•oP• REGULATORY GUIDE · to ensure safety and should promptly report incidents and potential problems to the authorized user or Radiation Safety Office (RSO). 1.3.2 ALARA in Medical

Revision 2*vkl REG&,_ August 1987•oP• 0 -. U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY GUIDEOFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 10.8(Task FC 4154)

GUIDE FOR THE PREPARATION OF-APPLICATIONS FOR MEDICAL USE PROGRAMS

'The substantial number of changes in this revision has made it impractical to indicate the cbange with lines in the margin.

USNRC REGULATORY GUIDES

Regulatory Guides are issued to describe and make available to thepualic methods acceptable to the NRC staff of implementingspecific parts of the Commission's regulations, to delineate tech-niques used bY the staff in evaluating specific Problems or Postu-lated accidents, or to provide guidance to applicants. RegulatoryGuides are not substitutes for regulation, .and compliance withthem is not required. Methods and solutions dlferent from those setout in the guides will be acceptable if they provide a basis for thefindings requisite to the issuance or continuance of a permit or

, license by the Commission.

This guide was issued after consideration of comments received fromthe public. Comments and suggestions for improvements in theseguides are encouraged at all times. and guides will be revised, asappropriate, to accommodate comments and to reflect new informa-tion or experience-

Written comments may be submitted to the Rules and ProceduresBranch, DRR. ADM, U.S. Nuclear Regulatory Commission,Washington. DC 20555.

The guides are issued in the following ten broad divisions:

1. Power Reactors 6. Products2. Research and Test Reactors 7. Transportation3. Fuels and Materials Facilities 8. Occupational Health4. Environmental and Siting 9. Antitrust and Financial Review5. Materials and Plant Protection 10. General

Copies of issued guides may be purchased from the GovernmentPrinting Office at the current GPO pricem Information on currentGPO prices may be obtained by contacting the Superintendent ofDocuments, U.S. Government Printing Office, Post Office Box37082, Washington. DC 20013-7082, telephone (202)275-2060 or(202)275-2171.

IsSued guides may also be purchased from the National TechnicalInformation Service on a standing order basis. Details on thisservice may be obtained by writing NTIS, 5285 Port Royal Road,Springfield, VA 22161.

TABLE OF CONTENTS

Section Page

1. INTRODUCTION .................................................... 1

1.1 General ................................................... 1.1.2 Applicable Regulations ....................................... 11.3 As Low As Reasonably Achievable (ALARA) Philosophy ......... 21.4 Types of Licenses .......................................... 3

2. FILING AN APPLICATION ........................................... 43. CONTENTS OF APPLICATION ......................................... 6

Item 1 - License Information .................................... 6Item 2 - Applicant's Name and Mailing Address ................... 6Item 3 - Locations of Use ....................................... 6Item 4 - Person To Be Contacted About.Application ............... 7Item 5 - Radioactive Material and Item 6 - Purpose .............. 7Item 7 - Individuals Responsible for Radiation Safety

Programs--Their Training and Experience ................ 8

7.1 Authorized Users for Medical Use ................. 87.2 Authorized Users for Nonmedical Use .............. 97.3 Radiation Safety Officer ......................... 9

Item 8 through 11 .................................................. 9Item 8 - Training for Individuals Working in or Frequenting

Restricted Areas ....................................... 11

8.1 Training Program ........................... 118.2 Other Training Program ........................... 11

Item 9 - Facilities and Equipment ............................... 11

9.1 Annotated Drawing ................................ 119.2 Survey Instrument Calibration .................... 119.3 Dose Calibrator Calibration ...................... 119.4 Personnel Monitor Program ........................ 119.5 Imaging Equipment ................................ 129.6 Other Equipment and Facilities .................... 12

Item 10 - Radiation Safety Program ............................... 12

10.1 Radiation Safety Committee/Radiation SafetyOfficer ... ...................................... 12

10.2 ALARA Program ......................... ........... 1210.3 Leak Test ........................................ 1210.4 Safe Use of Radiopharmaceuticals ................. 1210.5 Spill Procedures ................................ .12

iii

TABLE OF CONTENTS

Section Page

10.6 Ordering and Receiving .......................... 1210.7 Opening Packages ................................. 1210.8 Unit Dosage Records ............................. 1310.9 Multidose Vial Records .......................... . 1310.10 Molybdenum Concentration Records ................ 1310.11 Implant Source Use Records ...................... 1310.12 Area Survey Procedures .......................... 1310.13 Air Concentration Control ý ...................... 1310.14 Radiopharmaceutical Therapy ....................... 1310.15 Implant Therapy ................................. 1310.16 Other Safety Procedures ......................... 13

Item 11 - Waste Management ...................................... 14

11.1 Waste Disposal .................................. 1411.2 Other Waste Disposal ............................ 14

Item 12 - License Fees .......................................... 14Item 13 - Certification ......................................... 14Item 14 - Voluntary Economic Data................................. 14

4. AMENDMENTS TO LICENSE ........................................... 165. RENEWAL OF LICENSE .............................................. 166. IMPLEMENTATION .................................................. 16

LIST OF APPENDICES

PART 1 - MODEL PROCEDURES THAT APPLICANTS MAY USE TO PLAN RADIATIONSAFETY.PROGRAMS

Appendix Page

A Model Training Program ........................................... A-iB Model Procedure for Calibrating Survey Instruments .............. B-1C Model Procedure for Calibrating)Dose Calibrator ................. C-iD Model Personnel External Exposure Monitoring Program ............ . D-IE Model Procedure for Checking Equipment Used in Mobile Nuclear

Medicine Service ................................................. E-1F Model Radiation Safety Committee Charter and Radiation Safety

Officer Delegation of Authority ................................. F-iG Model Program for Maintaining Occupational Radiation Exposure

at Medical Institutions ALARA ................................... G-iH Model Procedures for Leak-Testing Sealed Sources ................. .H-I Model Rules for Safe Use of Radiopharmaceuticals ................ I-iJ Model Spili Procedures .......................................... J-1K Model Guidance for Ordering and Receiving Radioactive Material K-iL Model Procedure for Safely Opening Packages Containing

Radioactive Material ............................................ L-1M Records of Byproduct Material Use ............... ................ M-i

iv

TABLE OF CONTENTS

LIST OF APPENDICES (Continued)

Page

N, Model Procedure for Area Surveys ................................. N-i0 Model Procedure for Monitoring, Calculating,.and Controlling

Air Concentrations .............................................. 0-1P -Model Procedure for Radiation Safety During Iodine Therapy

Over.30 Millicuries ............................................. P-iQ Model Procedure for Radiation Safety During Implant Therapy ..... Q-1R Model Procedure for Waste Disposal .............................. R-1

PART 2 - ADDITIONAL INFORMATION.'FOR MANAGING RADIATION SAFETYPROGRAMS FOR MEDICAL USE LICENSEES

S Regulatory Requirements ......................................... S-iT Consideration' in Making Radiation Safety Program Changes ....... T-iU Recommended Support Equipment and Services .................. I....' .U-iV Filing System .................................................. V-iW Bibliography ..................................................... W-i

LIST OF EXHIBITS

Exhibit Page

1 NRC Form 313, Application for Material License .................. EXH-32 Supplement A, Training and Experience ........................... EXH-53 Supplement B, Preceptor Statement ................................ EXH-64 Resident's Support Technology Training Task Log ................. . EXH-85 Resident's Clinical Procedures Training Log'...................... EXH-96 Layout Diagram ................................................. EXH-117 Survey Meter Calibration Report Form ............................ EXH-128 Dose Calibrator Linearity Test Form ............................. EXH-149 Dose Calibrator Geometry and Accuracy Form ....................... EXH-16'10 Radioactive Spill Report Form ................................... EXH-1811 Radioactive Spill Contamination Survey Form ...................... EXH-2012 Package Receipt and Monitoring Log Form ......................... EXH-2213 Unit Dosage Receipt and Use Log ................................. EXH-2414 Multidose Vial Preparation and Use Log Form ..................... EXH-2615 Short-Lived Implant Source Log .................................. EXH-2816 Sample Radiation Survey Form .................................... EXH-3017 Nursing Instructions for Patients Treated with Iodine-131,

Phosphorus-32, or Gold-198 ...................................... EXH-3218 Radiation Safety Checklist for Iodine Therapy Over

30 Millicuries ................................................. EXH-3419 Radiation Safety Checklist for Temporary Implant Therapy ......... . EXH-3520 Nursing Instructions for Patients Treated with Temporary

Implant Sources ................................................. EXH-3621 Sample Cesium Implant Source Log ................................ EXH-38

Value/Impact Statement ............................................... V/I-i

v

1. INTRODUCTION

1.1 GENERAL

The Nuclear Regulatory Commission (NRC) regulates the intentional internalor external administration of byproduct material, or the radiation therefrom,to human beings. This type of use is called medical use, and a specific licenseis required. The regulations governing medical use are contained in 10 CFRPart 35, "Medical Use of Byproduct Material."

The NRC usually issues a single byproduct material, license to cover anentire radioisotope program except teletherapy, nuclear-powered pacemakers, andirradiators. Separate licenses are not normally issued to different departmentsof a hospital or to individuals employed by a hospital. A license applicantshould carefully study this guide and all the regulations identified inSection 1.2 and should then complete the application form, NRC Form 313. TheNRC may request additional information when necessary to provide-reasonableassurance that the applicant has established an adequate radiation protectionprogram.

1.1.1 Purpose of Guide

This guide is designed to describe the type and extent of informationneeded by the NRC to evaluate an application for a medical use license and todescribe the medical use byproduct material regulations. (Separate guidanceis being developed to meet the specific needs of a teletherapy applicant. DraftRegulatory Guide FC 414-4, "Guide for the Preparation of Applications forLicenses for Medical Teletherapy Programs," has been issued for public comment.)This guide does not apply to academic programs that do not use byproduct mate-rial for medical use.

1.1.2 Purpose of Appendices to Guide

The regulations require that the licensee develop and implement proceduresthat will ensure compliance with the regulations. Appendices A through R tothis guide describe model radiation safety procedures. Each applicant shouldcarefully read the applicable regulations and model procedures and then decideif the model procedures are appropriate for its specific radiation safety needs.In the application, applicants may certify that they will follow model procedure(appropriate certification language is given at the beginning of each appendix)or may say that they have developed a procedure that is enclosed for review(appropriate reference language is given at the beginning of each appendix).

1.2 APPLICABLE REGULATIONS

In addition to 10 CFR Part 35, other regulations pertaining to the medicaluse of byproduct material are found in 10 CFR Part 19, "Notices, Instructions,and Reports to Workers; Inspections"; 10 CFR Part 20, "Standards for ProtectionAgainst Radiation"; 10 CFR Part 21, "Reporting of Defects and Noncompliance";10 CFR Part 30, "Rules of General Applicability to Domestic Licensing ofByproduct Material"; 10 CFR Part 71, "Packaging and Transportation of Radio-active Material"; and 10 CFR Part 170, "Fees for Facilities and MaterialsLicenses and Other Regulatory Services Under the Atomic Energy Act of 1954,as Amended."

1

This regulatory guide identifies the information needed to complete NRCForm 313 when applying for a license for a medical use program. The informationcollection requirements in NRC Form 313 have been cleared under OBM ClearanceNo. 3150-0120.

1.3 AS LOW AS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY

Paragraph 20.1(c) of 10 CFR Part 20 states "...persons engaged in activitiesunder'licenses issued by the Nuclear Regulatory Commission pursuant to theAtomic Energy Act of 1954, as amended, and the Energy Reorganization Act of1974 should, in addition to complying with the requirements set forth in thispart, make every reasonable effort to maintain radiation exposures, and releasesof radioactive materials in effluents to unrestricted areas, as low as is rea-sonably achievable." Regulatory Guides 8.10, "Operating Philosophy for Main-taining Occupational Radiation Exposures As Low As Is Reasonably Achievable,"and 8.18, "Information Relevant to Ensuring That Occupational Radiation Exposuresat Medical Institutions Will Be As Low As Reasonably Achievable," provide theNRC staff position on this important subject. Applicants should consider theALARA philosophy as described in Regulatory Guides 8.10 and 8.18 in developingplans for work with licensed radioactive materials.

1.3.1 General ALARA Considerations

Each individual who is authorized to use byproduct material should provideappropriate instruction to all individuals who work with or in the vicinity ofbyproduct material and should ensure that the facility and equipment are ade-quate.for safe use. NUREG-1134, "Radiation Protection Training for PersonnelEmployed in Medical Facilities," provides information on training programs foruse by medical use licensees. Each worker should follow procedures developedto ensure safety and should promptly report incidents and potential problemsto the authorized user or Radiation Safety Office (RSO).

1.3.2 ALARA in Medical Institutions

Each medical licensee must have a formal ALARA program (see § 35.20 of10 CFR Part 35). The success of an ALARA program depends on the cooperationof each person who works at the licensee's facility. Management should make aformal policy commitment to the ALARA philosophy and implement that commitmentwith adequate resources. A Radiation Safety Committee composed of individualswho have special expertise in the safe use of byproduct material is requiredby § 35.22 to review uses for safety and ALARA considerations. (SeeSection 1.4.2 of this guide).

The Committee, the RSO, and management should audit the byproduct materialprogram to ensure the continued safe use of byproduct material. In addition tobeing a member of the Committee, the RSO serves as a technical consultant tothe Committee and is also responsible for the day-to-day operation of the radia-tion safety program.,

A model ALARA management program is contained in Appendix G to this guide.Several other NRC publications contain background information on the ALARAphilosophy and its application in the medical environment. For example,Regulatory Guide 8.18 and NUREG-0267, "Principles and Practices for KeepingOccupational Radiation Exposures at Medical Institutions As Low As Reasonably

2

Achievable," contain information, methods, and references useful in establishingradiation safety programs to maintain exposures ALARA is medical institutions.Applicants should consider the ALARA philosophy in the development of plans forwork with radioactive materials.

1.4 TYPES OF LICENSES

The NRC issues three types of licenses for the use of byproduct materialin the practice of medicine. They are described below. This guide is only forpersons who want to apply for a specific medical use license. However, personswho are applying for other types of licenses may find the information in thisguide useful in designing their radiation safety program.

1.4.1 General License

Section 31.11 of 10 CFR Part 31, "General Domestic Licenses for ByproductMaterial," establishes a general license authorizing physicians, veterinarians,clinical laboratories, and hospitals to receive, acquire, possess, or use cer-tain small quantities of byproduct material for in vitro clinical-or laboratorytests not involving medical use (that is, not involving administration to humans).Section 31.11 explains the requirements for using materials listed in thatsection. If the general license alone meets the applicant's needs, onlyForm NRC-483, "Registration Certificate--In Vitro Testing with Byproduct Mate-rial under General License," need to be filed. Medical use licensees do notneed to file the form (see paragraph 31.11(b)).

If you need more than 200 microcuries of photon-emitting § 31.11 materials,you may request an increased inventory limit as a separate line item on yourNRC Form 313 application. Licensees generally request 3 millicuries. The useof materials listed in § 31.11 within the inventory limits of that section willonly be subject to the requirements of that section and not subject'to therequirements of Parts 19, 20, 21, and 35 except as provided in § 31.11. If yourequest an increased inventory limit, you will be subject to the requirementsof those parts, including the requirements regarding waste disposal.

1.4.2 Specific License

Specific licenses for physicians in private practice are generally limitedto physicians who are located in private offices and not on hospital premises.A Radiation Safety Committee is not required. Methods of use that requirehospitalization of the patient are not permitted.

Specific licenses are also issued to medical institutions. A medicalinstitution is an organization in which several medical disciplines are prac-ticed. These licenses authorize byproduct material for medical uses by physi-cians named on the institution's license. The regulations in § 35.22 of 10 CFRPart 35 require an institutional licensee to have a Radiation Safety Committeeto oversee the use of licensed material throughout the institution and to reviewthe institution's radiation safety program. The physicians named on the insti-tution's license conduct their programs with the approval of the Radiation SafetyCommittee.

A specific license may also be issued for a mobile nuclear medicine service(see § 35.29 of Part 35). Both private practitioners and institutions may applyfor authorization to use byproduct material in a mobile service.

3

1.4.3 Specific License of. Broad Scope

Some medical institutions provide patient care and conduct research programsthat use radioisotopes for in vitro, animal, and medical procedures. In thesecases, the NRC may issue a specific license of broad scope as discussed in10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Mate-rial." Specific licenses of broad scope for medical use, i.e. , licenses autho-rizing multiple quantities and types of byproduct material for unspecified uses,are issued to institutions that (1) have had previous experience operating under

-a specific institutional license of limited scope and (2) are engaged in medicalresearch as well as routine diagnosis and therapy using radioisotopes.

Such programs operate under the supervision of the Radiation SafetyCommittee. A broad scope license allows the Radiation Safety Committee toreview proposed methods of use and to permit individuals to use material underthe provisions of the broad scope license. An applicant for a-broad scopelicense must show that appropriate personnel, equipment, and facilities areavailable. Individual users are not named on the license nor are radioisotopeslimited to specified uses. Individual users and methods of use are authorizedby the institution's Radiation Safety Committee. This type of license is notappropriate for most institutions performing routine procedures with byproductmaterial.

Institutions may also apply for a broad scope license that combines featuresof the specific license and the specific license of broad scope discussed above.It authorizes medical uses as described in Part 35 and authorizes the Committee'to review and approve in vitro animal research uses. This type of license isnot appropriate for most institutions performing routine medical procedureswith byproduct material.

2. FILING AN APPLICATION

You should apply fo r a license by completing NRC Form 313 (see Exhibit 1).You should complete Items 1 through 2, 12, 13, and 14 on the form itself. ForItems 5 through 11, submit the required information on supplementary pages.You should identify and key each separate sheet or document submitted with theapplication to the items number of the application to which it refers. Alltyped pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inchpaper to facilitate handling and review. If larger drawings are necessary,fold them to 8-1/2 x 11 inches.

You shoul d complete all items in the application in enough detail for theNRC to determine that your equipment, facilities, training and 'experience, andradiation safety program are adequate to protect health and minimize danger tolife and property.I

Please note that license applications are available for review by thegeneral public in the NRC Public Document Rooms. Do not submit proprietaryinformation unless absolutely necessary. If submittal of such information isnecessary,' *follow the procedure in § 2.790 of 10 CFR Part 2. Failure to followthis procedure may result in disclosure of the proprietary information to thepublic or substantial delays in processing your application.

4

Do not submit personal information about your individual employees unlessit is necessary. For example, the training and experience of individuals shouldbe submitted to demonstrate their ability to manage radiation safety programsor to work safely with radioactive materials. Home addresses and home telephonenumbers should be submitted only if they are part of an emergency response plan.Dates of birth, Social Security numbers, and radiation dose information shouldbe submitted only if specifically requested by NRC.

You should file your application in duplicate. Retain one copy for your-self because the license will be. issued based on the statements and representa-tions in your application and any supplements to it as well as the requirementsin the regulations.

If you wish to possess or use licensed material on Federal property or inany State subject to NRC jurisdiction, you should file your application withthe NRC Regional Office *for the State in which the material will be possessedor used. The exceptions to the above are the United States Air Force and Navyand persons wishing to distribute exempt material under 10 CFR Part 32, Sub-part A, who should file their applications directly with the U.S., NuclearRegulatory Commission, Division of Fuel Cycle and Material Safety, Washington,DC 20555.

Many States have entered into agreements with the NRC that give them theauthority to license radioactive materials used or possessed within their borders.These States are called Agreement States. A current list of Agreement States(including names, addresses, and telephone numbers of responsible officials)may be obtained upon request from the Material Licensing Branch, U.S. NuclearRegulatory Commission, Washington, DC 20555, or from NRC's Regional Offices,whose addresses are listed below. If you are a non-Federal organization thatwishes to possess or use licensed material in one of these Agreement States,your application should be filed with the State's radiation control programand not with the NRC.

If you are located in Connecticut, Delaware, District of Columbia, Maine,Maryland, Massachusetts, New Hampshire, New Jersey, New York-, Pennsylvania,Rhode Island, or Vermont, send your applications to the U.S. Nuclear RegulatoryCommission, Region I, Nuclear Material Section B, 631 Park Avenue, King ofPrussia, PA 19406.

If you are located in Alabama, Florida, Georgia, Kentucky, Mississippi,North Carolina, Puerto Rico, South Carolina, Tennessee, Virginia, Virgin Islands,or West Virginia, send your applications to the U.S. Nuclear Regulatory Commis-sion, Region II, Material Radiation Protection Section, 101 Marietta Street,Suite 2900, Atlanta, GA 30323.

If you are located in Illinois, Indiana, Iowa, Michigan, Minnesota,Missouri, Ohio, or Wisconsin, send your applic 'ations to the U.S. NuclearRegulatory Commission, Region III, Material'Licensing Section, 799 RooseveltRoad, Glen Ellyn, IL 60137.

.If you are located in Arkansas, Colorado, Idaho, Kansas, Louisiana, Montana,Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas, Utah, or

5

Wyoming, send your applications to the U.S. Nuclear Regulatory Commission,Region IV, Material Radiation Protection Section, 611 Ryan Plaza Drive,Suite 1000, Arlington, TX 76011.

If you are located in Alaska, Arizona, California, Hawaii, Nevada, Oregon,Washington, or U.S. territories and possession in the Pacific, send your appli-cations to the U.S. Nuclear Regulatory Commission, Region V, Material RadiationProtection Section, 1450 Maria Lane, Suite 210, Walnut Creek, CA 94596.

3. CONTENTS OF APPLICATION

This portion of the guide explains, item by item, the information requestedon NRC Form 313 (Exhibit 1). The appendices to this guide serve several dif-ferent purposes, i.e., to provide additional information on certain subjectareas, to provide a model procedure the licensee may adopt in response to anitem on the application form, or to provide an outline the applicant may use todevelop a procedure for review by the NRC staff. The exhibits following theappendices include copies of the application form (NRC Form 313, Exhibit 1);Supplements A and B (Exhibits 2 and 3) that may be used to document trainingand experience; and two logs to document training, the Resident's Support Tech-nology Training Task Log (Exhibit 4) and Resident's Clinical Procedures TrainingLog (Exhibit 5). Exhibits 4 and 5 may be used as worksheets when preparingSupplements A and B.

If you have specific questions after careful review of this guide, contactthe NRC material licensing staff at the appropriate address as specified inSection 2 of this guide.

Item I - LICENSE INFORMATION

For a new license, check subitem A. For an amendment to an existinglicense, check subitem B. For a renewal of an existing license, check subitem C.

Item 2 - APPLICANT'S NAME AND MAILING ADDRESS

If you are an individual, you should be designated as the applicant onlyif you are acting in a private capacity and the use of the radioactive materialis not connected with your employment with a corporation or other legal entity.Otherwise, you, the applicant, should be the corporation or other legal entityapplying for the license.

The address specified here should be your mailing address for correspon-dence. This may or may not be the same as the address at which the materialwill be used as specified in Item 3.

Item 3 - LOCATIONS OF USE

You should specify each location of use by the street address, city, andState or other descriptive address (such as 5 miles east on Highway 10, Anytown,State) to allow us to easily locate your facilities. A post office box addressis not acceptable. If byproduct material is to be used at more than one loca-tion, you must give the specific address of each location. In Items 5 through11 of the application, describe the intended use and the facilities and equipmentat each location.

6

If you are applying for a license for a mobile nuclear medicine service,specify so and list the name and location of each client.

Item 4 - PERSON TO BE CONTACTED ABOUT APPLICATION

You should provide the name and telephone number of the individual whoknows your proposed radioactive materials program and can answer questions aboutthe application. This individual, usually~the RSO or a principal user of radio-active materials, will serve as the point of contact during the review of theappl.ication and during the period of the license. If this individual is notyour full-time paid employee, specify your relationship with this individual.Notify the NRC if the individual assigned to this function changes. Notificationof a contact change is for information only and would not be considered anapplication for a license amendment.

Item 5 - RADIOACTIVE MATERIAL and Item 6 - PURPOSE

Part 35 divides byproduct material for medical use into six types of use.Using the table format of Table 1 as a guide,.you may indicate only the typesof use you want and the maximum amount. You may say "As needed" in the "Amount"column as shown. For § 35.400 implant material, express the total amount inmillicuries (mCi). If you plant to have an eye applicator, list it as a separateline item and note its total activity in mCi.

Table 1

Byproduct Material Amount Purpose

5.a Material in § 35.100 As needed 6.a Medical use5.b Material in § 35.200 As needed 6.b Medical use5.c Material in § 35.300 As needed 6.c Medical use•5.d Implant Material in § 35.400 mCi 6.d Medical use5.e Eye applicator in § 35.400 mCi 6.e Medical use5.f Material in § 35.500 As needed 6.f Medical use

(Note: Broad scope medical use applicants may request "Any byproduct materialwith atomic numbers 3 through 83 for medical use.")

If you need other items (for example, more byproduct material for in vitrotesting than is. allowed under § 31.11,.depleted uranium for linear acceleratorshielding, a survey meter calibration source, a teletherapy dosimetry system.constancy check source, or material for in vitro, animal, or human studies, orauthorization to participate in a protocol approved by a Radioactive DrugResearch Committee that has been approved by the Food and Drug Administration),make a separate line entry for each item. (Do not list sources that areauthorized in § 35.58.) Number each line entry consecutively following thePart 35 material. Each line entry must identify the radionuclide, the physicalform, maximum amount of hand expressed in mCi, and the purpose for which thematerial will be used. If you do not want all the material listed in a Part 35section, you must identify, line by line, the material that you do want fromthe section.

7

Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAMS--THEIR TRAINING-AND EXPERIENCE

Responsible individuals are the authorized users, the RSO, and for tele-therapy the teletherapy physicist. Paragraph 30.33(a)(3) of 10 CFR Part 30requires that an applicant be qualified by training and experience to use therequested radioactive materials for the purposes requested in such a manner asto protect health and minimize danger to life or property. Subpart J of Part 35provides specific criteria for acceptable training and experience for authorizedusers for medical use, for the RSO, and for the teletherapy physicist. Notethat curriculum vitae do not usually supply all the information needed toevaluate an individual's training and experience.

Authorized users involved in medical use have the following specialresponsibilities:

1. Examination of patients and medical records to determine if a radia-tion procedure is appropriate,

2. Prescription of the radiation dosage or dose and how it is to beadministered,

3. Actual use of, or direction of technologists or other paramedicalpersonnel in the use of, byproduct material, and

4. Interpretation of results of diagnostic procedures and evaluation ofresults of therapy procedures.

Numbers 1 through 4 may be delegated to a physician who is under the super-vision of an authorized user. Technologists or other personnel may use byproductmaterial under an authorized user's supervision when permitted under applicableFederal, State, or local laws. Supervision is defined in § 35.25.

For in vitro and'animal research or other uses that do not involve theintentional exposure of humans, the list of proposed authorized users shouldinclude those individuals who will actually be responsible for the safe use ofthe byproduct material for the requested use. Note which user will be involvedwith which use by reference to Items 5 and 6 of the application. Those author-ized users may direct the use of the byproduct material by-technologists orother individuals for the requested use.

7.1 Authorized Users for Medical Use

1. Make a separate attachment for the RSO and each authorized user.Number the attachments "ATT 7.1.1," "ATT 7.1.2," etc. Type the full name ofthe individual and note, by reference to Items 5.a, 5.b, etc., which proposeduses are requested for the individual.

2. If a physician has been previously authorized for medical use and onlywants to use material permitted by the previous license, you only need to submitthe previous license number (if issued by AEC or NRC) or a copy of the license(if issued by an Agreement State) on which the physician was specifically namedas an authorized user.

8

3. If a physician is certified by an organization listed in the appro-priate section of Subpart J of 10 CFR Part 35,* submit Supplement A (see Ex-hibit 2) with Items 1, 2, and 3 completed. A physician certified as a British"Fellow of the Faculty of Radiology" (FFR) or "Fellow of the Royal College ofRadiology" (FRCR) should submit a copy of the certificate and evidence ofspecialization in radiation therapy.

4. Physicians not previously authorized by AEC or NRC or an AgreementState and not certified by an appropriate organization must submit a completedescription of their training and experience using Supplements A and B (seeExhibits 2 and 3). This documentation will be reviewed on a case-by-case basis.If the training and experience does not appear to meet the Subpart J standards,the NRC will request the assistance of its Advisory Committee on the MedicalUses of Isotopes.

5. Broad scope medical use applicants should submit the criteria they willuse to evaluate the training and experience of authorized users. Subpart J maybe used as a guide. The criteria may include a provision that allows theapplicant's Radiation Safety Committee to grant case-by-case exceptions.

7.2 Authorized Users for Nonmedical Use

List the full name of each individual proposed as an authorized user fornonmedical use. Submit a complete description of the person's training andexperience using Supplement A (Exhibit 2). If the individual was alreadyidentified in Item 7.1, no additional attachment is needed here.

7.3 Radiation Safety Officer

State the name and title of the person designated by, and responsible to,the applicant's management as RSO. If the RSO is not one of the proposed author-ized users, submit a complete description of the individual's training and ex-perience using Supplement A (see Exhibit 2). The RSO should be a full-timeemployee of the licensee. Even if the licensee employs a consultant to assistthe RSO, the licensee is still responsible for the radiation safety program asrequired by the license.

Items 8 through 11

Your responses to these items should consist of one sentence that says thatyou will follow the model procedure in Appendix _ in Regulatory Guide 10.8, orthat you have enclosed your procedure for review, or simply the notation "NA"for "not applicable." Follow the instructions on the Applicability Table,'Table 2, to determine whether you must provide information or may simply respond"NA" to each item that follows. Before you respond to an item, read the intro-ductory paragraphs of the referenced appendix. Your short sentence or NAresponses to Items 8 through 11 should run consecutively on one or more sheets.Lengthy responses should be appended as attachments.

If you edit a model procedure solely to identify responsible individuals,equipment by name or model, room numbers, or other site-specific information,there is no need to submit that procedure for review.

9

Table 2

APPLICABILITY TABLE

To determine those items to which you must respond, "highlight" the columnsunder the categories of material you requested in Item 5. If any "4" beside anitem is highlighted, you must provide information in response to the item. Ifonly the letters "NA" (not applicable) are highlighted, you may respond "NA" inyour application.

Item Topic

8.1 Training program8.2 Other training program9.1 Annotated drawing9.2 Survey instrument

calibration9.3 Dose calibrator

calibration9.4 Personnel monitor program9.5 Imaging equipment QA9.6 Other equipment and

facilities10.1 Radiation Safety

Committee/RadiationSafety Officer

10.2 ALARA program10.3 Leak test10.4 Safe use of radio-

pharmaceuticals10.5 Spill procedures10.6 Ordering and receiving10.7 Opening packages10.8 Unit dosage records10.9 Multidose vial records10.10 Mo-99 concentration

records10.11 Implant source use

records10.12 Area survey procedures10.13 Air concentration

control10.14 Radiopharmaceutical

therapy10.15 Implant therapy10.16 Other safety procedures11.1 Waste disposal11.2 Other waste disposal

Material in 1035.100 35.200 35.300

CFR Sections35.400 35.500 Other

4NA4

4NA4

4NA4

4NA4

4NA4

4

NA44

App.

A

Exh.

4 4 4 B

4 44 4(See special

44i nstructi or

NA NA4 NA

9.5 in the

NA4

text)

CDE

NA NA NA NA NA 4

(See(See4

444444

specialspecial4

444444

instruction 10.1 in theinstruction 10.2 in the

4444444

4 4NANA44NANA

NANA44NANA

text)text)

NA

NANA44NANA

FGH

IJKLMM

NA 4

NA4

NA4.

NA NA NA NA M

NA 4 NA NA M4 4 NA 4 N

NA NA NA NA 0NA 4

NANANA4NA

NANANA4NA

4NANA4NA

NA4NA4NA

NANANA4NA

NANA4NA4

PQ

R

10

Item 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS

8.1 Training Program

Describe your training program for individuals who work with or in thevicinity of radioactive material described in Part 35. See Appendix A of thisguide.

8.2 Other Training Program

Describe your training program for individuals who handle radioactivematerial other than the Part 35 material that you listed in Item 5 of thisapplication. Append it as ATT 8.2.

Item 9 - FACILITIES AND EQUIPMENT

9.1 Annotated Drawing

Submit an annotated drawing of the room or rooms and adjacent areas wherebyproduct material will be used. Append it as ATT 9.1. Note the following:

1. The scale. Use the same scale (preferably 1/4 inch = 1 foot) for alldrawings.

2. The direction of north.

3. Room numbers and principal use of each room or area (for example, invitro, hot lab, waiting, examining, imaging, reading, office, file,fresh materials storage, radioactive waste storage, film processor,toilet, closet, hallway).

4. Any shielding available.

5. Additional safety equipment (for example, fume hoods, L-blocks, orfixed area monitors).

See Exhibit 6 for an example.

9.2 Survey Instrument Calibration

Submit your procedure for calibrating survey instruments. See Appendix B.

9.3 Dose Calibrator Calibration

Submit your procedure for calibrating the dose calibrator. See Appendix C.

9.4 Personnel Monitor Program

Describe your personnel occupational exposure monitor program. SeeAppendix D of this guide.

11

9.5 Imaging Equipment

If you are transporting imaging equipment as part of a mobile nuclearmedicine service, describe your procedure for checking the equipment to ensureit has not been damaged in transit. See Appendix E. If you are not going toprovide mobile nuclear medicine service, say "NA."

9.6 Other Equipment and Facilities

Describe other equipment and facilities available for the use and storageof material described in Item 5 of this application other than materialdescribed in Part 35. Append it as ATT 9.6.

Item 10 - RADIATION SAFETY PROGRAM

10.1 Radiation Safety Committee/Radiation Safety Officer

Describe your Radiation Safety Committee Charter and Radiation SafetyOfficer delegation of authority. A Radiation Safety Committee must be estab-lished by each medical institution licensee (see § 35.22) unless the applicationis only for devices listed in § 35.500 (such institutions will be exempted bylicense condition). If you are not an institution, you only need to submit theRadiation Safety Officer delegation of authority. See Appendix F.

10.2 ALARA Program

Submit your ALARA program. Each medical licensee must have an ALARAprogram (see § 35.20) unless the application is only for devices listed in§35.500 (such institutions will be exempt by license condition). If you areonly applying for devices in § 35.500, say "NA." Otherwise, see Appendix G.

10.3 Leak Test

Submit your procedure for leak-testing sealed sources. See Appendix H.

10.4 Safe Use of Radiopharmaceuticals

Submit a copy of your rules for the safe use of radiopharmaceuticals. SeeAppendix I.

10.5 Spill Procedures

Submit a copy of your spill procedures. See Appendix J.

10.6 Ordering and Receiving

Submit a copy of your procedure for ordering and receiving radioactivematerial. See Appendix K.

10.7 Opening Packages

Submit your procedure for opening packages that contain radioactivematerial. See Appendix L.

12

10.8 Unit Dosage Records

Submit your procedure for keeping records of unit dosage use. SeeAppendix M.1.

10.9 Multidose Vial Records

Submit your procedure for keeping records of multidose vial use. SeeAppendix M.2.

10.10 Molybdenum Concentration Records

Submit your procedure for measuring and recording molybdenum concentration.See Appendix M.3.

10.11 Implant Source Use Records

Submit your procedure for keeping an inventory of implant sources. SeeAppendix M.4.

10.12 Area Survey Procedures

Submit your area survey procedures. See Appendix N.

10.13 Air Concentration Control

1. Submit your procedure for estimating worker dose from submersion innoble gases. See Appendix 0.

2. Submit your procedure for estimating worker dose from aerosol concen-trations. See Appendix 0.

3. Submit your procedure for estimating aerosol.and gas concentration ineffluents. See Appendix 0.

4. Submit your procedure for calculating spilled gas clearance times.See Appendix 0.

10.14 Radiopharmaceutical Therapy

Submit your procedure for radiation safety during radiopharmaceuticaltherapy. See Appendix P.

10.15 Implant Therapy

Submit your procedure for radiation safety during implant therapy. SeeAppendix Q.

10.16 Other Safety Procedures

Submit safety procedures that will be followed by individuals who handleradioactive material described in Item 5 of this application other than materialdescribed in Part 35. Append them as A1F 10.16.

13

Item 11 - WASTE MANAGEMENT

11.1 Waste Disposal

Submit your procedures for waste disposal. See Appendix R.

11.2 Other Waste Disposal

Submit waste disposal procedures that will be followed for radioactivematerials described in Item 5 of this application other than material describedin Part 35. Append them as ATT 11.2. (If they are the same as the proceduressubmitted in Item 11.1, say "See Item 11.1.")

Item 12 - LICENSE FEES

An application fee paid in full is required by paragraph 170.12(a) of10 CFR Part 170 for most types of licenses, including applications for licenseamendments and renewals. You should-refer to § 170.31, "Schedule of Fees forMaterials Licenses and Other Regulatory Services," of 10 CFR Part 170 to deter-mine the amount of the fee that must accompany your application. An applicationreceived without a fee or with an inadequate fee may be returned to you. Allapplication fees may be charged irrespective of the NRC's disposition of theapplication or your withdrawal of the application.

Item 13 - CERTIFICATION

If the application is for a private practice, it should be signed by asenior partner or the president. If the application is for an institution,hospital, or medical center, it must be signed by its director or chief execu-tive officer. Identify the title of the office held by the individuail who signsthe application.

BEFORE SUBMITTING IT, REVIEW YOUR APPLICATION TO BE SURE YOU HAVE RESPONDEDTO EACH ITEM AND TO BE SURE THAT EACH PAGE THAT YOU HAVE ATTACHED HAS AN ATTACH-MENT NUMBER AND IS DATED.

Item 14 - VOLUNTARY ECONOMIC DATA

The Regulatory Flexibility Act of 1980 requires Federal agencies to con-sider the effects of their rules on small businesses and other small entities.In order for the NRC to maintain an up-to-date data base of its licensees, fourcategories of economic information are sought from applicants. This economicdata will be used by the NRC in preparing regulatory analyses that contain,among other things, the anticipated economic burden a proposed rulemakingaction will have on affected licensees. To the extent that it is possible andconsistent with public health and safety, the NRC will consider the economicburden in light of the size of the entities affected by the rule in an attemptto mitigate the potential for a significant economic impact on a substantialnumber of small entities.

14

Item 14.a Annual Receipts

Guidance for determining the approximate box in 14.a, Annual Receipts:*

1. Holders of One NRC License. If your organization (named on thelicense or application) holds one NRC license and operates from one address,check the box that most closely approximates your annual receipts; in the caseof hospitals, academic institutions, or other entities that do not operate onthe basis of receipts, check the box that most closely approximates the annualoperating budget of your organization.

2. Holders of Multiple NRC Licenses Issued for One Address. If yourorganization (named on the license or application) holds multiple NRC licenses,all of which are issued to tha same address, check the box that most closelyapproximates the annual receipts or annual operating budget for your entireorganization, regardless of the number of NRC licenses possessed at that singleaddress.

