X-Ray

Systems (Form FDA 2579) for CX-RC US QT ARTD part 2 - ARTD - Working with Radioactive Calibration Sources 002.731.06.00 E032 CX RC- US Personnel Dose Monitoring SOP

This section contains definitions and acronyms for this document.

Word/Acronym Definition A LARA As Low as Reasonable Achievable CRSO Chief Radiation Safety Officer CSE Customer Service Engineer DRSO District Radiation Safety Officer LRSO Local Radiation Safety Officer Ml Molecular imaging - includes PET, SPECT NMG Nuclear Medicine Group, Hoffman Estates, IL. PET Positron Emission Tomography RAM Radioactive Materials Radioactive Material Siemens CX RC-US employees that are Users required to handle radioactive material for

installation, calibration or repair of imaging or therapy systems. Job titles would include but are not limited to CSEs, TSEs, IM/CP Trainers, and Clinical Applications Specialists.


Page 3 of 15

2041-6


E190-3

REM Radiation Exposure Monitoring RGM Radiation Generating Machines RGM Personnel Siemens CX RC-US employees that are

required to sell, install, repair or disassemble radiation generating machines. Job titles would include but are not limited to CSEs, TSEs, IM/CP Trainers, Clinical Applications Specialists and Sales.

RO Radiation Oncology RSM Regional Service Manager RSO Radiation Safety Officer SAP Software use for purchasing, receipt of goods

and service call tracking. SOP Standard Operating Procedure SPECT Single Photon Emission Computed

Tomography TSE Technical Support Engineer

Prerequisites The prerequisites section lists what is necessary, suggested, or required prior to carrying out the function in the document.

I Type Column Title Here None

Responsibilities The responsibility section states which functions are responsible for the tasks described in the document and what roles they are expected to fulfill.

Function Name


2041-6

Responsibility

Page 4 of 15


E190-3

Radioactive Material Licensing and Radiation Producing Machine Registration

This section applies to requirements for registration of radiation producing devices and licensure of radioactive materials in DEMONSTRATION- SALES -INSTALLATION and SERVICE of machines in all states and territories of the United States of America.

The Chief Radiation Safety Officer is responsible for obtaining registrations and licenses for radiation producing devices and radioactive sources used in machine calibration.

Registration and licensing is required to establish compliance with State and Federal regulation regarding radiation emitting devices.

States and territories have different registration and licensing requirements. In all cases where it is known that a license or registration permit is required, but not available for Siemens work, the Radiation Safety office will be notified as soon as practical in order to facilitate work in that state. It is the responsibility for the Regional Service Manager for that region to ensure that work is not done where Siemens is not registered or licensed for that work.

In some states or territory, any new service personnel must be added to the registration or license before they are able to work in that state or territory. This process may take 45 to 60 days and require fees. RSM or Manager Notify the Radiation Safety Office to start this process for any new workers to a state or territory. Any new personnel must have training, experience, and dosimetry in order to be approved by the state regulatory agency.

The CRSO will attempt to register or license work in any state or territory but may not be able to get registration or licensure unless notice is available at least 45 days before any planned work.

In some states licensure reciprocity is held against the Siemens North Carolina radioactive material license. In those states where reciprocity was obtained, the state radiological control agency must be notified at least three days before work in that jurisdiction. It is the Responsibility of the District and Local Radiation Safety Officers, Regional Service Managers, Technical Service Engineers, and Customer Service Engineers to ensure compliance with registrations, licenses, and state and federal regulations.

Untrained personnel must not work on radiation generating machines or radioactive material.

Siemens personnel are not authorized to: • Order radioactive material for use at a customer site. • Use radioactive material at a customer's site without customer

authorization. • Remove radioactive material from a customer's site.

• Transport or assist in the transport of radioactive material unless they have proper training.

• Draw radioactive sources in hot labs

Un nntrnll<>rl nnr1 •rn<>nt \Aih,~n nrint<>rl ,. Please verify current revision prior to use.

2041-6


E190-3

Document Support, Continued

Responsibilities, continued

Function Name Responsibility Radiation Exposure Monitoring This is a requirement and responsibility for all who work on (REM) Badges radiation generating machines or work with radiation sources to

have and wear a Radiation Exposure Monitoring badge.

If you do not have a badge you cannot work on radiation generating equipment or with radioactive materials.

Executive Management Executive Management is responsible for providing the staffing and resources necessary to ensure the effective implementation and application of the Radiation Safety program as well as overall compliance to requirements for RAM and RGM.

Director of Service Quality Director of Service of Quality is responsible for providing an active Radiation Safety Program, RAM licensing, RGM registration and Radiation Exposure Monitoring for Siemens Medical Solutions USA, Inc. Service Group.

Chief Radiation Safety Officer CRSO is responsible for obtaining registrations and licenses for radiation producing devices and radioactive sources used in machine calibration.

Registration and Licensing is required to establish compliance with State and Federal regulation regarding radiation emitting devices

Regional Service Manager Regional Service Managers are responsible for direct supervision of CSEs and their compliance to the licensing or registration requirements for RAM and RGM.

RSMs are responsible to ensure that work is not conducted where Siemens is not registered or licensed for that work.

RSMs are responsible to notify the CRSO of new workers in their area, 45 days prior to their work start.

In addition, RSMs must notify the CRSO when a CSE changes modalities effecting their REM badging or radiation safety training requirements or their coverage within the region changes to where they cover a different state or state(s).

RSMs shall ensure that all employees who work on or could be exposed to radiation as a normal part of their job wear the required REM badge.

RSM is responsible for the timely reporting of radiation exposure, ensuring radiation training and technical training completion in adherence to license or registration conditions and timely reading or return of REM badges.


Page 6 of 15

2041-6


E190-3

Local or District Radiation Safety Officer

The Local (LRSO) or District Radiation Safety Officer (DRSO) is responsible for administration of the radiation safety program in the local area or state where they are assigned, which includes being the technical resource for licensing, registration and dosimetry within their coverage area.

LRSO and DRSO serve as a local contact for state regulators where required.

LRSO and DRSO assist the CRSO or proxy in maintaining RGM and RAM licenses, audits and compliance to the radiation safety program.

Continued on next page


Page 7 of 15

2041-6


E190-3

Document Support, Continued

Responsibilities, continued

Radioactive Material Users and Radiation Generating Machine Personnel

Responsible for wearing a REM badge when working and timely submission or reading of the REM badge when required.

If you do not have a badge you cannot work on radiation generating equipment or handle RAM. To handle RAM you must also have ring badges that can be obtained by contacting the CRSO or his proxy.

Comply with all regulations in regards to RAM and RGM. Comply with all safety requirements when working. Safeguard all RAM assigned to them by the customer

Do NOT store RAM.

Immediately inform the CRSO at 800-546-7494 and facility RSO if a serious incident occurs (loss, theft, flood, or fire)

Maintain a record of their radiation exposure per the REM badge program.

Complete 2579 installers report whenever installing a RGM, per doc # 2002 FDA Report of Assembly of Diagnostic X-Ray Systems.

Ensure radiation and technical training completion within the prescribed renewal period

Adhere to the ALARA principles of reducing exposure by time, distance and shielding


Page 8 of 15

2041-6


E190-3

Radiation Exposure Monitoring (REM) Badges

Radiation Exposure Monitoring Badges (REM)

1.1. Radiation Exposure Monitoring (REM) Badges This is a requirement for all who work on radiation generating equipment or work with radiation sources. If you do not have a REM badge you cannot work on radiation generating equipment. If you handle RAM then you must also have ring badges.

Maximum Exposure permitted

• Maximum exposure to ionizing radiation shall be restricted to 5000 millirem total effective dose equivalent per year.

• Any exposure reading exceeding 100 millirems in any single quarter shall require an exposure investigation; the investigation will be conducted by the CRSO.

• Any whole body exposure exceeding 1000 millirems shall require that the exposed person be removed from a work environment that may potentially expose them to further ionizing radiation until the investigation of this exposure is complete and the CRSO authorizes return to work, unless justification is otherwise documented. The most senior executive of the Service organization will be notified in writing of the individual temporarily removed from service operations.

Type of Monitoring

• Whole Body (J1 type) or lnstadose Badge (All Modalities) • Fast Neutron (P1 type) (RO Modality) • Extremity (Ring) (RO and Ml Modality) • Chirper (RO Modality, if desired)

Frequency

• Quarterly • Wear Periods: January 1 -March 31, April 1 -June 30, July 1 -

September 30, October 1- December 31

Vendor(s)

• Mirion Technologies- Whole Body Clnstadose)

• Global Dosimetry- Fast Neutron - TLD and Extremity

Ordering/Replacing/Terminating REM Badge service

First Time Ordering/Initiating Participation First time ordering will be initiated by the CRSO through the onboarding process and/or new employee orientation or manager request.


Page 9 of 15

2041-6


E190-3

Replacing a Lost/Stolen or Broken REM Badge If an individual has lost his/her REM badge or it is stolen the individual shall initiate a search for the dosimetry and complete Lost/Stolen Dosimetry Report. A dose estimate will be calculated for the period of missing monitoring. The CRSO will then request a replacement dosimeter upon completion of a dose estimate.

Terminating Participation Upon termination of an employee participant in the REM badge program, the immediate SUPERVISOR IS RESPONSIBLE to terminate the participation of the individual in the badge program by obtaining the REM badge, ring badges etc and returning them to the CRSO.

Reporting Exposure

REM badges (wear and control badge) MUST be returned to the vendor for analysis within 14 days after the end of the wear period. This will enable the vendor to generate an exposure report. Failure to return the REM badge or read your lnstadose badge may result in disciplinary action, up to and including, termination.

The exposure report is sent to the REM badge wearer in the following ways.

lnstadose- the REM badge wearer will download their exposure report quarterly and their Form 5 annually.

Global Dosimetry- the REM badge wearer will download their exposure report quarterly. The REM badge wearer Form 5 will be sent by mail annually.

THIS DOCUMENT SHALL BE MAINTAINED BY THE EMPLOYEE AND BE AVAILABLE FOR INSPECTION.

1.2. Training The following are training requirements for radioactive material handlers.

• Radiation physics and instrumentation • Radiation protection • Mathematics pertaining to the use and measurement of activity

• Biological effects of radiation

The training must be a minimum of 8 hours of formal course work.

Training will be documented in TC Manager and proof of training will be provided by wallet card by the Training and Development Center.

1.3. Radioactive Material

Radioactive sources that contain radionuclides such as 68Ge; Germanium lsoto~e rods, phantoms containing 68Ge; Germanium sources, 99mTc, 15 Gd, etc., are all responsibility of the customer.


Page 10 of 15

2041-6


E190-3

For each use of these sources, the Siemens CSE shall ensure that the sources are protected from damage, theft, and loss while they are being used and ensure that a customer representative will be available for return of the source(s) that are used at the customer's facility or arrangements are made to return the sources to a secure location identified by the customer.

Siemens Medical Solutions, USA Inc., does not at any time own or take custody of these materials so as a practice is not licensed for this material. They are never under Siemens' control away from the customer's facility. The customer's RSO is responsible at all times for all RAM listed under their license.

Siemens personnel are not to handle the radioactive sources in the Service Process without the Customer's RSO knowledge I supervision (RSO for the valid license holder).

These sources are the responsibility of the Radiation Safety Officer who holds the license (customer). The customer's RSO or their representative must authorize any work associated with these sources.

The Siemens employee must have been properly trained on the source in question in order to handle the source under the RSO's supervision. Without documented training in the following areas the CSE cannot handle the source:

• Proper handling • Health Hazards • Isotope specific information/data

1.4Phantom/Rod Sources for PET Equipment Covered by Contract I Sources for Profile option Covered by Contract

• CSEs will not order radioactive material for the customer. This section is included to guide a for providing information to the customer.

• The Contract Administrator in the Processing Center identifies/verifies if Source Replenishment is included under the terms of the service agreement, and creates a Purchase Order with the source Vendor for one replenishment per year of service agreement (two replenishments per year of service agreement for NM Profile option).

• The PM Coordinator schedules the PM with the Customer and CSE.

• If the customer contacts the CSE about source replenishment. The CSE contacts the PM coordinator or Processing Center about the PET Source Replenishment, to ensure delivery of the radioactive material to the Customer at the appropriate place and time. The Customer will be required to provide a copy of their Radioactive Materials (RAM) license to the Vendor, prior to receiving shipment of replenishment sources. A new Purchase Order for the Vendor is generally not required, since a Purchase Order has already been established by the Processing Center for the source replenishment under the terms of the service agreement. The Vendor will contact the Processing Center for proper invoicing.

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E190-3

• For replenishments that fall outside the normal PM scheduling process, the CSE should contact the RSM or Contract Administrator to verify that source replenishment is covered in the Service Agreement, prior to ordering sources from the Vendor.

• The Vendor ships the RAM (Radioactive Material) to the customer's site RSO under the customer's license at the address specified in the customer's RAM license. Customer's site RSO inspects the RAM, inventories and leak tests (swipe test) the RAM in accordance with the customer's license, At no time will a service employee inspect and receive, inventory or perform a wipe test on customer owned RAM.

The Siemens service employee provides access to replace the rods/sources. The RSO (customer) or their representative must oversee all operations in which the RAM is handled. The CSE must be trained in Proper handling, Health Hazards and Isotope specific information/data in order to replace RAM acting as an agent of the License holder's RSO (customer).

The Customer's Site RSO returns RAM to the Vendor. The Customer's Site RSO signs all shipping documents. Siemens service employee may not sign any shipping documents for the customer. The return of the material must be done by the customer's site RSO or designated representative.

1.4. Return/Disposal

All Sources are the responsibility of the owner.

1.4.1.Customer Material

No Returns to Siemens for disposal. Disposal is COMPLETELY the customer's responsibility CSE can not sign any shipping documents or package /label for shipment All required testing (leak test, field survey) is reasonability of the owner I RSO (customer) indicated on the license for the material.

Radioactive Spill Procedures and Emergencies

2.1 General Guidance

When an emergency situation is identified, SMS employees will immediately notify the customer so that actions may be taken to protect other employees, patients, and members of the public.


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E190-3

SMS employees will follow directions provided by the customer for any emergency action upon agreement with the Siemens RSO.

In the case of spills of radioactive materials, the SMS employee will provide assistance to the customer RSO if the Siemens RSO determines that the SMS employee is suitably trained in decontamination techniques and the customer requires that assistance.

Access to hot labs shall be at the request of the customer.

Siemens CSE's shall not prepare radioactive solutions. All work with unsealed radioactive material must be done by the customer and provided to the SMS CSE as a contained radioactive solution. The CSE shall take precautions to prevent spillage of the radioactive liquid such as movement to the work site in a container with sufficient absorbent to contain the entire liquid volume if the container should fail.

2.2 Decontamination of Areas Contaminated with Radioactive Material

Spills or transfer of radioactive liquids to surfaces of devices, furniture, or floors shall be immediately identified to the customer RSO and assistance provided as indicated previously in this section.

2.3 Decontamination of Customer/Siemens Personnel Contaminated with Radioactive Material

Any contamination of site or Siemens personnel with radioactive material shall be immediately reported to the customer RSO and the Siemens RSO. The customer RSO shall initiate emergency actions in accordance with the customer's radioactive material license. The customer RSO will take actions as necessary to remove contamination from skin surfaces and retain clothing for decay in storage as required.

Guidance for removal of radioactive contamination from skin surfaces:

1. Initially and periodically throughout the decontamination readings of the contamination level on the skin surface should be measured and recorded to allow for skin dose determination. 2. Cover non contaminated areas of skin or clothing to prevent cross contamination due to the decontamination of the affected surfaces. 3. Set up a tray or other large container with absorbent material to collect the drippings of contaminated water from washing the contaminated skin surface. 4. Using a mild- non-caustic- non-abrasive soap and warm water, wash the affected area with a minimum of water while making suds on the contaminated location. Wipe frequently with a dry absorbent material. Do not scrub the skin and do not exceed three minutes wash time. 5. If contamination remains on the surface after washing, cover the affected area with a moisturizing skin cream and a rubber glove or other means to contain the cream without possibility for cross contamination.