3. Holders of Multiple NRC Licenses at Multiple Addresses. If yourorganization (named on the license or application) holds multiple NRC licensesat multiple addresses, check the box that most closely approximates the annualreceipts or annual operating budget for the operations conducted at the addresson this license or application and not for the entire corporate-entity.

14.b Number of Employees

The number of employees reported should reflect all employees for theorganization at the address listed on the license or application, excludingoutside contractors. The number of employees reported should not be that of asingle department or division within the organization.

14.c Number of Beds (Hospitals Only)

Enter the total number of beds in the hospital, excluding bassinets andnursing-home-type units.

14.d Would You Be Willing To Furnish Cost Information on the Economic Impactof Current Regulations or any Future Proposed NRC Regulations That MayAffect You?

Indicate if you would be willing to furnish additional economic data tothe NRC that would help the NRC evaluate the economic impact of a rule onaffected licensees.,

*If the applicant is a university with a teaching hospital that operates under

a separate annual budget and has been issued multiple licenses, the applicantshould check the box that most closely approximates the annual operating budgetof the entity that is the applicant,,either the university or the teachinghospital.

15

4. AMENDMENTS TO LICENSE

A licensee must receive a license amendment before changing the scope ofthe program, changing the Radiation Safety Officer or teletherapy physicist, oradding to the staff of authorized users. See § 35.13 for the specific require-ments. An application for an amendment must be filed in duplicate either onNRC Form 313 or as a letter and must be signed as described in Item 13. If theamendment application is the first one submitted after the effective date ofthe revision of 10 CFR Part 35 (April 1, 1987), the NRC will use this oppor-tunity to list the Radiation Safety Officer and teletherapy physicist on thelicense. The teletherapy physicist's credentials must be submitted as part ofthe amendment application.

5.' RENEWAL OF LICENSE

An application for the renewal of a license should be filed at least30 days before the expiration date. This will ensure that the license doesnot expire before final action on the application has been taken by the NRC asprovided for in paragraph 30.37(b) of 10 CFR Part 30. The application forrenewal must be filed in duplicate on' NRC Form 313. The application for renewalmay reference attachments that were previously submitted. For example, "SeeATT 10.7 dated November 14, 1985."

6. IMPLEMENTATION

The purpose of this section is to provide information to you about the NRCstaff's plans for using this regulatory guide and how these plans affect you.

The guide was distributed for comment to encourage public participation inits development (Task FC 415-4, August 1985). This final Revision 2 representsthe staff position of the NRC, which incorporates the public comments that werereceived on the draft guide.

The draft guide and final guide differ. If your license was issued oramended based on recommendations in the draft guide that are more restrictivethan those in the final guide, you may choose to request an amendment to yourlicense to incorporate the less restrictive guidance.

In cases where the final guide is more restrictive than the draft guide,licensing actions already completed will not be affected because all requiredregulatory findings have been made. However, the more restrictive recommenda-tions in the final guide reflect items identified by the NRC staff as importantto health and safety. Discrepancies may be addressed for effective licensesby license amendment or rule change. In unusual cases in which immediate actionis required, you would be contacted directly by the NRC.

The information in this regulatory guide is guidance, not requirements.The NRC reviews each application to ensure that users of byproduct material arecapable of complying with NRC's regulations. This guide provides one set ofmethods approved by the NRC for meeting the regulations.

16

APPENDICES

Part I - MODEL PROCEDURES THAT APPLICANTS MAY USETO PLAN RADIATION SAFETY PROGRAMS

*APPENDIX A.

Model Training Program(See §§ 19.12 and 35.21)

The following guidance may be used to develop a training program. Ifyou use the frequency 'and subject listings to develop your training program,you may say on your application, "We will establish and Iimplement the modeltraining program that was published in Appendix A to Regulatory Guide 10.8,Revision 2, and have appended a table ATT 8.1 that identifies the groups ofworkers who will receive training and the method and frequency of training."You may use lectures, video-taped presentations, or demonstrations, for example,as methods of training.

If you prefer, you may develop your own training program for review.If you do so, you should consider for inclusion all the features in the modelprogram and carefully review the requirements of § 19.12, Say on your applica-tion, "We have developed a training program for your review that is appendedas ATI 8.1." Be sure to include the table that identifies groups of workers,the method of their training, and the frequency of training.

It may not be assumed that safety instruction has been adequately coveredby prior occupational training, board certification, etc. Site-specifictraining should be provided for all workers. Ancillary personnel (e.g., nursing,clerical, housekeeping, security) whose duties may require them to work in thevicinity of radioactive material (whether escorted or not) need to be informedabout radiation hazards and appropriate precautions. All training should betailored to meet the needs of the individuals in attendance. A training programthat provides necessary instruction should be written and implemented.

MODEL PROGRAM

Personnel will be instructed:

1. Before assuming duties with, or in the vicinity of, radioactive materials.

2. During annual refresher training.

3. Whenever there is a significant change in duties, regulations, or theterms of the license.

Instruction for individuals in attendance will include the following subjects:

1. Applicable regulations and license conditions.

2.. Areas where radioactive material is used or stored.

3. Potential hazards associated with radioactive material in each area wherethe employees will work.

4. Appropriate radiation safety procedures.

5. Licensee's in-house work rules.

A-1

6. Each individual's obligation to report unsafe conditions to the RadiationSafety Officer.

7. Appropriate response to emergencies or unsafe conditions.

8. Worker's right to be informed of occupational radiation exposure andbioassay results.

9. Locations where the licensee has posted or made available notices, copiesof pertinent regulations, and copies of pertinent licenses and licenseconditions (including applications and applicable correspondence), asrequired by 10 CFR Part 19.

10. Question and answer~period;

A-2

APPENDIX B

Model Procedure for Calibrating Survey Instruments(See § 35.51.)

You or your contractor may use the following guidance to calibrate surveyinstruments. If you, or the contractor, follow all the guidance, you may sayon your application, "We will establish and implement the model procedure forcalibrating survey instruments that was published in Appendix B to RegulatoryGuide 10.8, Revision 2."

If your procedure does not follow the guidance in the model, you maydevelop your own procedure for review. If you do so, you should consider forinclusion all the features in the model and carefully review the requirementsof § 35.51. Say on your application, "We have developed a survey instrumentcalibration procedure for your review that is appended as ATT 9.2," and appendyour survey instrument calibration procedure.

Radiation survey meters should be calibrated with a radioactive source.Electronic calibrations alone are not acceptable. Survey meters must be cali-brated at least annually and after servicing. (Battery changes are not con-sidered "servicing.")

MODEL PROCEDURE

1. The source must be approximately a point source.

2. Either the apparent source activity or the exposure rate at a givendistance must be traceable by documented measurements to a standardcertified within 5 percent accuracy by the National Bureau of Standards.

3. A source that has approximately the same photon energy as the environmentin which the calibrated device will be employed should be used for thecalibration.

4. The source should be of sufficient strength to give an exposure rate ofabout 30 mR/hr at 100 cm. Minimum activities of typical sources are85 millicuries of Cs-137 or 21 millicuries of Co-60.

5. The inverse square law and the radioactive decay law must be used tocorrect for change in exposure rate due to changes in distance or sourcedecay.

6. A record must be made of each survey meter calibration.

7. A single point on a survey meter scale may be considered satisfactorilycalibrated if the indicated exposure rate differs from the calculatedexposure rate by less than 10 percent.

B-I

8. Three kinds of scales are frequently used on survey meters:

a. Meters on which the user selects a linear scale must be calibratedat no less than two points on each scale. The points should be atapproximately 1/3 and 2/3 of full scale.

b. Meters that have a multidecade logarithmic scale must be calibratedat no less than one point on each decade and no less than two pointson one of the decades. Those points should be at approximately 1/3and 2/3 of the decade.

c. Meters that have an automatically ranging digital display device forindicating rates must be calibrated at no less than one point oneach decade and at no less than two points on one, of the decades.Those points should be'at approximately 1/3 and 2/3 of the decade.

9. Readings above 1,000 mR/hr need not be calibrated. However, such scalesshould be checked for operation and approximately correct response.

10. At the time of calibration, the apparent exposure rate from a built-in orowner-supplied check source must be determined and recorded.

11. The report of a survey meter calibration should indicate the procedureused and the data obtained. The description of the calibration willinclude:

a. The owner or user of the instrument;

b. A description of the instrument that includes manufacturer, modelnumber, serial number, and type of detector;

c. A description of the calibration source, including exposure rate ata specified distance on a specified date, and the calibrationprocedure;

d. For each calibration point, the calculated exposure rate, the indi-cated exposure rate, the deduced correction factor (the calculatedexposure rate divided by the indicated exposure rate), and the scaleselected on the instrument;

e. The reading indicated with the instrument in the "battery check"mode (if available on the instrument);

f. The angle between the radiation flux field and the detector (forexternal cylindrical GM or ionization-type detectors, this willusually be "parallel" or "perpendicular" indicating photons travelingeither parallel with or perpendicular to the central axis of thedetector; for instruments with internal detectors, this should bethe angle between the flux field and a specified surface of theinstrument);

g. For detectors with removable shielding, an indication of whether theshielding was in place or removed during the calibration procedure;

B-2

h. The apparent exposure-rate from the check source; and

i. The name of the person who performed the calibration and the date onwhich the calibration was performed.

12. The followi~ng information will be attached to the instrument as a calibra-tion sticker or tag:

.a. The source that was used to calibrate the instrument;

b. The proper deflection in the battery check mode (unless this isclearly indicated on the instrument);

C. For each scale or decade, one of the following as appropriate:

(1) The average correction factor,

(2) A graph or graphs from which the correction factor for eachscale or decade may be deduced, or

(3) An indication that the scal'e was checked for function but notcalibrated or an indication that the scale was inoperative;

d. The angle between the radiation flux and the detector during thecalibration; and

e. The apparent exposure rate from the check source.

Note: One-word reminders or symbols that are explained on the Survey MeterCalibration Report may be used on the calibration sticker.

See Exhibit 7 for a form you may want to use.

B-3

APPENDIX C

Model Procedure for Calibrating Dose Calibrator(See § 35.50.)

You or your contractor may use the following model procedure for checkingand testing the dose calibrator. If you, or the contractor, follow the modelprocedure,.you may say on your application, "We will establish and implementthe model procedure for calibrating our dose calibrator that was published inAppendix C to Regulatory Guide 10.8, Revision 2."

If you develop your own dose calibrator calibration procedure for review,you should carefully review § 35.50 and all the features in the model procedure:Say on your application, "We have developed a dose calibrator calibrationprocedure for your review that is appended as ATT 9.3," and append your dosecalibrator calibration procedure.

MODEL PROCEDURE

1. Test for the following at the indicated frequency. Consider repair, re-placement, or arithmetic correction if the dose calibrator falls outsidethe suggested tolerances. (These recommended tolerances are more restric-tive than those in the regulations to ensure that corrective action will betaken before the dose calibrator is outside permissible tolerances.)

a. Constancy at least once each day prior to assay of patient dosages(±5 percent).

b.-' Linearity at installation and at least quarterly thereafter (±5

percent).

c. Geometry dependence at installation (±5 percent).

d. Accuracy -at installation and at least annually thereafter (±5percent).

2. After repair, adjustment, or relocation of the dose calibrator, repeat theabove tests as appropriate.

3. Constancy means reproducibility in measuring a constant source over along period of time. Assay at least one relatively long-lived sourcesuch as Cs-137, Co-60, Co-57,* or Ra-226* using a reproducible geometryeach day before using the calibrator. Consider the use of two or moresources with different photon energies and activities. Use the followingprocedure:

a. Assay each reference source using the appropriate dose calibratorsetting (i.e., use the Cs-137 setting to assay Cs-137).

b. Measure background at the same setting, and subtract or confirm theproper operation of the automatic background subtract circuit if itis used.

*Co-57 and Ra-226 are not subject to NRC licensing; the appropriate State agency

should be consulted to determine its requirements for possessing this material.

C-1

c. For each source used,.either plot on graph paper or log in a bookthe background level for each setting checked and the net activityof each constancy source.

d. Using one of the sources, repeat the above procedure for all commonlyused radioisotope settings. Plot or log the results.

e. Establish an action level or tolerance for each recorded measurementat which the individual performing the test will automatically notifythe chief technician or authorized user of suspected malfunction ofthe calibrator. These action levels should be written in the logbook or posted on the calibrator. The regulation requires repair orreplacement if the error exceeds 10 percent.

4. Inspect the instrument on.a quarterly basis to ascertain that the measure-ment chamber liner is in place and that the instrument is zeroed accordingto the manufacturer's instructions.

5. Linearity means that the calibrator is able to indicate the correctactivity over the range of use of that calibrator. This test is doneusing a vial or syringe of Tc-99m whose activity is at least as large asthe maximum activity normally assayed in a prepared radiopharmaceuticalkit, in a unit dosage syringe, or in a radiopharmaceutical therapy,whichever is largest.

Decay Method

a. Assay the Tc-99m syringe or vial in the dose calibrator, and subtractbackground to obtain the net activity in millicuries. Record thedate, time to the nearest minute, and net activity on the DoseCalibrator Linearity Test Form (see Exhibit 8). This first assayshould be done in the morning at a regular time, for example, 8 a.m.

b. Repeat the assay at about noon, and again at about 4 p.m. Continueon subsequent days until the assayed activity is less \than 10 micro-curies. For dose calibrators on which you select a range with aswitch, select the range you would normally use for the measurement.

c. Convert the time and date information you recorded to hours elapsedsince the first assay.

d. On a sheet of semilog graph paper or on a copy of the sample form inExhibit 8, label the logarithmic vertical axis in millicuries andlabel the linear horizontal axis in hours elapsed. At the top of thegraph, note the date and the manufacturer, model number, and serialnumber of the dose calibrator. Then plot the data.

e. L-aw a "best fit" straight line through the data points. For thepoint farthest from the line, calculate its deviation from the valueon the line. (A-observed - A-line)/(A-line) = deviation.

f. If the worst deviation is more than +0.05, the dose calibrator shouldbe repaired or adjusted. If,this cannot be done, it will-be necessary

C-2

to make a correction table or graph that will allow you to convertfrom activity indicated by the dose .calibrator to "true activity."

g. Put a sticker on the dose calibrator that says when the next linearitytest is due.

Shield Method

If you decide to use a set of "sleeves" of various thicknesses to testJfor linearity, it will first be necessary to calibrate them.

a. Begin the linearity test as described in the decay method describedabove. After making the first assay, the sleeves can be calibratedas follows. Steps b through d below must be completed within6 minutes.

b. Put the base and sleeve I in the dose calibrator with the vial.Record the sleeve number and indicated activity.

c. Remove sleeve 1 and put in sleeve 2. Record the sleeve number andindicated activity.

d. Continue for all sleeves.

e. Complete the decay method linearity test steps b through g above.

f. From the graph made in step d of the decay method, find the decaytime associated with the activity indicated with sleeve I in place.This is the "equivalent decay time" for sleeve 1. Record that timewith the data recorded in step b.

g. Find the decay time associated with the activity indicated withsleeve 2 in place. This is the "equivalent decay time" for sleeve 2.Record that time with the data recorded in step c.

h. Continue for all sleeves.

i. The table of sleeve numbers and equivalent decay times constitutesthe calibration of the sleeve set.

The sleeve set may now be used to test dose calibrators for linearity.

a. Assay the Tc-99m syringe or vial in the dose calibrator, and subtractbackground to obtain the net activity in millicuries. Record thenet activity.

b. Steps c through e below must be completed within 6 minutes.

c. Put the base and sleeve I in the dose calibrator with the vial.Record the sleeve number and indicated activity.

d. Remove sleeve I and put in sleeve 2. Record the sleeve number andindicated activity.

C-3

e. Continue for all sleeves.

f. On a sheet of semilog graph paper or on a copy of the sample form inExhibit 8, label the logarithmic vertical axis in millicuries, andlabel the linear horizontal axis in hours elapsed. At the top of thegraph, note the date and the model number and serial number of thedose calibrator.

g. Plot the data using the equivalent decay time associated with eachsleeve.

h. Draw a "best fit" straight line through the data points. For thepoint farthest from the line,-calculate its deviation from the valueon the line. (A-observed - A-line)/A-line = deviation.

i. If the worst deviation is more than +0.05, the dose calibratorshould be repaired or adjusted. If this cannot be done, it will benecessary to make a correction table or graph that will allow you toconvert from activity indicated by the dose calibrator to "trueactivity."

j. Put a sticker on the dose calibrator that says when the next linearitytest is due.

6. Geometry independence means that the indicated activity does not changewith volume or configuration. This test should be done using a syringethat is normally used for injections. Licensees who use generators andradiopharmaceutical kits should also do the test using a vial similarin size, shape, and construction to the radiopharmaceutical kit vialsnormally used. The following test assumes injections are done With3-cc plastic syringes and that radiopharmaceutical kits are made in30-cc glass vials. If you do not use these, change the procedure sothat your syringes and vials are tested throughout the range of volumescommonly used.

a. In a small beaker or vial, mix 2 cc of a solution of Tc-99m with anactivity concentration between I and 10 mCi/ml. Set out a secondsmall beaker or vial with nonradioactive saline. You may also usetap water.

b. Draw 0.5 cc of the Tc-99m solution into the syringe and assay it.Record the volume and millicuries indicated on the Dose CalibratorGeometry and Accuracy Form (see Exhibit 9).

c. -Remove the syringe from the calibrator, draw an additional 0.5 ccof nonradioactive saline or tap water, and assay again. Record thevolume and millicuries indicated.

d. Repeat the process until you have assayed a 2.0-cc volume.

e. Select as a standard the volume closest to that normally used forinjections. For all the other volumes, divide the standard milli-curies by the millicuries indicated for each volume. The quotientis a volume correction factor. Alternatively, you may graph the

C-4

data and draw horizontal 5 percent error lines above and below thechosen "standard volume."

f. If any correction factors are greater than 1.05 or less than 0.95,or if any data points lie outside the 5 percent error lines, it willbe necessary to make a correction table or graph that will allow youto convert from "indicated activity" to "true activity." If this isnecessary, be sure to label the table or graph "syringe geometrydependence," and note the date of the test and the model number andserial number of the calibrator.

g. To test the geometry dependence for a 30-cc glass vial, draw 1.0 ccof the Tc-99m solution into a, syringe and then inject it into thevial. Assay the vial. Record the volume and millicuries indicated.

h. Remove the vial from the calibrator and, using a clean syringe,inject 2.0 cc of nonradioactive saline or tap water, and assayagain. Record the volume and millicuries indicated.

i. Repeat the process until you have assayed a 19.0-cc volume. Theentire process must be completed within 10 minutes.

j. Select as a standard the volume closest to that normally used formixing radiopharmaceutical kits. For all the other volumes, dividethe standard millicuries by the millicuries indicated for eachvolume. The quotient is a volume correction factor. Alternatively,you may graph the data and draw horizontal 5 percent error linesabove and below the chosen "standard volume."

k. If any correction factors are greater than 1.05 or less than 0.95 orif any data points lie outside the 5 percent error lines, it will benecessary to make a correction table or graph that will allow you toconvert from "indicated activity" to "true act.ivity." If this isnecessary, be sure to label the table or graph "vial geometrydependence," and note the date of the test and the model number andserial number of the calibrator.

7. Accuracy means that, for a given calibrated reference source, the indi-cated millicurie value is equal to the millicurie value determined by theNational Bureau of Standards (NBS) or by the supplier who has comparedthat source to a source that was calibrated by the NBS. Certified sourcesare available from the NBS and from many radioisotope suppliers. At leasttwo sources with different principal photon energies (such as Co-57, Co-60,or Cs-137) should be used. The regulations require that one must have aprincipal photon energy between 100 keV and 500 keV. The regulations alsorequire that, if a Ra-226 source is used, it must be at least 10 micro-curies; other sources must be at least 50 microcuries. Consider using atleast one reference source whose activity is within the range of activi-ties normally assayed.

a. Assay acalibrated reference source at the appropriate setting (i.e.,use the Co-57 setting to assay Co-57), and then remove the sourceand measure background. Subtract background from the indicatedactivity to obtain the net activity. Record this measurement on the

C-5

Dose Calibrator Geometry and Accuracy Form (see Exhibit 9). Repeatfor a total of three determinations.

b. Average the three determinations. The average value should bewithin 5 percent of the certified activity of the reference source,mathematically corrected for decay.

c. Repeat the procedure for other calibrated reference sources.

d. If the average value does not agree, within 5 percent, with thecertified value of the reference source, the dose calibrator mayneed to be repaired or adjusted. The regulation requires repairor replacement if the error exceeds 10 percent.

e. At the same time the accuracy test is done, assay the source thatwill be used for the daily constancy test (it need not be a certi-fied reference source) on all commonly used radioisotope settings.Record the settings and indicated millicurie values with the accuracydata.

f. Put a sticker on the dose calibrator that says when the next accuracytest is due.

8. The RSO will review and sign the records of all geometry, linearity, and

accuracy tests.

See Exhibits 8 and 9 for some forms you may want to use.

C-6

r

APPENDIX D

Model 'Personnel External Exposure Monitoring Program(See § 20.101.)

You may use the following model program to monitor personnel externalexposure. If you follow the guidance in the program, you may say on yourapplication, "We will establish and implement the model personnel externalexposure monitoring program published in Appendix D to Regulatory Guide 10.8,Revision 2."

If you prefer, you may develop your own program for review. If you do,you should consider for inclusion all the features in the model program andcarefully review the requirements. of § 20.101. Say on your application, "Wehave developed an external exposure monitoring program for your review that isappended as ATT 9.4," and append your monitoring program.-

MODEL PROGRAM

1. , The RSO will promptly review all exposure reports to look for workers orgroups of workers whose exposure is unexpectedly high or low. This proce-dure does not apply to backup monitor records, for example, pocket ioniza-tion chambers, when the monitor of record is a film or thermoluminescencedosimeter (TLD).

2. All individuals who are occupationally exposed to ionizing photon radia-tion on a regular basis will be issued a film or TLD whole body monitorthat will be processed by a contract service on a monthly basis.

3. All individuals who, on a regular basis, handle radioactive material thatemits ionizing photons will be issued a film or TLD finger monitor thatwill be processed by a contract service on a monthly basis.

4. All individuals who are occupationally exposed to radiation on an occa-sional basis, such as nurses caring for radiopharmaceutical therapy orimplant patients, will be issued a whole body monitor when caring for suchpatients.

5. Other individuals who are exposed to radiation on an occasional basissuch as security personnel who deliver packages, secretarial personnelwho work in the nuclear medicine clinic but do not work with patients,and nurses who occasionally care for patients who have received diagnosticdosages will not normally be issued exposure monitors.

D-1

APPENDIX E

Model Procedure for Checking EquipmentUsed in Mobile Nuclear Medicine Service

(See §§ 35.29 and 35.80.)

The NRC normally limits its review of equipment quality assurance programsto those programs developed for radiation safety equipment. However, whendelicate imaging equipment is transported from one location of use to another,e.g.,by a mobile nuclear medicine service, it is reasonable to assume that itmay suffer damage in transit. Therefore, the NRC requires that mobile nuclearmedicine services have an imaging equipment quality assurance program to ensurethat the use of byproduct material will not be inimical to the public healthand safety. Mobile nuclear medicine services should also check ventilationequipment if gases or aerosols will be used.

You may use the following procedure to ensure the proper operation ofimaging equipment that has been transported. If you follow the procedure, youmay say on your application, "We will establish and implement the model proce-dure for ensuring equipment performance that was published in Appendix E toRegulatory Guide 10.8, Revision 2."

If you want to develop your own procedure for review, you should considerfor inclusion all the features in the model procedure and the procedure recom-mended by the manufacturer and carefully review the requirements of §§ 35.29and 35.80. Say on your application, "We have developed a procedure for ensuringequipment performance for your review that is appended as ATT. 9.5," and appendyour imaging equipment quality assurance procedure.

MODEL PROCEDURE

Survey Meter

Check the survey meter with the dedicated check source at each location ofuse. Material may not be used if the survey meter is not working. There is noneed to keep a record of these checks.

Camera

1._ Perform the following checks daily at each location of use before admin-istering byproduct material:

a. Peak each camera according to the manufacturer's instructions.

b. Using either Tc-99m or Co-57, perform an extrinsic flood field with a)

frequently used collimator in place, or perform an intrinsic floodfield test. Accumulate at least 1,000,000 counts for small-field-of-view cameras and 3,000,000 counts for large-field-of-view cameras.Process the image as if it were an image of a patient.

c. Do not administer material until an authorized user or a designatedtechnologist approves the camera for use.

E-1

d. You do not have to make a permanent record of these daily checks.

2. Perform the following checks weekly:

a. With the same frequently used collimator in place, image a floodsource and either a parallel-line-equal-space (PLES), bar, orthogonal-hole (OH) or resolution-quadrant phantom with the flood field as asource.

b. If a PLES or bar phantom is used, rotate it 900 so that the camerais tested for both vertical and horizontal geometric linearity.

c. If a resolution-quadrant phantom is used, rotate it so that eachquadrant is imaged in each quadrant of the crystal. Then turn itover and again image it four more times. This procedure will checkboth resolution and horizontal and vertical geometric linearity ineach quadrant of the crystal.

d. Process the images as if they were images of a patient. Mark themclearly to indicate image orientation, source activity, and date.

e. Retain the images for 2 years.

3. Perform the following safety checks after repairs and quarterly:

a. Check the motion interlocks by activating the emergency-off switcheson the camera. With the camera in motion, activation of theemergency-off switch should stop the motion. If this mightjeopardize imaging components in the system, perform only the checksdescribed in paragraph 3.b.

b. Check the motion switches. Put the camera in motion and firstrelease just the direction switch to stop the motion. Then put thecamera back in motion and release just the dead-man switch. Testall motion switches and all directions in this manner. Release ofeither the motion switch or the dead-man switch alone should disablethe camera motion. If this is not the case, repair the camerabefore clinical use.

4. Set the equipment in the same manner each time checks are run. Make arecord of all these checks. Keep a separate file or ring binder for eachcamera. Retain the record for 2 years.

Ventilation

If gases or aerosols will be used, check the ventilation supply, exhaustvents, and collection devices for operation with tissue paper or a velometer.There is no need to keep a record of these checks.

E-2

APPENDIX F

Model Radiation Safety Committee Charterand Radiation Safety Officer Delegation of Authority

(See H§ 35.21, 35.22, and 35.23.)

You may use the following text as it appears here, saying on your applica-tion, "We will issue the model Radiation Safety Committee Charter and RadiationSafety Officer Delegation of Authority that was published in Appendix F toRegulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own statement of authority, duties,administrative procedures, and delegation of authority. If you do so, youshould consider for inclusion all the features in the model text and carefullyreview the requirements of §§ 35.22. Say on your application, "We will issuethe Radiation Safety Committee Charter and Radiation Safety Officer Delegationof Authority that are appended as ATTU10.1," and append your charter-and dele-gation.

MODEL CHARTER

Charge. The Committee shall:

L. Ensure that licensed material will be used safely. This includes reviewas necessary of training programs, equipment, facility, supplies, andprocedures;

2. Ensure that licensed material is used in compliance with NRC regulationsand the institutional license;

3. Ensure that the use of licensed material is consistent with the ALARAphilosophy and program;

4. Establish a table of investigational levels for individual occupational

radiation exposures; and

5. Identify program problems and solutions.

Responsibilities. The Committee shall:

1. Be familiar with all pertinent NRC regulations, the license application,the license, and amendments;

2. Review the training and experience of the proposed authorized users, theRadiation Safety Officer •RSO), and the teletherapy physicist to determinethat their qualifications are sufficient to enable the individuals to per-form their duties safely and are in accordance with the regulations and thelicense;

3. Review on the basis of safety and approve or deny, consistent with thelimitations of the regulations, the license, and the ALARA philosophy,all requests for authorization to use radioactive material within theinstitution;

F-1

4. Prescribe special conditions that will be required during a proposedmethod of use of radioactive material such as requirements for bioassays,physical examinations of users, and special monitoring procedures;

5. Review quarterly the RSO's summary report of the occupational radiationexposure records of all personnel, giving attention to individuals orgroups of workers whose occupational exposure appears excessive;

6. Establish a program to ensure that all persons whose duties may requirethem to work in or frequent areas where radioactive materials are used(e.g., nursing, security, housekeeping, physical plant) are appropriatelyinstructed as required in § 19.12 of 10 CFR Part 19;

7. Review at least annually the RSO's summary report of the entire radiationsafety program to determine that all activities are being conductedsafely, in accordance with NRC regulations and the conditions of thelicense, and consistent with the ALARA program and philosophy. Thereview must include an examination of records, reports from the RSO,results of NRC inspections, written safety procedures, and the adequacyof the management control system;

8. Recommend remedial action to correct any deficiencies identified in theradiation safety program;

9. Maintain written minutes of all Committee meetings, including members inattendance and members absent, discussions, actions, recommendations,decisions, and numerical results of all votes taken; and

10. Ensure that the byproduct material license is amended if required priorto any changes in facilities, equipment, policies, procedures, andpersonnel.

Administrative Information

1. The Committee shall meet as often as necessary to conduct its businessbut not less than once in each calendar quarter.

2. Membership must include one authorized user for each type of use authorizedby the license, the RSO, a representative of the nursing service, and arepresentative of management who is neither an authorized user nor an RSO.Management may appoint alternate members to participate in meetings in thecase of absence of principal members and should consider appointing asadjunct members representatives from security, physical plant, housekeeping,and other departments. (Adjunct members should abstain from balloting onradiation safety technical questions such as Items 2 through 5 in the"Responsibilities" section above.)

3. To establish a quorum, one-half of the Committee's membership, includingthe RSO and the management representative, must be present.

4. To the extent that they do not interfere with the mission of the Committee,management may assign other responsibilities such as x-ray radiationsafety, quality assurance oversight, and research project review andapproval.

F-2

MODEL DELEGATION OF AUTHORITY

Memo To: All EmployeesFrom: Chief Executive Officer

Subject: Delegation of Authority

has been appointed Radiation Safety Officer and isresponsible for ensuring the safe use of radiation. The Radiation SafetyOfficer is responsible for managing the radiation safety program; identifyingradiation safety problems; initiating, recommending, or providing correctiveactions; verifying implementation of corrective actions; and ensuringcompliance with regulations. The Radiation Safety Officer is hereby delegatedthe authority necessary to meet those responsibilities.

The Radiation Safety Officer is also responsible for assisting the RadiationSafety Committee in the performance of its duties and serving as its secretary.

F-3

APPENDIX G

Model Program for Maintaining Occupational Radiation Exposureat Medical Institutions ALARA

(See § 35.20.)

You may use the text as it appears here, saying on your application, "Wewill establish and implement the model ALARA program that was published inAppendix G to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own ALARA program for NRC review. Ifyou do so, you should consider for inclusion all the features in the model andcarefully review the requirements of § 35.20. Say on your application, "Wehave developed an ALARA program for your review that is appended as A1- 10.2,"and append your program.

ALARA PROGRAM

(Licensee's Name)

(Date)

1. Management Commitment

a. We, the management of this (medical facility, hospital, etc.), arecommitted to the program described herein for keeping individual andcollective doses as low as is reasonably achievable (ALARA). Inaccord with this commitment, we hereby describe an administrativeorganization for radiation safety and will develop the necessarywritten policy, procedures, and instructions to foster the ALARAconcept within our institution. The organization will include aRadiation Safety Committee (RSC) and a Radiation Safety Officer (RSO).

b. We will perform a formal annual review of the radiation safety program,including ALARA considerations. This will include reviews of operatingprocedures and past dose records, inspections, etc., and consultationswith the radiation safety staff or outside consultants.

c. Modifications to operating and maintenance procedures and to equip-ment and facilities will be made if they will reduce exposures unlessthe cost, in our judgment, is considered to be unjustified. We willbe able to demonstrate, if necessary, that improvements have beensought, that modifications have been considered, and that they havebeen implemented when reasonable. If modifications have been recom-mended but not implemented, we will be prepared to describe thereasons for not implementing them.

d. In addition to maintaining doses to individuals as far below the limitsas is reasonably achievable, the sum of the doses received by allexposed individuals will also be maintained at the lowest practicable

G-1

level. It would not be desirable, for example, to hold the highest-doses to individuals to some fraction of the applicable limit if thisinvolved exposing additional people and significantly increasing thesum of radiation doses received by all involved individuals.

2. Radiation Safety Committee

a. Review of Proposed Users and Uses

(1) The RSC will thoroughly review the qualifications of each appli-cant with respect to the types and quantities of materials andmethods of use for which application has been made to ensurethat the applicant will be able to take appropriate measures tomaintain exposure ALARA.

(2) When considering a new use of byproduct material, the RSC willreview the efforts of the applicant to maintain-exposure ALARA.

(3) The RSC will ensure that the users justify their proceduresand that individual and collective doses will be ALARA.

b. Delegation of Authority

(The judicious delegationrof RSC authority is essential to theenforcement of an ALARA program.)

(1) The RSC will delegate authority to the"RSO for enforcement ofthe ALARA concept.

(2) The RSC will support the RSO when it is necessary for the RSOto assert authority. If the RSC has overruled the RSO, it willrecord the basis for its action in the minutes of the quarterlymeeting.

c. Review of ALARA Program

(1) The RSC will encourage all users to review current proceduresand develop new procedures as appropriate to implement theALARA concept.

(2) The RSC will perform a quarterly review of occupational radiationexposure with particular attention to instances in which theinvestigational levels in Table I are exceeded. The principalpurpose of this review is to assess trends in occupational expo-sure as an index of the ALARA program quality and to decide ifaction is warranted when investigational levels are exceeded (seeSection 6 below for a discussion of investigational levels).*

*The'NRC has emphasized that the investigational levels in this program arenot new dose limits but, as noted in ICRP Report 26, "Recommendations of theInternational Commission on Radiological Protection," serve as check pointsabove which the results are considered sufficiently important to justifyinvestigations.

G-2

Table 1

Investigational Levels

Investigational Levels

(mrems per calendar quarter)

Level I Level II

1. Whole body; head and trunk; 125 375active blood-forming organs;lens of eyes; or gonads

2. Hands and forearms; feet 1875 5625and ankles

3. Skin of whole body* 750 2250

*Not normally applicable to medical use operations except thoseusing significant quantities of beta-emitting isotopes.,

(3) The RSC will evaluate our institution's overall efforts formaintaining doses ALARA on an annual basis. This reviewwill include the efforts of the RSO, authorized users, andworkers as well as those of management.

3. Radiation Safety Officer

a. Annual and Quarterly Review

(1) Annual review of the radiation safety program. The RSO willperform an annual review of the radiation safety program foradherence to ALARA concepts. Reviews of specific methods ofuse may be conducted on a more frequent basis.

(2) Quarterly review of occupational exposures. The RSO will reviewat least quarterly the external radiation doses of authorizedusers and workers to determine that their doses are ALARA inaccordance with the provisions of Section-6 of this program andwill prepare a summary report for the RSC.

(3) Quarterly review of records of radiation surveys. The RSO willreview radiation surveys in unrestricted and restricted areasto determine that dose rates and amounts of contamination wereat ALARA levels during the previous quarter and will prepare asummary report for the RSC.

b. Education Responsibilities for ALARA Program

(1) The RSO will schedule briefings and educational sessions toinform workers of ALARA program efforts.

G-3

(2) The RSO will ensure that authorized users, workers, and ancillarypersonnel who may be exposed to radiation will be instructed inthe ALARA philosophy and infotmed that management, 'the RSC, andthe RSO are committed to implementing the ALARA concept.

c. Cooperative Efforts for Development of ALARA Procedures

Radiation workers will be given opportunities to participate informulating the procedures that they will be'required to follow.

(1) The RSO will be in close contact with all users and workers inorder to develop ALARA procedures for working with radioactivematerials.

(2) The RSO will establish procedures for receiving and evaluatingthe suggestions of individual workers for improving healthphysics practices and will encourage the use of those procedures.

d. Reviewing Instances of Deviation from Good ALARA Practices

The RSO will investigate all known instances of deviation from goodALARA practices and, if possible, will, determine thecauses. Whenthe cause is known, the RSO will implement changes in the program tomaintain doses ALARA.

4. Authorized Users

a. New Methods of Use Involving Potential Radiation Doses

(1) The authorized user will consult with the RSO and/or RSC duringthe planning stage before using radioactive materials for newuses.

(2) The authorized user will review each planned use of radioactivematerials to ensure that doses will be kept ALARA. Trial runsmay be helpful.

b. Authorized User's Responsibility to Supervised Individuals

(1) The authorized user will explain the ALARA concept and the needto maintain exposures ALARA to all supervised individuals.

(2) The authorized user will ensure that supervised individuals whoare subject to occupational radiation exposure are trained andeducated in good health physics practices and in maintainingexposures ALARA.

5. Individuals Who Receive Occupational Radiation Doses

a. Workers will be instructed in the ALARA concept and its relation-ship to work procedures and work conditions.

b. Workers will be instructed in recourses available if they feel thatALARA is not being promoted on the job.

G-4

6. Establishment of Investigational Levels in Order to Monitor IndividualOccupational External Radiation Doses

This institution hereby establishes investigational levels for occupa-tional external radiation doses which, when exceeded, will initiate reviewor investigation by the RSC and/or the RSO. The investigational levelsthat we have adopted are listed in Table 1. These levels apply to theexposure of individual workers.

The RSO will review and record on Form NRC-5, "Current OccupationalExternal Radiation Exposures," or an equivalent form (e.g., dosimeterprocessor's report) results of personnel monitoring not less than oncein any calendar quarter as required by § 20.401 of 10 CFR Part 20. Thefollowing actions will be taken at the investigational levels as statedin Table 1:

a. Personnel dose less than Investigational Level I.

Except when deemed appropriate by the RSO, no further action will betaken in those cases where an individual's dose is less than Table Ivalues for the Investigational Level I.

b. Personnel dose equal to or greater than Investigational Level I butless than Investigational Level II.

The RSO will review the dose of each individual whose quarterly doseequals or exceeds Investigational Level I and will report the resultsof the reviews at the first RSC meeting following the quarter whenthe dose was recorded. If the dose does not equal or exceed Investi-gational Level II, no action related specifically to the exposure isrequired unless deemed appropriate by the Committee. The Committeewill, however, review each such dose in comparison with those of othersperforming similar tasks as an index of ALARA.program quality andwill record the review in the Committee minutes.

c. Personnel dose equal to or greater than Investigational Level II.

The RSO will investigate in a timely manner the causes of all person-nel doses equaling or exceeding Investigational Level II and, ifwarranted, will take action. A report of the investigation, anyactions taken, and a copy of the individual's Form NRC-5 or itsequivalent will be presented to the RSC at its first meeting follow-ing completion of the investigation. The details of these reportswill be included in the RSC minutes.

d. Reestablishment of investigational levels to levels above thoselisted in Table 1.

In cases where a worker's or a group of workers' doses need to exceedan investigational level, a new, higher investigational level maybe established for that individual or group on the basis that it isconsistent with good ALARA practices. Justification for newinvestigational levels will be documented.