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E190-3

6. After several hours, wash the cream off of the skin surface and monitor the skin to determine if the decontamination was effective. 7. Repeat with more skin cream. If the contaminated individual must leave the facility, then the surface should be covered to prevent transfer of contamination from the skin and the skin cream washed off periodically to remove the contamination.

If clothes or personal property are contaminated, they will be controlled in accordance with the customer's radioactive material handling procedures.

2.4 Emergencies

CSEs are instructed to contact the customer/site RSO and Siemens CRSO at 800-546-7494 and their supervisor if any unexpected emergencies arise. When necessary, appropriate notification will be made by the customer to the customer's licensing agency to inform them of the nature of the emergency. If work is being conducted out-of-state under a reciprocity agreement, the appropriate state regulatory agency or the US Nuclear Regulatory Commission may be notified if required. The Siemens CRSO should be notified for any such situation.


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Records and Attachments

E190-3

Records The records section lists the specific records that are created from the instructions detailed in this document. This section also lists any special disposal requirements for the records.

Record Record Location Record Owner Retention Period Identification License I Electronic File CRSO Min. of 5 years Registration Radiation Exposure Electronic CRSO 30 years plus Monitoring (REM) File/Secure Web- employment

site/Hard File

Attachments Any supporting information for the process should be attached in this section.

None


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Page 15 of 15

SIEMENS Healthcare

CX RC-US Memorandum of Understanding Regarding Service Provider Use of Radioactive Material

Dear Valued Siemens Customer,

Monday, August 11, 2014

We know you share our commitment to workplace safety and risk minimization and, more specfically, the safe management of radioactive materials at your sites. Proper control of radioactive materials is crucial, and we want to assure you that our Customer Service Engineers are required to follow established Siemens standard operating procedures for working with radioactive material while on your site(s), to ensure adherence to ALARA principles including radiation dosimetry.

In addtion, we want to advise you of processes and support our Customer Service Engineers can provide in the management of radioactive materials as detailed in our service agreement between the customer and Siemens. These actions include:

Accepting pre-made sources for testing/calibration from onsite (customer) personnel. Pre-made sources may include:

Tc- 99m (Technicium) Tl-201 (Thallium) 1-25 (Iodine) Other radionuclides as available and licensed

Using pre-made sources for testing/calibrations prepared by onsite (customer) personnel: In accordance with site license In accordance with site procedures In accordance with manufacturer's instructions In accordance with Siemens procedures

Returning pre-made sources to onsite (customer) personnel, including: Physical return to site personnel Return to storage/decay area as designated by authorized site personnel

Accepting solid/sealed sources for testing/calibration from onsite (customer) personnel. Sources may include:

Co-57 Gd-153 Ge-68 Cs-137

Using solid/sealed sources provided by onsite (customer) personnel for testing/calibration.

Replacing solid/sealed sources in holders inside systems (i.e. Ge-68/Cs-137 in ECAT, Gd-153/Co-57 in Symbia).

We also want to clarify restrictions our Customer Service Engineers have for managing radioactive materials. To help ensure that limitations regarding service are fully understood, below are the services that our Customer Service Engineers cannot provide:


0739-01

221 Gregson Drive Cary, NC, 27511


Ordering of radioactive sources for a customer Receiving incoming source shipment Unboxing incoming shipment of radioactive material Performing leak test for new or old sources Inventorying sources for a license

Storing material in any way other than described above Drawing liquid source from any generating source Making usable dilution of liquid source by changing from one vessel to another or adding solution Filling any phantom or mix solutions with liquid sources for testing Boxing sources for shipment Filling out shipping paperwork Transporting sources other than room to room at the same facility Removing sources from a facility Packaging sources or in any way participating in preparation of sources for transportation Shipping packaged sources Accepting unlabeled sources

- In certain circumstances, radiological surveys may be required to be performed by someone trained in their use from your organization. These surveys would be necessary during emergent situations like an accidental liquid source spill or in the unlikely instance where a source becomes trapped within the holder. The surveys would be performed using instruments your company already has listed on your Radioactive Materials License. Any survey records would be retained under the tiedown conditions detailed within your materials license. Siemens encourages all customers to perform surveys after maintenance Siemens performs which involves the use of radioactive sources.

Finally, it is important to note, as stated in Siemens license conditions, that you are responsible for the security and ownership of radioactive sources in accordance with all applicable regulations. Considering that safe management of radioactive materials is crucial, and that penalties for violations can be severe, regulatory requirements must be stricly adhered to.

We appreciate your business and look forward to continuing to support your equipment management efforts. If you have any questions or need additional information please refer to your Operator's Manual and/or agreement or contact your local service representative who is available to assist you. Our Siemens' Chief Radiation Officer Matthew Oaut is also available to answer questions with regard to use and handling of radioactive material, he can be reached at (919) 319-2952 or by email matthew. daut@siemens. com.

Best Regards

Mike Guin Vice President of Service Siemens Medical Solutions USA Inc.

Manual Rod Source Retract Procedure

Manual Rod Source Retract Procedure ECAT ACCEL, ECAT EXACT, and ECAT EXACT HR+ CPS P/N 9060017-01

This procedure outlines the process of manually retracting the rod sources when they have been left extended by a power outage.

Safety Considerations

1

In the event of a power outage, it is highly recommended that all nonessential personnel/eave the area until radioactive sources are secured within adequate shielding or retracted.

The procedure that follows must be implemented by the site's trained service engineer.

Tools and Equipment needed

Radiation survey meter

Medium Phillips-head screwdriver

Large flat-head screwdriver

Antistatic kit.

Antistatic precautions should be taken to limit the possibility of scanner damage due to ESD.

Procedure: If Power has been Restored

When power has been restored to the facility following a power outage, the scanner will come up in E-STOP mode. If the rods were extended when the power went out, they will remain extended when the power comes back up. The easiest way to determine if they are fully or partially extended is to check the front panel message. If the rod and septa positions are unknown, then the rods are at least partially in the field of view. On systems with EL front panels, determine if the rod source indicator light is blinking, indicating rod activity in the field of view. If power has been restored, the best practice is as follows.

1. Determine if the rods are in the field of view by checking one of the front panels.

2. If the rod and septa positions are unknown, reset the gantry by pressing either the reset button on the E-STOP box at the operator's console, or the reset button on the gantry entrance panel.

3. From an ECAT login command tool window, send the following command to retract the rod sources:

ecatcon:1>move -t -retract

4. After the retract process is complete, check one of the front panels to verify that the rods are indeed retracted, and to observe the position of the septa.

CPS P/N 9060017-01 Rev. F

2 Manual Rod Source Retract Procedure

5. If the septa position is "Unknown," the septa must be homed. Either press the "Remove Septa" softkey on one of the front panels, or type the following command at the console:

ecatcon:2>move -p -retract

The front panel softkeys can also be used to retract the rods and septa, but that requires getting relatively close to the sources. Use the front panel commands only if the console did not start back up in a cooperative state.

Procedure: If Power Has NOT been Restored

If power has not been restored to the system, the rods must be retracted manually. The procedure for doing this follows.

Note: The personnel performing this procedure will be exposed to ionizing radiation if the transmission rod sources are in the field of view.

1. Use the survey meter to determine if the rods are extended.

2. If the rods are extended, go to the next step. Otherwise there is no reason to continue.

3. Switch CB1 on the gantry entrance panel to shut off power to the scanner.

Should the facility power come back up in the middle of the procedure, gantry power must not be enabled.

4. Using the Phillips-head screwdriver, remove the screws holding the laser tunnel in place.

5. Carefully remove the laser tunnel taking care not to mangle the fingerstock or knock the lasers out of alignment.

6. Using the flat-head screw driver, loosen the lock-bolts holding the rear cover in place.

These need only be loosened to the point at which they yield. Turning them too much can break them!

7. Remove the back cover of the gantry.

8. Locate the stopblock as shown in Figure 1 (Page 3).

CPS P/N 9060017-01 Rev. F

Manual Rod Source Retract Procedure 3

& WARNING

Figure 1: A look at the shotbolt and stopblock as seen from the rear of the gantry with the back cover removed.

9. Manually move the shotbolt stopblock in a clockwise direction around the scanner's field of view.

The rods should begin to retract immediately.

1 0. Continue to move the stopblock until the rod-retract limit switch closes, indicating that retraction is complete. See Figure 2 (Page 4) for the location of the limit switch.

11. Use the survey meter to verify that the rods are indeed fully retracted.

12. Check the main circuit breaker inside the rear of the gantry (bottom center) to verify that it is in the "on" position.

This circuit breaker can open as a result of the power outage.

13. Replace the rear cover, being careful not to over-tighten the locking latches.

14. Replace the laser tunnel, again taking care with the fingerstock.

15. Flip CB 1 into the "on" position.

CB1 MUST be in the "on" position so that the gantry will come up at the same time as the chiller does. If the scanner is left off while the chiller is on, the condensation that occurs will wreak havoc as it is blown by the fans onto the gantry electronics when the gantry does finally come back up.

CPS P/N 9060017-01 Rev. F

4

Figure 2: Placement of the rodretract limit and kill switches with detail showing the limit switch. Note that the rods should NOT be retracted to the point where the actuator ring makes contact with the kill switch.

Manual Rod Source Retract Procedure

When the rods retract, their housings push back on the actuator ring. At some point, the actuator ring is pushed back into the limit switch, which is the determination of the fully retracted position. If the rods are retracted past the limit switch into the kill switch, the system will recognize it as a problem and not allow drive current to reach the drive motor.

CPS P/N 9060017-01 Rev. F

Siemens Medical Solutions USA, Inc. Copyright© Siemens AG 2013. All rights reserved.

CX RC- US Personnel Dose Monitoring SOP

E032-2

Restricted

Table of Contents

Change History ................................................................................................. 2 Document Support ............................................................................................ 3 Purpose ............................................................................................................. 3 Scope ................................................................................................................ 3 Reference ......................................................................................................... 3 Definitions/ ........................................................................................................ 4 Acronyms .......................................................................................................... 4 Prerequisites ..................................................................................................... 5 Responsibilities ................................................................................................. 5 Process Description .......................................................................................... 7 Dosimeter Requirements .................................................................................. 7 Records and Attachments .................................................................... 11

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Robert Verburgt Process Owner Signature I Date

Dea Dougherty Director EHS I Date

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CX RC-US Personnel Dose Monitoring SOP E032-2

Change History


1 10/28/10 All Initial release to document management system. Training was completed via Learn at Siemens Course# 00257114, prior to this document being made effective.

2 3/24/14 All Updated dosimetry contact information and acronyms due to organizational title/role changes and updated responsibilities to include an organizational change. Added information concerning losUdamaged badges, exposure investigations and off-boarding. A read and understand task will be deployed via Learn@Siemens.

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Document Support

Purpose

Scope

Reference

• To provide a procedure for monitoring personnel occupational dose • To comply with 1 0 CFR 20 .1502( a) • To identify the "Badge Vendor" currently as Dade Moeller and

Associates, contact information: Dade Moeller and Associates 438 N. Frederick Ave Gaithersburg, MD 20877 Phone# 1-301-990-6006 x25 (direct) [email protected]

Dade Moeller will supply lnstadose Badges from Mirion Technologies, and TLD and Rings from Global Dosimetry.

The scope includes details for dosimeter use (types of dosimeters, ordering dosimeters, exchange or read frequency, placement of dosimeters, storage of dosimeters and receipt of new dosimeters from the Badge Vendor and reading or return of used dosimeters to the Badge Vendor as required) for CX RC- US identified personnel.

This document also lists other documents for the dosimetry program.

The Training and Development Center in Cary, NC has additional requirements and procedures.


Document Number Document Title 10 CFR 20.1502 Conditions requiring individual monitoring of

external and internal occupational dose Nuclear Regulatory Instruction Concerning Prenatal Radiation Commission Regulatory Exposure Guide 8.13 ARTD -002.731.02 Radiation Protection for X-Ray Systems EHSD 7.9 Radiation Protection Procedure E0 52 CX RC-US (IM/CP) Lost or Missing Badge

Report E0 53 CX RC-US (IM/CP) Erroneous Dose Results-

Personal Dose Equivalent Estimate

E0 54 CX RC-US (IM/CP) Level1 ALARA Investigation Form

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I


E0 55 CX RC-US (IM/CP) Level2 ALARA Investigation Form

E056 CX RC-US (IM/CP) Declaration of Pregnancy E0 57 CX RC-US (IM/CP) Occupational Exposure to

Embryo/Fetus E065 CX RC-US (IM/CP) Prior Occupational Dose

Request for New Employees E131 Environmental Health and Safety Guide E163 CX RC-US (IM/CP) Level3 ALARA

Investigation Form E164 CX RC-US(I M/CP) Level 4 A LARA

Investigation Form E198 CX RC-US (IM/CP) Dose in Excess of Limits



Word/Acronym Definition A LARA As Low as Reasonably Achievable Ancillary Worker Individual employed by Siemens who is

trained in radiation safety and often works in or around areas that use radioactive material or radiation generating machines. This group includes (but is not limited to) CSEs, PSEs, and PM Techs.

CAS Clinical Applications Specialist Chirper Personal dose monitor with active

alarm/notification assigned by Tool and Test CRSO Chief Radiation Safety Officer, overall

responsible for Radiation Protection Plan CSE Customer Solutions Engineer css Clinical Sales Specialists ex RC- us The sales, service, and logistic

implementation organization for Siemens Healthcare's portfolio of medical imaging, laboratory diagnostics, medical information technology, medical therapy, consulting, and services in the United States.

DPW Declared Pregnant Worker DRSO District Radiation Safety Officer, RSM

responsible for RAD Protection in the general area, over LRSOs

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IM/CP Imaging and Clinical Products ISE Installation Solutions Engineer LRSO Local Radiation Safety Officer, CSE

responsible for Radiation Protection in states or sites assigned

Ml Molecular Imaging ocs Oncology Care Systems PEH Prior Exposure History PET Positron Emissions Tomography PM (Tech) Project Manager- Technical PSE Product Sales Engineers Radiation Worker Individual employed by Siemens who is

trained in radiation safety and has the potential to work with radiation generating machines or handle radioactive material. This group includes (but is not limited to) CASs, CSEs, ISEs, TDC/Tis and TSEs

RAM Radioactive Material REM Radiation Exposure Monitoring RGM Radiation Generating Machine RSM Regional Service Manager TDC/TI Training & Development Center, Technical

Instructors TLD Thermoluminescent Dosimetry TSE Technical Solutions Engineer

Prerequisites Radiation Exposure Monitoring (REM) Badges are a requirement for all who work in customer locations on radiation generating equipment or work with radiation sources, or have the potential to work in areas where radiation may be present enough to potentially result in an occupational exposure as listed in 10 CFR 20.1502.

Badges are assigned by job classification until such a time as the individual or group of individuals in a specific job classification has been found to not fall under the potential listed in 10 CFR 20.1502. Badge types are assigned by type of work done, either with x-ray machines, radioactive material or Radiation Therapy systems.

Responsibilities The responsibility of wearing assigned dosimetry is not only a requirement by regulation, it is a safety function and company policy that must be adhered to for the protection of the employee, the company and the

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Page 5 of 24


customer on whose site the person is working.

Function Name Chief Radiation Safety Officer

Regional Service Manger

District Radiation Safety Officer

Local Radiation Safety Officer

Ancillary Worker

Responsibility • Responsible for the Office of Radiation Safety

and Protection and all of its functions including dosimeter ALARA Investigations.

• Responsible for implementing an active Radiation Exposure Monitoring Program for Siemens Medical Solutions USA, Inc. (CX RCUS)

• Responsible for direct supervision of CSE and their compliance to the dosimetry

• Implementing performance measures to aid and support dosimetry compliance

• Timely reporting of radiation exposure • Return of REM badges • Assure conformance to radiation work

prohibition for lost badges or exposures in excess of limits

• Responsible for overseeing the Radiation Safety Program for the area assigned to them.