G-5

The RSC will review the justification for and must approve or.disapprove all revisions of investigational levels.

7. Signature of Certifying Official*

I hereby certify that this institution has implemented the ALARA Programset forth above.

Signature

Name (print or type)

Title

*The person who is authorized to make commitments for the administration ofthe institution (e.g., hospital administrator).

G-6

APPENDIX H

Model Procedure for Leak-Testing Sealed Sources(See § 35.59.)

You or your contractor may use the following model procedure to leak-testsealed sources. If you, or the contractor, follow the model procedure you maysay on your application, "We will establish and implement the model procedurefor .leak-testing sealed sources that was published in Appendix H to RegulatoryGuide 10.8, Revision 2."

You may develop your own procedure for review. If you do so, you shouldconsider for inclusion all the features in the model and carefully review therequirements of §.35.59. Say on your application, "We have developed a leak-test procedure for your review that is appended as ATT 10.3," and append yourleak-test procedure.

MODEL PROCEDURE

1. Make a list of all sources to be tested. This should include at leastthe isotope, the activity on a specified date, and the physical form.

2. If you will be testing sources stronger than a few millicuries, set out asurvey meter, preferably with a speaker, so you can monitor your exposurerate.

3. Prepare a separate wipe sample for each source. A cotton swab, injectionprep pad, filter paper, or tissue paper is suitable. Number each wipe soyou will know for which source it is to be used. Samples should be takenas follows:

a. For small sealed sources, it may be easier to wipe the entire acces-sible surface area. Pay particular attention to seams and joints.However, do not wipe the port of beta applicators.

b. For larger sealed sources and devices (survey meter calibrator, bonemineral analyzer source), take the wipe near the radiation port andon the activating mechanism.

c. For teletherapy machines, take the wipe with the source in the offposition. Wipe the area near the shutter mechanism, taking care totouch neither field light and mirror nor crosshairs. Also wipe theprimary and secondary collimators and trimmers.

d. If you are testing radium sources at the same time you are testingNRC-licensed sources, they should also be checked for radon leakage.This can be done by submerging the source in a vial of fine-grainedcharcoal or cotton for a day. Then remove the source and analyzethe adsorbent sample as described below. A survey should be done tobe sure the sources are adequately shielded during the leak-testperiod.

H-i

4. The samples will be analyzed as follows:

a. Select an instrument that is sufficiently sensitive to detect0.005 microcurie. For beta sources, a proportional flow counter,liquid scintillation counter, or thin-end-window GM survey meter maybe appropriate. For gamma sources, a crystal with a ratemeter orscaler or a GM survey meter may be appropriate. Dose calibratorsused 4- nuclear medicine are not sufficiently sensitive.

b. To estimate the detection efficiency of the analyzer used to assaythe wipe samples, assay a check source that has the same isotope asthe sealed source and whose activity is certified by the supplier.If one is not available, it will be necessary to use a certified checksource with a different isotope that has a similar spectrum. Ifcalculations demonstrate that the instrument is not sufficientlysensitive to detect 0.005 microcurie, a different instrument mustbe used.

c. Assay the wipe sample. It must be in the same geometry relative tothe detector as was the certified check source.

d. Record the wipe sample counts per minute. Then calculate and recordthe estimated activity in microcuries on the wipe sample.

e. Continue the same analysis procedure for all wipe samples.

f. If the wipe sample activity is 0.005 microcurie or greater, notifythe RSO. The source must be withdrawn from use to be repaired ordiscarded. If it is a source distributed under an NRC or AgreementState license, the NRC must be notified. (See paragraph 21.21(b) of10 CFR Part 21 and paragraph 35.59(e)(2) of 10 CFR Part 35.)

g. Sign and date the list of sources, data, and calculations.

H-2

APPENDIX I

Model Rules for Safe Use of Radiopharmaceuticals(See § 35.21.)

You may use the following model rules as they appear here, saying onyour application, "We will establish and implement the model safety rules pub-lished in Appendix I to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own rules for safe use of radio-pharmaceuticals for review. If you do so, you should consider-for inclusionall the items in the model rules and carefully review the requirements ofPart 35. Say on your application, "We have developed rules for the safe useof radiopharmaceuticals for yogr review that are appended as ATT 10.4," andappend your model rules for the safe use of radiopharmaceuticals.

MODEL RULES

1. Wear laboratory coats or other protective clothing at all times in areaswhere radioactive materials are used.

2. Wear disposable gloves at all times while handling radioactive materials.

3. Either after each procedure or before leaving the area, monitor your handsfor contamination in a low-background area with a crystal probe or camera.

4. Use syringe shields for routine preparation of multi-dose vials andadministration of radiopharmaceuticals to patients, except in those circum-stances in which their use is contraindicated (e.g., recessed veins,infants). In these exceptional cases, consider the use of other protectivemethods such as remote delivery of the dose (e.g., through Use of a butter-fly valve).

5. Do not eat, drink, smoke, or apply cosmetics in any area where radioactivematerial is stored or used.

6. Do not-store food, drink, or personal effects in areas where radioactivematerial is stored or used.

7. Wear personnel monitoring devices at all times while in areas where radio-active materials are used or stored. These devices should be worn asprescribed by the Radiation Safety Officer. When not being worn to moni-tor occupational exposures, personnel monitoring devices should be storedin the work place in a designated low-background area.

8. Wear a finger exposure monitor during the elution of generators; duringthe preparation, assay, and injection of radiopharmaceuticals; and whenholding patients during procedures.

9. Dispose of radioactive waste only in designated, labeled, and properlyshielded receptacles.

10. Never pipette by mouth.

I-I

11. Wipe-test byproduct material storage, preparation, and administrationareas-weekly for contamination. If necessary, decontaminate or securethe area for decay.

12. With a radiation detection survey meter, survey the generator storage,kit preparation, and injection areas daily for contamination. If necessary,decontaminate or secure the area for decay as appropriate.

13. Confine radioactive solutions in shielded containers that are clearlylabeled. Radiopharmaceutical multidose diagnostic vials and therapy vialsshould be labeled with the isotope, the name of the compound, and the dateand time of receipt or preparation. A log book should be used to recordthe preceding information and total prepared activity, specific activityas mCi/cc at a specified time, total volume prepared, total volume remain-ing, the measured activity of each patient dosage, and any other appro-priate information. Syringes and unit dosages should be labeled with theradiopharmaceutical name or abbreviation, type of study, or the patient'sname.

14. Assay each patient dosage in the dose calibrator before administering it.Do not use a dosage if it is more than 10 percent off from the prescribeddosage, except for prescribed dosages of less than 10 microcuries. Whenmeasuring the dosage, you need not consider the radioactivity that adheresto the syringe wall or remains in the needle. Check the patient's nameand identification number and the prescribed radionuclide, chemical form,and dosage before administering.

15. Always keep flood sources, syringes, waste, and other radioactive materialin shielded containers.

16. Because even sources with small amounts of radioactivity exhibit a high doserate on contact, you should use a cart or wheelchair to move flood sources,waste, and other radioactive material.

1-2

APPENDIX J

Model Spill Procedures(See § 35.21.)

You may use the following model spill procedures as they appear here,,saying on your application, "We will establish and implement the model spillprocedures published in Appendix J to Regulatory Guide 10.8, Revision 2."

If you prefer' you may develop your own spill procedures for review. Ifyou do so, you should consider for inclusion all the items in the model proce-dures. Say on your application, "We have developed spill procedures for yourreview that are appended as ATT 10.5," and append your spill procedures.

MODEL PROCEDURES

Minor Spills of Liquids and Solids

1. Notify persons in the area that a spill has occurred.

,2. Prevent the spread of contamination by covering the spill with absorbentpaper.

3. Clean up the spill using disposable gloves and absorbent paper. Carefullyfold the absorbent paper with the clean side out and place in a plasticbag for transfer to a radioactive waste container. Also put contaminatedgloves and any other contaminated disposable material in the bag.

4. Survey the area with a low-range radiation detector survey meter. Checkthe area around the spill. Also check your hands, clothing, and shoesfor contamination.

5. Report the incident to the Radiation Safety Officer (RSO).

6. The RSO will follow up on the cleanup of the spill and will complete theRadioactive Spill Report (see Exhibit 10) and the Radioactive Spill Con-tamination Survey (see Exhibit 11).

Major Spills of Liquids and Solids

1. Clear the area. Notify all persons not involved in the spill to vacatethe room.

2. Prevent the spread of contamination by covering the spill with absorbentpaper, but do not attempt to clean it up. To prevent the spread-of con-tamination, limit the movement of all personnel who may be contaminated.

3. Shield the source if possible. This should be done only if it can bedone without further contamination or a significant increase in radiationexposure.

4. Close the room and lock or otherwise secure the area to prevent entry.

5. Notify the RSO immediately.

J-1

6. Decontaminate personnel by removing contaminated clothing and flushingcontaminated skin with lukewarm water and then washing with mild soap.If contamination remains, induce perspiration by covering the area withplastic. Then wash the affected area again to remove any contamination

.that was released by the perspiration.

7. The RSO will supervise the cleanup of the spill and will complete theRadioactive Spill Report (see Exhibit 10) and the Radioactive Spill Con-tamination Survey (see Exhibit 11).

The following is not part of the model, spill procedure:

Major Spills and Minor Spills

The decision to implement a maj6r spill procedure instead of a minor spillprocedure depends on many incident-specific variables such as the number ofindividuals affected, other hazards present, likelihood of spread of contami-nation, and types of surfaces contaminated as well as the radiotoxicity of thespilled material. For some spills of short-lived radionuclides the best spillprocedure may be restricted access pending complete decay.

Table J-1, which may be used as general guidance to determine whether a majorspill procedure or a minor spill procedure should be implemented, was developedbased on-a comparision of information from the following sources:

1. "Standards for Protection Against Radiation," Proposed-Rule, Part 20,published January 9,'1986, Appendix B, Table 1, Column 3 (Derived AirConcentration Values), 51 FR 1092.

2. "Gamma Radiation Levels for One Curie of Some Radionuclides," Radio-logical Health Handbook, January 1970 edition, Department of Health,Education, and Welfare, Washington, DC, p. 131.

3. National Council on Radiation Protection and Measurements, "Safe Handlingof Radioactive Materials," NCRP Report No. 30, paragraph 2.3 and Table 2,1964.

4. "Upgraded Emergency Preparedness for Certain Fuel Cycle and MaterialsLicensees," Advance Notice of Proposed Rulemaking on Parts 30, 40, and 70,46 FR 29712, Table 1, June 3, 1981.

Table J-1 may need to be modified before being used for guidance in a specificarea of use.

J-2

TABLE J-1

Relative Hazards of Common Radionuclides

Estimate the amount ofprocedure based on theamounts are considered

radioactivity spilled. Initiate a major or minor spillfollowing dividing line. Spills above these millicuriemajor, below are considered minor.

Radionuclide Millicuries Radionuclide Millicuries

P-32 10 Tc-99m 100Cr-51 100 In-Ill 10Co-57 100 1-123 10Co-58 10 1-125 1Fe-59 10 1-131 1Co-60 1 Yb-169 10Ga-67 100 Hg-197 100Se-75 10 Au 198 10Sr-85 10 TI-201 100

Spill Kit

You may also want to consider assembling a spill kit that contains:

6 pairs disposable gloves, 1 pair housekeeping gloves2 disposable lab coats2 paper hats2 pairs shoe covers1 roll absorbent paper with plastic backing6 plastic trash bags with twist ties"Radioactive Material" labeling tape1 china pencil or-marking pen3 prestrung "Radioactive Material" labeling tagsSupplies for 10 contamination wipe samplesInstructions for "Emergency Procedures"Clipboard with one copy of Radioactive Spill Report FormPencil

Forms

You may want to use Exhibit 10, Radioactive Spill Report, and Exhibit 11,Radioactive Spill Contamination Survey Forms.

J-3

APPENDIX K

Model Guidance for Ordering and ReceivingRadioactive Material

(See §§ 30.51 and 20.205.)

You may use the following guidance to control the ordering and receipt ofradioactive material. If you follow all the guidance, you may say on yourapplication, "We will establish and implement the model guidance for orderingand receiving radioactive material that was published in Appendix K to Regula-tory Guide 10.8, Revision 2."

If your procedure does not follow all the guidance in the model, you maydevelop your own procedure for'review. If you do so, you should consider forinclusion all the features in the model and carefully review the requirementsof §§ 30.51 and 20.205. Say on your application, "We have developed a proce-dure for ordering and receiving radioactive material for your review that isappended as ATT 10.6," and append your procedure for ordering and receivingradioactive material.

MODEL GUIDANCE

1. The Radiation Safety Officer (RSO) or a designee must authorize eachorder for radioactive materials and ensure that the requested materialsand quantities are authorized by the license for use by the requestingauthorized user and that possession limits are not exceeded.

2. The RSO will establish and maintain a system for ordering and receivingradioactive material. The system must contain the following information:

a. For routinely used materials

(1) Written records that identify the authorized user or department,isotope, chemical form, activity, and supplier will be made.

(2) The above records will be checked to confirm that materialreceived was ordered through proper channels.

b. For occasionally used materials (e.g., therapeutic dosages)

(1) The authorized user who will perform the procedure will make awritten request that indicates the isotope, radiopharmaceutical,activity, and supplier.

(2) The person who receives the material will check the physician'swritten request to confirm that the material received is whatwas ordered.

3. For deliveries during normal working hours, the RSO will tell carriers todeliver radioactive packages directly to a specified area.

4. For deliveries during off-duty hours, the RSO will tell security personnelor other designated persons to accept delivery of radioactive packages inaccordance with procedures outlined in the sample memorandum below.

K-i

Sample Memorandum

MEMO TO: Chief of SecurityFROM: Radiation Safety Officer

SUBJECT: Receipt of Packages Containing Radioactive Material

The security guard on duty shall accept delivery of packages containing radioactivemater *ial that arrive during other than normal working hours. Packages shouldbe placed on a cart or wheelchair and taken immediately to the Nuclear MedicineDepartment, Room .Unlock the door, place the package on top of the counter,and relock the door.

If the package appears to be damaged, immediately contact one of the individualsidentified below. Ask the carrier to remain at the hospital until it can bedetermined that neither the driver nor the delivery vehicle is contaminated.

If you have any questions concerning this memorandum, please call our hospitalRadiation Safety Officer, ___________-at extension*

Name Home TelephoneRadiation Safety Officer: _________________________

Chief of Nuclear Medicine: _________________________

Chief Nuclear Medicine Technologist: ____________________

Nuclear Medicine Technologist on call(call page operator at extension __

Nuclear Medicine Physician on call(call page operator at extension __

K- 2

APPENDIX L

Model Procedure for Safely Opening Packages Containing Radioactive Material(See §§ 35.23, 30.51, 20.203(f)(4), and 20.205.)

You may use the following model procedure for opening packages. If youfollow the model procedure, you may say on your application, "We will establish,and implement the model procedure for opening packages that was published inAppendix L to Regulatory Guide 10.8, Revision 2."

If you develop your own package opening procedure for review, you shouldconsider for inclusion all the features in the model. Say on your application,"We have developed a 'package opening procedure for your review that is appendedas ATT 10.7," and append your package opening procedure.

MODEL PROCEDURE

1. Special requirements must be followed for packages containing quantitiesof radioactive material in excess of the Type A quantity limits specifiedin paragraph 20.205(b) of 10 CFR Part 20 (e.g., more than 20 curies ofMo-99, Tc-99m; uncompressed Xe-133, or more than 3 curies of Xe-133, 1-131,Cs-137, Ir-192, 1-125, or more than 0.001 curie of Ra-226). Such packagesmust be monitored for external radiation levels and surface contaminationwithin 3 hours after receipt if received during working hours or within18 hours if received after working hours, in accordance with the require-ments of paragraphs 20.205(a) through (c). The NRC Regional Office mustbe notified if removable contamination exceeds 0.01 microcurie (22,000dpm)/100 cm2 .

2. For packages received under the specific license, the following procedure

for opening each package will be followed:

a. Put on gloves to prevent hand contamination.

b. Visually inspect the package for any sign of damage (e.g., wet orcrushed). If damage is noted, stop the procedure and notify theRadiation Safety Officer (RSO).

c. Measure the exposure rate from the package at 1 meter and at thepackage surface. If it is higher than expected, stop and notify theRSO. (The "transport index" noted on packages with "Yellow II" or"Yellow III" labels is the approximate dose rate, in millirem perhour, at 1 meter from the package surface (see § 71.4 of 10 CFRPart 71); the surface dose rate for such packages should not exceed200 millirem per hour. The dose rate from packages with "White I"labels should be less than 0.5 millirem per hour at the package sur-face. (See § 172.403 of 49 CFR Part 172.))

d. Open the package with the following precautionary steps:

(1) Remove the packing slip.

L-1

(2) Open the outer package following the supplier's instructions,if provided.

(3) Open the inner package and verify that the contents agree withthe packing slip.

(4) Check the integrity of the final source container. Look forbroken seals or vials, loss of liquid, condensation, or dis-coloration of the packing material.

(5) If anything is other than expected, stop and notify the RSO.

e. If there is any reason to suspect contamination, wipe the externalsurface of the final source container and remove the wipe sample toa low-background area. Assay the wipe sample to determine if thereis any removable radioactivity. [The licensee should specify in theprocedure manual which instrument, for example, a thin-end-window GMsurvey meter, a NaI(Tl) crystal and ratemeter, a liquid scintillationcounter, or a proportional flow counter, should be used for these assays.The detection efficiency must be determined to convert wipe samplecounts per minute to disintegrations per minute. Note that a dosecalibrator is not sufficiently sensitive for this measurement.] Takeprecautions against the potential spread of contamination.

f. Check the user request to ensure that the material received is the.material that was ordered.

g. Monitor the packing material and the empty packages for contaminationwith a radiation detection survey meter before discarding.

(1) If contaminated, treat this material as radioactive waste.

(2) If not contaminated, remove or obliterate the radiation labelsbefore discarding in in-house trash.

h. Make a record of the receipt.

3. For packages received under the general license in §31.11, the followingprocedure for opening each package will be followed:

a. Visually inspect the package for any sign of damage (e.g., wet orcrushed). If damage is noted, stop the procedure and notify the RSO.

b. Check to ensure that the material received is the material that wasordered.

See Exhibit 12 for a sample-record form you may want to use.

L-2

APPENDIX M

Records of Byproduct Material Use

General

Many suppliers include pressure-sensitive stickers or forms that have muchof the information required by the regulations. You may use these in yourrecords and need not duplicate the information on them. Be sure to write downwhatever additional information is required but is not cued or printed on them.Information does not have to be recorded in the order given in these procedures.Also, you do not have to replicate entries. For example, if you prepare amultidose vial for use one day, you do not have to record the date each timeyou draw a dosage from it; if you take 30 Ir-192 seeds that are each 0.5 milli-curies, you do'not have to list each seed individually.

M.1 Records of Unit Dosage Use (§§ 30.51, 35.21, 35.53)

You may use the following model procedure to keep a record of unit dosageuse. If you will follow the model procedure, you may say on your application,"We will establish and implement the model procedure for a unit dosage recordsystem that was published in Appendix M.1 to Regulatory Guide 10.8, Revision 2;"

If you prefer, you may develop your own unit dosage record system forreview. If you do so, you should consider for inclusion all the features inthe model procedure and carefully review the requirements of §§ 30.52, 35.21,and 35.53. Say on your application, "We have developed a procedure for a unitdosage record system for your review that is appended as ATT 10.8," and appendyour unit dosage record procedure.

MODEL PROCEDURE

For each unit dosage received from a supplier, make -a record of the:

1. Radionuclide;

2. Generic name or its abbreviation or trade name;

3. Date of receipt;

4. Supplier;

5. Lot number or control number, if assigned;

6. Activity in millicuries or microcuries as recorded on the unit dosage orpacking slip and its associated time;

7. Date of administration or disposal;

8. If administered,

a. Prescribed dosage (unless already recorded in clinical proceduremanual),

M-1

b. Measured activity in millicuries or microcuries and date and timeof measurement,

c. Patient name and identification number if one has been assigned;

9. If discarded, the date and method of disposal; and

1.0. Initials of the individual who made the record.

See Exhibit 13 for a Unit Dosage Receipt and Use Log Form you may want touse.

M.2 Records of Multidose Vial Use (§§ 30.51, 35.21, 35.53)

You may use the following model procedure to keep a record of multidosevial use. If you will follow the model procedure, you may say on your applica-tion, "We will establish and implement the model procedure for a multidose vialrecord system that was published in Appendix M.2 to Regulatory Guide 10.8,Revision 2."

If you prefer, you may develop your own multidose vial record system forreview. If you do so, you should consider for inclusion all the features inthe model system and carefully review the requirements of §§ 30.51, 35.21, and35.53. Say on your application, "We have developed a procedure for a multidosevial record system for your review that is appended as ATT 10.9," and appendyour multidose vial record procedure.

MODEL PROCEDURE

For each multidose vial that you receive from a supplier or that you prepare,make a record of the:

1. Radionuclide;

2. Generic name or its .abbreviation or trade name;

3. Date of receipt or preparation;

4. Date and time of initial assay and amount in both millicuries andcubic centimeters (cc) or milliliters (ml);

5. Supplier or kit manufacturer;

6. If administered,

a. Prescribed dosage (unless already recorded in clinical proceduremanual),

b. Date and time dosage was drawn and measured,c. Calculated volume that is needed for the prescribed dosage,d. Measured activity in millicuries or microcuries,e. Patient name and identification number if one has been assigned;

7. If discarded, the method of disposal and date; and

8. Initials of the individual who made the record.

M-2

See Exhibit 14 for a Multidose Vial Preparation and Use Log Form you may'want to use.

M.3 Measuring and Recording Molybdenum Concentration (§ 35.204)

The regulations require that each licensee who uses a technetium generatorto prepare radiopharmaceuticals must test each elution or extraction for itsmolybdenum concentration. (This does not have to be done when using radio-pharmaceuticals obtained from a distributor.) This measurement is usually madewith a dose calibrator. Licensees may not administer radiopharmaceuticals thatcontain more than 0.15 microcurie of Mo-99 per millicurie of Tc-99m at the timeof administration. If an elution or extraction has.a higher concentration, theremay be a manufacturing defect that should be reported under paragraph 21.21(b) of10 CFR Part 21.

The model procedure for measuring molybdenum concentration is based on theuse of a "molybdenum breakthrough pig." Your dose calibrator manufacturer willusually supply, as an option, a molybdenum breakthrough pig made of lead. Thepig is usually thick enough to shield all the technetium photons but only afraction of the molybdenum photons. The manufacturer will specify the Mo-99correction factor to convert from measured Mo-99 to total Mo-99.

The following model procedure may be used to measure the molybdenum concen-tration in Mo-99/Tc-99m generator elution. If you will follow the model proce-dure, you may say on your application, "We will establish and implement themodel procedure for measuring and recording molybdenum concentration that waspublished in Appendix M.3 to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own molybdenum concentration procedurefor review. If you do so, you should consider for inclusion all the featuresin the model procedure and carefully review the requirements of § 35.204. Sayon your application, "We have developed a procedure for measuring and recordingmolybdenum concentration for your review that is appended as ATT 10.10," andappend your procedure for measuring and recording molybdenum concentration.

MODEL PROCEDURE

Each time a generator is eluted, make a record of the:

1. Date the generator was received;

2. Date and time of elution;

3. Measured Mo-99 activity in microcuries;

4. Product of the measured Mo-99 activity and the correction factor noted bythe molybdenum breakthrough pig manufacturer;

5. Measured Tc-99m activity in millicuries;

6. Ratio of the total Mo-99 microcuries per millicurie of Tc-99m and check-mark that the ratio is less than 0.07 microcurie of Mo-99 per millicurieof Tc-99m. (If it isn't, stop and notify the RSO. In conformance withparagraph 21.21(b) of 10 CFR Part 21, the licensee must notify the NRC if

M-3

a leaking generator is detected.) [The 0.07 action level allows for thequicker decay of the Tc through the day of use. It is assumed that thematerial will be used within 6 hours, at which time the concentration of

- Mo-99 to Tc-99m would have doubled.]

7. Initials of the person who made the record.

M.4 Keeping an Inventory of Implant Sources (§§ 30.51, 35.21, 35.406)

You may use the following model procedure to keep an inventory and userecord for implant sources. If you will follow the model procedure, you maysay on your application, "We will establish and implement the model procedurefor keeping an inventory of implant sources that was published in Appendix M.4to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own procedure for keeping an inventoryand use record for implant sources. If you do so, you should consider forinclusion all the features in the model system and carefully review the require-ments of §§ 30.51, 35.21, and 35.406. Say on your application, "We have devel-oped a procedure for keeping an inventory of implant sources for your reviewthat is appended as ATT 10.11," and append your procedure for keeping aninventory and use record for implant sources.

MODEL PROCEDURE

1. Use a locking installed cabinet or safe to store all implant sources.

2. Make a list of names of those individuals you allow to handle implantsources and have them initial beside their names.

3. For long-lived sources, draw a map of the storage drawer and indicate theactivity of the source at each storage point. For short-lived sourcesthat you store in the manufacturer's shipping container, indicate thearea in the safe where you put the container. Also, be sure to add thesources to the inventory log.

4. Post the map and the list of individuals whom you permit to handle thesources in the storage area or on the inventory log.

5. Each time you remove a source, make a record of the number and activityof sources removed, the room number of use or patient's name, and the timeand date they were removed from storage; initial the record.

6. Each time you return sources to storage, immediately count them to ensurethat every source removed has been returned. Then make a record of thenumber and activity of sources returned, the room number of use orpatient's name, and the time and date they were returned to storage;initial the record.

7. If you ever perceive a discrepancy between the record and the number of

sources in use and in storage, notify the R.O immediately.

See Exhibit 15 for a sample form you may want to use.

M-4

APPENDIX N

Model Procedure for Area Surveys(See § 35.70.)

You may use the following model procedure to perform area surveys. If youfollow the model procedure, you may say on your application, "We will establishand implement the model procedure for area surveys that was published inAppendix N to Regulatory Guide 10.8, Revision 2."

You may develop your own procedure for review. If you do so, you shouldconsider for inclusion all the features in the model procedure and carefullyreview the requirements of § 35.70. Say on your application, "We have developedsurvey procedures for your review that are appended as ATT 10.12," and appendyour survey procedures.

MODEL PROCEDURE

Ambient Dose Rate Surveys

1. Survey Areas

a. In radiopharmaceutical elution, preparation, and administration areas,survey at the end of each day of use with a radiation detection surveymeter. If diagnostic administrations are occasionally made in patients'rooms and special care is taken to remove all paraphernalia, thoserooms need not be surveyed.

b. In laboratory areas where only small quantities of gamma-emittingradioactive material are processed (less than 200 microcuries at atime), survey monthly with a radiation detection survey meter.

c. In radiopharmaceutical storage and radiopharmaceutical waste storageareas, survey weekly with a radiation detection survey meter.

d. In sealed source and brachytherapy storage areas, survey quarterly with

a radiation measurement survey meter.

2. Immediately notify the RSO if you find unexpectedly high or low levels.

Removable Contamination Surveys

1. Survey Areas

a. In radiopharmaceutical elution, preparation, and administrationareas, survey weekly for removable contamination. If diagnosticadministrations are occasionally made in patients' rooms and specialcare is taken to remove all paraphernalia, those rooms need not be

.surveyed.

b. In laboratory areas where only small quantities of photon-emittingradioactive material are processed (less than 200 microcuries at atime), survey monthly for removable contamination.

N-1

c. In radiopharmaceutical storage and radiopharmaceutical waste storageareas, survey weekly for removable contamination.

2. The wipe sample assay procedure should be sufficiently sensitive to detectthe presence of 2000 dpm/100 cm2 of removable contamination (200dpm/100 cm2 for isotopes of iodine). You must use a radioactive sourcewith a known amount of activity to convert sample measurements (usuallyin counts per minute or cpm) to disintegrations per minute or dpm.

3. Immediately notify the RSO if you find unexpectedly high levels.

Records

1. Keep a record of dose rate and contamination survey results. It mustinclude the following information:

a. The date, area surveyed, and equipment used.

b. The name or initials of the person who made the survey.

c. A drawing-of the areas surveyed with contamination and dose rateaction levels as established by the RSO. (Recommended removablesurface contamination action levels are published in RegulatoryGuide 8.23, "Radiation Safety Surveys at Medical Institutions." SeeRegulatory Guide 8.23 or Table N-i below for guidance in establish-ing your action levels.)

d. Measured dose rates in mR/hr or contamination levels in dpm/100 cm2 , as appropriate.

e. Actions taken in the case of excessive dose rates or contaminationand followup survey information.

2. The RSO will review and initial the record at'least monthly and alsopromptly in those cases in which action levels were exceeded.

The following information is not part of the model procedure.

See Exhibit 16 for a sample record form.

N-2

Table N-i

Recommended Action Levels in dpm/100 cm2 for SurfaceContamination by Radiopharmaceuticals

P-32, Co-58, Fe-59,Co-60, Se-75, Sr-85, Cr-51, Co-57,In-111, 1-123, 1-125, Ga-67, Tc-99m,1-131, Yb-169, Au-198 Hg-197, Tl-201

1. Unrestricted areas,personal clothing

2. Restricted areas,protective clothingused only in restrictedareas, skin

200 2,000

2,000 20,000

N-3

APPENDIX 0

Model Procedure for Monitoring, Calculating, and ControllingAir Concentrations

(See §§ 20.103, 20.106, 20.201, 35.90, and 35.205.)

WORKER DOSE FROM NOBLE GASES (Item 10.13.1)

Noble gases such as xenon in the air present an external source ofradiation exposure that must be calculated. Many commercially availabledosimeters and survey instruments are not capable of accurately measuringworker doses from immersion in noble gases.

If you will collect spent gas in a shielded trap with an effluent aircontamination monitor and will follow the monitor manufacturer's instructionsfor checking its accuracy and constancy, you may respond to Item 10.13.1 bysaying, "We will collect spent noble gas in a shielded trap and monitor thetrap effluent with an air contamination monitor that we will check regularlyaccording to the manufacturer's instructions."

If you will collect spent gas in a shielded trap and will follow themodel procedure for checking trap effluent, you may respond to Item 10.13.1by saying, "We will collect spent noble gas in a shielded container and willestablish and implement the model procedure for checking trap effluent thatwas published in Appendix 0.3 to Regulatory Guide 10.8, Revision 2.

If you are not monitoring trap effluent or if you exhaust spent gas tothe atmosphere, you must estimate worker dose by calculation. (You do nothave to submit the calculations, but you should keep them for NRC review duringinspections.) If you will follow the model procedure below for calculatingworker dose from noble gases, you may respond to Item 10.13.1 by saying, "Wewill follow the model procedure for calculating worker dose from noble gasesthat was published in Appendix 0.1 to Regulatory Guide 10.8, Revision 2."

If none of the above apply, you may develop your own procedure for review.If you do so, you should consider all the above information and carefullyreview the requirements of §§ 20.103, 20.201, 35.90, and 35.205. Say on yourapplication, "We have developed a procedure for monitoring worker dose due tosubmersion in noble gases that is appended as ATT 10.13.1," and append yourprocedure for monitoring'worker dose from noble gases.

WORKER DOSE FROM AEROSOLS (Item 10.13..2)

If you will collect spent aerosol in a shielded trap, will use an aircontamination monitor for reusable traps, and will follow the monitor manu-facturer's instructions for checking for accuracy and constancy, you mayrespond to Item 10.13.2 by saying, "We will collect spent aerosol in ashielded trap and, for reusable traps, monitor the trap effluent with an aircontamination monitor that we will check regularly according to the manufac-turer's instructions." You do not have to monitor the trap effluent ofsingle-use devices.

Ifyou are not monitoring reusable trap effluent or if you are exhaustingspent aerosol to the atmosphere, you must estimate worker dose by calculation.(You do not have to submit the calculations, but you should keep them for NRC

0-1

review during inspections.) If you will follow the model procedure below forcalculating worker dose from aerosols, you may respond to Item 10.13.2 bysaying, "We will follow the model procedure for calculating worker dose fromaerosols that was published in Appendix 0.1 to Regulatory Guide 10.8, Revision 2."

If neither of the above apply, you may develop your own procedure forreview. If you do so, you should consider all the above ýinformation and care-fully review the requirements of §§ 20.103, 20.106, 20.201, 35.90, and 35.205.Say on your application, "We have developed a procedure for monitoring workerdose due to aerosol concentrations that is appended as ATT 10.13.2," andappend your procedure for monitoring worker dose from aerosols.

0.1 MODEL PROCEDURE FOR CALCULATING WORKER DOSE FROM CONCENTRATIONS OF GASES

AND AEROSOLS IN WORK AREAS

1. Collect the following data:

a. Estimated number of studies per week;

b. Activity to be administered per study;

c. Estimated activity lost to the work areas per study (you may assume20 percent loss);

d. Measured airflow supplied by each vent in the imaging room (ifdifferent during heating and cooling seasons, use the lesser value);

e. Measured airflow exhausted by each vent in the imaging room (the

exhaust should be vented and not recirculated within the facility);

f. Measured airflow exhaust at the storage site (e.g., a fume hood); and

g. Maximum permissible air concentrations in -restricted and unrestrictedareas. For Xe-133, the maximum permissible values are 1 x I0-5 pCi/mlin restricted areas and 3 x i0-7 pCi/ml in unrestricted areas. Forsoluble Tc-99m, the maximum permissible values are 4 x I0-5 pCi/mlin restricted areas and 1 x 10- pCi/ml in unrestricted areas. Forother gases or aerosols, see Appendix B to 10 CFR Part 20.

2. The following calculations must be made:

a. The sum of all measured exhaust rates and the sum of all measuredsupply rates. If the former is larger than the latter, this ensuresthat the imaging room is at negative pressure.

b. The estimated average concentration in restricted areas.

(1) The total activity released to the restricted area (activityused each week multiplied by estimated fractional loss perstudy) divided by the total air exhausted (sum of all exhaustrates multiplied by the length of the work week) must be lessthan the applicable maximum permissible value for a restrictedarea.

0-2

(2) If this is not the case, plan for fewer studies. (An increasein the ventilation rate will not significantly reduce the down-wind effluent concentration because it is primarily a functionof the natural dispersion in the atmosphere.)

0.2' MODEL PROCEDURE FOR CALCULATING AIRBORNE EFFLUENT CONCENTRATION

1. Divide the total activity released to an unrestricted area (activity usedeach week that is released in an exhaust system) by the total volume of-air exhausted over the week ("on" time multiplied by measured airflow rate).The quotient must be less than the applicable maximum permissible valuefor an unrestricted area.

2. If this is not the case, plan for fewer studies and do the calculationagain. Alternatively, you may consider collection and decay-in-storagefor waste, or restriction of access to the release point and calculationof concentration at the boundary of the restricted area.

0.3 MODEL PROCEDURE FOR MONITORING OR CHECKING TRAP EFFLUENT

Charcoal traps can significantly reduce air contamination. They can also becomesaturated or be spoiled by improper use, humidity, chemicals, or inadequatemaintenance.

1. If the trap effluent is monitored by a radiation detector designed tomonitor effluent gas, check the detector according to the manufacturer'sinstructions and keep a record of the checks.

2. If you do not monitor the trap effluent, check it on receipt and once eachmonth. Collect the effluent from the trap during one patient study in aplastic bag and then monitor the activity in the bag by holding the bagagainst a camera, with the camera adjusted to detect the noble gas, andcompare its counts per minute (cpm) to background.cpm with no otherradioactivity in the area. Keep a record of the date, background cpm, andbag cpm.

3. The RSO will establish an action level based on cpm.or a multiple of back-ground cpm. If you measure a significant increase in the bag cpm, thetrap is breaking down and must be replaced.

4. Follow the trap manufacturer's instructions for replacing thetrap.

PUBLIC DOSE FROM AIRBORNE EFFLUENT (ITEM 10.13.3)

Effluent release presents a potential source of dose to the public.Usually a calculation of concentration at the release point is done andcompared to the appropriate value of Table II of Appendix B to 10 CFR Part 20.

If you are not directly venting aerosols and gases to the atmosphere, youmay respond to Item 10.13.3 by saying, "We will not directly vent spent aerosolsand gases to the atmosphere and therefore no effluent estimation is necessary."

If you are going to vent aerosols or gases to the atmosphere, you mustestimate effluent concentrations by calculation. (You do not have to submit

0-3

the calculations with your application, but you should keep them for NRCreview during inspections.) If you will follow the model procedure below forcalculating release concentrations, you may respond to Item 10.13.3 by saying,"We will follow the model procedure for calculating airborne effluent concen-tration that was published in Appendix 0.2 to Regulatory Guide 10.8, Revision 2."

If neither of the above apply, you may develop your own procedure forreview. If you do so, you should consider all the above information and care-fully review the requirements of §§ 20.106, 20.201, 35.90, and 35.205. Say onyour application, "We have developed a procedure for monitoring airborne efflu-ent concentration that is appended as ATT 10.13.3," and append your procedurefor monitoring airborne effluent concentration.

SPILLED GAS CLEARANCE TIME (Item 10.13.4)

Because normal room ventilation is usually not sufficient to ensure timelyclearance of spilled gas, the calculations described in Appendix 0.4 should bedone to determine for how long a room should be cleared in case of a gas spill.This clearance time should be posted in the room.

If you will calculate spilled gas clearance times according to the follow-ing procedure, you may respond to Item 10.13.4 by saying, "We will calculatespilled gas clearance times according to the procedure that was published inAppendix 0.4 to Regulatory Guide 10.8, Revision 2."

You may develop your own procedure for review. If you do so, you shouldconsider all the above information and carefully review the requirements of§ 35.205. Say on your application, "We have developed a procedure forcalculating spilled gas clearance times that is appended as ATT 10.13.4,"and append your procedure.

0.4 MODEL PROCEDURE FOR CALCULATING SPILLED GAS CLEARANCE TIME

1. Collect the following data:

a. A, the highest activity of gas in a single container, in microcuries;

b. Measured airflow supply from each vent in the room (if differentduring heating and cooling seasons, use the'lesser value), inmilliliters per minute;

c. Q, the total room air exhaust determined by measuring, in millilitersper minute, the airflow to each exhaust vent in the room (the exhaustshould be vented and not recirculated within the facility); thismay be either the normal air exhaust or a specially installed gasexhaust system;

d. C, the maximum permissible air concentrations in restricted and unre-stricted areas. For Xe-133, the maximum permissible values are1 x I0-5 pCi/ml in restricted areas and 3 x 10-7 pCi/ml in unrestrictedareas. For other gases, see Appendix B to 10 CFR Part 20; and

e. V, the volume of the room in milliliters.

0-4

2. For each room make the following calculations:

a. The airflow supply should be less than the airflow exhaust to ensurethe room is at negative pressure.

b. The evacuation time t = -V x In (C x V/A).Q

0-5

APPENDIX P

Model Procedure for Radiation Safety During Iodine Therapy Over 30 Millicuries(See §§ 35.300, 35.75, and 20.105.)