• Assists CRSO with audits/inspections and dosimetry as required

• Assists CRSO in x-ray service provider renewals and RAM applications.

• Serves as a point of contact for Radiation safety questions and concerns

• Responsible for the radiation safety program in the local area or state including dosimeter compliance where required.

• Assists CRSO and/or DRSO with duties as required.

• Responsible for wearing a REM badge when working and responsible for its timely submission.

Note: If the Ancillary Worker does not have a badge, work in areas where radiation generating equipment or radiation sources are in use cannot be performed.


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Radiation Worker • Responsible for wearing a REM badge(s) when working.

VP Service

• Responsible for not losing or damaging dosimetry.

• Timely submission of the REM badge(s) when required.

• Timely completion of lost/damaged dosimetry report.

• Timely completion of exposure investigations • Turn in of dosimetry for off-boarding to the

CRSO or Dosimetry provider. Note: If the Radiation Worker does not have a badge or badges as described by work type, work with or in areas where radiation generating equipment or radiation sources are in use cannot be performed.

• Responsible for providing support and resourcing an active Radiation Exposure Monitoring Program for CX RC-US

Process Description

Dosimeter Requirements

Dosimetry Assignment

1. All CX RC- US Ancillary Workers and Radiation Workers who are required to enter potential radiation or radiological use areas must wear a whole body (ex: lnstadose or TLD) dosimeter if they are expected to receive an annual whole body dose of 1 mSv or more. The determination of who is required to wear badges will be kept by the CRSO.

2. All Ml Radiation Workers that handle radioactive sources must wear a TLD and two ring badges (left and right hand) for monitoring of their extremity dose when handling radioactive sources.

3. All Therapy Radiation Workers must have a TLD badge with a Neutron detector in their wear badge and two ring badges (left and right hand) for monitoring of their extremity dose when handling potentially activated parts, as well as a Chirper when in the radiation treatment room.

4. Employees that declare pregnancy in accordance with United States Nuclear Regulatory Commission Regulatory Guide 8.13, "Instruction Concerning Prenatal Radiation Exposure", will complete the Form E056 CX RC-US (IM/CP) Declaration of Pregnancy. These employees shall be required to wear a whole body badge and a fetal monitoring badge and will be limited to a whole body dose of 500 millirem for the course of their pregnancy. The dose should be controlled to minimize the monthly dose received, but typically they should not receive more than 55 millirem/month. Form E057 CX RC-


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US (IM/CP) Occupational Exposure to Embryo/Fetus shall be used to track the exposure of each declared pregnant female.

5. Any changes to current personnel (name, address, delivery information) can be made by the employee by contacting the Badge Vendor. Any new badge requests or changes in badging type must be made by contacting the CRSO.

Type of Monitoring

• Whole Body lnstadose Badge • Whole Body TLD Badge • Whole Body TLD with Fast Neutron (Therapy CSE and TSE

only) • Extremity (Ring) (Therapy, MI-SPECT and MI-PET Personnel

only) • Chirper (Therapy CSE personnel only) • Fetal Dosimetry for Pregnant Workers as requested in E056

Training

• Each individual receiving dosimetry will receive annual Radiation Safety training on radiation controls including the principle of ALARA.

Prior Exposure History

1. Prior Exposure History (PEH) must be obtained for each new employee from the individual's prior employer(s}, if monitoring was provided.

2. All new employees must complete E065 CX RC-US (IM/CP) Prior Exposure History Request and indicate that they did not receive exposure to radiation in previous work, or indicate all previous employers that provided monitoring. Form E065 will be used to document this information

3. When completed, fax or e-mail the Prior Exposure Requests to the CRSO. The CRSO will contact the individual's previous employers for completion of the PEH using the Prior Exposure Request.

4. The CRSO will keep a copy of each employee's PEH on file. 5. The CRSO will enter the employee's PEH into the Badge Vendor's

permanent exposure history for the individual.

Exchange Frequency/Reading

1. Whole body dosimeters must be exchanged or read quarterly (type dependent).

2. Ring badges must be exchanged quarterly. 3. Fetal monitoring badges will be exchanged on a monthly basis. 4. Wear Periods (quarters): January 1 -March 31, April 1 -June 30,

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5. The badge vendor will automatically send new badges with return envelopes within the last 2 weeks of the quarter. All badges must be mailed back to the vendor prior to the 14th day of the new quarter.

6. lnstadose badges are not returned to the dosimetry vendor quarterly like whole body TLD or ring badges are. They should be read at a minimum quarterly during the prescribed read period (generally the 15th of the closing quarter's month to 15th of the new quarter's month). lnstadose badges are returned to the RSO office or the dosimetry vendor at the following times:

• When the badge is damaged or stops working, • When requested to be sent back for QA of the badge, • When the badge is no longer needed for radiation work, or • When you are restricted from radiation work.

Initializing, Reading and Saving reports instructions for lnstadose

1. lnstadose badges are initialized and read via a USB connection on your computer.

Note: DO NOT CONNECT THE DEVICE UNTIL PROMPTED TO DOSO.

2. Upon receipt, you are instructed to take the Learn@Siemens course catalog number# 00257114. The Power Point will explain step by step process for each of the three required steps.

3. For touchpad users, an extension cable may be required to connect device, contact the CRSO for this device.

4. In applications where a stronger clip is required, contact the CRSO for an additional clip.

5. These devices are attracted by MRI systems, but are not a danger according to testing done by the MR factory in Germany. The device is not harmed by the magnetic field. If assigned the device, you must wear it even in the magnet rooms.

Lost or Damaged Dosimetry

1. Lost badges must be reported immediately to the CRSO

2. Employees must complete the E052 CX RC-US (IM/CP) Lost or Missing badge report and timely submit to the CRSO.

3. For lost or damaged dosimetry, the employee may not perform duties that would expose them to radiation until they receive a new badge.

4. An estimated dose will be calculated and applied to the employee's permanent dose record by the CRSO using E053 CX RC-US (IM/CP) Erroneous Badge Reading and Dose Estimate

Exposure Investigations

1. Investigations of ALARA triggers will be timely and documented on the


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following forms using the documented levels on those forms:

E054 ex Re-US (IM/eP) ALARA Level 1 ALARA Investigation Form • A message is sent to the worker to alert them regarding the

dose and request further information. A dose estimate that more appropriately reflects the worker's dose may be made. This is the most common ALARA level to be exceeded. The reason is primarily related to exposure of the dosimeter in checked luggage at an airport.

E055 eX Re-US (IM/eP) ALARA Level 2 ALARA Investigation Form • It is unusual that any Siemens workers would receive such a

dose; however, it does happen that a dosimeter may respond with a dose in this category. A message is sent to the worker to alert them regarding the dose and request further information. A dose estimate that more appropriately reflects the worker's dose may be made.

• This level may be indicative of a faulty dosimeter or a real situation of exposure that may or may not be associated with work on radiation producing devices or radioactive sources. The district or local Siemens RSO or eRSO will contact the worker to determine if there must be an action to change the way the worker is handling sources or exposed to radiation.

E163 eX Re-US (IM/eP) ALARA Level 3 ALARA Investigation Form • THE WORKER MUST STOP WORK WITH RADIATION

EXPOSURE

• It is unusual that any Siemens workers would receive such a dose; however, it does happen that a dosimeter may respond with a dose in this category. A message is sent to the worker to alert them regarding the dose and request further information. A dose estimate that more appropriately reflects the worker's dose may be made.

• This level may be indicative of a faulty dosimeter or a real situation of exposure that may or may not be associated with work on radiation producing devices or radioactive sources. The district or local Siemens RSO or eRSO will contact the worker to determine if there must be an action to change the way the worker is handling sources or exposed to radiation.

• This level may also be indicative of a situation that may be causing personnel an unacceptable dose due to inappropriate use of a radiation producing device or a radioactive source. The district or local RSO or eRSO will evaluate the field


Page 10 of 24

2041-6


situation and provide input to the evaluation of this exposure before the worker will be allowed to receive further radiation exposure.