You may use the following procedure for reducing worker and public doseduring radiopharmaceutical therapy. If you will follow the model procedure,you may say on your application, "We will establish and implement the modelprocedure for radiation safety during radiopharmaceutical therapy that waspublished in Appendix P to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own procedure for review. If you doso, you should consider for inclusion all the features in the model procedureand carefully review the requirements of §§ 19.12, 20.105, 35.75, and 35.300.Say on your application, "We have developed a procedure for radiation safetyduring therapeutic use of radiopharmaceuticals for your review that is appendedas ATT 10.14,",.and append your procedure.

MODEL PROCEDURE

1. The patient's room will be as far away from the nursing station and heavytraffic hallways as is consistent with good medical care. It will be aprivate room with private sanitary facilities and should be without carpet.

2. Prepare the room for the procedure as follows:

a. Use leak-proof absorbent paper to cover large surfaces (the bed,chairs, and the floor around the toilet) that are likely to be contam-inated. Small items (telephone, door knobs, bed remote control,television control, and nurse call cord) may be covered withabsorbent paper or plastic bags.

b. Prepare separate boxes for linen, disposable waste, and nondisposablecontaminated items. Place a single large reclosable plastic bag ineach box, or supply several small plastic bags.

c. Determine whether urine will be discarded by release to the sanitarysewer or collected. If urine will be collected, prepare collectioncontainers.

(1) Containers should be unbreakable and closable.

(2) If there is no need for assay or volumetric determination andurine will be decayed in storage, add to each container anabsorbent such as Vermiculite.

(3) To avoid room contamination in the case of a spill, placecontainers in a box or deep tray that has been lined with aplastic bag and absorbent paper or vermiculite.

(4) Supply a few half-value layers of shielding for each container.(For 1-131, one half-value layer is approximately 3 mm of lead.)

(5) Supply a wide-mouth antisplash funnel.

P-1

d. Stock additional-disposable gloves, absorbent paper, and radioactivewaste labels in the room for use as necessary by nursing, nuclearmedicine, and radiation safety personnel.

3. Order disposable table service for the duration of the patient's stay.Inform the Housekeeping Office that personnel should stay out of the roomuntil otherwise notified.

4. Supply the nurses with film badges, TLDs, or pocket ionization chambers.

5. Brief the nurses on radiation safety precautions. Use the sample form,"Nursing Instructions for Patients Treated with Iodine-131, Phosphorus-32,or Gold-198" (Exhibit 17), or your own nursing instruction form as anoutline. Allow time -for questions and answers during the briefing. Leavea written copy of the radiation safety precautions in the patient'schart or at the nurses' station.

6. Brief the patient on radiation safety procedures for the dosage adminis-tration, visitor control, urine collection, radioactive waste, and otheritems as applicable.

7. Only those persons needed for medical, safety, or training purposesshould be present during the administration.

8. Mark a visitors' "safe line" on the floor with tape as far from thepatient as possible.

9. Following administration of the dosage, measure the exposure rate in mR/hrat bedside, at 1 meter from bedside, at the visitors' "safe line," and inthe surrounding hallways and rooms (the last rates must conform to require-ments in paragraph 20.105(b)). Record this and any other necessary infor-mation on the nursing instructions form or the nurses' dosimeter signoutform. Post the room. with a "Radioactive Materials" sign.

10. For patients treated with liquid or gelatin-capsuled 1-131, 1 day afterthe dosage administration, measure the thyroid burden of all personnelwho were present for the administration. Also consider a thyroid burdenassay for patient care personnel 2 days after the administration. Makea record of the worker's name, amount of 1-131 activity in a thyroidphantom in microcuries and associated counts per minute, the counts perminute from the worker's thyroid, the calculated thyroid burden, and date.

11. As the therapy proceeds, pick up waste for transfer to a decay-in-storageor decontamination area.

12. Do not release any patient until either the exposure rate from the patientis less than 5 millirem per hour at I meter or the retained radioactivityis less than 30 millicuries (see § 35.75). If you use the exposure ratestandard as the release criterion, measure it with a radiation measurementsurvey meter at a distance of 1 meter from the umbilicus while the patientis standing or, if the patient is not ambulatory, 1 meter from the bedsidewith the patient supine.

P-2

13. Before using the room for general occupancy, it must be decontaminatedand released to the Admitting Office.

a. Remove all absorbent paper, and place it in the appropriate container.

b. Transfer all containers to a decay-in-storage or decontaminationarea.

c. Use a radiation detection survey meter to check for room contamination.Clean contaminated areas until removable contamination is less than200 dpm/100 cm2 .

d. Call the Housekeeping Office to remove the cleaning restriction andcall the Admitting Office to return the room to the vacant list.

Exhibit 18, "Radiation Safety Checklist for Iodine Therapy over 30 Milli-curies," may also be helpful to you.

P-3

APPENDIX q

Model Procedure for Radiation Safety During Implant Therapy(See §§ 35.75, 35.404, and 35.406.)

You may use the following procedure to reduce worker and public dose duringimplant therapy. If you will follow the model procedure, you may say on yourapplication, "We will establish and implement the model procedure for radiationsafety during implant therapy that was published in Appendix Q to RegulatoryGuide 10.8, Revision 2."

If you prefer, you may develop your own procedure for review. If you doso, you should consider for inclusion all the features in the model procedureand carefully review the requirements of H§ 19.12, 20.105, 35.75, 35.404, and35.406. Say on your application, "We have developed a procedure for radiationsafety during implant therapy for your review that is appended as- ATT 10.15,"and append your procedure.

You may find a checklist to be helpful, such as Exhibit 19, "RadiationSafety Checklist for Temporary Implant Therapy."

MODEL PROCEDURE

1. The patient's room will be as far away from the nursing station and heavytraffic hallways as is consistent with good medical care. It will be aprivate room unless the dose at one meter from the implant meets the re-quirements in paragraph 20.105(b) of 10 ,CFR Part 20.

2. Supply the nurses with film badges, TLDs, or pocket ionization chambers.

3. Brief the nurses on radiation safety precautions. Use the sample form,"Nursing Instructions for Patients Treated With Temporary Implant Sources,"Exhibit 20, or your own nursing instruction form as an outline. Allowtime for questions and answers during the briefing.

4. Brief the patient on radiation safety procedures for confinement to bed,visitor control, and other items as applicable consistent with goodmedical care.

5. Only those persons needed for medical, safety, or training purposes shouldbe present during the implant procedure.

6. Mark a visitors' "safe line" on the floor with tape as far from the patientas possible.

7. Following the implant, measure the exposure rate in mR/hr at bedside, atI meter from bedside, at the visitors' "safe line," and in the surroundinghallways and rooms (the last rates must conform to requirements in para-graph 20.105(b)). Record this and any other necessary information on thenursing instruction form or the nurses' dosimeter signout form. Post theroom with a "Radioactive Materials" sign.

8. Do not release.any patient who has received a temporary implant from thehospital until both a radiation survey of the patient and a count of

Q-1

implant sources, trains, or ribbons confirms that all sources have beenremoved from the patient and are accounted for. Perform this check imme-diately after the removal of the sources. Keep a record confirming thesource count and radiation survey on the implant source running inventoryform. For low-activity seeds (less than 1 millicurie), use an individualseed to check the survey meter to be sure it will easily detect a seed thathas not been removed or has been lost.

9. Do not release any patient who has received a permanent implant from thehospital until the exposure rate from the patient is less than 5 mR/hr at1 meter. Measure this exposure rate with a radiation measurement surveymeter at a distance of 1 meter from the umbilicus with the patient standing.

You may want to use the sample forms in Exhibit 19, "Radiation SafetyChecklist for Temporary Implant Therapy," Exhibit 20, "Nursing Instructionsfor Patients Treated with Temporary Implant Sources," and Exhibit 21, "SampleCesium Implant Source Log."

Q-2

APPENDIX R

Model Procedure for Waste Disposal(See §§ 20.301, 20.303, 20.306, and 35.92.)

The following general guidance and procedure may be used for disposalof radioactive waste. If you follow all the general guidance and procedures,,you may say on your application, "We will establish and implement the general'guidance and model procedures for waste disposal that were published inAppendix R to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own procedure for review. If you doso, you should consider for inclusion all the features in the general guidanceand models and carefully revi.ew the requirements of §§ 20.301, 20.303, 20.306,and 35.92. Say on your application, "We have developed a procedure for wastedisposal for your review that is appended as Afl 11.1," and attach your procedure.

Overview

There are four commonly used methods of waste disposal: release to theenvironment through the sanitary sewer or by evaporative release; decay-in-storage (DIS); transfer to a burial site or back to the manufacturer; andrelease to in-house waste. With the exception of the patient excreta (seeparagraph 20.303(d)) and generally licensed in vitro kit exemptions (see para-graph 31.11(f)), nothing in these guidelines relieves the licensee from main-taining records of the disposal of licensed material. (See paragraphs 30.51(a)and 20.401(c)(3).)

General Guidance

1. All radioactivity labels must be defaced or removed from containers andpackages prior to disposal in in-house waste. If waste is compacted, alllabels that are visible in the compacted mass must be defaced or removed.

2. Remind employees that nonradioactive waste such as leftover reagents, boxes,and packing material should not be mixed with radioactive waste.

3. Occasionally monitor all procedures to ensure that radioactive waste isnot created unnecessarily. Review-all new procedures to ensure that wasteis handled in a manner consistent with established procedures.

4. In all cases, consider the entire impact of various available disposalroutes. 'Consider occupational and public exposure to radiation, otherhazards associated with the material and routes of disposal (e.g., toxi-city, carcinogenicity, pathogenicity, flammability), and expense.

MODEL PROCEDURE FOR DISPOSAL OF LIQUIDS AND GASES

Liquids may be disposed of by releas~e to the sanitary sewer or evaporativerelease to the atmosphere. This does hot relieve licensees from complying withother regulations regarding toxic or hazardous properties of these materials.

R- 1

1. Regulations for disposal in the sanitary sewer appear in § 20.303. Mate-rial must be readily soluble or dispersible in the water. There are dailyand monthly limits based on the total sanitary sewerage release of yourfacility. (Excreta from patients undergoing medical'diagnosis or therapyis exempt from all the above limitations; see paragraph 20.303(d).) Makea record of the date, radionuclide, estimated activity that was released(in millicuries or microcuries), and of the sink or toilet at which thematerial was released.

2. Limits on permissible concentrations in effluents to unrestricted areasare enumerated in Table II of Appendix B to 10 CFR Part 20. These limitsapply at the boundary of the restricted area. Make a record of the date,radionuclide, estimated activity that was released (in millicuries or micro-curies) and estimated concentration, and of the vent site at which the mate-rial was released.

3. Liquid scintillation-counting media containing 0.05 mili~curie per gramof H-3 or C-14 may be disposed of without regard to its radioactivity(§ 20.306). Make a record of the date, radionuclide, estimated.activity(in millicuries or microcuries), calculated concentration in microcuriesper gram, and how the material was disposed of.

MODEL PROCEDURE FOR DISPOSAL BY DECAY-IN-STORAGE (DIS)

Short-lived material (physical half-life less than 65 days) may be dis-posed of by DIS. If you use this procedure, keep material separated accordingto half-life.

1. Consider using separate containers for different types of waste, e.g.,capped needles and syringes in one container, other injection paraphernaliasuch as swabs and gauze in another, and unused dosages in a third container.Smaller departments may find it easier to use just one container for allDIS waste. Because the waste will be surveyed with all shielding removed,the containers in which waste will be disposed of must not provide anyradiation shielding for the material.

2. When the container is full, seal it with string or tape and attach anidentification tag that includes the date sealed, the longest-livedradioisotope in the container, and the initials of the person sealing thecontainer. The container may then be transferred to the DIS area.

3. Decay the material for at least 10 half-lives.

4. Prior to disposal as in-house waste, monitor each container as follows:

a. Check your radiation detection survey meter for proper operation;

b. Plan to monitor in a low-level (less than 0.05 millirem per hour)area;

c. Remove any shielding from around the container;

d. Monitor all surfaces of each individual container;

R-2

e. Discard as in-house waste only those containers that cannot be distin-guished from background. Record the date on which the container wassealed, the disposal date, and type of material (e.g., paraphernalia,unused dosages). Check to be sure no radiation labels are visible.

f. Containers that can be distinguished from background radiationlevels must be returned to the storage area for further decay ortransferred for burial.

5. If possible, Mo-99/Tc-99m generators should be held 60 days before beingdismantled because of the occasional presence of a long-lived contaminant.When dismantling generators, keep a radiation detection survey meter (pref-erably with a speaker) at the work area. Dismantle the oldest generatorfirst, then work forward chronologically. Hold each individual column incontact with the radiation detection survey meter in a low-background(less than 0.05 mR/hr) area. Log the generator date and disposal date foryour waste disposal records. Remove or deface the radiation labels on thegenerator shield.

MODEL PROCEDURE FOR TRANSFER FOR BURIAL

Except for material suitable for DIS and some animal carcasses, solidsmust be transferred to a burial site. Follow the packaging instructions youreceived from the transfer agent and the burial site operator. For your recordof disposal, keep the consignment sheet that the transfer agent gave you.

MODEL PROCEDURE FOR RELEASE TO IN-HOUSE WASTE

Waste from in vitro kits that are generally licensed pursuant to § 31.11is exempt from waste disposal regulations. Radioactive labels should bedefaced or removed. There is no need to keep any record of release or make anymeasurement.

MODEL PROCEDURE FOR RETURNING GENERATORS TO THE MANUFACTURER

Used Mo-99/Tc-99m generators may be returned to the manufacturer. Thispermission does not relieve licensees from the requirement to comply with10 CFR Part 71 and Department of Transportation (DOT) regulations.

1. Retain the records needed to demonstrate that the package qualifies as aDOT Specification 7A container (see DOT regulations, paragraph 173.415(a) of49 CFR Part 173).

2. Assemble the package in accordance with the manufacturer's instructions.

3. Perform the dose rate and removable contamination measurements requiredby paragraph 173.475(i) of 49 CFR Part 173.

4. Label the package and complete the shipping papers in accordance with themanufacturer's instructions.

R-3

Part 2 - ADDITIONAL INFORMATION FOR MANAGING RADIATIONSAFETY PROGRAMS FOR MEDICAL USE LICENSEES

APPENDIX S

Regulatory Requirements

The following documents provide licensees with a summary of the informationconsidered by the Commission when preparing the revision of 10 CFR Part 35.

S-i

UNITED STATES NUCLEAR REGULATORY COMMISSION

RULES and REGULATIONSTITLE 10. CHAPTER 1. CODE OF FEDERAL REGULATIONS--ENEROY

COMMISSION NOTICES

POLICY STATEMENTS

Medical Uses

"4 FR 1242Pubblinm 2Ml91Effectve 2il/i9

gIullo•lim ef 1%. Medical US&$ ofIAMd100etopes Slatement of Gon-.

AENCIY: Nuclear Regulatory Com-

ACTION: Final Policy Statement.

UGLARy: The Nucla RegulatoryCommission CNRC) has the followingPolicy Satement regarding NRC'Sfuture role In regulatng the medicaluses of radlobsotopes. This NRC policyMtatemmt In Intended to inform NRCNineca. other Pederal and -Stateagencies and the public of the Com-ms elon' general Intention regardingthe regulation of &he medical uses ofradioisotopes. It is expected thatfuture NRC actvities In the medarea. Sudh as promaulvgas of new reg.ulations and development of coopera.Uwe relationships with other Federalagence. will follow this staltment ofIRC pValq.

I'FW1¶VE DATE February 9. I.

MOR FURTHER DTFORMAT7ONCONTACT

Mr. Vdwald Podolak. Offlice ofStandard Development. U.S. Nudle.ar Regulatory Commision. Wash.h .D.C. 20555 (Phour. 301-443-1860L

SPL21'CNTAL DTWORMAT70OMThe NRC has developed the f.Jo'Winjthree part policy statement regardingnRC's futur role In regulsting themedical umas of radiolsotopex. OnMarch 17. 1978. the three prt PoUciystatement was pblished In the F'mza-aL Rmzs= (43 FR 11308) for PubliccornmeaL Copies .of the Policy state-mJcit sere spot to all 21RC medical I1-censees. the States and 25 professionalsocIeties. Federal agencles, and IndJ.viduals. The comment period expiredMay 16. 192L Twenty•two commentswere received. Nine commenten fa.vored all three PA of the poUcystatement. four commenters opposedone pan of the Policy statement anidnine commenters addressed specificissues discussed In the Mardi 17. 1978F=Emsa. Riarics- notice: The Com-ments La-e discussed In Section ILCopies of the comments may be exam-

tned In the NRC Public DocumentRoom at 1717 H Street. N.W. Wash-ingionl. D.C.

L STATr.TMT r OVEL4tML POLICY

This NRC policy statement Is •n:tended to Inform NRC license-e, otherFederal and State agencies and thepublic of the Commisslon's general In-tentlon retarding the resulation ofthe medical uses of radioisotope.

It is expected that future XRC actyv.Itles In the medical area. such as pro-mulgation of new regulations and de-velopment of cooperative relationshipswith other Federal agencies. willfollow this statement of NRC p~licy.

Based on past experience and theco.-ar.ents and advice of the public.other Federal aencles. the States. andNRC's Advisory Committee on theMedical Uses of Isot.,pes. the Czmms.5-Lien hs deevel:ped the f:llowiIng state-ment of general policy to guide its reg-illation of the medical uses of radioiso-tope='

L The NRC will continue to regulatethe medical uses of radioisotopes asnecessary to pr;vide for the radiationsafety of workers and the generalpublic.

2. The NRC will regulate the 1,41.atlon safety of patients where Justifiedby the risk to patients and where vol-untary standards, or compliance withthese sandards, are Inadequate.

3. The NRC will minimize IntrusionInto medical judcments affecting pa-tients and into other areas traditional-ly considered to be apart of the pran-tice of medicine.

.NRC licenses radiobomt In three cats,-sailor byproduct. source ad sec nucle-ar matertal. The NRC doe not regulate natlura' occurrIns or accelerator produced ir-diobotope. The term byroduct mUal,'rma -ay radoactive material texec% t .ow nluciear mterlau yielded in cr made rb-djlacsfte by exposure to the radiation inaOWL to the pro of WWducin8 or utiLInMgspecial nuclear materaL The term souolmaceie means (1) urn•um, thorium or anycombcaluan thereatSi any -Physical orehemical form or C2) -r- which contain byweight ne-twen.,eth of one pernit (00.0%)w mor of Ci) ulrnum. (U) thoMm or CIU)Any combination thereoi Source materialdon not Include saW nuclear material.spe"suol eare. VaaoZiilw means (1) plutoolum, wuanum 2=5. uranium enriched In thebotope 223 or in the isotope 1= or (2) aymateri• artificially enriched by any of theforegain, but does not include source m-te-MAIL

ML RA-anoNaz

The NRC and Its predecessor theAtomic Energy Commission have regw-lated the medical uses of radioLsotopessince 1946. AEC recognized that phye'-clans have the prima'Y responsibltyfor the protection .of their 'patents;and designed Its regulations according-ly. The physicians were required to belicensed by the State. and their apUll-cable training mad experience wereevaluated in consultation with the Ad-visory Committee on the Medical Usesof Isotopes. This regulation has beengenerally oriented toward assistingqualified physicians in dischargingtheir responsibilities to patients. How-ever. regulation by AEC/NRC has atone time or another encompassednearly every aspect of the delivery of,radioisotope medical services to pl-tientS. The broadest regulation oe-curred between 1962 and 19-.5. whenthe Food and Drug AdmInistration(FDA) exempted from Its require-merits fogr new drugs allradiopharmaceutlc.% regulated byAEC. During this period AEC reull24-ed the radiation safety of workers andthe general public and the safety andefficacy of radioactive drugs a.id de-ries with respect to patients. AECregulation Included production of theraduoisotope. mnuufacture of the finalradioactive drug product or device. dis-tributtlon use and disposal of the PrOd-ucts. In 1975. the FDA terminated theexemption for radiophafhinaceuticala.staltig that U would now regulate thesafety and erffca=y of rae'oactivedrugs with respect to patlents. (ASnote-I later in this statement. F`DAdoes rot regulate the ph)-yacans lo-tine use of raolophazamaceuticaft-) Atthe same time. NRC withdrew frmregulatt raidioactve drug safety andefficacy, stating that It would regu:atethe radiation safety of the wokenand the putilic. The 1926 MedicalDevice Amendments to the I ood. Drugand Cosmetic Act extended FDA's aw-thorilty over medical devices (Incl'jd:ngdevices contafaIn radioactive mater6-als) In a way simila to its authorityover drugs.

N'RC's authority to regulate dome*-UcaflU the medical -ses of byproductmaterial is found In the AtomicEnergy Act of 1954. as amended. Foexample. section 31 of that Act autho-rizes NRC -to issue general or specificllcenses to applicants seeking to usebyproduct material for r - med:caltherapy * * ".' Section 81 directs XRC

S-3

POLICY STATEMENTS

to regulate the manufacture, produc-tion. transfer. receipt in interstatecommerce. acquisition. ownership. pos-session. Import and export of byprod-uct material Finall, SecUon 81 alsodirects that

The Com: oian shall not permit the dis-tribution of any byproduct material to Anlicensee, and shall recal or order the recallof any distrIbuted msterila from any Vcem-cc. %ho is not equipped to observe or fal•s toobserve such safety standard" to protecthealth as may be established by the Com.

mssion or who am such material An vola.tion of law or regu]a&U~on of the Comminssiloor In a manmer other than as dWsclosed inthe appljca.•n therefor or approved by theCommission,

Commission regulations. for themost part set forth in 10 CFR Parts 30through 35. •were promulgated to carryout the broad regulatory scheme en-visaged by section 81. Fur example.Part 35 estahishes regulations specificto human uses of byproduct materialFDA's statutory authority (FederalFood. DrugL and Cosmetic Act. asamended. 21 U.S.C. 301 et seq.) doesnot diminish NRC-s authority. WhereXRCs and FDAs authorities overlap.the respective authorities can be bar-monuzed by Interagency agreement

The central question Is a question ofolicy not authority. namely.To what extent should the protec-

tion of the patient be considered inNRCa regulation of the medical use ofbyproduct material?

From the standpoint of dufhrity. Itis clear that NRC can regulate themedical uses of byproduct material toprotect the health and safety of usersof this material. for Instance. patlets.In i/censing the possession and use ofbyproduct material. 'RC establisheslimits within which physicians exer-cise professional d Usercton. From thestandpoint of pol€t these lmUSdepend upon how 'RC views the pM-tential baard to the patient's healthand safety in the uses of the byprod-uct material. The greater the potentialhazard to a patient from the byprod-uct material or Its uwe by a physician.the more XRC may elect to circm-acr'be areas that might otherwise beregarded as within the discretion ofthe physician-

The fint part of NRCs policy state-mwnt indicates that XRC will continueto. regulate the medical uses of radlol-stop as necesary to provide for the

radiation safety of workers and thegeneral public.- This is the u-aditiooalregulatory function of NRC for alluses of byproduct. source and specialnuclear material. It Is a regulatoryrole that was not questioned by any ofthe commenters but. rather. It wasconsistently recognized as a necessaryrole In the medical uses of radiOiso-to.pes

NRCs regulation of the radiationsafety of workers and the generalpublic In the medical uses of radioiso-topes is relinquished by XRC to Agree-ment States; does not overlap with

'The term general publ€ cIn thi state-went spectificaly excludes ptaient..

FDA's activities. Is In har-mony withregulation by the Departn:cnt ofTransportation. Social Security Ad-ministration and the Joint Commis-dion on Accreditation of Hospitals; anddovetails with Occupational Safetyand Health Administration regulationof the work-place for the use of natu--rally••curring and accelerator-pro-duced radioactive materials.

The second part of NRC's policystatement Ind!cates that NRC will reg-ulate the radiation safety of patlentswhere justified by the risk to patie-tsand where voluntary standards. orcompliance with these standards. areinadequate. As noted betore. KRC hasthe authority to regulate the radiationsafety of palients.

The NAS-BEIR ' report discuseslimiting the exposure of the popula-tion to medial applications of loa-..Lgtradiation. That reporL which includesall medical uses of Inizing radiation.shows an average dose rate fromradiopharmaceuticals of I mrem/yearand an average dose rate from dLag-nostic radiology of 72 mrem/year in1970.

The following quotation is from theWAS-BEIR report:

In the foreeeable future, the major on-tributors to radiation expoz.ie of the popu-lation will continue to be -a.al back-ground with an average who!.e body dose ofabout too mrem/year. and medrsal applos.-tions which new ear?_rqu~e rom.4wit'e ex-.Vo-suv to var-ous tiasces of the body. Iedi-al exposures are not under control or rg.;d-anee by regulation or law at present.- Theuse of kwlonii radiation In medicine ft oftremendous value but it Is esenial toreduee exsposures since this ca be accom-pushed Without I= of benefit and at rela-stely low eos. The aim Is no only toreduce the 1aao epon•tu to the 1ll-vidual but also to bae procedures amiedout with -maimum efctency so that therecan be a contriung increase in med-cabenefits accompan.ed by a minimum radi-stion exposure.-

NRC will act to help ensure that ra-diation exposure to patients is as lowas is reasonably achievable. consistentwith competent medical care and withminimal intrusion into medical judg-ments. NRC will not exercise regula-tory control In those areas where.upon careful examination. it deter-mines that there ar adequate regula-tions by other Federal or State agen-ciee or well administered professionalstandards. Wherever possible. NRCwill work closely wi•.h Federal andState agencies and professional groupsin designing new voluntary guidancefor practitioners to limit minecessarYpatient radiation expos'ne.

The tmird part of Z;RC's polcy State-ment Indicates that KRFC will mini-mize its Intrusion into medical Judg-ments affectirg the patent and intoother areas traditionally considered to

*National Acadr•ny of S.fences Adt.uoryComn!'ttet on the S]:olegirl lr-fccts of Ion-is~r: Radiaa~ons (NArZZR) re;:ort. Thec£ffect on PoP6.scious of F.-posure to LowLerels af lonwing Rcdc:mc%, Nc'onalAcae&-my of Sc.teucts-Rcane29 ResearchCouncil Washl-sgton. D.C. (1972L

be a part of the pract!ce of r-rd:.clne.The Cornmission recog::!zes that phy-sirians have the primary respons'bflItyfor the protection of their pat!ent&The Commission believes that basidecisions concerning the diagnosis andtreatment of dlsease are a part of thephystclan-patient relat!onshiP and aretraditionally considered to be a part ofthe -practice of medicine. NRC regula-tions are predicated on the ass-np:ionthat properly truemed and adequatelyinformed physician w=l make decl-sions in the best interest of their pa-tients.

Th•e regulations try to find a balancebetween adequate controls and avoid-ance of undue interference in medicaljudgments. A consequence of toomuch regulation could be poorerhealth care delivery to patients- A con-sequence of leaving to phYsidcias themajority of the decisions Concerningtheir patients is that the physicianswill make mistakes. The tightest rerJ-lation of physlciazn" deciions by Fed-eral. State and profcss!onal groups willniot be able to prevent future Incidentsin the medi-cal uses of radloisotopes.

The Commisson recognizes thatFDA regulates the manufaCture andinterstat=e distribution of drugs, includ-ing those that are radioactive, FDAalso regulates the investigationals andresearch uses of drugs ats well as thespecific guidance on doses and proce-dures found in the product label!-However. FDA does not have the aU-thority to restrict the routine use ofdrugs to procedures (described In theproduct labeling) FDA has approvedas safe and effective. Indeed. ,RC isthe only Federal Agency that is cur-rently authorized to regulate the rou-tine use of radioactive drugs from thestandpoint of reducing unnecessary ra-

-dition exposure to patients.The Commlssion believes that the

diagnostic use of radioactive drugs &s.In mnst cases clearly an area of lowradiaUon risk to patients. Therefore.NRC wil not control physician's pre-rogatives on patient selection. Insru-ment selection. procedure selection,drug selection and dose level for mostdiagnostic uses of r oiSoOpes. Forall therapeutic uses of radioacUved.-ugs. and in irtain diagnoic uses -

for example, the ue of pbosphorus-3:for jlcallzaton of eye tumors--therusk to patients is not Sow. The risk oftissu or organ damage (or even death)is inherent in the use of therapeuticleels ef radioactive drugL XRC Willcontinue to restrict the uses of thera-peutic and certain diasnosic radioaL-uve drugs tothe indicated proceduresthat haie been approved by FDA- TheNRC will not control the physiceiansprerogatives on paUent selection anftistriffnent selection for therapy pro-cedureis because these procedures areso specilid and patient specific.

Congress recently Cave FDA authori-ty to regulate medical devices, simlarto FDA* authority to rCuae drug.but with addtional azthbolty to re-strict the routine use of medical de-

S-4

POLICY STATEMENTS

vices as may be necessary to providereasonable assurance of their safetyand effective=ess. FDA has not yetbad s"flIcent time to Implemert Itsfull authority to regulate medical de-vices contala-ng b)product. source orspecW nuc:ear materlaL Therefore.NRC wM. contLue to restrict phys.-clan's uses of these med:.-al device.both for d~agnosis and therapy. tothose procedures that NRC has deter.mined (in Consultation with Its Adviso-rY Committee on the Medical Uses ofIsotopes) to be sate and effective.

The Commission does not considerequipment callbration. qualificationsof paramedical personnel or reportingto XRC misadminlstrations of radioac-tive material to be exclusively thepractice of medicine or a part of physi-clan-patient relationships. 'The Com-mission intends to regulate these areasof patient radiation safety where justi-tied by the risk to patients and wherevoluntary standards, or compliancewith these standards, are itadeQuate.

l11. DIscUssIox or PoVXJc CoMMENTS

A. COM~tD6T5 ON rT= POLUCY STATlI T

One commenter opposed the use ofthe general term -radioisotopes" Inthe first part of the policy statement.This commenter was concered that.if taken out of the context of the foot-note. It could be interpreted to Includenaturally occurring and acceleratorproduced radioisotopes.

The Commission believes that thegeneral term -radioisotopes- is plainEnglish and easily recognized by thepublic- It w-as properly footnoted Inthe policy statement to include themore cumbersome but specific terms:b)product. source and special nuclearmateriaJ and to exclude naturally oc-curring and accelerator produced rm-dioactive material.

One commenter. in opposition toNRC's regulation of patient radiationsafety, suggested that NRC limit Itsrole to the radiation safety of the hos-pital staff and the general patientpopulationo Be believes that patientdosimetry Is a responsibility of the in-dividual Instiution and not NRC. Thiscommenter feels that N1RC shouldfirst require adequate staffing. Includ-Ing a board certified phystcian or mSdiopharmacist, and a radiation &afetyofficer. and then essentially leave theinstitution alone regarding dosimetry.instrunentation. callbratlon. drug pro-curement or any other function con-sidered to be the practice of medicine.

XRC does require the licensee tostaff its operation with a radiationsafety officer and a physician (notnecessarily board certified) trained toadminister radioactive material or nb-diation to patients. However. the Com-mission cannot limit its regulatory roleto protecting the hospital Stf andthe general patient population and atthe same time fulfill Its congressIonalmandate to protect the health andsafety of the public as regards source.byproduct and special nuclear materi-al. The patient being treated or diag-

nosed with radioactive material. wwell as the general public who may beexposed to radiation as a result of thattreatment, are all members of thepublic to be protected by NRC.

Two commenters objected to NRC'Sregulation of patient radiation safetybecause they believe that NRC doesnot have the authority to regulate Pa-tient safety. They note that NRC's en-abling legislation does not specific&alymention the radiation safety of pa-tients. They believe that patientsafety is the responsibility of the phy-siclan. a responsibility that cannot beshared. They believe that the Commis-Sion is in error to equate patients withthe public and .to consider patients asusers. rather -than2 recipients -of radio---active material

As noted in the analysis of the simi-lar comment above. the NRC's overrid-Ing congressional mandate is to pro-tect the health and safety of thepublic. The patient is a member of thepublic. notwithstanding the Commls-sIon's recognition of physicians' prima-17 responSibillty for protection oftheir patients. The policy statementand. indeed, aln of the Commission'sactions in regulating the medical usesof radiolsotopes, acknowledge the sec-ondary but necessary role of NRC tnregulatint the radiation safety of pa-tients. The Commission also considerspatients to be both users and recipi-ents of radioactive material. However.the distinction between receipt anduse of radioactive materials Is notmeaningful In this case because NRCregulates, among other things, receipt.possession. use and transfer of byprod-aet. source and special nuclear materl-al In protecting the health and safetyof the public.

Is. coVXyKS OR srcZ=c mumVThere were six comments on the

question of reporting mlsadmlnistr-tions of radioactive materiaL Threecommenters opposed any misadminis-tration reporting and three com-menters offered suggestions on howthey should be reported. All of thecomments will be considered In dea.lngwith NRC's newly proposed missAdmin-stamtion ,reporting requirement that

Was published in the Fwu.t RzczsRfor public comment on July 7. 1978 (431FR 29231).

There were six comments on the spe-cifIc I-ue of Paramedical trainIn.Three commenters believe that It Ismmecesary for NRC to become In-volved In paramedical training becauseseea organizations ar already pro-vdlnt or develpintg minlmum stand-aids, guidelines or certification. Onecommenter believed that NRC shouldbe involved in this area because thetechnologst, not the physician, doesmost of the work with radlolsotopeLTwo commenters believe that radiolog-Ik-a physicists should be separated outfrom other paramedical personnel andone of these commenteu offered adefinition of radiological physiciL

As noted in the propo:ed policystatement. NRC Is studying the -ar-bous allied health certification pro-grams currently In effect or beingdrafted by other Federal. State andprofessional groups. If the coverageprovided by these programs Is not ade-quate to protect the patient from un-necessary radiation exposure. NRCwill work with these groups to developa new NRC proposed rule for thetraining of allied health personnel.

There were five bomments on thespecific subject of nuclear pharmacies(radlopharmaeles)-

One commenter urged NRC to di-tinguish between radiopharmacistllworking in a hospital setting and thoseworking in a-retaBlenvironment.(com.mercial nuclear pharmscy). This com-mrenter also noted the complexity ofthe problem of definition when thehospital based radlopharnaCY pro-vides radiopha.rmiceutieals to otherhospitals and practitioners In Its area.

As noted in the proposed policystatement. the NRC will defer to theFood and Drug Administration (FDA)regarding a determination of those ac-tivities of nuclear pharmacies that willbe considered manufactwe and thoseactivities that will be considered theordinary practice of pharmacy (tem-pounding and disp=sintX

Four commenters objected to NRC'slicensing nuclear pharmacies to di.tribute only those products that theyhave prepared from FDA-pprovedradiopharmaceutlcals or reagent kits.One commenter cited the practice ofnuclear pharmacies supplying radio-chemicals to researchers who usethem on hummas under their ownFDA "Notice of Claimed Investigation-al Exemption for a New Drug- CIUNDOne commenter noted that FDA per-mits nuclear pharmacies to operate inthe absence of a final determination oftheir statm, providing they meet allState and local pharmaceutical re-ula-tions. The two other commenterscharacterized the NRC'S restrictionson the distributilo ofradlopharmaeutias by nuclear phar-macies as an unwarranted intrusionInto the practice of pharmacy which Isregulated by the States.

NR licenses nuclear pharmacies todistribute radioactive drugs that havebeen approved by FDA. This includesradioactive drugs subject to an FDA-approved -New Drug Applicatlon"(N1DA). or -Notce of Claimed Investi-gationul Exemption for a New Drug-(111D). NRC relies on FDA approval ofradioactv drugs because XRC hasnot regulated the Safety and effective-non of radioactive drugs since 197".Also, there are not many States thatare equipped to regulate radioactive

g safety and e.-fe•Uvenes-Dated af Washintlon. D.C- this 1st

day of February 193.

S-5

.36932 Federal Register / Vol. 51, No. 206 1 Thursday, October 16. 1936 1 Rules and Regulations363 eea eitr/ o.5.N.20/Turdy coe 6 96 ue n euain

NUCLEAR REGULATORYCOMMISSION

10 CFR Parts 30, 31, 32, 35, and 40

Medical Use of Byproduct Material

AGENCY: Nuclear RegulatoryCommission.AC•ION: Final rule.

SUMMARY* The Nuclear RegulatoryCommission (NRC) is revising itsregulations to modify the process forlicensing and regulating the medical useof radioactive byproduct material. Therevision will primarily affect hospitals,clinics, and individual physicians.

By clarifying and consolidating all theessential radiation safety requirementsthat are now contained in theregulations. license conditions.regulatory guides. and staff positions.the regulation provides a single sourceof requirements related specifically tothe medical use of byproduct materials.The regulation also provides flexibilityfor licensees by allowing them to updatetheir day-to-day radiation safetyprocedures without applying for andreceiving a license amendment. Therevised regulations provide for a moreefficient method of regulating themedical use of byproduct material.EFFECTIVE DATE: April 1. 1987. Theincorporation by reference of certainpublications listed in the regulations isapproved by the Director of the FederalRegister as of April 1, 1987.£OR ,ES: Copies of the regulatoryanalysis. analysis of major issues.environmental impact assessment, andthe comments received on the proposedrule may be examined at theCommission's Public Document Room at1727 H Street NW. Washington. DC.Single copies of the regulatory analysis.analysis of major issues, andenvironmental impact assessment areavailable from Norman L McElroy,Office of Nuclear Material Safety andSafeguards. US. Nuclear RegulatoryCommission. Washington. DC 20555,Telephone: (301) 427-4108.POR FURTER INFORMATION CONTACT.Norman L McElroy. Office of NuclearMaterial Safety and Safeguards. U.S.Nuclear Regulatory Commission.Washington. DC 20555. Telephone: (301)4Z7-4108.SUPPLEMENTARY INFORMATION:

Table of ContentsL By products Material in Medicine

Use for Patient CareState and Federal Regulation

U. NRC'S Regulatory ProgramPolicy Regarding the Medical Use of

Byproduct Material

Current Licensing PracticeIl1. Revision of the Regulator. Program

OverviewCodification of Requirements in the

Regulationslicense Application. Issuance. and

Authority and ResponsibilityTraining and Experience CriteriaEnforcementAmendmentsRenewalsSummary of Changes in the Regulatory

ProgramTransition Policy for General LicenseesTransition Policy for Specific Licensees

IV. Analysis of CommentsOveri•ewGeneral CommentsComments on Specific Sections

V. Derivation TableVL Administrative Statements

Finding of No Significant EnvironmentalImpact: Availability

Paperwork Reduction Act StatementRegulatory AnalysisRegulatory Flexibility CertificationResolution of Petition for Rnlemaking PRM

35-2VII. List of Subjects in 10 CFR Parts 30. 321. 32.

35. and 40VIII. Text of Final Regulations

L Byproduct Material in Medicine

Use for Patient CareRadioactive materials are used in

drugs in the field of nuclear medicine.Drugs labeled with radioisotopes areknown as radiopharmaceuticals. Indiagnostic nuclear medicine, patientsreceive these materials by injection.inhalation. or oral administration.Physicians use radiation detectionequipment to visualize the distributionof a radioactive drug within the patient.Using this technology, it is possible tolocate tumors, assess organ function. ormonitor the effectiveness of a treatment.in therapeutic nuclear medicine, largerquantities of radiopharmaceuticals areadministered to treat hyperactivethyroid conditions and certain forms ofcancer. An estimated 10 million nuclearmedicine procedures are performed in,this country annually.

Sealed radioactive sources thatproduce high radiation fields are used inradiation therapy to treat cancer. Aradioactive source in a teletherapymachine can be adjusted to direct aradiation beam to the part of thepatient's body to be treated. Anestimated 100.000 patients receivecobalt-60 teletherapy treatments fromNRC licensees each year. Smaller. lessradioactive sealed sources are designedto be implanted directly into a tumorarea or applied on the surface of an areato be treated. This procedure is knownas brachytherapy. NRC licenseesperform approximately 10.000brachytherapy treatments annually.

Sealed radioactive sources can E:sobe used in machines that a:'e used !ordiagnostic purposes. The sourceprovides a beam of radiation that isprojected through the patient. A deviceon the other side of the patient detectsthe amount or spatial distributior ofradiation that goes through the patient.This can provide information abozuttissues within the patient. This is arelatively new development in the fieidof medicine and the NRC has noestimate of the number of thesediagnostic procedures performedannually.

State and Federal Regulation

Twenty-eight States, known asAgreement States, have assumedresponsibility for regulating certainradioactive materials within theirrespective borders by agreement withthe NRC. (This kind of agreement isauthorized by the Atomic Energy Act.)They issue licenses for the medical useof byproduct material, and currentlyregulate about 5.000 licensees. In non-Agreement States, the NRC issueslicenses to medical institutions (most!.yhospitals and clinics) and to individualphysicians. These licenses authorizecertain diagnostic and therapeutic usesof radioactive materials.

I. NRC's Regulatory Program

Polkcy egard7ing the Medical Use ofByproduct Material

In a policy statement publishedFebruary 9, 1979 (44 FR 8242). the NRCnoted that it regulates the medical use ofbyproduct material as necessary toprovide for the radiation safety ofworkers and the general public,regulates the radiation safety of patientswhere justified by the risk to patients.and minimizes its intrusion into medicaljudgments affecting patients and intoother areas traditionally considered tobe the practice of medicine. The NRCdoes have the authority to regulate themedical use of byproduct material toprotect the health and safety of patients.but also recognizes that physicians havethe primary responsibility for theprotection of their patients. NRCregulations are predicated on theassumption that properly trained andadequately informed physicians willmake decisions in the best interest oftheir patients.

This revision retains NRC's currentbalance between adequate controls andundue interference in medicaljudgments. Too much regulation couldresult in poorer health care delivery topatients. Insufficient regulation could

S-6

Federal Register / Vol. 51, No. 200 / Thursday, October 16, 1986 / Rules and Regulations , 36933

result in the unwarranted or unsafe useof radiation.

Current Licensing PracticeThe current regulations in 10 CFR Part

35. "Human Uses of ByproductMaterial," provide for licensing medicalinstitutions and physicians for medicaluse. A license may be issued for one ormore of'six types of medical use. Thetypes of use are defined in Groups I-VIin the current 5 35.100. Each group iscomprised of a number of diagnostic ortherapeutic procedures that have beengrouped together because they requiresimilar physician training and radiationsafety precautions for safe use. Aseparate specific license may also beissued for use of a teletherapy unit.Applications for a specific license arevery detailed and contain theapplicant's step-by-step radiation safetyprocedures. which are reviewed andapproved individually by NRC.

NRC currently has about 2500 specificmedical licensees (2200 hospitals and300 physicians in private practice]. Eachyear the NRC receives about 100 newapplications. 500 license renewalapplications, and 2.000 licenseamendment requests.

To help licensees design theirradiation safety programs. the NRC haspublished many NUREG reports andregulatory guides that contain radiationsafety guidance. These publicationsaddress three general areas: radiologicalhealth and safety. personnel trainingand experience. and facilities andequipment. Experience has shown that iflicensees follow the guidance in thepublications, the medical use ofbyproduct material generally poses nohazard to workersa'nd the public.

Because of the potential radiationhazard to workers and the public. thespecific license program that NRC usesto regulate medical use incorporatesthree regulatory features: case-by-casereview of applications, on-siteinspections, and periodic licenserenewals.

A major problem with the currentlicensing program is that radiationprotection requirements are not locatedin one document. Requirements arescattered in the regulations, Inspectionand Enforcement (ME) orders that modifya license or group of licenses, and inconditions attached to individuallicenses. Suggestions for good practiceare contained in NRC regulatory guidesmad technical reports (NUREG's). Forexample. Rgulatory Guide 10.8, "Guidefor the Preparation of Applications forMedical Programs." 1 and NUREG-O2,

6Retegulato l de available for spemoo atthe C~ammin's P•ic Doastiat Ro.L 2737 H

"Principles and Practices for keepingOccupational Radiation Exposure atMedical Institutions As Low AsReasonably Achievable," a containmany recommendations that the NRCbelieves are important for the safe useof byproduct material. The revision ofPart 35 incorporates thoserecommendations, and also corrects thepiecemeal fashion in which theregulations have been amended over theyears to address specific problems.

When preparing a specific licenseapplication for review under the currentlicensing program, the applicant mustinclude sufficient information to assureNRC reviewers that byproduct materialwill be used safely. Applicants include.as an integral part of the applicationpackage, copies of their proposed step-by-step radiation safety procedures. Inmany cases. the procedures are editedversions of procedures described inRegulatory Guide 10.8.

When NRC receives the application. alicensing reviewer evaluates theapplicant's training and experience.facility, equipment, and radiation safetyprocedures in detail. If the application isfound to be incomplete or inadequate. a"deficiency letter" is sent to theapplicant explaining what additionalinformation is needed. Review of theapplication is not resumed until awritten response from the applicant hasbeen received. Staff studies indicate thatabout 40 percent of all applicantsreceive either a deficiency letter or aphone call for additional information.The need for deficiency letters stemsfrom two sources. Guidance on whatsubmissions are required to get a licenseis unclear and scattered in various -documents. Application review practicemust be conservative because theapplication and license comprise thebasis for regulatory control. Deficiencyletters are costly for the NRC and theapplicant and greatly increase the timeneeded to complete licensing actions.

Sute NW. Waabigo. D_. M.Capies of seave d•susmy be pardeaed at the comat CowmvesmstPnMg Office pete. Asubampbiptavie Eortuum suides i spaecifi divisious is avilabethroug the Goveniment1.Przg Orris. laofamationan the ubsciptior; service and crmat prhces maybe obtamed by whi*n* to the SupereAideu ofDo taits, US. Governent Psmst Office. PostOfice Box = Wahigon. DC ,-0e.,

• Copi of ,'4tU A may be puwcband thbonhthe US. Govem=ent PntiAg Office by ealling tt)VS254M or by writag to the US. GaveamstoPriting Office M.O Box 3703 Waslington DC

W.-27=Z. Copie may also be purchased fom theNatioes Tecnsa •d normation Ser ice. US.Deparmtet of Ciaomere. SM Part Royal Road.Sprfnisged. VA =015. A copy is available forinspection and copying for a fee i the NRC PIblicDocument Room. 177 H Soeet NW. Washigton.DCm 2s.

When the application, including anyadditional submitted information, isapproved, the NRC issues a specificlicense that grants the authority formedical use of byproduct material inaccordance with the program describedii the application. Requirements inaddition to those contained in theregulations are frequently incorporatedin the license as conditions of use. Sincethe licensee must comply withconditions specified in the license, thelicense, rather than the regulations, isfrequently used to regulate radiationsafety in the day-to-day use ofbyproduct material.

The specific license is valid for fireyears. The license must be amendedbefore methods of use or proceduresmay be added or changed, or beforepermitting additional physicians to usematerials. Amendments to a specificlicense involve an application. review.and approval process similar to that fornew licenses. Renewals are treated inthe same manner as new licenseapplications.. This regulatory process wasappropriate during the evolution of theuse of byproduct material in medicine.Radiation safety problems were not welldefined, regulatory requirements had notcaught up with developing technology.physician training curricula had notbeen established, and there were noformal training programs for nuclearmedicine technologists. Therefore. itwas necessary to regulate by reviewingeach individual radiation safety programto ensure that the applicant hadadequate personnel, facilities. andequipment

1IL Revision of the Regulatory Program

Overview

NRC is modifying its regulation of themedical use of byproduct material. TheCommission has revised the regulationsto provide a single source ofrequirements specifically related tomedical use of byproduct materials.Within the boundaries set by theregulations. NRC will allow medicallicensees to make minor changes in theirradiation safety procedures that are notpotentially important to safety. Suchchanges are sometimes needed solicensees can make prompt use of newsafety methods and also meet newneeds caused by changes in the demandfor various patient care services orchanges in the number of patientsServed by the licensee. The revision of10 CFR Part 35 is consistent with theCommission's general policy on medicaluse of byproduct material issuedFebruary 9.1979 (44 FR 8242). As stated

S-7

36934 Federal Register / Vol. 51, No. 200 / Thursday. October 16, 1986 / Rules and Regulations

in the policy statement. "NRC willcontinue to regulate the medical uses ofradioisotopes. as necessary. to providefor the radiation safety of workers andthe general public."

Codification of Requirements in theRegulations

The proposed revision was publishedfor public comment on July 26.1985 (50FR. 30616). In the proposal, the NRC saidit would simplify regulation of medicallicensees by incorporating all medicaluse requirements into 10 CFR Part 35.These regulations would become theprimary means of regulating the medicaluse of byproduct material. Generalsafety requirements for workerinstruction, worker safety.noncompliance reports, and materialslicensing that are in Parts 19.20.21. and30 will also continue to apply to Part 35licensees.

The current license applicationprocess will be unchanged. Theapplicant still will complete Form NIRC-313. which asks for the followinginformation: the name and mailingaddress of the applicant: the location ofuse; a person who can be contactedabout the application: what materialsare requested; the purpose (in this case."medical use-): the training andexperience of the authorized users andRadiation Safety Officer. the workerradiation safety training program:facilities and equipment; the radiationsafety program: and waste management.

Licensees will not face significant newregulatory burdens in their radiationsafety programs because, in most cases.the information submitted on Form 313is transformed into license conditions.Under the revised regulations thelicense authorizes medical use ofbyproduct matenials for specified typesof use. A licensee's use of byproductmaterial is controlled by the regulationsand by license conditions for sitespecificcircumstances that can not begenerically covered by regulations. Thissimplifies inspections for NRC becauseinspectors need only be familiar withone set of regulations rather than adifferent set of license conditions andradiation safety procedures at eachfacility.License Application, Issuance, andAuthority end Responsibility RadiationSafety Programs.

New revisions of Regulatory Guide10.8. -Guide for the Preparation ofApplications for Medical Programs.-and Draft Regulatory Guide TM 608-4.3

lRequests for stave opies of draft uide, iwhilhwaj' ,-a n acmdured) or for laomern un anauto•mtic dtaib*utaa• list for siagle cm of futre

*"GuL.-- for the Preparation of Licensesin Medical Teletherapy Programs."which were distributed to licensees forcomment, contain instructions on the,type and extent of information that mustbe submitted based on the byproductmaterials for which the applicant hasrequested a license. The regulatoryguides also contain model proceduresthat the applicant can use to developsite-specific procedures. (Consistentwith current practice, applicants willalternatively be allowed to simplycertify that they will follow a modelradiation safety procedure developed byNRC staff with public comment andpublished in a regulatory guide. Thismethod significantly reduces the amountof time NRC must spend reviewingradiation safety procedures.) Theapplicant mails the completed licenseapplication, with application fee, to theNRC office identified on the form.

The NRC staff will continue to reviewthe application to determine whether theapplicant's radiation safety program issufficient to comply with the regulations.After completing the review, if theapplicant's program appears incompleteor inadequate. NRC will issue adeficiency letter that describes theapparent shortcomings in the applicant'sprogram and requests clarification orcorrection. If the applicant's response tothe. deficiency letter is satisfactory, or ifno deficiency letter was needed, thelicense will be issued.

In most cases license conditions willonly be used to identify authorized usersfor each type 'of use, the RadiationSafety Officer. a teletherapy physicist ifrequired, types of material authorized.'possession limits for teletherapy unitsand brachytherapy sources, and areasset aside for byproduct material use.This regulatory scheme will notincorporate the current license conditionrequirement that licensees usebyproduct material in accordance withthe statements made in the application.

Major radiation safety programchanges that are clearly potentiallyimportant to safety are listed in I J35.13and 35.805 of the final rule; they willrequire a license amendment. This isrequired because such chasges couldsignificantly affect the public health andsafety. Licensees will be free to makeminor changes in their radiation safetyprograms that are not potentiallyimportant to safety after conducting an

drah guides m spedfac dnuia•aa wsould be made mtwritin to the U.S. Nucler Regulatory CommindomWashaiaum. DC 2mss. Artentuo: Drector. Divisionof Technical Infaimation and Docrent Control.Telsephoe requests carnt be accommodated.Reglatory guides an not cpyrighted. andCommissiom approval s nam required to ieproducethem.

internal review and approval process.This will allow each licensee to makeprompt use of new safety methods andto adjust radiation safety procedures tomeet new needs caused by changes indemand for patient care services orpatient load. A list of radiation safetytopics that should be considered whenreviewing proposed changes appears inthe new revision of Regulatory Guide10.8. The right to make.minor changesdoes not relieve the licensee from therequirement to comply with theregulations. For example. requirementsto have certain equipment on hand andto conduct certain surveys at a certainfrequency are required by regulationand cannot be changed. See the analysisof comments on I 35.31 for furtherdiscussion of this matter.

The regulations require specifictraining and experience for each type ofuse. Proposed authorized userphysicians, teletherapy physicists. andRadiation Safety Officers will have tosubmit summaries of their training andexperience. The NRC will review thoseindividuals' training and experienceagainst the standards in the regulationbefore authorizing them to work underthe license. Consistent with currentpractice, any individual who does notmeet the standards may ask for anexemption from the training andexperience requirements. The NRC staffwill review the individual's training andexperience with the assistance of itsAdvisory Committee on the MedicalUses of Isotopes. and may issue theexemption as a license condition.

Tminin and Experience Criteria

The NRC notes that, as a separateproject. it is reviewing its physiciantraining and experience criteria. If itdecides that changes might be in order.the proposed changes will be publishedfor public comment as a separaterulemakin action.Enforcement

Licensees will be cited for failure tomeet the requirements of the regulationsor license conditions (which will list. forexample. authorized users, address ofuse, types of use. byproduct materialand inventory limits, and site-specificlimitations). falure to have on hand thewritten procedures required by theregulations. failur to follow theprocedures on band. failure to have therecords required by the regulations, orfailure to follow technically validradiation safety procedures (examples:using an instrument that doesn't work.not determining instrument detectionefficiency, not allowing an instrumentenough time to respond, or making

S-8

Federal Register / Vol. 51. No. 200 / Thursday. October 16, 1986 / Rules and Regulations 36935

unsubstantiated assumptions incalculations). Use of material can beauthorized either by license or by virtueof working under the supervision of anauthorized user. Use withoutauthorization would be a violation of theregulations and the Act, which wouldsubject the licensee and individual toenforcement action.

Amendments. Under current regulatory policy, the

application coupled with the licenseecondition requirement to use material inaccordance with the statements made inthe application usually provides thebasis for inspection citations. Now theregulations will contain sufficientprescriptive and performance criteria onwhich to base enforcement actions.Therefore, the NRC will allow a licenseeto make minor changes in its radiationsafety procedures that are notpotentially important to safety aftermaking an internal review to assure thatthe change complies with the regulationsin Part 35 and in other parts of 10 CFRChapter L

However. amendments still will berequired for some changes. The NRCwill review the training and experienceof each proposed authorized user.Radiation Safety Officer. andteletherapy physicist before theindividual is listed on a license. Alicensee's request to add a type of use(for example, addingradiopharmaceutical therapy to alicense that authorizesradiopharmaceuticals for imaging) to anexisting license will be handled as anew application. The authorized user'straining and experience and theprocedures needed in support of therequest will be reviewed for •completeness and adequacy withrespect to the new type of use before theamendment is issued.

A request to leave one location of useand begin working in a new location, forexample when moving a private practiceto a new office or when moving into anew hospital building, will have to besupported by a complete new licenseapplication package.

Licensees that are already allowed toreceive packages, prepareradiopharmaceuticals, and packagewaste at a central facility, but use thebyproduct material at satellite locations.will only have to identify the newlocation. (Due to the training, space, andequipment commitments needed forsafety during therapy procedures, theNRC will generally not authorizelicensees to perform therapies. exceptlow-level iodine therapies. outsidemedical institutions. This type of request

will be handled on a case-by-casebasis.)

Renewols

The NRC license is valid for fiveyears. If a person wants to continueusing byproduct material after the five-year license period the license must berenewed. The renewal application mustcompletely describe the entire radiationsafety program just as a new applicationdoes. If a radiation safety procedure,facility description, or equipment listthat was submitted in the application oran approved amendment still accuratelyreflects that part of the licensee'sprogram, the renewal applicant maysimply make a clear reference to theprevious submission. If the licensee haschanged a procedure, or is usingdifferent equipment, a complete newdescription of the particular procedureor equipment must be submitted. Thelicensee may also take this opportunityto identify new authorized users orrequest wider authorization.

Summary of Changes in the RegulatoryPrOgTm

In summary, the new regulation willrequire that licensees meet standardsthat are currently imposed by licenseconditions. The NRC will continue toreview user training and experience.The NRC will review applicants'radiation safety programs, including thesite-specific radiation safety procedures.for completeness and adequacy andissue deficiency letters if necessary. butwill allow licensees to make minorchanges in their radiation safetyprocedures that are-not potentiallyimportant to safety after conducting aninternal radiation safety review of eachchange. However, the right to changeprocedures does not relieve the licenseefrom the requirement to comply with theregulations. Amendment requests willgenerally be reviewed just as newapplications are reviewed, but they mayinclude by reference material containedin the original application and anyprevious amendments.

Transition Policy For General Licensees

The Generaml icense for Medical Use.The general license program is based onthe fact that the quantities and forms ofmaterial that are authorized by ageneral license present a very lowhealth risk. The NRC believes it is nolonger efficient to issue medical generallicenses that allow the administration ofbyproduct material to humans. The testsauthorized under I 35.31 have beensuperseded by newer procedures withgreater diagnostic accuracy. Thesedevelopments have been reflected by a

significant decrease in applications forgeneral licenses.

To determine the status of generallicense use. the staff performed atelephone survey of 10 percent of thecurrent registrants. The survey resultsindicated that less than 9 percent of allthe current registrants still use materialfor medical use under a general license.Many general licensees are now usingbyproduct material under a specificlicense. Because of the low level of useof the general license, the NRC hasconcluded that it no longer serves auseful role in licensing the medical useof byproduct material.

The in vivo general license containedin current 9 35.31 has been eliminatedfrom the regulations. in the future, allmedical use will be authorized by aspecific license. Current generallicensees, all of whom are physicians.will receive a specific license that willbe incorporated into NRC's filing systemfor keeping track of specific licensees.However, these licensees will be limitedto the clinical procedures described inthe current § 35.31, and relieved, bylicense condition on a pre-printedlicense, from the requirements that aremore burdensome than currentrequirements under the general licensee.The only action they will need to take isto respond affirmatively to an NRCnotice that asks if they want to continieto have an NRC license that is limited tothe clinical procedures authorized by tlhrcurrent general license.

The Commission will. underi 170.11(b), exempt these licensees fro."napplication and renewal fees as long astheir programs are limited to thematerial uses described in current1 35.31. Under the new specific Ecer.sinFsystem. former general licensees thatwant to make any changes in theý:programs. amend their licenses, ortransfer them to other physicians. wi!lhave to apply for a specific license andwill be subject to all the fees that applyto other specific licensees.

The Commission has decided to waivefees to former general licensees for thefollowing reasons. General licensees donot now pay fees. About 90 of the 1.200or so general licensees are inactive.Each year NRC receives only a very fewrequests for general licenses under1 35.31. There would be no NRC reviewtime needed and only a minor NRCadministrative cost to process theselicenses. It would be unfair to cha.gethese licensees the fees listed in 10 CFRPart 170. and it would be more costly forNRC to alter that fee structure than togrant the exemption.

The General License for in vitro use.The current Part 35 also grants a general

S-9

36936 Federal Register / Vol..51, No. 200 j Thursday. October 16. 1986 1 Rules and Regulations363Leea eitrIVl 1 o 0 hrsa.OtbT1,18 ue n euain

license for in vitro work described in§ 31.11 to group licensees withoutrequiring that they submit an in vitroregistration form. The NRC will continuethis program unchanged.

Transition Policy for Specific Licensees

Under the current regulatory program.the license document with the appendedapplication is used to regulate eachindividual licensee. Because therequirements in the revision were takenfrom commonly used topical licenseconditions and from regulatory guidancethat most licensees have incorporatedinto their applications, the Commissiondoes not expect any significantinconsistencies between currentlicensee radiation safety programs andradiation safety programs of applicantsthat apply after the effective date of theregulations. Therefore. current licenseeswill normally be cited if they do notcomply with the new regulations.However. because each currentlicensee's radiation safety program wasreviewed individually and licenseconditions were tailored to meet thelicensee's individual needs, there maybe an occasional inconsistency betweena license condition and the regulation(for example. a license may requiresurvey instrument calibration biennially.but the proposed regulation wouldrequire calibration annually). There isno health and safety reason to undothese licenses to effect compliance withthe regulation. To impose the regulationin addition to or in lieu of the licenseconditions would not provide forsignificant additional protection for thepublic health and safety. TheCommission has decided to resolvepossible temporary inconsistenciesbetween license conditions and theregulation by providing in the regulationa transition period between the effectivedate of the rule and the expiration dateof each license. During this transitionperiod. if there is an inconsistencybetween a provision in a license (issuedprior to the regulation) and theregulation. the license condition takesprecedence over the regulation. Becausethe license conditions were reviewedfrom the perspective of overall safetyand approved by the NRC. theinconsistency would not result in anincreased risk to workers or the public.

In addition to the topical licenseconditions mentioned above (forexample, sealed source leak testrequirements. special bioassayrequirements, radioactive patientsurveys and release limits, or wastedisposal restrictions), each specificlicense has an encompassing licensecondition that requires each licensee topossess and use licensed material in

accordance with the statements.representations. and procedurescontained in the license application andin letters of clarification. Despite thisencompassing condition, licenseeswould be allowed to make minorchanges in their radiation safetyprocedures that are not potentiallyimportant to safety; permissible changeswould be restricted to those identified in§ 35.31. and the licensee would have toconduct the internal review required bythat section.

In the case of record retention, theregulation will take precedence because.in the past, the Commission has notoffered much guidance on this topic. If arecord is substantively the same as arecord described in the proposedregulation and the licensee has notstated a retention period for thatspecific record. licensees may adopt theretention period stated in the final rule.However, during the transition period.licensees still will have to comply withany record retention period required bya license condition that deals with aspecific topic. or by another Part of 10CFR Chapter I (for example Part 20). Forexample. surveys that provide the basis

for occupational dose records ormeasurements of effluent release aregoverned by Part 20. A license conditionthat requires retention of a particularrecord would only have been imposedfor a specific public health and safetyreason.

NRC does not currently reviewteletherapy physicist credentials. anddoes not identify the Radiation SafetyOfficer on the license. NRC will begin toreview the credentials of the RadiationSafety Officer and Teletherapy Physicistand identify both of them just as it doesnow for authorized users. To addcurrent licensees to this new scheme.licensees must submit the credentials furreview and approval when the nextamendment or renewal request isrequired. These individuals will beidentified on the next licenseamendment.

IV. Analysis of Comments

OverviewThe NRC analyzed all 213 comment

letters that were received prior todrafting the final rule. Comments camefrom many different sources. A tally isprovided in Table 1.

TAmE 1

~101 20 1; 1~

pocmn. 041.muc Womw m4rAAC

Twenty-nine of the letters addressedtraining and experience criteria fordiagnostic radiopharmaceuticals. anissue which the NRC stated in theNotice of Proposed Rulemaking wasbeing handled as a separate project thatwill be published for public commentseparately. Thirty-three complimentedthe agency on the completeness andclarity of the rule.

Many commenters addressed thethree major issues raised by theproposed rule: the requirement to havean ALARA program. misadministrationreporting requirements, and theprovision that allows licensees to makeminor changes in their radiation safetyprograms. Nine of the 11 commentsreceived on the ALARA programrequirement recommended that therequirement be placed on privatepractitioners as well as medicalinstitutions. Two recommended eitherno change or lessening of therequirement. Of those that addressedthe provision for minor changes in

licensees* radiation safety programs.individuals. associated with stateregulatory programs were unanimous inrecommending that all program changesrequire license amendment. The othercomments indicated satisfaction withthe provision. Of the 17 letters thataddressed the misadministrationreporting requirement, 13 recommendeddeletion of the diagnosticmisadministration reportingrequirement, and 4 recommended nochange.

The NRC mailed notices'to all 1.100general medical licensees that arelicensed under the current I 3.31. Tenrequested more information. and 5indicated that they wanted a licensethat would rilow them to continue theirwork. The Postal Service returned 141 ofthe notices as undeliverable.

General Comments

1. Consolidotion and clorification.Commenters were almost unanimous incomplimenting the agency for publishing

S-10

Federal Register / Vol. 51, No. 200 / Thursday. October 16, 1986 / Rules and Regulations 36937Federal Reister I Vol. 51, No. 200 I Thursday. October 16, 1986 / Rules and Regulations 38937

the proposed consolidation ofrequirements. Many endorsed the NRC'sview that noncompliance is frequentlyborn of ignorance rather thannegligence, and that this problem is bestdealt wit by putting all requirements inone place. Furthermore, the timing of therevision is appropriate given the growthover the past two decades of theprofessional literature and variousprofessional organizations.

2. Word use. In the notice of proposedrulemaking. the NRC clarified severalterms of art that it proposed to use whendealing with medical licensees. Severalcomments were received.

Licensee. Several commenters notedthat the regulations should be revised toallow contractors to do certain chores.noting that the regulation requires "thelicensee" to perform certain tasks, whilein practice licensees frequently hireoutsiders to perform these tasks. TheNRC stated in the Notice of ProposedRulemaking. "The person (individual.partnership, corporation, or agency)listed on the license as the 'licensee' isresponsible for compliance withregulations and license conditions. Thelicensee may effect compliance throughfull-time or part-time employees.contracts with consultants or serviceorganizations, or other businessarrangements. The word *licensee* isused throughout the regulation to stressthe fact that. no matter which method isused. the licensee is legally responsiblein case of noncompliance." Therefore.there is no need to revise the regulationsin this regard.

Operable. Some commenterssuggested that the word "operable"should be inserted "where appropriateto obviate the need. in the future, toconstantly explain to licensees thatmeters must, in fact, be operable." TheNRC can only repeat what was stated inthe notice of proposed rulemaking. "Theword 'operable' is not used in theproposed regulation because every pieceof equipment must be operable. If apiec• of equipment is not operable orreliable, whether due to old or absentbatteries, incomplete or impropermaintenance, damage. inappropriateuse. or improper use, it cannot be usedto meet a regulatory requirementbecause there is no assurance that itaccomplished the task for which it wasused." The NRC repeats: Every piece ofequipment used to meet a regulatoryrequirement must be operable.

Telethe•opyphysicist The currentPart 35 uses the term 'qualified expert,"which is usually used to denote anindividual with special training andexperience in a field determined incontext by the reader. The proposedPar' 35 used the term of art "qualified

teletherapy calibration expert" todenote the field of special expertise. Thefinal regulation uses the less unwieldyterm of art "teletherapy physicist."Although the terminology was changed,the functions of the individual have not.

Roentgen. rod, and rem. These baseunits are used to measure three differentquantities: exposure, dose, and doseequivalent respectively. The NRC notesin 20 CFR 20.4(c) that a dose of one remis equal to an exposure of one roentgenof x or gamma radiation or a dose of onerad of x. gamma, or beta radiation. Inthis final rule the NRC has used the baseunit rem throughout.

Dose and dosage. In pharmacy, theword "dose" is used to indicate theamount of chemical administered: inradiation biology it is used to indicatethe amount of ionizing energy absorbedper unit mass; and in radiation safety itis used as a shorthand term to indicate aworker's exposure to radiation. In orderto avoid confusion, the word "dosage" isused in the revised Part 35 to indicatequantities of radioactivity that aremeasured with the base unit Curie. Theword dose is used to indicate quantitiesof radiation absorbed dose or doseequivalent that are measured with thebase unit rad or rem.

Record and report A Tecord is a user-retrievable notation or completedocument. It may consist of somethingas small as a check-mark on a form orsomething as extensive as a survey of anewly installed teletherapy unit withappended calculations to demonstratecompliance with the limits on exposurein unrestricted areas. A report is atransfer of information which might bemade face to face, by telephone,telegram, computer link, or hard copytransmittal.

Test and check For many pieces ofequipment, drafting committeescomprised of industry experts haveprepared standards of performance andcomplete calibration protocols. If a pieceof equipment is subjected to the protocolin the calibration laboratory and meetsall the standards, then the ability of theequipment to perform as expected innormal field use is assured. In therevised Part 35, this concept of completeexamination is referred to as a "test."During field use it is common practice tosubject a piece of equipment to a quickexamination to determine whether it isworking. This procedure does notexamine all parameters of equipmentperformance. In the revised Part 35, thisperfunctory examination is referred toas a "check."

Address of use. facility, and area ofuse. The phrase "address of use" is usedto describethe building or buildings(typically identified by a single street

address) where byproduct material isused. The word "facility" connotes aroom or contiguous rooms wherebyproduct material is used. such as anuclear medicine clinic comprised of anoffice, an imaging room. and a dosagepreparation and waste slorage room.The phrase "area of use*-cornnotes thespace used by a worker whenperfor ming a specific task connectedwith receiving. handling, or storingbyproduct material.

Dedicated check source. A long-livedradioactive source can be used to checkthe day-to-day constancy of aninstrument The some source (a"*dedicated- source) must be used everyday so that the user knows what readingto expect from the instrument. Thesource may also be used for otherpurposes.

3. Instruction. Several commentersasked if instruction for workers had tobe in classroom lecture format. The NRCrecognizes that instruction can be in theform of lectures, laboratory exercises.audiovisual packages, printed handouts.preceptorials, Or apprenticeships. Theimportant point here is not the format ofthe instruction. but rather that theinstruction be retained and used by theworker. To help correctmisunderstandings. an opportunity forquestions and answers should be anintegral portion of each instructionmodule.

The NRC did not address thefrequency of review sessions becausethat judgment must be made on-site. Ifemployees are performing all theirassigned tasks correctly, there is noneed to spend time reviewingprocedures with the employees. Ifinstruction has not been followed byregular use of the procedures taught.then review instruction is probablynecessary. If an employee is unable todo things correctly. then review andcontinued close supervision, or re-assignment, is necessary.

4. Snatures on records. Severalcommenters stated that the requirementthat a certain individual sig a record orreport implicitly required that individualto perform the survey, check. or test thatis documented by the record or report.No such implication was or is intended.The NRC realizes that technicians.students, and residents do many of thetasks required by the regulations. Thepurpose of having a particular individualsign a report is to assure that someonewith special training or radiation safetyprogram oversight responsibilities hasreviewed the document for correctness,completeness, and need for follow-upaction.

s-11

36938 Federal Register / VoL 51, No. 200 / Thursday. October 16. 1986 / Rules and Regulations

5. Temporary absence. Severalcommenters asked if a licenseamendment or notification was requiredif an authorized user. Radiation SafetyOfficer, or Teletherapy Physicist wasabsent for illness, vacation, sabbatical,or continuing education. Because thespecific facts and circumstances woulddictate the appropriate action by thelicensee. it would be impossible for theNRC to make generic determinations inadvance of the situation.

The point can not be reiteratedsufficiently that the licensee. despite theabsence of personnel, remainsresponsible for assuring continuedcompliance with NRC radiation safetyrequirements.6. Deletion of the general medico)license in § 35.31. As noted in thediscussion of the transition policy forgeneral licensees for medical use, thegeneral medical license, whichauthorizes a few radiopharmacentcalsfor a few listed clinical procedures. isnot frequently used and therefore nolonger an efficient way of regulating themedical use of byproduct material. Thus.it has been deleted. However. currentgeneral medical licensees will beallowed to continue using materialsunder specific licenses that the NRC willissue.

7. Fees. One licensee said NRC shouldreduce its medical ihsme fees whenapplicants propose to use radiationsafety procedures that are published inregulatory guides because that reducesthe time NRC needs to review theapplication. The comment can not beaddressed in this rulemaking becausethe proposed rulemaking did notpropose any changes to-the fee schedulein 10 CFR Part 170. A petition forrulemaking to change Part i10 may besubmitted.

L. Record. A few commenters saidthe detailed nature of somerecordkeeping requirements ran counterto the philosophy of flexibility on whichthe revision is based, and may require achange in other administrativeprocedures. The NRC has retained thedetailed prescriptive requirements thatdescribe the information that must beincluded in each recoed. The NRC hascarefully reviewed each element of datarequired and believes each is animportant part of the record or indicatescompletion of an important step in aproceure.

Some commenters said a certainrecord requirment duplicated otherrecords kept elsewhere-for example,diagnostic radiopharmacentical dosagesmay be listed in a clinical proceduresmanual. There is no need to duplicatethat information unless the regulation

specifically requires that the informationbe posted or recorded in a certain place.

The NRC notes that, as a separaterulemaking, it is reviewing all of itsrecord retention requirements. Some ofthe retention periods in this finalrulemaking may be changed as a resultof that project. which will be publishedfor public comment.

9. SI Units. A few commentersrecommended that the newerInternational System of Units (SI), whichhas new units for amount ofradioactivity, radiation exposure.radiation dose. and dose equivalent. beused in place of the special radiationunits because the SI system is nowbeing used more frequently. The NRC,believes that. if indicated, such a changeshould be made through all NRCregulations at one time, not where itwould affect only one group of licensees.

10. Specialty certification. Somecommenters questioned whether certainphysicians who have successfullycompleted an examination in a medicalspeciality (diplomates) should beauthorized to serve as Radiation SafetyOfficer. and some recommended thatother additional certifications berecognized. The NRC compared theexamination criteria applied todiplomates to the responsibilitiesshouldered by certain individuals andmade a judgment that the certificationsidentified for certain individuals providean appropriate demonstration ofadequate training and experience. Thus.some certifications have been addedthat were not listed in the proposed rule:American Board of Nuclear Medicine orBoard of Pharmaceutical Specialties inNuclear Medicine for Radiation SafetyOfficer: and American Board ofRadiology for therapeutic use ofradiopharmaceuticals.

21. Trainig and experience criteui.Several commenters recommendedchanges in the training and experiencecriteria the NRC applies to physicianswho want to use mdiopharmaceuticalsfor diagnostic clinical procedures. In thenotice of proposed rulemakdug the NRCnoted that It had 'eceived and isreviewing m4uested alternative traistandards for some methods of me. Thereview is being handled as a separateproject. If any chanes in in*ngstandards come ant of that projec teywill be published for public comment.

.. The NRC is contirnuig to reviewrecommendations for alternativetraining criterla: they will be IpbIlshedfor public commemt at a lrte• date.

A few commenlers said authorizedusers and Teletherapy Pysicists shouldbe at least 'board eligible," meaningthat they have training and experiencesufficient to allow the individual to

apply for the certification examination.The NTRC notes that most boards do notuse this term (instead saying anindividual is certified. not certified, or inthe examination process). and believesthe use of the term might create moreconfusion than it would resolve.

A few commenters said the requiredhour-by-hour distribution of content inthe classroom and laboratory portions ofthe training and experience sectionswas overly restrictive, and would notrecognize differences in students orprograms. The NRC agrees. and hassimply listed required topics, but hasretained the total time requirements.

12. Effect on medical broad licensees.A'few commenters said the NRC shouldindicate wh.zL, sections apply to broadlicensees authorized for medical useunder Part 33: some are allowed to nameauthorized users and some are alsoallowed to develop new byproductmaterials for medical use. The NRC hasretained the solution to this questionthat was in the notice of proposedrulemaking- 7hese licensees would berequired to comply with the proposedprescriptive and performance criteria ofPart 35, but would be exempted from thetraining and experience requirements ofSubpart J and the authorized materialsand authorized use restrictions inproposed I §35.49. 35100.32,3S00. 353=0.35.400. and 35,500." These changes willnot limit broad licensees' authority toconduct medical research and identifyauthorized users.

13. Therapy patients. One commentersugested that requirements be draftedregarding the handlin of deceasedpatients who had been administeredtherapeutic radioph araceuticals orimplants. The NRC notes that 1 35.404requires that the licensee retrievetimporary implants. The regulations. ini 53535 and 35A15. require promptnotification of the Radiation SafetyOfficer in cae of the patient's death.who then *s responsible for taking stepsto ensmue compliance with requirementsin Part 20. in case of death after releasefrom connement for radiation safetypurposes. the NRC expects licensees totake steps to reduce doses topathologists. morticians and otherindividuals. but also recognizes thelicensee ay, no longer have controlover the remains. Therefore, the NRCcan not expect that the licensee is ableto take appropriate action.

14. Volnitry submdssion of economicdata. Several cmmensters noted that theapplication form asks applicants toindicate their annual receipts. number ofemployees, number of beds. andwillingness to furnish additional costInformation on the economic impact of

S-12

Federal Register / Vol. 51, No. 200 / Thursday, October 16, 1986 / Rules and Regulations 36939

NRC regulations, and said this hasnothing to do with NRC's responsibilityto assure the public health and safety.The NRC notes that the RegulatoryFlexibility Act of 1980 requires Federalagencies to fit requirements to the scaleof the entity being regulated. That Actrequires that each agency consider theeconomic effect of its regulations onsmall entities and that. if a proposedregulation will have a "significanteconomic impact on a substantial•number of small entities." the agencyprepare an analysis of the impact. Thus.the NRC requests voluntary submissionof economic data to determine whatportion of affected licensees are smallentities, how they are affected, andwhether the regulation could be changedto alleviate adverse effects.

Comments on Specific Sections

Section 35.14 Nobjication.

CommenLt There is no need for alicensee with several authorized users tonotify the NRC when one of themleaves. The collective expertise is stillsufficient to assure the public health andsafety.

Response: The NRC believes thisnotification is important because highturnover in professional staff mayindicate inadequate management of theradiation safety program. Therequirement has been retained.

Section 35.0 AL4RA program.CommenL All medical licensees

should have such a program because thehazards are the same. whether in ahospital or a clinic. Although it may beburdensome, theprivate practitioners'programs should be reviewed by anoutside consultant.

Comment: "It appears that theprinciple of ALARA is replacingmaximum permissible dose as astandard in matters of radiationexposure. This means that an objectivestandard with a widely recognized andapproved set of limits can no longer berelied upon in quality control and riskmanagement. Instead, radiationexposure will be weighed, post hoc. bythe *reasonable man.'