E164 CX RC-US (IM/CP) ALARA Level4 ALARA Investigation Form • THE WORKER MUST STOP WORK WITH RADIATION

EXPOSURE IMMEDIATELY

• FURTHER EXPOSURE MAY CAUSE A DOSE IN EXCESS OF REGULATORY LIMITS

• It is unusual that any Siemens workers would receive such a dose; however, it does happen that a dosimeter may respond with a dose in this category. A message is sent to the worker to alert them regarding the dose and request further information. A dose estimate that more appropriately reflects the worker's dose may be made.

• This level may be indicative of a faulty dosimeter or a real situation of exposure that may or may not be associated with work on radiation producing devices or radioactive sources. The district or local Siemens RSO or CRSO will contact the worker to determine if there must be an action to change the way the worker is handling sources or exposed to radiation.

• This level may also be indicative of a situation that may be causing personnel an unacceptable dose due to inappropriate use of a radiation producing device or a radioactive source. The district or local RSO AND CRSO will evaluate the field situation and provide input to the evaluation of this exposure before the worker will be allowed to receive further radiation exposure.

2. Investigations where occupational dose limits are exceeded will be conducted immediately. All radiation work will be suspended for the employee while the investigation is being conducted. Notifications to the authority having jurisdiction will be made by the CRSO based on legal requirements.

E198 CX RC-US (IM/CP) Dose in Excess of Limits

• NOTIFICATION WILL BE MADE TO THE REGULATORY AUTHORITIES FOR THE STATE IN WHICH THE EXPOSURE OCCURRED OR NORTH CAROLINA IN THE CASE OF RECIPROCITY, OR THE NUCLEAR REGULATORY COMMISSION IN THE CASE OF A NONAGREEMENT STATE, US TERRITORY, OR FEDERAL


Page 11 of 24

2041-6


FACILITY by the CRSO.

Off-Boarding

1. Employees leaving the company will return their lnstadose dosimeter to the CRSO and their rings and TLD to the dosimetry provider.

2. For lnstadose a final reading will be obtained and an annual Form 5 will be sent to the employee's last known address.

For TLD Badges and TLD ring badges, the Form 5 will be generated by the dosimetry provider after the TLD badges have been processed. This may be as long as 60 days past the time that the badges are turned in for processing.


Records The records section lists the specific records that are created from the instructions detailed in this document. This section also lists any special disposal requirements for the records.

Record Record Location Record Owner Retention Period Identification Radiation File CRSO Length of Exposure cabinet/Electronic employment plus Monitoring (REM) 30 years Employee Dosimeter Record Prior Exposure File CRSO Length of History (PEH) cabinet/Electronic employment plus

30 years Radiation Safety Learn@Siemens LMS Length of Awareness employment plus Training 30 years ALARA Level 1 File CRSO Length of Investigation cabinet/Electronic employment plus Report 30 years ALARA Level 2 File CRSO Length of Investigation cabinet/Electronic employment plus Report 30 years


Page 12 of 24

2041-6


ALARA Level 3 File eRSO Length of Investigation cabinet/Electronic employment plus Report 30 years ALARA Level 4 File eRSO Length of Investigation cabinet/Electronic employment plus Report 30 years Dose in Excess File eRSO Length of of Limits cabinet/Electronic employment plus

30 years Declaration of File eRSO Length of Pregnancy Form cabinet/Electronic employment plus

30 years Erroneous Badge File eRSO Length of Reading and cabinet/Electronic employment plus Dose Estimate 30 years Fetal Dose File eRSO Length of Record cabinet/Electronic employment plus

30 years Lost or Missing File eRSO Length of Badge Report cabinet/Electronic employment plus

30 years

Attachments Any supporting information for the process should be attached in this section.

Attachment 1 E052 ex Re-US (IM/eP) Lost or Missing Badge Report Attachment 2 E053 ex Re-US (IM/eP) Erroneous Dose Results/

Personal Dose Equivalent Estimate

Attachment 3 E054 ex Re-US (IM/eP) Level1 ALARA Investigation Form

Attachment 4 E055 ex Re-US (IM/eP) Level2 ALARA Investigation Form

Attachment 5 E056 ex Re-US (IM/eP) Declaration of Pregnancy Attachment 6 E057 ex Re-US (IM/eP) Occupational Exposure to

Embryo/Fetus Attachment 7 E065 ex Re-US (IM/eP) Prior Occupational Dose Request

for New Employees Attachment 8 E163 ex Re-US (IM/eP) Level 3 ALARA Investigation

Form Attachment 9 E 164 ex Re-US (IM/eP) Level4 ALARA Investigation

Form Attachment 10 E 198 ex Re-US (IM/eP) Dose in Excess of Limits


Page 13 of 24

2041-6


Attachment #1 - E052, CX RC-US (IM/CP) Lost or Missing Badge Report Refer to Library for Current Version

SIEMENS CX I!~US(II.CP)Lo.torMhdng llldgt P:tport

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llapbytt ID.'IZ!gt Pld:t:JattNo: cc>''

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B1hadDou: TQIII'":*'•"A• "II"""Y M•t'•------RSO Nttes:

CRSO~e


Page 14 of 24

2041-6


Attachment #2 E053, CX RC-US (IM/CP) Erroneous Dose Results - Personal Dose Equivalent Estimate

Refer to Library for Current Version

SIEMENS CK ltC-US \IM/CP) lrroneous Dos• Jtasults- hrsonll Dos• (qulvat.nt lstlm••

lnOrdt:ttoCOmpl·t ~~ith I'WI:Uitt~N tellr'difl CIQrt monitr,ri'1 O'fpii'SOnntl o:-mmitnw1'11111'1: rra

pro~ ift dO: i nwtrt ~ pe 11on nel in nw rrr jcob ••sorias ..,. ht: 1'1: rwd iltion c~ per urt I in~oh•CI.

cour:t ot monitorirt ptt'l¢n!WI'I:Ir Ndilltient~pcuu' thll'l I an OCG:IIic!Wl t=ass ofti'M' imt>r n1ion duo 1<> lees eft"' lledCt dt naco 1<> t"' lie dCO O• pee"" Oft"' lie dCO tc fU:hl$ a n~·l'll·r nwehine atanairpott rraffunctionoftM C.dt:t Cluri'1 read in tnt tledCt.

:_:·_ ... __ <to_:'_:' ___ .

-··--·

C. 'til trtnir: estimate .... s coi•C11td 1n2 •·~-. h81ltd b't ------------·

109-:


Page 15 of 24

2041-6


Attachment #2 E053, CX RC-US (IM/CP) Erroneous Dose Results - Personal Dose Equivalent Estimate (Cont.)


Thil t>r m i in,oktd "hi n 1hl111 is 1 IQCs ofda'la thl1 m1.11 toll e nl!l11td into a .. or I.e r 1 rwcon:t to demo nrt1111a ~mplilnce ·,.·itn rwquirwmerm for monitori!J thl1 -.,orkert>r 111d iltcne• . The meti'IO<I mt&t De inl!l111cti.t "ith thl monitorw d ind i. id .. , to 1 n: urw thin II i~r ICCU1111a II pOls ibll,

a, In thl IQCI Of I dCG i me'la r or 1hllbili1:1 to 11110 thlt is not It Ill 11ttrit •I bilL This is I CISe "hl111 thl

thOle 11111:.

lfthi:

b. lfthl "one rca n not pro·. ides unlc:itnt int>rlllttc n 11111 n:t i!J thl •· pos ""' 111111 in -.oro. 111111 or thl

timu thltthl 1 111t 1 hi ·• tole n •· posed to raa iltion thl n it lilt 1 toll mc>N a as ira bll to tollst 1hl ir t•'lllrnel den equi.llllntonthl dCICI eq ui-1111nt1hltothlr .. orl:tr: 11t(lli.td on1hlir bldps d uri!J 1hl

pt l't)r 111t net of: i mitt r .. orl. It 1 imitt r times, It ir most des ira bll to ccttnir in'br 111ttion for multipll .. ortel'l:. LStthe ~-... or~.er: thltarw ~rciaerwa fOrtnr 1 •• l .. tion:

Nlmt: ttot: _______ r..1s:_,c _-' __ to_!_-' __

Name: ltot: _______ r..-,.::_:'- .'--to __ :--'--

ltot: _______ t:llrs: __ : _:' __ to_:' __ , __

lftni: methOd coulll not tollt&td e• pllin heN:

Other ptr.:onneldl'lll nota.aittbll: 0

Other ll•pltinj:

lOS·:


Page 16 of 24

2041-6


Attachment #3- E054, CX RC-US (IM/CP) Level1 ALARA Investigation Refer to Library for Current Version

SIEr.fieNS CX RC-US (IMICP) Level 11-J....AA.A Investigation Form l!edlellon Exposure

.....