Response: The NRC agrees thatindividuals may have difficulty definingwhat is reasonable, although most canoffer -reasonable" solutions tohypothetical problems. However.ALARA is an operating philosophy orprinciple on which safety programsshould be based. It does not prescribepermissible exposure limits.

The NRC has broadened therequirement to apply to all medicallicensees. Although on occasion thismay result in a private practitioner

having a "one-participant conversation."the NRC believes that reviewing aradiation safety program from theperspective of worker protection ratherthan from clinical or business need mayallow for insight or alternative methodsthat provide for increased safety.Moreover. the requirement for anALARA program may help inculcate thephilosophy of reducing unnecessaryexposure-in operating procedures.

The NRC agrees that an independentoutside review may be helpful, butbelieves there is inadequate basis forimposing such a requirement. It isbeyond the ken of a federal agency toknow whether an outsider is needed toreview the program managed by theRadiation Safety Officer.

Comment- There is no need for twotrigger levels that initiate investigationof higher than usual worker doses; oneis sufficient.

Response: The lower level initiates atimely investigation into the cause of aworker dose: the higher level initiates aprompt investigation and a review ofviable mitigating actions because theinvestigation may indicate possibility ofhigh worker dose or likelihood ofunnecessary worker dose.

Section 35.21 Radiation Safety Officer.

Comment: It is unlikely that anauthorized user/Radiation SafetyOfficer will have the time or inclinationto do all the required tasks.

Response: The assignedresponsibilities are essential elements ofa radiation safety program. Because itsinspection program has indicated a highdegree of voluntary compliance. theNRC does not foresee adequatemotivation as a problem. The NRCrepeats that tasks, but not responsibility,can be delegated.

Section 35.22 Radiation SafetyCommittee.

Comment-" The requirement that alicensee's Radiation Safety Committeeapprove each clinical procedure isunnecessarily burdensome. The NRChas acknowledged that physicians aremotivated to act in the best interest oftheir patients, yet. because of the timeneeded to conduct the approval process.the physician may not be able to offerservices needed by the patient. It isdifficult to conceive of radiation safetyissues that warrant this requirement.

Response: The NRC agrees thatphysicians need latitude to provide carefor their patients. Once a physician hasdemonstrated training and experienceadequate to safely use a group ofmaterials with similar radiation hazards,an additional internal review is

unnecessarily burdensome. Therequirement has been withdrawn.

However. to allow the RadiationSafety Committee to meet its oversightresponsibilities, the authorized usershould report these new diagnosticclinical procedures so they may beincorporated as part of the annualRadiation Safety Program review.

Comment- To avoid potentialconflicts, the regulation should identifywho should chair the Radiation SafetyCommittee.

Response: It is beyond the ken of aFederal agency to know whichindividual or officer in each of 2500 localorganizations is best suited to chair acommittee.

Comment: NRC should require that aradiopharmacist sit on each committeebecause medical use includes the use ofnew radiopharmaceuticals.

Response: FDA's review of newradiopharmaceuticals and packageinserts provides adequate assurancethat materials distributed for medicaluse can be used safely. Furthermore.diagnostic radiopharmaceuticals do notpresent a credible risk to the patient.Therapy radiopharmaceuticals are notcompounded or reconstituted bymedical licensees.

Comment." The proposed regulationwould allow several committees toshare the responsibilities of theRadiation Safety Committee. This maycause coordination problems.

Response: The NRC believes thatallowing more than one committee tooversee the radiation safety programmay lead to misunderstandings aboutjurisdiction and responsibility that resultin incomplete oversight of the prograrn.The section has been changed to call fora single committee. That committee miy-of course consult with other committeesand individuals.

Comment' The Radiation SafetyCommittee should be allowed to nameauthorized users. Other committees in ahospital are allowed to confer certainmedical privileges.

Response: The NRC considered this.but believes that an independent reviewof training and experience credentials isnecessary to assure the public healthand safety.Section 35.23 Statements of authorityand responsibilities.

Comment-" The NRC should clarify theregulation to indicate that the RadiationSafety Committee and the RadiationSafety Officer should have not onlytechnical responsibilities, but authorityto assure that the policy is adhered toand that the radiation safety program is

S-13

nM FWwal RqOder. / Vol. 52, No. 200 Thmday. October 16, 2986 / Rules and RegulationsI

5M0 Federal Register I Vol. 51. No. 200 1 Thursday. October 16, 1986 1 Rules and Regulationsmanaged in a businesslike and efficientway.

Response: The section has beenmodified to indicate that both must havethe authority to manage the progrom soas to assure that materials are used inaccordance with NRC regulations.Section 35.25 Supervisioz.

CommenLt There may be only oneauthorized user on a hospital's license.If the authorized user is absent, thehospital has to hire an authorized userfrom another area to care for thepatients. There may be capableresidents at a nearby medical collegewho cannot be hired only because theyare not listed as authorized users on alicense. Yet. they may have beensupervised by the authorized user beforeand found capable of delivering propercare for patients.

Comment: The NRC should requirethat each physician authorized user andtechnologist be certified by theappropriate board. This would helpassure that individuals have beentrained.

Commenti Requ'n the authorizeduser to be physically present on onehour's notice is arbitrarily stringent.Choose a more easonable time.

Comment There should be a timelimit on use of the supervision clausewith respect to a pbysicIan-in-training inorder to avoid use of the supervisionclause"in lieu of licensure

Response: The purpose of supervisionis to provide assurance thattechnologists and physicians do not usebyproduct materials in s manner that iscontrary to the requirements of thelicense. the regulations, or that ishazardous to the public health andsafety. The proposed requirement thatthe authorized user be immediatelyavailable by telephone and physicallypresent on one hour's notice was anattempt at a prescriptive definition ofsupervision in the medical setting.

NRC recognizes that medical practiceis regulated differently in each statde butthat. in the end. the physician isresponsible for providing qualitymedical caon. A prescriptive definitionthat describes delegable tasks, timelyresponse in case of untoward events,and training requirements that aresuited for one setting may hinder thedelivery of medical care in anothersetting. The authorized user physicianidentified on the license is responsiblefor delivering quality medical cam. andis best situated to determine what tasksa certain physician or technologist iscapable of performing and the amount ofpersonal supervision that each needs.

Under the final regulation, a licenseemay delegate to unnamed Individuals

performance of any task associated withthe medical use of byproduct materialfrom package receipt thmugh qualitycontrol prescription. adminlstrationinterpretation or follow-up for individualclinical procedures, sad radioactivewaste disposal. The delegations must beconsistent with other insttutionalrequirements and the state's regulationof medicine. The NRC did not retain the"immediately available by telephoneand physically present on one hour'snotice" claumse.

The licensee can not delegateresponsibility to supervised individuas.If a supervised individual. throughmisunderstanding. negligence. orcommission. acts contrary to therequirements of the license, theregulations. or an order, the licenseeremains responsible.

The NRC believes this strikes the bestbalance between its responsibility toassure the public health and safety anda physician's responsibility to deliverquality medical care.

Section 35M~ AdminhetrWtivwrequirements that apply to the prsioof mobile nucear mediace Seice.

CommenL- The proposed requirement"that mobile service not be provided toNRC-licensed hospitals because ofclouded responsib)ities eliminates anoption a hospital needs for delivery ofmedical care in case of prolongednuclear medicine department downtime.There could be significant delay inproviding necessary clincal proceduresand patients may have to be transportedto another hospital The egulation couldresult in Inferior health cam deliver topatients and could be couterproducteto health care cost contabent.

Response: To respond to its charge toprotect the public health and safety. it isappropriate for NRC to place restrictionson where and by whom byproductmaterial may be used. Thesemake compliance more likely andcorrective action simpler in case ofhazards or noncompliance.

In this cuse. however. commentersproperly - out that the regulationcould have an adverse impact on thepublic health by malkig certain clinicalprocedures unavailable or Inconvenient.The NRC's responsibility to assurepublic safety must be balanced with therespo•mbilift of the NRC4iiensedhospital-dlient of a mobile nuclearmedicine service to pmovide care for Itspatients.

The regulation has been changed toallow mobile nuclear medicine servicesto provide service to NRC-icenmedhospitals because they may need thisoption to provide timely medical care.However. when an NRCkicensed

hospital exercises its authority to invitea mobile nuclear medicine service toprovide medical service, the NRC willdeal with Ns as though the hospital hasdelegated tasks to another licensee. TheNRC-licensed hospital, not the mobilenuclear medicine service, will normallybe held nesponsilbe for items ofnoncompliance that occur at thehospital.

The same considerations and decisionapply to NRC-licensed privatepractitioners who invite a mobilenuclear medicine service to provideservice.

Comment- Can a mobile nuclearmedicine service receive byproductmaterial at a client's address of use.

Response: This is not allowed becausethere is no assurance that the clientknows what safety measures to initiate.The section has been clarified by addinga paragraph that clearly forbids suchpractice.

Section 35.3 Radiation SafetyProgram ChAOng

Comment Although the proposedsection will relieve the incnsing staff ofsome-casework. the responsibility toassure that new radiation safetyprocedures are adequate will fall on theinspector's shoulders. An inspector doesnot have time to review procedures inthe field, and will not have theopportunity to consult reference worksor colleagues if necessary.

Comment Many licensees do not havetVe expertise needed to properly reviewa proposed change. A licensee mayunwittingly degrade a radiation safetyprocedure or the Radiation SafetyOfficer may be pressured into Angingit the degraded procedure could be ineffect for years before an NRCinspection triggers its correction.

About 40 percent of amendmentrequests mre deficien. Thisdemonstrates that many licensees arenot capable of making an adequatesafety review of a proposed chang. TheNRC should reduce.the scope of theterm 'minor chane" or continue toreview all changes.

Comment The NRC is shirking itsr onibility. Why is the NRCbothering to require applicants to submitradiation safety procedures if liceneewon't be required to follow them?

Caomn A licensee should earn theauthority to make minor changes. NRCshould grant this authority case-by-cseafter examining a licensee's Inspectionhistory and radiation safety staff.Perhaps only those with certifiedphysicists would be allowed to makechanges.

S-14

Federal Register I Vol. 51, No. 200 / Thursday, October %6, 1988 / Rules and Regulations 36941.

Comment" Although the proposedpolicy will give management theopportunity to promptly implement newor better safety procedures, it may alsoallow for increased productivity at theexpense of safety. Committee membersmight be removed without cause. Thiscould be predluded by requiringlicensees to notify the NRC ofmembership changes.

Comment: The Joint Commission onthe Accreditation of Hospitals statesthat "The service of a health orradiation physicist should be available,at least on a consultant basis. foreducational purposes and for safetyevaluations of all equipment and storageand handling practices." This negatesthe argument made by some thatinadequately trained hospital staff willmake changes in radiation safetyprocedures without guidance.

While accreditation of hospitals is avoluntary system. it is important to notethat if a hospital does not volunteer foraccreditation, it cannot be reimbursedby Federal programs such as Medicareand Medicaid. and other insuranceorganizations will not reimburse thathospital either. Although this is a carrotand stick system. the stick is so largethat very few hospitals are notaccredited.

Therefore, national voluntarystandards and business considerationsprovide alternative assurance thathospital licensees will not makeuntoward changes in their radiationsafety Programs.

Private practitioners and smallmedical institutions do not look forways to change procedures sofrequently because they are disinclinedto change things if their most recentinspection was favorable and businessis running smoothly.

Comment- NRC should clarify thedistinction between major and minorchanges. The examples given areextree.

Response: Changes that require alicense amendment are listed in I J35.23and 35M.o License amendments. Beforepublishing the proposed rule. the NRCanalyzed 5 percent of the requests formedical license amendments received ina one year period. A summary of theanalysis appears in Table 1. The NRCbelieves the list of major changes thatare potentially important to safetyprovides adequate guidance regardingthose cases in which an amendment "request must be submitted.

7able L. Analysis of Medical LicenseAmendment Requests

Number of completed icni thatweft anasiyad.- -,--.. .1.0

Number of tqueata that included amajor change which would nquirean amendment under the proposedn wvi on o f 20 C Y:R P m tan 35 60

User 5sType of uae isAddren of we 5inventory 2

Number of requesta for an administra.five change. eg.. name change.change of eddime but not location.short-term extension. ecr 5

Number of nqmeto that included aminor change which would not re-quir an amendment under the pro.posed revia"n of 10 CFR Part 35- V

Area of usee 'eplapement equipment

Equipment quality aunmce pru-cedes ,$21

Service cntactor 8Handl procedue a

sme 1keb md ane dI both Major and M om. dTheRCi use tloreed twh *a thep dimim

"mnoa~t~e"d Maw din oe newat ad toTh rovoo MW g, would ha, allomdv jlceam to

Use vodi MIaait Io Was of we talat WM norAdote &Phc~hLbf60. fortha onsideroum I"e

imporsant t aq gandt Should ba usauud by the=

The NRC has clarified the concept of-minor change" by using a new wordand providing a list of examples. Minorchanges should be ministerial in nature.As used by NRC in this section. aministerial change is one that Is made,after ascertaining the applicablerequirements. by persons in authority inconformance with the requirements andwithout making a discretionaryJudgment about whether thoserequirements are needed in the case athand to assure the public health andsafety. A licensee may not makediscretionary judgments about thingssuch as survey frequencies, minimumdetectable amounts of radioactivity ordose rates, or what informationconstitutes a minimally adequate recordof an action. The NRC has already madea discretionary judgment about suchmatters.

The examples provided in theregulatory text were taken from recentlysubtitted amendment requests and staffsiggestions. They are not the only kindsof minor changes that may be made.There will undoubtedly be unclear casesin which the licensee is not certainwhether an amendment request shouldbe submitted. In unclear cases, licenseesmay consult the licensing staff.

Before selecting a course. NRCreviewed its inspection and enforcementrecord for medical licensees. In 1985. theNRC took escalated enforcement actionagainst 35 byproduct materialslicensees. Only eight involved medicallicensees, and none of those eightinvolved overexposures to workers or

the public. In 1982, NRC conducted 1.5Winspections of medical licensees. Almostall of the 1.240 line items that were citedwere for minor safety infractions thatdid not represent a worker or publicsafety hazard. More recent data aresimilar. The NRC believes that itsinspection findings demonstrate a highlevel of voluntary compliance with itsrequirements, whether they be couchedin terms of regulations or site-specificlicense conditions.

The NRC believes the deficiency ratein the current application process iscaused by having requirementsscattered in several documents and notcaused by ignorance of basic radiationsafety practice. Thus, the deficiency rateis not a valid measure of a licensee'sability to design and operate a radiationsafety program.

The NRC does not believe thatadministrators will pressure RadiationSafety Officers into compromising theirprograms. The impact of the adversepublicity that accompanies an escalatedenforcement action far outweighs thepotential short-term savings of acompromised program.

The NRC will provide, in RegulatorYGuide 10.8,a list of questions that -should be considered when a licenseemakes an internal review of a proposedchane. The NRC notes that manylicensees use the servicesbof radiationsafety consultants to periodically reviewtheir programs now, and assumes that,in many cases. these consultants willalso be asked to provide an independentreview before a change is made.However. even absent an independentreview, the NRC is convinced thatsafety will not be endangered bypermitting licensees to make minorchanges that are not potentiallyimportant to safety in their radiationsafety programs. -

The NRC notes that it currentlyreceives about 800 requests foramendment each year from its 2.500medical licensees for licenseamendments that are characterized as"minor changes" under this rule. Thisrepresents a minor radiation safetyprogram change about once each threeyears for each licensee. The NRC doesnot believe it likely that licensees willmake frequent changes in their radiationsafety programs, even when spared theamendment fee.

The requirement to submit a detailedradiation safety program as part of theapplication process provides assurancethat the licensee will have a program inplace when byproduct materials arereceived. However. the NRC recognizesthat a licenee's needs and resourceschange with time. At issue here is

5-15

36942 Federal Register / Vol. 51. No. 200 / Thursday. 'October 16. 19M / Rules and RegulationsIIJ eerlRgstrIVl 5 I o.ZI husa.O obr1.98 /Rle an Rglaion

whether a regulatory .agency mustapprove minor changes in a licensee~sday-to-day radiation safety program.Does a desk review of minor operationalchanges contribute significantly topublic health and safety? The NRC isconvinced that it does not.. The NRC believes the essential

elements ora medical licensee'sradiation safety program are welldefined and have been consolidated inthe regulation. The present reviewpolicy is resource intensive, causesbacklogs due to the bulk of materialsubmitted for review and the number oflicense amendments needed. and resultsin a different set of radiation safetyrequirements for each licensee.Inspectors may occasionally reviewchanges to assure that the process.required for making changes wasfollowed. However, inspectors willexamine the working day-to-dayradiation safety program for compliancewith the regulations.

The NRC believes this change inlicensing policy provides both necessaryflexibility by permitting licensees tomake minor changes in their radiationsafety programs and yet provides forNRC oversight of changes that mightaffect the public health and safety.

The NRC notes that the proposed rulewould have allowed licensees to usebyproduct material in areas of use thatwere not described in the application forlicense. The NRC now believes that sucha change should require a licenseamendment because physical structuresoften provide features that arepotentially important to safety. Such achange might also compromise NRC'sability to conduct an unannouncedinspection.

Section 35.33 Records ond reports ofmisodministrotions.

Comment- The level of publicemphasis that NRC has placed onmisadministrations has proven to be aneffective mechanism to limit theirnumber. No change is needed.

Comment: At least to the extent that itdeals with diagnostic clinicalprocedures. the misadministration ruleshould be deleted or substantiallymodified. The case for its deletion ismade by the misadministration reportssubmitted to the NRC.

The misadministration rate forradiopharmaceuticals is much less thanfor non-radioactive drugs. The hazard tothe patient is much less than thatassociated with the misadministration ofphysioiogically active drugs or withother medical mistakes. In virtually allinstances, the patient sustains neithersctup' nor theoretically significant

potential injury. The hazard to workersand the public is almost non-existent.

Misadministrations are precipitatedby human error. such as momentarydistraction or miscommunication. notradiation safety program deficiencies.Although a fail-safe system might beachieved through multiple levels ofchecking and cross-checking, the addedcosts would far outweigh the marginalbenefit that would accrue to society.

Response: The NRC is well aware thatthe misadmninistration rate forradiopharmaceuticals is much lowerthan for other drugs. that there is noreporting requirement formisadministrations of cyclotron-produced radiopharmaceuticals. x-rays.and nonradioactive drugs. and that therisk to patients, workers, and the publicis small. None of the assertions are atissue.

The fact that there are other greaterpotential hazards found in the medicalarena does not relieve NRC of itsresponsibility to assure public healthand safety as it may be affected bymaterial under its jurisdiction. Rather, atissue is whether there is a safetyproblem, and, if so. can it be correctedat an expense that is reasonablecompared to the hazard.

Therapy clinical procedures, in theview of the NRC, present a greater riskto the public and patients thandiagnostic clinical procedures. Given theincreased risk to the public health andsafety. the reasoned judgment of theNRC requires the maintenance of thecurrent misadministration rule fortherapy uses of byproduct material TheNRC will continue to carefully reviewtherapy misadministration reports. TheNRC staff is also considering anadvance notice of proposed rulemakingthat would request public comment onregulations regarding quality assurancein radiation therapy as well as otherNRC actions resulting from therapymisadministrations. This request forearly public comment will be publishedat a later date.

The NRC believes thatmisadministrations that result in a doseto the patient greater than a dose to amember of the public permitted underI 2O.105(a) should require a report to theNRC and the referring physician.Furthermore, licensees should keeprecords of all misadministrations. As aresult, the diagnostic administrationreporting requirement has been changedto require reports for misadministrationswhen such misadministrations result ina whole body dose greater than 500millirem or an organ dose greater than 2rem. (Licensees may use dosimetrytables in package inserts, corrected only

for administered millicuries. todetermine whether a report is requirted.)

In order to assure that diagnosticmisadministrations are not occurring .na particular licensee's program withexcessive frequency. the NRC believesthat there should be an internalinvestigation and report by theRadiation Safety Officer. The NRC willreview these reports during its fieldinspections. In addition. the reports willassist the licensee in carrying out theALARA principles of Parts 20 and 35.

Because of the public health andsafetv nature of the reportingrequirement. the NRC will requireAgreement States to implementcompatible requirements.

Comment- While it should be retained.the therapy misadministration reporttrigger should be relaxed from 10percent error to 20 percent error. Thatrange better reflects the diversity ofmedical opinion on the optimum dosefor a particular patient.

Response: The NRC has not changedits requirements that apply to therapymisadministrations because of theirimportance to public health and safety.The NRC reiterates that the 10 percenttrigger level is not based on the diversityof medical opinion regarding theoptimum radiation dose for a certaindisease stage. Rather, the NRCrecognizes there are uncertainties in themeasurement and administration ofradiation that make it impossible todemonstrate that the exact radiationdose that was prescribed was delivered.However, when the dose delivered ismore than 10 percent different than thedose prescribed, it is clear that amistake has been made. The mistakeshould be investigated and steps shouldbe taken to prevent its recurrence.

Comment: NRC should takeenforcement action against licenseeswho administer radioactive materia!when it might have seriousconsequences for the patient.

Comment Ef.orcement actions mayreduce compliance with themisadministration reportingrequirement.

Response: The diagnosticmisadministration reporting requirementwill continue to require reports to theNRC for certain diagnosticmisadministrations that are listed in theregulations. The reporting requirementfor all therapy misadministrations hasbeen retained.

The NRC deals withmisadministrations case-by-case.Various levels of enforcement areavailable. It does not appear that NRC73enforcement program has caused

S-16

Federal Register I Vol. 51, No. 200 / Thursday. October 16, 1988 / Rules and Regulations 36943

noncompliance in any area of itsjurisdiction.

Section 35.50 Possession. use.colibrntion. and check of dosecolibrators.

Comment Does this possession anduse requirement mean that even smalllicensees that use only precalibratedunit dosages of radiopharmaceuticalswill have to buy a dose calibrator?

Riesponse: The NRC believes thatrequiring licensees to ensure that thedesired dosage has been prepared isessential to fulfilling its statutoryresponsibilities. The NRC recognizesthat the overwhelming majority of itslicensees use a dose calibrator to meetthis requirement. and therefore. in theregulations, directly addresses their use.This does not prevent an applicant fromproposing an alternative method formeasuring dosages and requesting anexemption in the application. If theapplicant is able to demonstrate that thealternative provides adequate accuracyand reliability, the licensee will beallowed, by license condition, to use thealternative method.

Commen- Is a volumetricdetermination of a dosage from acalibrated multi-dose vial an acceptablealternative method for measuringdosages?

Response: No. Any alternative mustprovide for the measurement of theamount of radioactivity in the individualdosage.

Comment. Sealed sources that areused for dose calibrator accuracy testsshould be traceable to the NationalBureau of Standards.

Response: The NRC reviews proposedlabel wording and traceabilityassertions before a manufacturer isauthorized to distribute sealed sources.This provides adequate assurance ofaccuracy.

Comment: The regulation requiresmathematical correction or repair if thedose calibrator shows inaccuracygreater than 20 percent; RegulatoryGuide 10.8 has a 5 percent trigger level.Which is the requirement?

Response: The regulation imposes therequirement: the Regulatory Guideprovides a method for meeting therequirement. The guide has a morestringent trigger level so the licensee cantake action before the regulatory limit. ispassed instead of after. However. thelicensee is not required to follow theRegulatory Guide. The licensee canspecify an alternative method in theapplication. The NRC will review thealternative method to determinewhether it provides adequate assuranceof public health and safety.

Section 35.51 Calibration and check ofsurvey instruments.

Comment Not all survey instrumentshave a built-in check source. If aninstrument is shipped to a calibrationlaboratory. the check source readingthat is required at the time of calibrationcould be made instead when theinstrument is returned.

Response: The NRC believes thecheck source reading made at the timeof calibration is important todemonstrate that the instrument has notstopped operating properly since it wascalibrated. Thus the source shouldaccompany the instrument to thecalibration laboratory. For instrumentsthat do not have a built-in check source,the NRC notes that uncalibrated 10microcurie Cs-137 sources are availablefor only S25.

Comment This requirement willincrease personnel dose from handlingthe check source. and takes time. Adaily or weekly check is sufficient.

Response: The NRC does not believethe check source presents a significantexposure source when compared -toother sources in the laboratory. butagrees that a requirement to checkinstruments before and after each periodof use may be unnecessarilyburdensome. The section has beenchanged to require a daily check.

Comment: With all the errors inherentin measuring radiation, there is no needto calibrate a survey instrument within20 percent; a factor of 2 would suffice.

Response: The NRC believes that arange of 20 percent provides adequateleeway in the calibration process. Thisis consistent with the recommendationin ANSI N323-1978. Radiation ProtectionInstrumentation Test and Calibration,section 4.2.2.1.4

Section 35.53 Measurement ofrodiophcrmoceuticai dosages.

Comment: Clarify when themeasurement should be made.

Response: The NRC has purposefullynot specified when the measurementmust be made so as to allow fordifferent licensees' procedural needs.

Comment It is difficult to removeiodine-131 therapy dosage containersfrom their radiation shields and theyshould therefore be exempted from themeasu.rement requirement.

Response: It is very important toassure that the manufacturer hassupplied the prescribed therapy dosageso the patient will receive the prescribedradiation dose. The requirement tomeasure therapy dosages remains. The

This repo is available from Amenian NationalStandafdo Institute. 1430 Broadway. New York. NY

majority of commenters did not mentiondifficulty making the measurement.

Comment." The NRC should allow thelicensee to use the trade name orabbreviation in place of the genericname in the dosage measurementrecord. These alternative identificationsare equally well-recognized.

Response: The alternative has beenallowed.

Comment- The need for verifying theactivity of manufacturer-supplied unitdosages is unclear.

Comment" Dose calibrators are tooexpensive to require their use for smallprograms.

Response: The NRC believes it isnecessary to require an independentmeasurement. to the extent possible. toassure that the patient is receiving theprescribed dosage. Licensees thatbelieve the expense of acquiring a dosecalibrator is unwarranted may requestpermission to use an alternative methodof assuring that the prescribed dosage isbeing administered.

Comment: The rule should not requirethe measurement ofradiopharmaceuticals that emit onlybeta radiation. Such measurements aredifficult when made in a calibrationlaboratory and tenuous when made inthe clinical setting.

Response: The rule has been clarifiedonly to require the measurement ofphoton-emitting radiopharmaceuticals.

Comment. It is not clear whether theproposed rule applies to brachytherapysources.

Response: The proposed rule onlyapplies to radiopharmaceuticais. TheNRC recognizes that there are spec;alproblems associated with themeasurement of brachytherapy sourceactivity that must be worked out beforea measurement requirement could beproposed.

CommenL- It is not clear whether NRCexpects licensees to suspend operationsif the dose calibrator breaks.

Response: The NRC expecti eachlicensee to measure dosages beforeadministering them. Licensees may wantto make arrangements that providealternative measurement procedures incase of equipment breakdown.

Comment The requirement tomeasure each dosage will increasetechnologist finger exposure.

Response: Any time radioactivematerial is handled there is the potentialfor exposure. The magnitude of thce::posure must be balanced against theneed to handle the material. NRCbelieves that the-measurement isimportant because if the incorrectamount of radiopharmaceutical isadministered to the patient, the

S-17

36944 Federal Register / Vol. 51. No. 200 / Thursday, October 16. 1956 / Rules and Regulations

diagnosis or therapy may becompromised. The NRC believes itscalculations and dose records ofworkers who measure dosages indicatethat the amount of exposure is smallcompared to the benefit that comes withassurance that the correct amount ofactivity is being administered.

Section'35.57 Authorization forcolibrotiorn and reference sources.

Comment. You should raise the sealedsource design limit from 6 millicuries to15 millicuries. These reference andcalibration sources are needed bynuclear medicine clinics for qualityassurance checks and do not pose asignificant radiation hazard when used,in that setting.

Response: The change has been made.

Section 35.W Syringe shields andlabels.

Comment: NRC should recommend.but not require. that licensees usesyringe shields when drawing individualdosages. In sonme cases experience hasrevealed that only a leaded-glasssyringe shield permits viewing theminiscus when drawing dosages--thesesyringe shields are expensive andfragile.

Response: No change has been made.However. the section has beenreworded to clarify that syringe shieldsare only required when preparingradiopharmaceutical kits.

Comment: The open literature isambiguous on the effectiveness ofsyringe shields.

Response: The NRC disagrees. Syringeshields may dramatically reduce fingerdose ("Efficacy of various syringeshields for 99mTc," NL McElroy. HealthPhysics. v41 n3 pp 535-542. September1981).

Comment: In some hospitals oneindividual draws a dosage and thenimmediately administers it. In this casea syringe label is not needed.

Response: The NRC does not believethis is an unreasonably burdensomerequirement for the few licensees that fitthat description. The NRC considereddrafting criteria that addressed clinicswith one technician but notes that, evenin that case., some misaedministrationshave been caused by accidentallytransposing syringes after drawing twodosages. Therefore, the benefits fromavoiding misadministrations outweighthe costs to the licensee.

Comment More information, such asamount of activity and time of syringepreparation. should be included on thelabel.

Response: The NRC believes therequired information supplies sufficient

information to those handling thesyringes.

Comment: The NRC should allowcolor coding of syringes with differentradiopharmaceuticals rather thanrequiring the name or abbreviation.

Response: Different manufacturersuse different color schemes for the sameradiopharmacuetical. Allowing the useof color coding in place of labeling maylead to misadministrations. Thereforelabeling is required.

Section 35.61 Viol shields and labels.

Comment This label should alsoinclude the lot number. activity, andexpiration time.

Response: This information may beincluded in the dosage measurementrecords, but is not required by NRCbecause these are matters of pharmacy.

Section 35.70 Surveys orcontaminotion and ambient radiationexposure rate.

Comment- A licensee mayoccassionally administer a dosage in thepatient's room. Is a survey necessarythere?

Response: No. However, employeesshould be reminded to take care tocollect all potentially contaminatedmaterial.

Comment: The regulation allows alicensee flexibility in setting removablecontamination levels, then removes thatflexibility by arbitrarily setting asensitivity limit of 200 disintegrationsper minute. Can't wipe samples beevaluated by holding them next to theGM tube of a survey instrument?

Response: The purpose of setting asensitivity limit is to ensure thatsamples are not simply compared to thebackground counting rate of themeasurement system: that comparisondoes not provide a measure of theamount of radioactivity on the sample.Action levels indicate when mitigatingaction should be taken. The regulationallows the Radiation Safety Officer toset different trigger levels for differentareas of use because different levels ofcontamination are to be expected indifferent areas of use.

Comment: The sensitivity limit of 200disintegrations per minute isunnecesary retrictive.

Response: The NRC agrees. For mostof the radionuclides used in medical use,a sensitivity limit of 2000 disintegrationsper minute provides adequate assuranceof public health and safety. (The NRChas retained the 200 disintegrations perminute limit for radiopharmaceuticaltherapy rooms. See § 35.315 SafetyPrecautions.)

Section 35.75 Release ofpotienscontaining radiopharmoceuticals orpermanent implants.

Comment. The NRC should requirethat patients released with residualradiopharmaceutical or permanentimplants be provided informationregarding the activity of the byproductmaterial so that special precautions canbe taken if the patient is re-hospitalizedelsewhere.

Response: The NRC believes therelease criteria, which are similar tocriteria recommended by NCRP (NCRPReport No. 37. "'Precautions in theManagement of Patients Who HaveReceived Therapeutic Amounts ofRadionuclides." Chapter 4 s) provideadequate assurance of safety. Althoughthe suggestion is well taken. it seemsmost likely that the patient would visit aphysician familiar with the patient'smedical history. In case of emergencytreatment there is no assurance thepatient would be capable of reportingthe information to the attendingphysician.

Comment- The proposed rule statedthat the 30-millicurie release limit isbased on NCRP guidance. In fact. NCRPprovides a range of limits.

Response: The NRC meant to implythat the limit was based onconsiderations addressed in the subjectchapter. not that it was adopting anNCRP recommendation.

Release limits are based onapproximate dose rates emanating fromthe source-patient and time-st-a-distance assumptions for householdmembers. Although the calculations arestra*ghtforward. the validity of theassumptions.(biological half-life of theradioactive material in the patient forthe radiopharmaceutical used. physicalsize of the patient. duration of proximityand exact distance of householdmembers) for a specific case is tenuous.The NRC believes that a 30-millicurierelease limit provides an adequatemeasure of public health and safety.

The alternative 6 millirem per hourcriterion has been reduced to 5 milliremper hour to provide a more conservativeand more easily remembered criterion. Itis the approximate dose rate that wouldbe expected from a patient with a 30-millicurie burden of 1-131. the mostradiotoxic byproduct material used formedical use.

This ftpoet a available hrm KMRP Publhcatom-MsO Woaodmom Avegue. Suite ime. Betbesda. MD

=524.

S-18

Federal Register / Vol. 51. No. 200 / Thursday, October.16, 1986 / Rules and Regulations 36945

Section 35.80 Technical requirementsthat apply to the provision of mobilenucleor medicine service.

Comment: A ban on the mobile use ofgenerators seems unnecessary.

Response: The NRC considered thiswhen drafting the proposed regulation.but believed the greater public benefitaccrued from the present system underwhich generators are received, stored.and eluted only at a base station. Therewere no commenters who demonstratedthat this system deprives some membersof the public of the benefits of diagnosticnuclear medicine, or that therequirement to use generators only in abase station is unduly burdensome.

Comment Mobile service licenseesshould be allowed to reconstituteradiopharmaceuticals at a client'sfacility.

Response: The NRC recognizes thatmany radiopharmaceuticals should beused within six hours afterreconstitution, and in some cases withinone hour. Thus. it is possible that theproposed requirement for mobilediagnostic nuclear medicine services totransport only preparedradiopharmaceuticals may adverselyimpact the delivery of services becausethe licensee may not be able to reach allthe day's patients within a few hoursafter reconstituting theradiopharmaceuticals at the basestation. Therefore. the section has beenreworded to allow licensees to transportradiopharmaceutical kits in addition toprepared radiopharmaceuticals.

Comment. You should not requirequality assurance programs for imagingequipment. Quality assurance is theresponsibility of the user.

Response: Nuclear medicineequipment is generally not designed fordaily highway transportation (somenuclear medicine imaging equipment isdesigned to be transported within ahospital). The possibility of damage tothe equipment during transportationmight lead to useless administration ofbyproduct material. Thus, the NRCbelieves an equipment performancecheck prior to the administration ofradiopharmaceuticals is indicated and isnot unduly burdensome. No change hasbeen made.Section 35.90 Storage of volatiles andgases.

Comment- There is no apparent needfor additional containment systemswhen storing xenon. The manufacturer'soriginal packaging is sufficient. Theventilation posting requirement shouldtake care of any problems.

Comment- Clarify what is meant bystoring these materials "in a containerwith two barriers against release."

Response: The NRC has re-examinedthis proposed requirement and agreeswith the comments. The NRC hasdetermined that storage in the originalshipping container will provideadequate control. This does not requireretention of the entire package. butrather just the radiation shields andcontainers.

Section 35-92 Decoy-in-storage.Comment The requirement to store

waste for ten half-lives is undulyburdensome. The requirement that thecontainer surface dose rate be atbackground is sufficient.

Response: This section allows foruncontrolled release of material thatwas contaminated with large amounts ofradioactivity. Given that, the NRCbelieves that the storage requirement.which reduces the amount ofradioactivity in the container byradioactive decay, coupled with aconfirmatory survey is not undulyburdensome.

Sectians 35.100 Use ofrodiophormoceuticals for uptake.dilution, and excretion studies, and35.20 Use of rodiopharrnaceuticals.generators, and reagent kits for imagingoand localization studies.

Comment, The requirements to usediagnostic radiopharmaceuticals inaccordance with the FDA-approvedpackage insert should be removed. Therisk associated with the administrationof diagnostic radiopharmaceuticals istoo small to justify a regulation thatdenies nuclear medicine practitionersthe latitude needed to provide up-to-date medical care for their patients.

The package insert represents asummary of available scientificevidence indicating that a drug is safeand effective for a particular indicationwhen used in accordance with thedirections in the package insert. TheFDA does not intend for the packageinsert to be a restrictive document: aphysician may use any drug in anyfashion deemed to be in the best interestof the patient. This is predicated on theassumption that physicians aremotivated to act in the best interest oftheir patients.

New uses of approvedradiopharmaceuticals are developed atmedical research institutions andreported, along with safety andeffectiveness information, in thescientific literature. However. thepackage insert is usually not updatedbecause the process for revising apackage insert is expensive and slow.

Manufacturers are not inclined toshoulder this burden because theadditional sales that would result wouldnot justify the expense of the revision.

Response: NRC's concern for workerand public health and safety must bebalanced by the physician's need toprovide proper medical services to !hepatient. The NRC believes thatdiagnostic radiopharmaceuticals hereproven to be safe when handled byindividuals with appropriate training.For diagnostic radiopharmaceuticals.the requirement to follow the packageinsert may have an adverse impact onthe public health and safety because itprevents physicians from performingdiagnostic clinical-procedures neededby their patients. and is thereforewithdrawn.

Comment- The NRC should not allowlicensees to change the chemical form ofa radiopharmaceutical.

Response: If a licensee altered thechemical form of a radiopharmaceut-cal.the modified radiopharmaceutical wouldbe a new radiopharmaceutical thatwould not be the subject of an FDAacceptance or approval. Therefore itwould not be authorized for use.

Comment Why does NRC listapproved radiopharmaceuticals in theregulations? It is only necessary to havea list available.

Response: The list has been deletedfrom the regulation: it will be availablefrom NRC's regional offices.

Sections 35.120. 35.220. 35.320. 35.520.35.620 Possession of surveyinstruments, and 35.420 A voilobii:--r fsurvey instrument

Comment A low level survey metercannot be used to survey around a stuc.lteletherapy source.

Comment The NRC should require atlow level meter for brachytherapyprograms.

Response: Quoting at length fromNCRP Report No. 57. Instrumentationand Monitoring Methods for RadiationProtection. Chapter S. Instrumentation:

*If the dose equivalents are smellcompared to the maximum permissiblevalue, then measurement errors by afactor of 2 are acceptable ... For doseequivalents close to the maximumpermissible value, an accuracy of about30 percent is desirable ... Most of the x-ray and gamma-ray exposure ratemeasurements... are made with small.portable ionization chambers ... G-44counters are used in surveys for thedetection of x- and gamma-ray fields.This generally limits their use toexposure rates in the range frombackground up to a few mR/h.... Thecounters respond to the number of

S-19

- 3696 Federal Register / Vol. 51. No. 200 / Thursday, October 16. 1986 / Rules and Regulations

ionizing events within them and give noinformation about the energy associatedwith the events. Therefore, they do notrespond with equal count rates to equalexpasuie rates from photons of differentenergies.... They are generally usedonly for detection rather thanmeasurement ... G..-M counters aresometimes used to estimate exposurerates where the rate is low enough forthe resulting inaccuracy of itsmeasurement to be unimportant...."