... , ~<'~:~~> To: ~otM.J,t) p,..: GMt~ .. II)-CI.tP __ ,.Oatr·C!lO

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Dkt'~ ~tct•-.,·tatlad Ua )O'tbJOjt Ill cMdH baggaJti' ....

••

Page 17 of 24


Attachment #4- E055, CX RC-US (IM/CP) Level 2 ALARA Investigation Refer to Library for Current Version

SIEMENS

CXRCUS (MCP)Leval21t.MA.h-JtSigalcn R-.Exposure

.....

.,., jllftri'O., To: !)11~11~ r .. : ~-r!'-f}cl•fP-1 :lalt, Ottti•C31

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------------------------------------------------CdU.Wtat(IJibi ----. ....

Page 18 of 24


Attachment #5 E056, CX RC-US (IM/CP) Declaration of Pregnancy Refer to Library for Current Version

SIEMENS

I.

2.

CX RC-US (M.CP) Decbndcln of Pr~

ot .. :::·~· Plttl Oltlt aldwOit I"•'*"· I~

WM aiS ~X ~-110! llllllll:ll ratt<l II a.y· uct IIICKUll taut

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s. 1w• lltllnl ex !'C-Ut: Wllbt pmcala 'wwtula. ao btgtrprtgaaat


Page 19 of 24

2041-6


Attachment #6 E057, CX RC-US (IM/CP) Occupational Exposure to Embryo/Fetus Refer to Library for Current Version

SIEMENS G\

CX RC-US (M.CP) OeCQ)atlonJI ExpoiO'eto frnbryo,.,._.


Tracking Form

~--

~--

Page 20 of24


Attachment #7 - E065, CX RC-US (IM/CP) Prior Occupational Dose Request for New Employees


SIEMENS Gl

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lllliiXO«<iitct •• <txt •cotdlllt Stcllrlt( N_,.r or '.a:lllb• :::a,.:

fiOIU: ----------·-

Nallt: _______ _

roN: ______ _

D.JI!: _______ _

llnp~df~~:.:_______ U111t ______ _


Page 21 of 24

2041-6


Attachment #8- E163 CX RC-US (IM/CP) Level 3 ALARA Investigation Form


SIEMENS CXRCUS(MCP)LWII3PLAAA~ Form lllldllllon Elcpoaure

r.to: ,.,,f.t ~~~ To: {ti;t,t~~~ ftoll: t'h,Jfrtitlillt:PRT ltdaton sattt1 Ollc•·CSO

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'It&t dt'cd»"'VHI$UIItctttlt0fpt0Wit ~· atalt.JIIIIa.albtU .... .,. ....... 'yOH'Go4t.~

-----

Page 22 of 24


Attachment #9- E164 CX RC-US (IM/CP) Level 4 ALARA Investigation Form


CX RC-US (IM/CP) Level4 M...ARA Investigation Form

R_,ExpoiU'e

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...----

... ..,.

Page 23 of 24


Attachment #10- E 198 CX RC-US (IM/CP) Dose in Excess of Limits


S._MENS

CX RC-US (IM/CP) Dose in Excess of Limits ft8Ciallon !xpos11e

. ., ....

to": tin<(! ClbJ To: (11wllloif~l

n•., ~·'PI ••·voer•• tot .. (1:00UII:J5-~ ••ptrtldtat«:.,. •gUibry L .. a. nt tbltliltbl tkWI: )Off t!pl'tfit w. It lll§tt&JIIMV·In• 'b Udlll)t tlfClCtrt 111-. U•IH~$.

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, ...... llb:


Page 24 of 24

...

Siemens Medical Solutions USA Inc '

Copyright© Siemens AG 2013 All rights reserved

A CX RC-US Declaration of Pregnancy 0733-1

Restncted

Table of Contents

Change History .......................................................................................................................... 2 Document Support ..................................................................................................................... 3

Purpose .................................................................................................................................. 3 Scope ..................................................................................................................................... 3 Reference ............................................................................................................................... 3 Definitions/ Acronyms ............................................................................................................. 3 Prerequisites .......................................................................................................................... 4 Responsibilities ...................................................................................................................... 4

Policy Description ...................................................................................................................... 4 Introduction ............................................................................................................................ 4 Declaration of Pregnancy ....................................................................................................... 4 Required Documents .............................................................................................................. 5 Dosimetry and Fetal Dose Monitoring ..................................................................................... 5

Records and Attachments .......................................................................................................... 6 Records .................................................................................................................................. 6 Attachment ............................................................................................................................. 6

Uncontrolled Document when printed. Signature on file. Page 1 of 9 Verify current revision prior to use.

Sales Matt Daut Process Owner Signature I Date Process Owner Signature I Date

Sales Robert Verburgt QA Rep. SiQnature I Date QA Rep. Signature I Date 2040-5

CX RC-US Declaration of Pregnancy 0733-1

Change History

The Change History table below describes the changes made to each revision level of the document.


1 All Initial release to document management system. Training Required.

Uncontrolled Document when printed. Verif current revision prior to use.

Page 2 of 9


Document Support

Purpose

Scope

Reference


As required by 10 CFR 20.1208, this document serves as a communication tool between a declared pregnant radiation worker and Local and Chief Radiation Safety Officers. This policy establishes proper dosimetry, required read dates, possible limitations working with sources of radiation and when termination of pregnancy is required.

This policy applies to all female radiation workers and their managers within the Siemens Medical Solutions USA, Inc.


Document Number Document Title 0734 CX RC-US Declaration of Pregnancy 0736 CX RC-US Fetal Dose Record 0737 CX RC-US Fetal Dose Limitations for Declared

Pregnancy 10 CFR 20.1208 Dose to an Embryo/Fetus NRC Regulatory Guide Instruction Concerning Prenatal Radiation 8.13 Exposure NCRP Report No. 174 Preconception and Prenatal Radiation Exposure:

Health Effects and Guidance


Word I Acronym Definition

Radiation Worker An individual who receives and is monitored for ionizing radiation as a routine part of their normal work related duties.

Pregnant Declared A woman who has voluntarily informed the Worker licensee, in writing, of her pregnancy and the

estimated date of conception.

Termination of A statement in writing to the Chief Radiation Pregnancy Safety Officer to notify them that a worker is no

longer pregnant.


Page 3 of 9


Prerequisites The prerequisites section lists what is necessary, suggested, or required prior to carrying out the function in the document. The individual this policy applies to must work with sources of ionizing radiation and be pregnant.

Responsibilities The responsibility section states which functions are responsible for the tasks described in the document and what roles they are expected to fulfill.

Function Name Responsibility Chief and/or Local Ensures declared pregnant worker: Radiation Safety Officer • Has fetal dosimeter

• Establishes and tracks dosimetry read dates no less than once per month

• Performs fetal dose estimate upon notice of Termination of Pregnancy

• Retains all records with regard to fetal dose and declared pregnancy status.

Declared Pregnant • Upon declaration, Completes Declaration Worker of Pregnancy Form and forwards to

Chief/Local Radiation Safety Officer • Reviews and signs Fetal Dose Limitations for

Declared Pregnancy Form 0737-01 Supervisor • Reviews potential limitations for exposure

to the fetus and discusses those limitations with the Worker; this evaluation is completed on Fetal Dose Limitations for Declared Pregnancy Form 0737-01 and forwarded to the CRSO.

Policy Description

Introduction

Declaration of Pregnancy

This policy describes the requirements and intent of CX RC-US with regard to reducing ionizing radiation exposure to declared pregnant employees. This policy, while optional is recommended to ensure exposure to the fetus is maintained within Federal Limits and to help minimize risks associated with ionizing radiation.

Declared pregnant woman means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant. In the case that a pregnancy declaration is not withdrawn, the declaration is considered expired after one year.

Uncontrolled Document when printed. Verify current revision prior to use.

Page 4 of 91 2040-5


Required Documents

Dosimetry and Fetal Dose Monitoring

It is beneficial, but not required, for an employee to declare her pregnancy to the Siemens Chief RSO as soon as possible, since the first four months of pregnancy is potentially the most radiosensitive time for a fetus. If an employee's pregnancy is formally declared to the RSO via completion of a Declaration of Pregnancy form, the RSO and/or the Employee's Manager will meet with the pregnant employee to review radiation safety procedures and discuss additional fetal badge dosimetry. In addition, the NRC Regulatory Guide 8.13 will be given to the employee and the employee will be given a chance to ask further questions regarding this information.

Forms for Declaration of Pregnancy, Withdrawal from Declared Pregnancy Status, Fetal Dose Limitations for Declared Pregnancy, and Fetal Dose Record are available in CX-USA Document Library and can also be found within the Live Link Quality Documents.

This declaration will be kept confidential unless circumstances create a need for disclosure. The people who are listed above will always be notified- this includes the CRSO, the local RSO and employee's manager.

Declared pregnant employees will be assigned two badges, one for the whole body (worn at collar or chest level) and one for the fetus (normally worn on the abdomen under the lead apron) Employees who have declared pregnancy will exchange (or read for the instadose) badges on a monthly basis. If the employee is wearing an instadose badge, they are welcome to read the badge more frequently if desired.

It is the responsibility of the CRSO, management and the employee to ensure that the dose equivalent to the embryo/fetus during the entire pregnancy due to the occupational exposure of a declared pregnancy women does not exceed 0.5 rem (5 mSv). If the dose equivalent to the embryo/ fetus is found to have exceeded 0.5 rem (5 mSv) or is within 0.05 rem (0,5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with the dose requirement if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy. The employee's dose history will be reviewed. Depending on the findings, the job duties of the employee may be altered. This will be determined by the RSO and employee's manager.


Page 5 of 9



Records

Attachment

The licensee shall maintain the records of a dose to an embryo/fetus in a separate location then the records of dose to non- declared pregnant woman. The declaration of pregnancy form shall also be kept on file.

Fetal dose records shall be retained until termination of the license.

Record Record Location Record Owner Retention Period

Identification ex Re-US Cary, NC Chief Radiation Indefinite Declaration of Safety Officer Pregnancy #0734-01 ex Re-US Fetal Cary, NC Chief Radiation Indefinite Dose Record Safety Officer #0736-01 ex Re-US Fetal Cary, NC Chief Radiation Indefinite Dose Limitations Safety Officer for Declared Pregnancy Form #0737-01

NRC Regulatory Guide 8.13

0734 CX RC-US Declaration of Pregnancy

0736 ex Re-US Fetal Dose Record

0737 ex Re-US Fetal Dose Limitations for Declared Pregnancy


Page 6 of 9


0734 CX RC-US Declaration of Pregnancy

Health care

CX RC-US Declaration of Pregnancy

Monday, July 28, 2014

From: Click llere to enter text. To : Chief Radiation Safety Officer

Ref: (a) 10 CFR 20.1208 Dose to an i;m~Q/Fetus (b) Siemens Radiation Safety Declaration of Pregnancy Policy

D Declaration of Pregnancy:

In accordance with reference (a) and (b) 1 am declaring that 1 am pregnant. I believe I became pragnant in the month of Click llere to enter text (M!!it!II1Dlltfrand J~R•I7-

1 understand the radiation dose to my~etus durtngmyentlrepregnancywill not be allowed to exceed Q.5rcm£5mSY..'I (unless that dose has already been exceededbeMIHn the time of conception and submitting this letter). I also understand that meetingthe lower dose limit may require a change in job or job responsibilities during my pregnancy.

D Revocation of Declaration or Termination of Pregnancy

This is to notify the Chief Radiation SafetyOfficerthat I am no longer pregnant or I wantto rescind my declaration of pregnancy.

To preserve thedi(litiJI signatunf: DigJtafo/ SiQn the Signatunf Block and save the file to a location on your drive. Attach the file to an open emeil. DO NOTumt .. an X attachmentfromwithin Word. tfyouhave --------------cfjffjcufty with thediflitiJI signature please sign, date, scan and return.


:: · ~ e-;,5.:·- : • e =·!. ·: -....: :;:-::·-: ...

..... -- --s· :.-:· :-;:·:.::.: ,;:. •• _-s!-.-s ~~-!'~3 ::~· -e! :~:.!.!

Page 7 of 9


0736 CX RC-US Fetal Dose Record

Health care

CX RC-US Fetal Dose Record


From: Chief Radiation Safety Officer (CRSO) To: File

S!J..bi: Fetal Dose Record for {Name of Declared Pregnant Worker)

Ref: (a) 10 CFR 20.1208 Dose to an ~etus (b) Siemens Radiation Safety Declaration of Pregnancy Policy

This form will be used to documentthe dose of the fetus for the individual named in the subject line. This form will be kept with the individuals Dedaration of Pregnancy Form 0734-01 and retained lndeflnlely.

Dose determination for unmonitored exposure to the fetus:

0 0

Dose Determined from Worker's Exposure Dose Estimated(Describe):l.----=-----------------,

(A) Dose to Fetus From Conception to Date Declared mRtm (B) Sum of Fetal Dose Exposure (to.m".QU): --- mRtm

Total Dose to Fetus (A) +(B): mRtm

Comments:

CRSO: --


-:; :'!.;-s;· :·· =·!'",; '-= :::-:·

-

0733-1

Page 8 of 91


0737 CX RC-US Fetal Dose Limitations for Declared Pregnancy

CX RC-US Fetal Dose Limitations for Declared Pregnancy

Health care

0733-1


From: (Name of Supervisor) To : Chief Radiation Safety Officer (CRSO)

S&l.bl: Limitations to Work Involving Radiation Exposure to the Declared Pregnant Worker (Name of Declared Pregnant Worker Here)

Ref: (a) 10CFR 20.1208Dosetoan~etus (b) Siemens Radiation Safety Dedaralion of Pregnancy Policy

In order to ensure exposuretotheunbomfetus Is kept below limits In references(a)and(b)the supervisor of the Declared Pregnant Worker must evaluate potential sources of ioniZing radiation to the worker during her remaining gestational period. tf any limitations are Implemented, they will be discussed; a record of this discussion wiD be made on this form. This form will beforwardedto the CRSO for review and approval. The CRSO should be contacted if there are any questions concerning dosetothefetus.

Supervisor's review of potential radiation dose to the subject line's fetus during the remaining gestational period:

0 I have reviewed the potential radiation dose and have not placed any limitations to work Involving Ionizing radiation.

0 I have reviewed the potential radiation doseand have placed the following restrictions to work Involving lonl:zlng radiation:

- <U.nlimitatlons here-I.e. NohandlingofF-18,1-131 IQ.)

Declared Pregnant Worker: The limitations and restrictions placed on me during my remaining gestational period have been described to me. I understand these restrictions and will cofllliY with these limitations until I my pregnancy 11. complete or I choose to u.ndtdi!ti.

Submitted:

Reviewed:

Approved:


- -- -- -

Page 9 of 9

This is to acknowledge the receipt of yourSapplication dated

f- 0 fo -/ tv , , and to inform you that the initial processing which includes an administra ive review has been performed .

. ~he~ist!: o~s~n~ ~ur~pz~~ assigned to a technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

0 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 & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your. action has been assigfled Mail Control Number ,5"fL/S7 2 When calling to inquire about this action, please refer to this control number. You may call 'us on (61 0) 337-5398, or 337-5260.

NRC FORM 532 (RI)

(6-96)

Sincerely, Licensing Assistance Team Leader

NRC: Home Page - 0303g/!.tJL U;S -o · 2019-12-12 · SIEMENS Kathy Modes Senior Health Physicist...

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Transcript of NRC: Home Page - 0303g/!.tJL U;S -o · 2019-12-12 · SIEMENS Kathy Modes Senior Health Physicist...