The NRC has reviewed its rationale asstated in the notice of proposedrulemaking for requiring certainlicensees to have certain surveyinstruments on hand or available. Theonly change that has been made is torequire that bracbytherapy licenseeshave a detection instrument on handbecause it might be needed to frind a lostbrachytherapy source. The wording ofeach section has been revised to betterindicate the range of dose rates theinstrument must be capable of detectingor measuring.

Section 35.2W Use ofradiopharmoceuticals. generators. andreagent kits for imaging and localizationstudies.

CommenL' The NRC should not listxenon-133 in a group withradiopharmaceuticals that areadministered by injection. Theregulations should require agencyapproval of areas of use because thereare special ventilation needs for its safeuse.

Response: The training andexperience needed for safe use and theradiological hazard of all the materialspermitted under each subpart aresimilar. The NRC realizes that specialventilation is necessary for the safe useof gases and aerosols, and thereforeplaced additional requirements in* 35.205 Control of aerosols and gases.

Section 35.204 Permissiblemolybdenum-9 concentmovin.

Comment The NRC notes that dosecalibrators cannot measure accuratelybelow 10 microcuries. yet proposes thatradiopharmaceuticals not have morethan 0.15 miaucurie of Mo49 permillicurie of Tc4-m. How is this to bemeasured?

Response: The amount of Mo-W in anelution of Tc-29m is usually measured.and recorded as a coacnaWrtlon ofmicrocuries of Mo-W per mlflicurie ofTc-9n. before usin the ekition. If thefresh elution hat as little as 200millicuries of Tc4-. then the licenseeneed only demonstrate that there is lessthan 15 microcurie ofMo-W in theelution. Note that this is one-half theallowed concentration: for sake of this

explanation the NRC assumes that thefreshly eluted Tc-99m is administeredover the next six hours, at which time,due to the radioactive decay of the Tc-99m. the Mo-99 concentration would beabout doubled.

Comment: The NRC should requirelicensees to notify the NRC in case ofexcessive Mo-99 concentration. Thiscould indicate a widespreadmanufacturing defect.

Response: Notification is requiredunder 10 CFR 21.21(b).

Section 35Z5 Control of aerosols andgases.

Comment. The need for negativepressure in a room where aerosols andgases are used is not apparent given theother safety measures that are required.

Response: The NRC disagrees. Apatient who is having trouble breathing.is under mental stress. oris disorientedmay remove the breathing mask that isused to administer the xenon gas andspill the dosage. Dispersion of a spillthroughout the workplace. which wouldresult if the room were at positivepressure, is not an acceptable cleanupmethod. The requirement has beenretained.

Comment: Trapping units should bechecked more frequently.

Response: The NRC notes that therehas not been much study ofbreakthrough rates of collection systems.that are used in the clinical setting.Given the simplicity of the procedureused to check for breakthrough. 'TheNRC believes that a more frequentcheck may be beneficial and is notunduly burdensome.

Section 35.315 Safety precaution and§ 35.415 Sofety pzrecutions.

Comment It is not necessary for theRadiation Safety Officer and authorizeduser to andtrize each visit by anindividual under age IS a a case-by-case basis.

CommenL" Visits by individuals underage 18 should only be allowmd in specialcases.

Responve:-The NRC did mat mean toimply that each individual visit need beapproved. Rather, the NRC reoognizesthat the benefits that migh be derivedby the patient amut be balanoed againstthe radiation dose incurred by thevisitor. If the physician determines thatthe greater benefit derives from allowingvisits. then a notation on the patientschart or door that visits are allowed isall that is needed. No changes havebeen made.

Commentr The patient release eriteriain 1 35.75 may cause unnecessaryradiabion dose to members of the

patient's household and the public frompatients who still have radioactivity.

Response: The sections have beenmodified to require the licensee toprovide radiation safety guidance to thepatient prior to release. "Guidelines forPatients Receiving RadioiodleTreatment., published by the Society ofNuclear Medicine, and NCRP Report No.37. "Precautions in the Management ofPatients Who Have ReceivedTherapeutic Amounts ofRadionuclides." 7 provide appropriateguidance.

Section 35.315 Safety precautions.

Comments: The proposed rule appearsto require that extensive safetyprecautions be taken when caring forany patient receivingradiopharmaceutical therapy whilehospitalized. This does not differentiatebetween patients who receive lowdosages and patients who receive highdosages.

Response: The wording has beenrevised to clarify that the safetyprecautions are only required whenpatients must be hospitalized until theamount of radioactivity in them is lowenough to allow their release.

Commenv: It is not necessary tomeasure the thyroid burden of personnelwho administer encapsulated iodine-131.

Response: The NRC disagrees. It hasbeen observed ("Contamination fromTherapeutic 1-231 Capsules," by D. R.Shearer. et a.l Heoath Physics v49 p81.July 1985) that individuals who handleencapsulated iodine-131 may beexposed to levels of surfacecontamination for which thyroidmonitoring is indicated. No change hasbeen made.

Comment' Does the 2000 dpmfIOOcm=removable contamination requirementapply to patient rooms that are releasedfor imresicted patient use?

Response: No. Because of its greaterradiotoxicity, the removablecontamination limit, for iodine-ll inpatient reams following completion ofhigh level radiopharmaceutical therapyis 200 dpm/l00cm 2.

Comment'This section should requirea muvey of the ambient dose rate incontiguous restricted and unrestrictedareas to demonstrate compliance withthe requirements of Part 20.

Response: The requirement has beenadded.

Mai* rbh=a*im is ,yuitabi 6=0 Ute Soce~ty?*,-4 rhediae. i20 MeAddis A=mi. •NW

loik. NY Srisa.97hai pobL-bw ins available &uaun NCRP

Publicatis. 7Mo0 Woodamt Avema. SWte 1016.Betlheu. MD 2014.

S-20

Federal Register / Vol. 51. No. 200 / Thursday. October 16, 1986 / Rules and Regulations 36947

Comment. We administer severaldosages of 1-131 each week. A weeklymeasurement of the technician's thyroidburden would be sufficient.

Response: The regulation assumesadministration of a therapeutic dosageis an occasional event. Those licenseeswho frequently administer 1-131 maypropose an alternative monitoringprogram that would be approved bylicense condition.

Comment: There is no need to quartera radiopharmaceutical therapy patientin a private room. These patients can bequartered safely with teletherapypatients.

Response: The NRC disagrees. Thiswould unnecessarily expose patient carestaff and visitors for the teletherapypatient to removable contaminationfrom the radiopharmaceutical therapypatient.

Section 35.400 Use of sources forbrachyt herpy.

Comment The NRC should requiresource intensity checks forbrachytherapy sources.

Response: The NRC considered thisbut is not convinced that the requisiteequipment and procedures are readilyavailable. The NRC may address thismatter at a later date in a separaterulemaking proceeding.

Section 35.406 Brochytherapy sourcesinventory.. Comment: The requirement to count

all the sources after returning to storagethe few that were used will increasepersonnel dose.

Response: The licensee need onlycount the number of sources returned tostorage. and add that to the number onhand to determine the total number instorage. There is no need to count eachsource that remained in storage.

Section 35.415 Safety precautions.Comment. A hospital may have a

radiation-shielded room designed fortwo brachytherapy patients. Theproposed requirement to provide aprivate room for each patient would notallow it to efficiently use this resource.

Comment Because the dose ratearound an 1-123 implant patient is onlyabout 0.2 millirem per hour at one meter,there is no need for a private room.

Response: In the past. most licenseesensured low dose rates in uncontrolledareas by providing brachytherapypatients with private rooms. The NRCnotes that some licensees have gone tothe expense of shielding a room forthese patients. Portable radiationshields specifically designed forbrachytherapy use are nowcommercially available. Therefore.

shielding is available and provides onacceptable method of keeping doses inuncontrolled areas within limits. Thesection has been changed to allowquartering more than one radiationtherapy patient in a room. Licensees arereminded that, for patient care staff andvisitors, dose limits in Part 20 forworkers and the public apply.

Because the dose rate around these 1-125 implant patients is very low, thesection has been revised to allow alicensee to quarter an implant patientwith a patient who is not receivingradiation therapy if the licensee canshow compliance with criteria for doserates in unrestricted areas.

Comment- This section should requirea survey of the ambient dose rate incontiguous restricted and unrestrictedareas to demonstrate compliance withthe requirements of Part 20.

Response: The requirement has beenadded.

Comment. The NRC should alsoprescribe radiation safety procedurerequirements for cases in which thesources are loaded in other than thepatient's room.

Response: The dose rate limits in Part20 apply. In this case, the NRC cannotprescribe safety measures specificallysuited to each licensee's needs.

Section 35.500 Use of sealed sourcesfor diagnosis.

Comment. This subpart should alsoallow the use of bone mineral analyzersthat use gadolinium-153.

Response: When the proposedregulation was drafted the NRC did notforesee the extent of medical interest.that would develop regarding thegadolinium-153 scanner. However,several commenters recommended it beincluded here. The NRC has determinedthat the training and experience andradiation safety procedures needed foruse of gadolinium-153 in a bone mineralanalyzer are similar to those for otherdevices in this subpart The NRC hasadded this device to this subpart.

Section 35.632 Full calibrationmeasurements, and § 35.633 Periodicspot-checks.

Comment. Timer accuracy is notimportant because the same timer that isused in source calibration is used inpatient treatments. Timer constancy isimportant and is indirectly checked eachmonth by measuring the output.However, timer linearity need not bechecked under the proposed regulationbut is important because manydosimetry systems can only measureabout 70 rads. while a single treatmentdose may be much higher than this.

Response: The requirement tomeasure timer accuracy has beenchanged to timer constancy andlinearity. The NRC agrees thatconstancy is indirectly checked bymeasuring the output, but believes thatthe additional assurance of accuracythat is provided by an independentcheck far outweighs the minimal cost.

Section 35.m Radiation SafetyOfficer.

Comment: Authorized users havesufficient training and experience tooversee the management of a radiationsafety program. To require anauthorized user to be authorized for allof the types of use authorized by thelicense before being designated as theRadiation Safety Officer is undulyburdensome.

Response: The requirement has beenmodified to allow any authorized userlisted on the license to serve asRadiation Safety Officer.

Comment" Revise the wordingregarding the one year of full timeexperience you require so that aconsultant who gets experience byworking at several institutions over a.year can be listed as Radiation SafetyOfficer.

Response: The NRC believes that theexperience should be gained workingfull time at one institution because anindividual serving as a consultant is notlikely to be exposed to the day-to-daybusiness management problems thatmust be effectively dealt with in aradiation safety program.

Comment: The grandfather clause inI 3S.902 would require a RadiationSafety Officer to get additional trainingand experience if only one new materialis added to a license.

Response: The NRC recognizes thatnew developments in medical carerequire changes in radiation safetyprocedures for which formal training ofexperienced individuals is unnecessary.Similarly. Radiation Safety Officers arecapable of determining whatrequirements apply to the receipt use,storage. and disposal of new byproductmaterial that comes under theirjurisdiction. The requirement has beenrelaxed.

Section 35-930 Training for therapeuticuse of radiophormoceuticais.

Comment The proposed rule requiresthat authorized users who are notcertified have experience using solublephosphorus-32 and colloidalintracavitary radiopharmaceuticals.These clinical procedures are notfrequently performed. so it may not bepossible for physicians to get the

S-21

8 Federal Register / Vol. 51. No. 200 f Thursday. October 16. 1988 / Rules and Regulations

required clinical experience.Furthermore. physician who only wantto treat hyperthyroidism do not needexperience tretiing thyroid carcinoma.

Respons•e The infrequently performedClinical procedures have been removedfrom the clinical experience requirementbecause experience with them would bedifficult to obtain and they no lonoemreflect the current state of medicalpractice. New sections have been addeddelineating training and experience

-,criteria for physicians who only want to.treat either hyperthyroidism or thyroidcarcinoma.

Section 35.MI Trniru forTeletherapy Physicist

Comment. One cannot become expertin teletherapy physics after doing justone full calibration and working for justone year. The criteria should be morestringent.

Response: The NRC notes that theproposed regulation required one year offull time training and ahso one year ofsupervised full time experience. TheNRC's traning criteria are not designedto provide assurance of clinicalexpertise, but rather adequate assuranceof public health and safety. The NRCbelieves this assurance can be gainedwith two years of full-time training andexperience.Section 31.7 Generl hvnse for we

of byproduct material for Certain invitro clinical orlabomtory testing.

Comment. The requirement to list Invitro use on the medical application willcause more confusion than letting thecurrent system stand. It has provenadequate to assure protection of publichealth and safety.

Response: The NRC agees that thecurrent method is adequate. The sectionhas been revised to reflect currentdrafting conventions but is. for practicalpurposes. unchanged.Sections •=72 Mrufactwm anddisufrition of rodi og:Iina lsconaMirdg byprodu&cW aaj formedico ume under group liensess=Manufactune and diariutioa ofgeneratoar or moeaunt ki't forpreparation of radiopharmoosudbalscontaining byproduct nmatenia and3Z,74 Manufacture and dfibution ofsources or devices continird byproductmateial• or medica am

Comament The NRC should motrequire manufacturs to pay anamendment fee to request approval ofword changes on package inserts thatm necessitated solely because of

NRC's change In nomearlawe. TheNRC should also provide a transitionperiod during which mnmufacturers maycontinue to use package inserts that arein stock.

Response: The NRC agrees. Th1 finalregulation simply prescribes thenecessary wording. NRC expectsmanufacturers to incorporate thisministerial change in their programs,and will check for compliance during itsinspections. A transition period hasbeen added.

Comment. Because some of the oldPart 35 goups were divided and somewere amalgamated, you should providea table that clarifies what amanufactmrer can deliver to a medicallicensee whose license is drafted interms of the old Groups I-VL

Responsae A manufacturer may onlydeliver to a licensee the byproductmaterial authorized by the license. If alicense only lists some of the materialsin a subpart, the licensee is notauthorized to receive the other materialsin the subpart.V. Derivation Table

The following derivation tableidentifies the origin of each section ofthe regulation. Origins of sectionsinclude current 10 CFR Parts 1. 20. 30.and 35. Federa Rester Notices (FRI.frequently used license conditions.licensing staff policy. current regulatoryguides (RG%, Office of Inspection andEnforcement bulletins, the United StatesPharmacopeia. and new text preparedby staff.

3.1 5.1 P.MW am n"2. a25.11 .252 3m - 52 naaw3M na 9. and~ "NOO am fm am5S2 5.15S

*90"BI M am I

A~mme Sm O. amm Tom am. animis

onaemw, ohm sut fwrs.

Im"M

"NN mmýs Mawsfamm

POOMMfew WToomwy tmm

saw OE Tm n nasmsee" w" 30Wyosm.

25.13 35.17 mm w___________________________-min IS5.1d 35191U35.12 35IS Now UHL am"" mrs. IM519 as" - wMasm 8011

S-22

Federal Regis.er /Vol. 51, No. 200 / Thursday, October 16, 1986 / Rules and Regulations S.949

Piseeew ev

-"W D-Geiea A&VA"Wmew -mimee35+21 ~ ~~~~~ .53 !, ,B ' ty ...... .... . .................... ..... ..... .. i most 1 see

35.22 . 35.22 Aa Sa " C Com m ittee . . .......... . ...... . ........... .... .......... ..... . .. .................. . .. -35.1 e eed35.23 35.33 StaSWMMs of Wnomity same 'espe u n.e .......... N-Isla3&27 3S.24 V~wag wmjmmued mwe *. ...............-....-- aLwu w.nob325. 2 35.25 MOW 04Mw MOC e Ot o, INCoRe iM.nWmI, ..... . . ....... . .. .... ............ .......... . .. -- L-- O- pesy3531 35.36 a on" Woret" Pe awg" ... ....... . _blowsell35.33 35.37 A-? s am a•ats 0menalm ...................... 35.423525 35.38 SUaWon - E .- 0Sam AG 10.8 p 3

Sadpepa C-Gamderv Technical Aq~~~ft

35.50 35-501 Pws•m•, m. acabhamana &•O oSee n e mae caWmars.__ RG 10.8 6Apr D2h r2m,. ana nv2 tX551 35.51 Cambincn aa cro o eque vow wow mewnwo.-___________ _ AG 1068 Appsee DI Mwess and meý Sir.

25.53 M.53 Mj umee•a S 0 mdoe"qmsAaa dasegn ....- Prieesd iwumkm, 3515 446 FA 43840. SOPL 1. l961.)25I. 35.56 'uAwxatis lar cat Io M0 geenesa suamo 35.14(d) ivmad25.59 25.59 fAwreqflnems 1W possaeson of lsed 30ms. 25.14•4eX1N. 35 14M.j re40025.60 35.60 Sypfaae sisas . ,s. . aea Erdocarnem was Api 16. 197935.61 25.61 V I si?0s .. _ _ __ . pean ana En awcoveine, Apr 16. 1979356.0 3562 SYMA, 1110" his but35.61 35.63 V ia a aiads .e.. tDA35.70 35.70 Sw"yi 1f €or cmtiutmO mad esteem ralna emsp een .... .. RG 10m Aweee.a i m•a357 2 5 75 ASWU of Pa'am OmewV Ihau6phs-AC60Ms or potew vpMA&Mv het Mtm.35.80 35.80 Meabeenucb emstsimme oeatei ame pmo ..m L..;. "y25.0 :35.90 Ssaeogeoeman-m AG 106AeeMa o twsded

ism ,aas. r b-4 .l lm. wld 3W61 le-r)'

U.100 35.100 Use aqA .mawm t. 1mm1 . . __am =ma ma - 5.31 WV 25.10,, (Glow 0 #1,ed251230 35.120 jPoesion ON mamP l. .. -oom Ara 10.6 pep S

Sa~pw 1- 111"Sd Locmotion

25.3 125200 Warne 0smmms gMew samt imad vaag s for oft"ea wam Mctgaue t W&e ... 100 0) wad (c) (Gias vs ag fin)emam34 I 35I,0 Po.tSet I I Ia us am.99 WWRU 30

35= .35S0 umnpeio o. ...f. suburnsef-RG 10.8 Sept S.

6.= 36= U, o3 Use eq ft, nI 3aet .W Im am1 00 m,, G v am V) imme35.310 3S.310 i So" mWOM 19.12 merad.35315 35.315 I Softy pmfau.,o..... . AdtG 10.6 Aepead L

I5.1•00 2IS.320 P 10eseeads, eq rnewyai, umu're ..... ... ~. A 108w pag 5

bt -D-.Sae Smmhe bUhmp"

25400 35400 LMa eq.Mus #W Stsaei"plupy 3-- . 5, 100() (Grow VI)fae32.404 36.4W R"M, fm mee - IWkmaiWs y W[IVW mw a

2546 35.406 b'.Uaw10inty m~estat ewwery . ______________________. AG 618S pag S.3S.410 35.410 1 Safety meevn " .9.12 amsad

254615 354iS15 I dSonel pee......-....... • 103S2 4 ARp'e1S L 8 9

35.410 254.e6 I esqa &•eo. ' .... .... l

a=S. 2 0 Us. eq mased eSw fo lr•agmes Pe amme 11139

3LS20 35.20 Avafifto eqvv imp hawawd 4D ian s

WS.W0 35.60 Useo as a msed esate ina teOeffesy am 1 mPe,25605 .6m 60 $MS smr sad Pam s Loca niat ode26.66 35 606 -1-me Now tean35.610L 25.610. SM" vinam t LMN.ee wý &vwad e e35.11 35&515Sati so" b~i Lo*we 011101.MOO2 35.620 Pasmewa eq apmmy egwamneil 1 Ne. mmt25.615 25.621 PAMabs amooV de 525 244 PA 2115: .Mnwy 18. 291963L615 35W3 Vowea epemfL~ 4.neaee wo25=13 25A3D Domtr 5 35*.5235 med25L=2 35*02 Pall em e e____________ 1252 medw25&634 35.633 Penaft SpP2althCS .V =A* 8e"ad besew ad"35.641 25.541 kmae imumps "W isieomy License COa esami35.62 35.42 jSa"a abacis MarW inmup latales Line coao25.5,3 35.643 atcamean eq tommmo Umt 01 eMM 9ee begu a "suwsm Fomep aim. -

25145 35.644 Aepe eq Of esups awov^ ternM wam uameaastwu_____________ft"? ý3.va5 F.".~ - icens

S-23

3695 Federal Register I Vol. 51, No. 2W0 1 Thursday. October 16, 1985W Rules arnd Regulations

slow J.-.7r999 ow Emwflutr 9n

25.90 35901 TamwwV W, e=~AW PAa6. So"et OY~s.Mg g290 35910 -11N20 V0 69. Wm .em. WaI. awsw k"rw vL

3s"92 25M ImC o~mwu SW nept am mo= of66 Fefa M 6 "W (469 m~rN 7 MR S3476. DeG~me Z. 3062).

35.93 5593 -wi 0W~aeSg6wl6Jw.. OFe ROMPu (4inr a 7 MR 53A76. Do.CWTO 2. 11062).

35.92 f 94~) To-* tg r'ueewwa of v~ mx.. 1mmss by0flWp tr590 6M 'Tev -fui 1W' wme*t 61 WSOY&Wn mo'm. I of'wun9 eroy FW~ (7 A U6,De

25.980 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ o 35.140 atwm 9, "il 040W (4np 601__________________ e 496,4~gs~7 fp 5&U76. Demsraw 2. 10162).

25 3 5.59W Tumas ow 131sagamc Ag -nm%9 Ofa .4 dwal Nu~w a Wcý $ (7 FR W376. 0ow

-er2.1962).35.961 35.961 T=Wft b' inim&Wy 1 . 5.24 935.190 35.970 Tuinwvawa -A &Wm4 a ~3169 N"________________ 1"35.9711 35.971 P orv Vo inwa va Uso IaU1 v0oU1 NOWI nai35.972 35"72 RW66um of boom PA emno of P.6g .W s RrMg $m 7 PR 55476 Dwea'

35.90 35.990 V4W. Wai35999m; 9 WM~ 010f C~W9~igfiniYUEs 6619 Wwn, pW W n m

VL Administrative Statements

Finding of No Significant EnvionmentnalImpact A vailability

The Commission is revising theregulations governing the medical use ofbyproduct material. The Commissionhas determined under the NationalEnvironmental Policy Act of 1969. asamended, and the Commission'sregulations in Subpart A of 10 CFR Part51. that promulgation of this regulationis not a major Federal actionsignificantly affecting the quality of thehuman environment and therefore anenvironmental impact statement is notrequired. The radiation levels andrelease of byproduct material authorizedby this regulation are consistent withthe Commission's other regulations andinternationally accepted standards.Most radiation experts agree that levelsand releases that are within theseregulations and standards will not havea significant effect on the quality of thehuman environment. The assessmentanalyzes the possible impact of releaseof radioactive patients, thetransportation of byproduct material formedical use. storage and control ofaerosols and gases, waste disposal bydecay-In-torag, and dose rates outsideteletherapy rooms. The environmentalassessment and finding of no signiicantimpact on which this determination isbased are available for public inspectionat the NRC Public Document Room. 1717H Street NW. Washington. DC. Singlecopies of the environmental assessimentand finding of no significant impact are

available from Mr. McElroy (see "MOPIRTHER RMFORMATIOW CONsTer."heading).

Poperwork Reduction Act Statement

This final rule amends informationcollection requirements that are subjectto the Paperwork Reduction Act of 1980(44 U.S.C. 350M et seq.). Theserequirements were approved by theOffice of Management and Budget underOMB Number 3150-0010.

Pegulatory Analysis

The Commission has prepared aregulatory analysis on this regulation.The analysis examines the costs andbenefits of the alternatives consideredby the Commission. The analysis isavailable for inspection in the NRCPublic Document Room. 1717 H StreetNW. Washington. DC. Single copies ofthe analysis may be obtained from Mr.McEroy (see "FOR PUwFN!R

•WOMAnoW C0oTAC:." headin.

Reuloatory Fexibiiy Certication

In accordance with section oS(b) ofthe Regulatory Flexibility Act of 1990,the Commission certifies that this rule.will not have a significant economicimpact on a substantial number of smanentities. The NRC has issuedapproximately 2500 medical licensesunder 20 CFR Part 35. Of these.approxitately 2200 ar held byInstitutions and approximately 300 byindividual physicians. Most of theinstitutional licensees are community

hospitals. The NRC has adopted sizestandards that classify a hospital as asmall entity if its average gross annualreceipts do not exceed $3.5 =min anda private practice physician as a smallentity if the physician's annual grossreceipts are $1 million or less. Underthese size standards, some NRC medicallicensees could be considered "smallentities" for purposes of the RegulatoryFlexibility Act.

The number of medical licensees thatwould fall into the small entity categorydoes not constitute a substantial numberfor purposes of the RegulatoryFlexibility Act.- The primary objective of the rule is tosimplif the medical licensing processby consolidating requirements withoutlessening the protection necessary forpublic health and safety. This has beenaccomplished by incorporatingfrequently used license conditions intothe regulations and eliminating ormodifying requirements that are notessential to the protection of publichealth and safety. These steps will makeit easier for persons to determine whatis required to obtain a license and whatIs required of licensees. Therefore. thereshould not be a significant economicimpact on these small entities.

The Commission has prepared aregulatory analysis for this regulationwhich contains information concerningthe anticipated economic effect of thisregulation on licensees and presents thebasis for the Commission's belief thatthe regulation will not result in

S-24

Federal Register ( Vol. 51, No. 2.00 / Thursday. October 16. 1986 / Rules and Regulations 36951

significant additional costs to anylicensees. It is available for publicinspection in the NRC Public DocumentRoom at 1727 H Street NW.,Washington. DC. Single copies areavailable from Mr. McElroy (see "FORFUMER INFORMATION CONTAC.'"'heading).

Resolution of Petition for RulemckingPRM 35-2

The American Association of'Physicists in Medicine filed a petitionregarding dosimetry equipmentcalibration frequency (Petition DocketNo. PRM 35.Z-2 see 47 FR 4311. January29. 1982). This rulemaking resolves thatpetition in J 35.630 Dosimetryequipment. The petition is grantedessentially as recommended by thepetitioner.

List of Subjects

10 CFR Part 30

Byproduct material Governmentcontracts. Intergovernmental relations.Isotopes. Nuclear materials, Penalty.Radiation protection, Reporting andrecordkeeping requirements.

10 CMr Pant 31

Byproduct material, Labeling. Nuclearmaterials. Packaging and containers.Penalty. Radiation protection. Reportingand recordkeeping requirements.Scientific equipment.

10 CFR Part 32

Byproduct materials. Labeling.Nuclear materials. Penalty. Radiationprotection. Reporting and recordkeepingrequirements.

10 CFR Paoz 35

Byproduct material Drugs. Healthdevices. Health professions.Incorporation by reference. Medicaldevices. Nuclear materials.Occupational safety and health. Penalty.Radiation protection, Reporting andrecordkeeping requirements.

10 CFR Part 40

Go•ernment contracts. Hazardousmaterials-transportation. Nuclearmaterials. Penalty, Reporting andrecordkeeping requirements. Sourcematerial. Uranium.

Under the authority of the AtomicEnergy Act of 1954. as amended. theEnergy Reorganization Act of 1974. asamended, and 5 U.S.C. 533 the NRC isadopting the following revision of 20CFR Part 35 and the followingamendments to 10 CFR Parts 30.31. 32.and 40.

S-25

APPENDIX T

Considerations in Making Radiation Safety Program Changes(See § 35.31.)

The regulations allow the licensee to make changes that are not potentiallyimportant to safety in radiation safety procedures, and in equipment. Whenmaking changes, it is the licensee's responsibility to ensure that the resultwill be in accord with the regulations and license conditions. Any change mustbe reviewed for radiation safety considerations before it is approved.

You should consider the following before making an application for a licenseamendment or making changes. Not all the questions apply to all changes. Theremay be other questions you should consider before making changes.

General

1. Proposed changes should be fully explained.2. Do not include unexplained acronyms, abbreviations, or undefined words.3. Spell out measurement units such as millicurie, microcurie, and millirem

per hour; use the abbreviations only in calculations or log sheets.4. Identify, by name or office, who is responsible for doing each task.

Room Changes

1. Whi is the change needed?2. What materials, and how much of each, will be used in the room?3. Can the room be secured in case of spills?4. Can the room surfaces be cleaned?5. Is the room adequately ventilated?6. Does the room provide radiation shielding?7. What are the anticipated doses each week in the room and in surrounding

areas?8. What are surrounding areas used for? What might they be used for in

the future?9. Can the old room be cleaned, surveyed, and released for unrestricted use?

Equipment Changes

1. Why is the change needed?2. Was the equipment designed for the intended purpose?3. For detection and measuring equipment:

a. What is the lowest level of detection for the equipment?b. What is the level of detection required?.c. Will the instrument be compromised by ambient radiations,

light, temperature, humidity, or chemicals in the area?d. In case it fails, is backup equipment available, and can it

6e repaired in a timely fashion?

T-1

4. For protection equipment:

a. What level of protection does it provide?b. What is the required level of protection?

.c. In.case it fails, is backup- equipment available, and can itbe repaired in a timely fashion?

Procedure Changes

1. Why is the change needed?2. What doses or dose rates apply to the individuals affected by the change?3. For each step in the procedure, what things are likely to go wrong either

because of equipment failure or human error?4. What are the likely cohsequences of problems noted in Question 3?5. What steps can be taken to mitigate the consequences noted in Question 4?

T-2

APPENDIX U

Recommended Support Equipment and Services

Depending on the type of use and the size of the program, you will needvarious types of equipment and services to support your radiation safety program.The suggested list provided here does not include the many disposable orreusable items that are also necessary. Also, the list is not all-inclusive,and all items are not absolutely necessary.

Needs are divided to correspond to the subparts of Part 35 that describedifferent'types of medical uses of byproduct material. While instrumentationoverlaps among subparts, duplication is generally not necessary unless aninstrument is to be dedicated to a single area of use or a single user.Descriptions of some of the items.follow the list.

Subpart D

1. Radiation detection survey meter2. Dose calibrator3. Constancy check source4. Sealed sources for dose calibrator accuracy test5. Constancy check source for uptake, dilution, and excretion equipment6. Leak-test service for sealed sources7. Syringe shield8. Personnel monitoring service9. Survey meter calibration service10. Vial shields11. Personnel shields

Subpart E

1. Radiation detection survey meter2. Radiation measurement survey meter3. Dose'calibrator4. Constancy check source5. Sealed sources for dose calibrator accuracy test6. Leak-test service for sealed sources7. Syringe shield8. Hot lab area monitor9. Flood source for gamma cameras10. PLES, bar, orthogonal-hole, or quadrant phantom for gamma cameras11. Lead L-block12. Fume hood13. Radioactive aerosol and gas administration system and trap14. Personnel monitoring service15. Survey meter calibration service16. Vial shields17. Personnel shields

Subpart F

1. Radiation detection survey meter2. Radiation measurement survey meter

U-1

3. Dose calibrator4. Constancy check source5. Sealed sources for dose calibrator accuracy test6. Leak-test service for sealed sources7. Syringe shield8. Fume hood9. Personnel' monitoring service10. Survey meter calibration service11. Vial shields12. Personnel shields

Subpart G

1. Radiation detection survey meter2. Radiation measurement survey meter3. Lead L-block4. Remote handling tools5. Shielded transport cart6. Shielded storage safe7. Leak-test service for sealed sources8. Personnel monitoring service9. Survey meter calibration service10. Personnel shields

Note: If you are authorized for only a Sr-90 ophthalmic applicator, only astorage safe or built-in locked storage cabinet and leak-test serviceare necessary.

Subpart H

1. Secure storage area2. Leak-test service for sealed sources3. Radiation monitoring service for measuring dose rates from packages with

replacement sources and decayed sources.

Subpart I

1. Radiation measurement or radiation detection survey meter2. Room monitor3. Patient viewing system4. Leak-test service5. Calibrated dosimetry system6. Spot-check dosimetry system7. Direct-reading pocket dosimeters8. Personnel monitoring service9. Teletherapy physicist service10. Survey meter calibration service

Descriptions

A radiation detection survey meter usually has a GM tube or NaI(T1) crystaldetector. The scale may be labeled in cpm or mR/hr. It is useful for detectingmicrocurie amounts of radioactivity and indicating approximate exposure levels.If it is calibrated in mR/hr, the most sensitive scale will probably have a

U-2

full-scale deflection between 0.1 and 1.0 mR/hr. It can be used for measuringsmall amounts of radioactivity if the user has measured its detection efficiency(cpm/dpm)'for the radionuclide being measured.

A radiation measurement survey meter can actually measure mR/hr. The detectoris an ionization chamber, which is usually much larger than a GM tube. Thescale is labeled in mR/hr, and the most sensitive scale usually will have afull-scale deflection between 1 and'I0 mR/hr.

The. dose calibrator uses an ionization chamber or GM detectors to determine theamount of radiation given off by a syringe or vial containing radioactive ma-terial. The logic system within the calibrator can then calculate the amountof radioactivity in the sample. Most dose calibrators have a digital displaywith either a "select range" switch or an automatic range-switching circuit.The final display is in microcuries, millicuries, or curies. A dose calibratorcan measure from a few microcuries to a few curies. It is not sensitiveenough to measure contamination wipe samples.

A constancy check source is a sealed source with the date of manufacture,radioisotope, and approximate activity noted.

A dedicated check source is a long-lived radioactive source used to check theday-to-day constancy of an instrument. The same source (a "dedicated" source)must be used every day so that the user knows what reading to expect from theinstrument. The source may also be used for other purposes.

The sealed sources for dose calibrator accuracy are also sealed sources withthe date of manufacture and radioisotope noted. However, the activity will becertified to within a few percent by the manufacturer. These need not be onhand if the dose calibrator accuracy test is done by a contract service.

The leak-test service may be done in-house or performed as a contract service.Leak-test wipes cannot be measured in a dose calibrator, and a GM survey metermay not be sensitive enough to detect contamination on a wipe sample. Usuallya well-type NaI(Tl) crystal with a ratemeter is necessary to assay gamma-emitterleak-test wipes. To determine the efficiency of detection, a sealed sourcewith the same radioisotope as the source being tested is used, but its activityshould be between 0.1 and 10 microcuries. This activity will be certified bythe manufacturer to an accuracy within a few percent.

The hot lab area monitor usually has a GM detector, and the scale may belabeled in cpm or mR/hr. It should be sufficiently sensitive to detect anunshielded patient dose left lying unshielded anywhere in the hot lab.

The flood source for gamma cameras may be either one that is sealed or onethat is filled by the user. The sealed sources usually contain about 5 milli-curies of Co-57. The sources that can be filled by the user usually have aremovable screw in a port through which radioactive material can be injectedeach morning.

PLES, bar, orthogonal-hole, and quadrant phantoms are used to monitor geometriclinearity and resolution capability in gamma cameras. This type of testshould be run weekly according to the instructions supplied by the manufactureror the instructions in Appendix E to this guide.

U-3

A fume hood should have an adjustable sash. It should be directly vented to theoutside air. The face velocity should be approximately 100 linear feet per minutewith the sash at its normal location. T 5is should be measured with a velometer.If one is not available, hang a strip o& tissue paper about 1 inch wide and 3 incheslong from the bottom of the sash; at the proper face velocity, it will be gentlydeflected into the hood.

A teletherapy room monitor usually has a GM detector and either a scale labeledin mR/hr or annunciator lights indicating when the source is on and off. Itmust be installed so it can be easily seen when entering the teletherapy room.A backup power supply must be provided.

When used by teletherapy technicians, direct-reading or indirect-reading pocketdosimeters provide an immediate indication of personnel whole body exposure incase of an accidental exposure. These should be calibrated using the sourceand procedure used for calibrating survey meters.

Personnel shields are used to shield workers from radioactive patients. Theymay be mobile upright shields in the nuclear medicine clinic or a patient'sroom when a technician or nurse must stay beside a patient, or they may belead sheets used to shield transporters from patients in wheelchairs.

U-4

APPENDIX-V

Filing System

The purpose of a filing system is to allow for the quick access of records.The system should be constructed to allow a person who is not familiar with thesystem to use it with minimal'training. I1f you-have not established a system,the one described below may be helpful. In addition to NRC-licensed activities,ft includes sections for State-licensed natural and accelerator-produced radio-active material programs, x-ray survey and maintenance reports that are some-times maintained by the Radiation Safety Officer, and various safety committees.

The filing system described contains two parts: The first part includesSections A and 0-9 for files that are small or occasionally accessed. Thesecond part consists of five looseleaf notebooks used to file records that arelarge, frequently accessed, or easily filed in alphabetical or chronologicalorder.

Section A -- Active Projects

Set up an individual file for each project, e.g., planning a new radioisotopelab or x-ray installation or a research project. Label each file with a shorttitle. File chronologically with new material in front. For example:

Shielding calculations for new x-ray roomTLD projectRegistration and travel to summer meeting

Section 0 -- Forms

Set up a file for master copies of the forms you use in your facility and afile for copies of each form. Label the files as indicated.

0.1 Masters0.2 Personal Exposure Monitor Applications0.3 Exposure History Request0.4 Exposure History Report0.5 Teletherapy Monthly Check0.6 Nuclear Medicine Daily Survey0.7 Survey Meter Calibration0.8 Sink Disposal Logs0*9 Vented Release Logs0.10 Decay-In-Storage Release Records0.11 Room Survey Master Forms

etc.

Section I -- Committees

Each subsection of this section is devoted to a single committee. In somecases, the file will contain only meeting minutes. In other cases, the filemay also include a committee charter, curricula vitae of members, and topicalreports.

V-1

1.1 Radioactive Drug Research Committee1.2 Hospital Safety Committee1.3 Research Safety Committee'1.4 Research Review Committee1.5 Radiation Safety Committee

etc.

Section 2 -- NRC License

2.1 License Applications, License2.2 Amendment Requests, Amendments2.3 Photocopies of License2.4 Records of Minor Changes2.5 Inspection Reports and Replies2.6 Visiting Authorized User Credentials2.7 Misadministration Reports2.8 Other Correspondence

etc.

Section 3 -- Inventories, Surveys, and Waste

3.0 Inventory Summary Sheet3.11 Nuclear Medicine Surveys and Inventory Summaries3.12 Research Lab Surveys and Inventory Summaries3.21 I-Therapy Room Release Surveys3.22 Brachytherapy/Sealed Source Quarterly Inventory and Survey3.23 Leak-Test Records3.30 Room Survey Sets for Future Use3.41 Annual Sink Disposal Summary3.42 Annual Vent Disposal Summary3.43 Hot Lab Sink Disposal Logs3.44 Research Lab Sink Disposal Logs3.45 Decay-In-Storage Release Logs

etc.

Section 4 -- Contract Services

4.1 Personal Dosimetry Service Contract4.2 Change Forms4.3 Monthly Exposure Reports4.4 Waste Shipment Contract4.5 Transfers of Byproduct Material

etc.

Section 5 -- Training Lecture Outlines, Handouts, and Attendance Logs

5.11 Nonradiology Physicians5.12 Nonradiology Technologists5.21 Radiology Physicians5.22 Radiology Technologists5.31 Administrators5.32 Security5.33 Physical Plant5.34 Housekeeping5.35 Animal Research Facility

V-2

5.41 Nursing--General Radiation Safety5.42 Nursing for Brachytherapy5.43 Nursing for Iodine Therapy5.51 Brachytherapy Team5.52 Diagnostic Nuclear Medicine Personnel5.53 Therapeutic Nuclear Medicine Personnel5.54 Teletherapy Personnel5.61 In Vitro Users

etc.

Section 6 -- Radiation Safety Equipment on Hand

Set up an individual file for each piece of equipment. The file should containthe user's manual, guarantee, service reports, and calibration reports. Filealphabetically by manufacturer.

Section 7 -- Incidents

7.1 Personnel Exposures7.2 Spills or Losses with No Personnel Exposure7.3 Procedural Incidents

Section 8 -- State-Regulated Sources

8.1 X-ray Registration Sheets8.2 NARM License Application, License

Set up an individual file for each piece of radiographic equipment. The fileshould contain the user's manual, guarantee, service reports, and inspectionand calibration reports. File by room number. For portable x-ray machines,file by manufacturer's name or normal storage location.

Section 9 -- Facility Description

Set up files for blueprints, drawings, and permanently ins-talled equipment suchas incinerators, fume hoods, and walk-in boxes.

Loose-Leaf Notebooks

1. Dosimetry Service Monthly Packing Slips. Checkmark each name when themonitor is returned at the end of the monitor period. This will highlightpersons who are not returning monitors promptly for processing.

2. Personnel Dosimetry Individual Applications. Behind each individual'sapplication form, file copies of previous employment exposure, incidents,requests for previous employment exposure, and bioassay results.

3. Budget and Purchase Orders

4. NRC Regulatory Guides -- Divisions 8 and 10

5. Standard Operating Procedures

6. NRC Rules and Regulations

V-3

APPENDIX W

Bibliography

Title 10, Code of Federal Regulations'

Part 19 - Notices, Instructions, and Reports to Workers; Inspections

Part 20 - Standards for Protection Against Radiation

Part 21 - Reporting of Defects and Noncompliance

Part 30 - Rules of General Applicability to Domestic Licensing of.ByproductMaterial

Part 31 - General Domestic Licenses for Byproduct Material

Part 32 - Specific Domestic Licenses To Manufacture or Transfer Certain ItemsContaining Byproduct Material

Part 33 - Specific Domestic Licenses of Broad Scope for Byproduct Material

Part 35 - Medical Use of Byproduct Material

Part 40 - Domestic Licensing of Source Material

Part 70 - Domestic Licensing of Special Nuclear Material

Part 71 - Packaging and Transportation of Radioactive Material

Part 170 - Fees for Facilities and Materials Licenses and Other RegulatoryServices Under the Atomic Energy Act of 1954, As Amended

USNRC Regulatory Guides 2

Regulatory Guide 8.4, "Direct-Reading and Indirect-Reading Pocket Dosimeters"

Regulatory Guide 8.10, "Operating Philosophy for Maintaining OccupationalRadiation Exposures As Low As Is Reasonably Achievable"

Regulatory Guide 8.13, "Instruction Concerning Prenatal Radiation Exposure"

Regulatory Guide 8.18, "Information Relevant to Ensuring That OccupationalRadiation Exposures at Medical Institutions Will Be As Low As ReasonablyAchievable"

'Title 10 of the Code of Federal Regulations is available from the Superintendentof Documents, U.S. Government Printing Office, Washington, DC 20402.

2 NRC documents may be purchased from the U.S. Government Printing Office, PostOffice Box 37082, Washington, DC 20013-7082, or the National Technical InformationService, Springfield, VA 22161.

W-1

Regulatory Guide 8.20, "Applications of Bioassay for 1-125 and 1-131"

Regulatory Guide 8.23, "Radiation Safety Surveys at Medical Institutions"

Regulatory Guide 10.2, "Guidance to Academic Institutions Applying for SpecificByproduct Material Licenses of Limited Scope"

Regulatory Guide 10.5, "Applications for Type A Licenses of Broad Scope"

Draft Regulatory Guide FC 414-4,3 "Guide for the Preparation of Applicationsfor Licenses in Medical Teletherapy Programs"

Other NRC Publications 2

A. Brodsky, "Principles and Practices for Keeping Occupational RadiationExposures at Medical Institutions As Low As Reasonably Achievable," NUREG-0267,Revision 1, USNRC, Washington, DC, October 1982.

N. L. McElroy and A. Brodsky, "Radiation Protection Training for PersonnelEmployed in Medical Facilities," NUREG-1134, USNRC, Washington, DC, May 1985.

Technical Reports

Bureau of Radiological Health, "Radiation Safety in Nuclear Medicine: APractical Guide," Department of Health and Human Services (HHS) PublicationFDA 82-8180, November 1981.

Center for Devices and Radiological Health, "Recommendations for QualityAssurance Programs in Nuclear Medicine Facilities," HHS Publication FDA 85-8227,October 1984.

International Atomic Energy Agency (IAEA), "Monitoring of Radioactive Contamina-tion on Surfaces," Technical Report Series No. 120, 1970.4

IAEA, "Handbook on Calibration of Radiation Protection Monitoring Instruments,"Technical Report Series No. 133, 1971.4,

International Commission on Radiological Protection (ICRP), "General Principlesof Monitoring for Radiation Protection of Workers," Report No. 12, PergamonPress, Elmsford, NY, 1969.s

3 Draft regulatory guides may be obtained at no charge by writing to the U.S.Nuclear Regulatory Commission, Washington, DC 20555, Attention: Director,Division of Information Support Services.

4 IAEA reports may be obtained from UNIPUB, Inc., 345 Park Avenue South,New York, NY 10010.

sICRP reports may be obtained from Pergamon Press, Maxwell House, FairviewPark, Elmsford, NY 10523.

W-2

International Commission on Radiation Units and Measurements (ICRU), "Certifi-cation of Standardized Radioactive Sources," Report No. 12, Washington, DC,1968.6

National Council on Radiation Protection and Measurements (NCRP), "Precautionsin the Management of Patients Who Have Received Therapeutic Amounts of Radio-nuclides," Report No. 37, Washington, DC, 1970.7

NCRP, "Radiation Protection for Medical and Allied Health Personnel," ReportNo. 48, Washington, DC, 1976.7

NCRP, "Instrumentation and Monitoring Methods. for Radiation Protection,"Report No. 57, Washington, DC, 1978.7

NCRP, "A Handbook of Radioactivity Measurement Procedures, Second Edition"Report No. 58, Washington, DC, 1985.7

NCRP, "Operational Radiation Safety Training," Report No. 71, Washington,DC, 1983.7

ANSI Standardss

American National Standards Institute (ANSI), ANSI N13.2-1969 (R1982),"Administrative Practices in Radiation Monitoring (A Guide for Management),"New York, NY.

ANSI N13.4-1971 (R1983), "Specification of Portable X- or Gamma RadiationSurvey Instruments," New York, NY.

ANSI N13.5-1972 (R1982), "Performance and Specifications for Direct Readingand Indirect Reading Pocket Dosimeters for X- and Gamma Radiation," New York, NY.

ANSI N13.6-1966 (R1982), "Practice for Occupational Radiation Exposure RecordsSystems," New York, NY.

ANSI N14.5-1977, "Leakage Tests on Packages for Shipment of Ra'ioactiveMaterials," New York, NY.

ANSI N42.12-1980 (R1985), "Calibration and Usage of Sodium Iodide DetectorSystems," New York, NY.

ANSI N42.13-1985, "Calibration and Usage of Dose Calibrator Ionization Chambersfor the Assay of Radionuclides," New York, NY. (Revision of ANSI N42.13-1978)

6 ICRU reports may be obtained from ICRU Publications, 7910 Woodmont Avenue,Suite 1016, Bethesda, MD 20814.

7 NCRP reports may be obtained from NCRP Publications, 7910 Woodmont Avenue,Suite 1016, Bethesda, MD 20814.

8 ANSI standards may be obtained from the American National Standards Institute,Inc., 1430 Broadway, New York, NY 10018.

W-3

ANSI N42.15-1980 (L.385), "Performance Verification of Liquid ScintillationCounting Systems," New York, NY.

ANSI N44.1-1973 (R1984), "Integrity and Test Specifications for SelectedBrachytherapy Sources," New York, NY.

ANSI N44.2-1979 (R1984), "Leak Testing Radioactive Brachytherapy Sources,".New York, NY.

ANSI N44.3-1973 (R1984), "Thyroid Radioiodine Uptake Measurements Using a NeckPhantom," New York, NY.

ANSI N323-1978 (R1983), "Radiation Protection Instrumentation Test and Calibra-tion," New York, NY.

ANSI N449-1974 (R1984),' "Guidelines for Maintaining Cobalt-60 and Cesium-137Teletherapy Equipment," New York, NY, 1973.

ANSI N449.1-1978 (R1984), "Procedures for Periodic Inspection of Cobalt-60 andCesium-137 Teletherapy Equipment," New York, NY, 1978.

Other Resources

Blatz, Hanson, Editor, Radiation Hygiene Handbook, McGraw-Hill, New York,NY, pp. 22-27, 1959.

Cember, Herman, Introduction to Health Physics--Second Edition, Pergamon Press,New York, NY, 1983.

Sanborn, Jeffrey, Radiation Safety During Nursing Care of Patients ReceivingInternal Radiotherapy, Maine Medical Center, 22 Bramhall Street, Portland, ME,04102 (undated).

Shapiro, Jacob, Radiation Protection--A Guide for Scientists and Physicians,Second Edition, Harvard University Press, Cambridge, MA, 1981.

Steere, Norman V., Editor, Handbook of Laboratory Safety, chapter on "Determin-ing Industrial Hygiene Requirements in Installations-Using Radioactive Mate-rials," pp. 482-502; also "Basic Units -of Radiation Measurement," pp. 391-426,CRC Press, Inc., 2000 N.W. 24th Street, Boca Raton, FL 33431, 1970.

Wang, Yen, Editor, Handbook of Radioactive Nuclides, Part VIII, "RadiationProtection and Regulation," CRC Press, Inc., 2000 N.W. 24th Street, Boca Raton,FL 33431, pp. 573-831, 1969.

W-4

LIST OF EXHIBITS

Exhibit Page

1 NRC Form 313, Application for Material License EXH-3

2 Supplement A, Training and Experience EXH-5

3 Supplement B, Preceptor Statement EXH-6

4 Resident's Support Technology Training Task Log EXH-8

5 Resident's Clinical Procedures Training Log EXH-9

6 Layout Diagram EXH-11

7 Survey Meter Calibration Report EXH-12

8 Dose Calibrator Linearity Test EXH-14

9 Dose Calibrator Geometry and Accuracy EXH-16

10 Radioactive Spill Report EXH-18

11 Radioactive Spill Contamination Survey EXH-20

12 Package Receipt and Monitor Log EXH-22

13 Unit Dosage Receipt and Use Log EXH-24

14 Multidose Vial Preparation and Use Log EXH-26

15 Short-Lived Implant Source Log EXH-28

16 Radiation Survey EXH-30

17 Nursing Instructions for Patients Treated with

Iodine-131, Phosphorus-32, or Gold-198 EXH-32

18 Radiation Safety Checklist for Iodine Therapy

Over 30 Millicuries EXH-34

19 Radiation Safety Checklist for Temporary Implant Therapy EXH-35

20 Nursing Instructions for Patients Treated with

Temporary Implant Sources EXH-36

121 Sample Cesium Implant Source Log EXH-38

EXH-1

EXHIBIT I

NRC FORM 313 U.S. NUCLEAR REGULATORY COMMISSION(1.84) APPROVED BY 0Wi0 CF:R 30.* 32. 33.34. 2 115"1203,.S0 and APPUCATION FOR MATERIAL UCENSE •vom53.-

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.

FEDERAL AGENCES FILE APPLICATIONS WITH:

U.S. NUCLEAR REGULATORY COMMISSIONDIVISION OF FUEL CYCLE AND MATERIAL SAFETY. NSWASHINGTON. cC 2MES

ALL OTHER Pknos FILE APPICATow AS FOLLOWS. IF YOU ARELOCATED IN:

CONNECTICUT. DELAWARE. OISTICT OF COLUMBIA. MAINE. MARYLAND.NASSAO4WUSETI'. NEW JERSEY. NEW YORK. PENNSYLVANIA. RHODE ISLAND.OR VERMONT. SEND APPLICATIrNS TO:

U.S. NUCLEAR REGULATORY COMMISSION. REGION INUCLEAR MATERIAL SECTION S631 PARK AVENUEKING OF PRUSSIA PA 1940

ALABAMA. FLORIDA. GEORGIA. KENTUCKY. NSEIPPI. mORTH CR..•UNPUERTO RICO, SOUTH CARODULATENNESSE. VIRGINIA. VIRGM ISLANDS, ORWErT VIRGINIA. SEND APLCATIONS TO:

U.S. NUCLEAR REGULATORY COMMISSION. REGION IIMATERIAL RADIATION PROTECTION SECTION101 MARIETTA STREET. SUITE 29110ATLANTA, GA 30313

IF YOU ARE LOCATED IN:

ILLNOIS. INDIANA. IOA MICIGAN. MINNESOTA. IMOURI. OHIO. ORWISCONPN. SEND APPLICATIONS TO:

U.S. NUCLEAR REGULATORY COMMISSION. REGION IIIMATERIALS LICENSING SECTION799 ROOSEVELT ROADGLEN ELLYN. IL 60137

ARKANSAS. COLORADO IDAHO. KANSAM. LOUISANA. MONTANA. NEBRASKA.NEW MEXICO. NORTH DAiKOTA. OKLAHOMA. SOUTH DAKOTA. TEXAS. UTAH,On WYOMING. SE• APPLICATIONS TO:

U.S. NUCLEAR REGULATORY COMMISSION. REGION IVMATERIAL RADIATION PROTECTION SECTION611 RYAN PLAZA DRIVE. SUITE 1WOARLINGTON. TX 76011

ALASKA, ARIZONA. CAUFORNIA. AWAIJI. NEVADA. OREGON. WASHINGITON.AIROUS TERRITORIES AND PIO 4 i IN TH4E PAIFIC. SEND APPLICATIONS70:

U.S. NUCLEAR REGULATORY COMMISSION. REGION VMATERIAL RADIATION PROTECTION SECTION1450 MARIA LANE. SUITE 210WALNUT CREEK. CA 94S96

PERSONS LOCATED IN AGREEMENT STATES $D APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMASSI ONLY IF THEY WI TO P E AND UE LICENSED MATERIALMi STATES SUBJECT TO U.& NUCLEAR REGULATORY COMMIlON JURRISICTION.

1. THIS IS AN APPLICATION FOR f w p w) 2. NAME AND MAILING ADDRESS OF APPLICANT J1.okdZ* Ca"J

A. NEW LICENSE

S. AMENDMENT TO LUCENS NUMMER

C. RENEWAL OF LICENSE NUMBER

3. ADOPES•ESI WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED.

4. NAME OF PERSON TO SE CONTACTED ABOUT THIS APPUCATION TELEPHONE NUMBER

SUBMIT ITEMS 5ITROUGH ?1 ON xl a 11 PAPER. THE TYPE AMC SCOPE OF INFORMATION TO BE PROVIDED IS DESCRISBED IN THE UICENSE APPLICAT;,ON GUIDE.

S. RADIOACTIVE MATERIALa. EWm wnI&meinu ft~. b. va.M lorM 1 0 mW ta.w M cn. . =W aanmo 6. PURPOSEISI FOR WHICH LICENSED MATERIAL WILL BE USED.

INDIVIODUALIS P REWONSIBLE FD3R RADIATION SAFETY PROGRAM AND THEIR S TRAINING FOR INDIVIDUALS WORKING 1N 0R PPEUENTNG RESTRICTED AREAS.TRAINING AND EXPERIENCE.

9. FACILITIES ANR EQIPI•MNT. 1 RADIATION SAFETY PROGRAM.

12. LICENSEE FEES 4 IO COR 170OA.•M w,, 4712.31)

11. WASTE MANAGEMENT. FECTGR

BINDING UPON THE APPLICANT.THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CER,'F:CATION ON BEHALF OF THE APPCICANT. NAMED IN ITEM 2. CERTIFY THAT THIS APPLICATION ISPREPARED IN COK'FORMITY WITH TITLE 10. CODE OF FEDERAL REGULATIONS. PARTS 30. 2.33.34.35. AND 40 AND THAT ALL INFORMATION CONTAINED HEREINIS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF.

WARNING: 18 U.S.C. SECTION 601 ACT OF JU•E 25. 194. E2 STAY. 749 MAKES IT A CRIMINAL CFFEr4E TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATIONTo ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISOICTION.

SIGNATURE-CERTIFIrING OFFICER "TYPED•/RNTED NAME rTITLE 1DATE

la VOLULTA-' E,.,NONiiC DATA---- %A=S U.L &Ul - b . NUMBER OF EMPLOYEES frowf for d, WOULD YOU BE WILLNG TO FURNItSH COST INFORMATION lamil.afOWS1wffhaum

ElM--3.M me mdws I'ov wkwaA -. 1 cW 'na ON THE ENOMIC IMPACT OF CURRENT NRC REGULATIONS OR ANY FUTUREPROPOSED NRC REGULATIONS THAT MAY AFFECT YOU' PNRCmpi94owo~

- SM-10 c7. NUMBER OF BEDS-- S;•->- Siam Y•'ES r-!No

FOR NRC USE ONLY

TYPE OF FEE FEE LOG FEE CATEGORY COMMENTS APPRDVED BY

AMOUNT RECEIVED NMECK N ER DATE

PRIVACY ACT STATEMENT ON THE REVERSE

EXH-3

EXHIBIT 1 (Continued)

PRIVACY ACT STATEMENT

Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the follow-ing statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on NRC Form313. This' information is maintained in a system of records designated as NRC-3 and described at 40 Federal Register 45334(October 1, 1975).

1. AUTHORITY: Sections 81 and 161 (b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201 (b)).

2. PRINCIPAL PURPOSE(S): The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFRParts 30, 32, 33, 34, 35 and 40 to determine whether the application meets the requirements of the Atomic Energy Act of1954, as amended, and the Commission's regulations, for the issuance of a radioactive material license or amendmentthereof.

3. ROUTINE USES: The information may be (a) provided to State health departments for their information and use;and (b) provided to Federal, State, and local health officials and other persons in the event of incident or exposure,for their information, investigation, and protection of the public health and safety. The information may also be dis-closed to appropriate Federal, State, and local agencies in the event that the information indicates a violation or potentialviolation of law and in the course of an administrative or judicial proceeding. In addition, this information may be trans-ferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for an NRC decision or toan appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT- PROVID-ING INFORMATION: Disclosure of the requested information is voluntary. If the requested information is not furn-ished, however, the appication for radioactive material license, or amendment thereof, will not be processed. A requestthat information be held from public inspection must be in accordance with the provisions of 10 CFR 2.790. Withhold-ing from public inspection shall not affect the right, if any, of persons properly and directly concerned need to inspectthe document.

5. SYSTEM MANAGER(S) AND ADDRESS: U.S. Nuclear Regulatory CommissionDirector, Division of Fuel Cycle and Material SafetyOffice of Nuclear Material Safety and SafeguardsWashington, D.C. 20555

EXH-4

NRC FORM 313-

EXHIBIT 2

SUPPLEMENT A

SULPLEMENT U.S. NUCLEAR REGULATORY COMMISSION

TRAINING AND EXPERIENCE -

AUTHORIZED USER OR RADIATION SAFETY OFFICER

i. NAME OF PROPOSED AUTHORIZED USER OR RADIATION SAFETY OFFICER 2. FOR PHYSICIANS, STATE ORTERRITORY WHERE LICENSED

3. CERTIFICATION

SPECIALTY BOARD CATEGORY MONTH AND YEAR CERTIFIEDA C

4. TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIOUES

TYPE AND LENGTH OF TRAINING

CLOCK HOURS IN CLOCK HOURS OFFIELD OF TRAINING LOCATION AND DATE S) OF TRAINING LECTURE OR SUPERVISED

A LABORATORY ON-THE-JOBEXPERIENCE

a. RADIATION PHYSICS ANDINSTRUMENTATION

b. RADIATION PROTECTION

r MATHEMATICS PERTAINING TOTHE USE AND MEASUREMENTOF RADIOACTIVITY

d. RADIATION BIOLOGY

a.RADIOPHARMACE UTICALCHEMISTRY

L EXPERIENCE WITH RADIATION. (Actual um of Radioistopes or EQuivalent Exprience)

ISOTOPE tamCt USED AT ONE TIME: LOCATION CLOCK HOURS TYPE OF USE

EXH-5

EXHIBIT 3

SUPPLEMENT B

SUPPLEMENT U. S. NUCLEAR REGULATORY COMMISSION

PRECEPTOR STATEMENT

SiPOlem wit 8 wstb c@mPked by Vi #plicatphysuicswspcemptue. If mewiwi twiepmmwor aneciny 0doJffntvxpewnce. obvin a 'epamm strahlmlt fmam ewl.

I. PROPOSED PHYSICIAN USER'S NAME AND ADDRESS

F?;ULL NAME

STREET ADDRESS

KEY TO COLUMN CPERONAL PARTICIPATION S4OULPD CONISIT OF:

1.Sugervised einmuuigtion of patietm to dtermine the ault bilitY forradolbtOpe8 €lauoSI aend/or trimtnnt end reaomnernmition forpwespbd dom

2-CllatbIon In dome cllbrmion and scUai acirnltramton of doseto the patient induding cmilation o the radiation done. relatedn•awumts and plotting of data.

3-Adauete p wlof training tO enable phyasician to manegp radioactivepatients and follow patieont through la oss and/or Cours oftetmennt.

ENCE OF ABOVE NAMED PHYSICIANkER OFVrOLVING CaMENTSONA. j *ci ffentoomt n or comunent; nmyWATION J a rubmiew Mi duopicad arpaw ~aee I.

0

CITY I bTATL 1 zip Cam

I

EXH-6

EXHIBIT 3 (Continuedc)

PROPOSED PHYSICIAN USER

I.

c

PRECEPTOR STATEMENT (Continued)

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Conwtinued)

NUIMBER OFCASES INVOLVING COMMENTS

ISOTOPE CONDITIONS DIAGNOSED OR TREATED PERSONAL IAdditonal infaormtion or cwunwmna my bePARTICIPATION wbmirtdin ipicam on aspa Ph eeoL)

A C DP.32 TREATMENT OF POLYCYTHEMIA VERA.

5 e6 LEUKEMIA. AND BONE METASTASESP-32P-32 a INTRACAVITARY TREATMENT

TREATMENT OF THYROID CARCINOMAI-I 31

TREATMENT OF HYPERTHYROIDISM

Au-198 INTRACAVITARY TREATMENT

Co6O INTERSTITIAL TREATMENTor

Cab137 INTRACAVITARY TREATMENT

1-126or INTERSTITIAL TREATMENT

or TE LETHE RAPY TREATMENTCs-137

Sr-90 TREATMENT OF EYE DISEASE

RADIOPHARMACEUTICAL PREPARATION

TMc.99 GENERATOR

Sn-113m GENERATORIn-1 13m

Tc-99rm REAGENT KITS

Odwr

3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CUNICAL RADIOISOTOPE TRAININGLOCATION DATES CLOCK HOURS OF EXPERIENCE

4. THE TRAINING AND EXPERIENCE INDICATED ABOVE & PRECEPTORs SIGNATUREWAS OBTAINED UNDER THE SUPERVISION OF:46 NAME OF SUPERVISOR

u. NAME OF INSTITUTION 7. PRECEPTOR'S NAME IPleam W orptnnti

c. MAILING ADDRESS

4L CITY B. DATE

5. MATERIALS LICENSE NUMBER(S)

EXH-7

EXHIBIT 4

RESIDENT'S SUPPORT TECHNOLOGY TRAINING TASK LOG

Name:

Task

1.. Hot lab.a. Log and monitor incoming packages.b. Elute generator.c. Measure and record Mo and Al

concentrations in eluate.d. Prepare each radiopharmaceutical kit

used. Measure tagging efficiency.e. Calculate volume of radiopharmaceutical

needed for prescribed dosage. Draw andmeasure dosage.

f. Perform constancy, accuracy, linearity,and geometry tests on dose calibrator.

g.h.

2. Camera.a. Center photopeak, focus lens and dot.b. Perform and evaluate extrinsic and

intrinsic field uniformity checks.c. Perform, and evaluate spatial resolution

checks.d. Check motion switches for safe

operation.e.f.

3. Processor and dark room.a. Operate processor.b. Prepare fresh chemistry.

Clean transport and crossover racks.d. Check safelight.e.f.

4. Safety surveys.a. Perform dose rate survey of clinic.b. Perform removable contamination survey

of clinic.c. Survey and log decayed waste.d.e.

DatePerformed

SupervisingTechnologist'sInitials

Preceptor

EXH-8

Supervi

s i ng

Technol

ogi

st' s

Initials

EXHIBIT 5

RESIDENT'S CLINICAL PROCEDURES TRAINING LOG

Name:

Clinical Procedure

Thyroid scan

Thyroid uptake

Lung perfusion scan

Xenon ventilation study

Aerosol ventilation scan

Renal flow scan

Brain scan

Liver/spleen scan

Bone scan

Gastroesophageal study

LeVeen shunt study

Cystogram

Dacryocystogram

Cardiac perfusion scan.

Cardiac stress ventriculogram

Cardiac rest ventriculogram

Gallium scan

DatePerformed

SupervisingTechnologist'sInitials

Preceptor

EXH-9

HALLWAY Rm 4579 Rm 4581

REST RESTGAMMA ROOM ROOM BUILDING E XTE RIOR

CAMERA

LEAD BRICKHOT LAB

- STORAGE

CAMERA ROOM LEAD

READING ,,xSROOM GENERATORROOM 1-4

"___V"L" SHIELD 4

DRESSINGROOM DOSE

E -CALIBRATORHOSIK

- HOT SINK'

DRESSING 7 -o -LEAD BRICKROOM

Rm 4504 Rm 4502 - WASTE AREA

HALLWAY FUME HOOD SCALE 1" 4'

EXAMPLE OF AN ACCEPTABLE TYPE OF LAYOUT DIAGRAM FORA FACILITY DESCRIPTION INCLUDING SHIELDING PROVISIONS

EXHIBIT 7

Owner:

Manuf acturer:

Meter model:

Calibration Source:

I

Survey Meter Calibration Report

Department:

Type: o Ion Chamber o GM o NaI(Tl) o

Meter S/N: Probe model: Probe S/N:

mci of . mR/hr at in on ,19 •

Instrument checks: Battery check:___ /hr or

Constancy check: o integral check source indicates

0 mCi of indicates

Calibration Geometry: ojv * Qwr iUf W ,V- C

Window: o open o closed o fixed

mR/hr.

mR/hr.

o0

dist =R/hr(feet) today

Scale:Rdng CorFac

Scale:Rdng

Scale:Rdng CorFac

Scale:Rdng CorFacCorFac

____________________ - - - d

________I. _________

Correctien Factors:

Calibration Sticker

game:Date:_____

Cald - - with// -, window:scale CorFac

bat_:"_mR/h.-

----- ,chk:"._/r"

EXH-12

EXHIBIT 7 (Example)

Survey Mete• Calibration Report

Owner: A6 ý $ Ae? 6ý W~ I Department: ZLLZ/d.JManM~a.f u.cr er: IAI Type: 4Ion Chamber o GM o NaI(TI) oMeter model:A 6ý /ter S/N:. Probe model: 44a Probe S/N:••r oo•ooo:/=f o Id. or__y=l 1962•.Calibration Source: , ;mCi of 462S Al .i~ZmPR/r at iX 'n± G 9.

Instrument checks: Battery check: _fyT or 4je%&4v .. ,L "i3'A 4a77

Constancy cAeck:, dintegral chck source indicates L 2_LzR/hr.

o __mCi of - indicates mPR/hr.

Calibration Geometry: 04v* ovv cjýv 0Window: o open o closed afixed

Idi~st mR/hr149,eet'rtoday

Scale: /140Rdng CorFac

Scale: /6ARdng CorFac

Scale: /ARdng CorFac

Scale:Rdng CorFac

4/a ,• -'l /,.0 7

-,771, _ -.- -

Correctien Factors: / 0ý

Naze:.6'I*7ADate:T "2,ý4

Calibration Sticker

.,d .with(~9±, window::scale CorFac

• i.' bchk:-,,!_./

EXH-13

EXHIBIT 8

in

C4

Dose Calibrator Linearity TestManufacturer:_- __ _

Model :__ __SN:

tCi hoursdate time assay elapsed

I I:-i -

- - -i

-i--i

I :1:1

worst point deviation:

-- I

Im i, J

aap.

S

m

q

#4

#4

0I I I III I i l l I . . . . I I • l l l , [ f l E

I I I I I I l i i

10 20 30EXH-14,

40 50 60 70

EXHIBIT 8 (Example) Dose Calibrator Linearity TestManufacturer: x-//•iJ

Model: -•.3 SN:1252-

mCi hoursdate time assay elapsed

60

J/ *

p..e

0)

*1

SSp.S

S

6

.,67. 6

0

warsy point, di ation:~

'D

- -- I *-.-.- ~ .. - .....c~:. . 3..0

±4 ... : .z~..-:..J...: .- :~;.- - - J

____________________ .~. *

-7 ::L : --. ;1- i4. -

S- I--.---I---t...I- -*--~~-**--- -,..--..--.-.iwI~~~~~~~~~:7 7 -7--- 4...----J.--- .i

t i I

p I ------------

0 10 20 30 40 50 60EXH-15

70

EXHIBIT 9

Dose Calibrator Geometry and Accuracy

Model-:Manu'--cturer:

Syringe Geometry Depe

SN:

~ndence Vial Geometry Dependence. m

44ii

+=

1 7 -4Z 7.

) 0.5 I.U 1.5 Z.O 0 5 10 15 20 25

RSO:Date: By:

Accuracy*Sources 19 19

mCi of first assay: mCi first assay: mCi

Model: second assay: mCi second assay: mCi

SN: third assay: mCi third assay: mCi

Calibration date: average: mCi average: mCi

mCi dev: mCi dev:





mCi dev: mCi dev:





mCi dev: mCi dev:

Name:

Date:

EXH-16

EXHIBIT 9 (Example)

Dose Calibrator Geometry and Accuracy

Manufacturer:___________

Syrnqe Geometry Dependence

Model ia SN:

......... -'---4.4 -~

.~--. + TI

Vial

I.,!'.11 Geometry Dependence

R II l l

...........

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

!

-, -

.3 0 0.5 1.0 1.5 Z.O b 5 10 15 20 25

.42.0 yg-& - -t0 •-j .%7 -_ _

Date: 5 2,7 f' By: O: 4z //~h7

l9~Accuracy Sources 19 __f• jnCi of first assay:._ mCi first assay:-./ mCi

Model: second assay: S Z mci second assay:/,5!n CiSN: Z third assay: mCi third assay :. mCiCalibration date: average: 47iu average:_ _._pCi

/ /Y 6 Ci devK --,• !_1 mCi dev:&4

___mCi of 6 /7 first assay: 9zICi f irst assay: .~ mCiModel: ."-5-1/27z..- second assay: 6mci second assay:,/o/,mCi

SN: oý Zthird assay: . mCi third assay: i/•nCi

Calibration date: average:..• mCi average: J._ MCi

/ 3/ .• _____mCi dev: 0C/ ./OJ mCi dey: ,v /


Model: second assay: mCi second assay: mCiSN: third assay: mCi third assay: mCi


mCi dev: mCi dev:

Name: AL eýta/AALa"7, 6'

/

Date:6

6'EXH-17

EXHIBIT 10

Radioactive Spill Report

amThe spill occurred at : 'pm on room

Instrument used to check for personnel contamination:Meter model: Meter S/N: Probe model: Probe S/N:

Personnel present Personnel contamination results*

*On the back of the sheet, indicate any personnel decontamination, additionalmonitoring, or care instituted.

Survey the spill area to identify hot spots, then begin decontamination. Whenfinished, conduct a postcleaning contamination wipe-test.

Radioisotopes present or suspected in the spill:

mCi of as

mCi of as

mCi of as

Give a brief description of the accident:

Give a brief description of followup actions taken to prevent recurrence:

Name:Date:

EXH-18

EXHIBIT 10 (Example)

Radioactive Spill Report

The spill occurred at "_1:L on _j__-/•-f4 inroomi .-"

Instrument used to check for perso nelMeter model: ,2/ Meter S/N:

.7roe preen

/ 'contamination:

Probe model: Probe S/N:

Personnel contamipation results*

*On the back of the sheet, indicate any personnel decontamination, additionalmonitoring, or care instituted.

Instrument used to survey spill area befcre cleanup:,Meter model: Meter S/N: Probe model: Probe S/N:Survey the spill area to identify hot spots, then begin decontamination. Whenfinished, conduct a postcleaning contamination wipe-test.

Radioisotopes present or suspected in the spill:

mCi of as /?mCi of as

Give a brief description of the accident: Z45 /A0

Give a brief description o followup tions taken/o preven, recurrence:..7.

Name: (Al A '74-X-,Date://-" /6 .4

EXH-19

The spill occurred at

Radioactive Spill Contamination Survey i

: •JR on - - in room . Decontamination complete~d at

S pre- pjiccleanIlcmR/hr mR

-*--Jffl.

ost-cleandpm/ 2

/rl 100cm

mr

0

- -

ms-I

-IHH

'Name:

Radioactive Spill Contamination Survey

The spill'occurred at ii- in room 4 '. Decontamination completed at

1 oc

pre-cleanmR/hr

post-cleandpm/ 2

mR/hrt100cm

m

'-AfI1

1-i

/ 2 6W __

£

- -~ - -

rri

MX

-A-e-4

X

Name:Name: 41.4

EXHIBIT 12

PACKAGE RECEIPT AIND MOHITOR LOG

date purchase packingreceived order no. slip no. mCI Iso

catalogue pkg mR/hrsupplier number nke? •tavfchemical nnfac 4 4 IF

TV'

NN

suplie nu e o? .-


PACKAGE RfCEIPT AND MONITOR LOG

datereceived

purchase packingorder no. slip no.

catalogue pkgnumber ok?

mR/hrsurfmci iso chemical supplier notes Initt

rnX

rlý

;a -6 --

EXHIBIT 13

UNIT DOSAGE RECEIPT AND USE LOG FOR AS

datei -ceived

dosagemci

labeltime

datedl spensed

measuredmCisupplier lot time patient ID number Itni

ID nube ini -

mN

I I I 1 1 1 1 1 1

- - -


UNIT DOSAGE RECEIPT AND USE LOG FOR • /?•d<AS, Y. •/

daterecei ved

dosage labelmCi time

datedispensed

measuredmCIsuppliler lot time patient ID number Init

ni

__ _ _ _ _ _ _"__ _ { k . I. 6'•

I--

4/ d5 I

EXHIBIT 14

IIULTIDOSE VIAL PREPARATION AND USE LOG FOR AS

measuredcc MCI patient

dateprepared

generatortime received, kit source kit lot mCI/cc ID ntwner 11i I

I I I T I I

1 I I I I I

1 r I 1 1

r" 1 1 I I 1 1 1 1 -F

---- I--I I -I- I I I- t I

____________ I I 4 4

I _


MULTIDOSE VIAL PREPARATION AND USE LOG FOR ASQV# a

dateprepared time

generatorreceived

measuredcc mcikit source kit lot mCi/cc patient ID number init

-.-

- -

_ _, -

EXHIBIT 15

SHORT-LIVED IMPLANT SOURCE LOG

Only the following individuals may handle these sources:

RSO:

isodate:

Received on

no_ _ seeds of

act

@ mCi each

in storageno mCi

taken outno mCi

returnedno mCidate time patient name mR/hr init

- - - --- --

- a - - --

- --- --

- -- -- a -

- - a - -- --

- - - - a a a

- - a - -- - -

- - - - - a -

- - a - - a a

- - - - -- a -

- a - a - a -

EXH-28


SHORT-LIVED IMPLANT SOURCE.LOG

Only the following individuals may handle these sources: S. MI dd,r1.D.Bea Wachen, Therapy Technologist Jq John Hewitt, RS

I

Received on 6 6) d•,no i / act

-IM__ seeds of .. inCi each

,ate:5J 2 JA6

In storageno mCidate time

taken outno mCI

returnedpatient name mPJhr ]ntt

no mi no mci Datlent name mRlhr init- --- -.. ...-J7 2 f4 L.15,/5 50 •, "• /5 oq i-. -<>, : • • •,,i1•, O •

/_____. .6 /, • ;•,____- 15-

-" - - --

- - - - - - -

- - - - - -

- --

EXH-29

EXHIBIT 16Radiation Survey for the month ofSAMPLE , 19

Instrument:__________

VAPDB VIEN OF NOT LO

mR/hr at location

5 6 7 8 9 10 -n 12date 1 2 3 4 imit'.l-i ger -

- -

- - --- - -

- - - - - - -

- - - - - - -,

- - - - - - - -

- - -- - - - -

-i-

EXH-30


SAMPLE Radiation Survey for the month of .•4 l., 19

Instrument / /_ _ '

IIMT±~nT=LiiEMVA VIEW OF 1 LAB

mR/hr at locationdate 1 2 3 5 6 7 8 9 10 3.1 12 init

. - . - - . - . - - p - - - - q - p - p - p - - p -$t' ~~ O 02 .02 .02 10.11 0.1 I .02 .02 Io.s 10,5 10.7 11.2 Ii.o

/ .ae.r .02 0.110.15 .02 .02 0.5 10.5 0.7, 11.2 1.0.a2.Z . . ..o.6 . • • a e

-,4 -/ -/ ---- -----------

- 14 -0 -0? 9e 6 02 ----- --------------

-... - - - - - - - - - - -

EXH-31

EXHIBIT 17

NURSING INSTRUCTIONS FOR PATIENTS TREATED WITH IODINE-131,PHOSPHORUS-32, OR GOLD-198

Patient Name:Attending: Phone:-

Patient Number:Pager: Patient Room:

Dose: mCi of as was administered at a:Signature: Date:

RADIATION EXPOSURE RATES

Unrestricted areas: door- mR/hr; rm - mR/hr; rm -Patient supine in bed or

mR/hr

Date Timeam

- _pmam.pmam

-___pm

am- _pm

amSpm

am: _ pm

Bedside

mR/hr

mR/hr

mR/hr

mR/hr

mR/hr

3 ft from bed

mR/h

mR/h

mR/h

mR/h

mR/h

mR/h

Door

mR/hr

mR/hr

mR/hr

mR/hr

mRihr

mR/hr

mR/hr

mR/hr

mR/hr

mR/hr

INSTRUCTIONS

Vistor Restrictions:o No visitors.o No visitors under 18 or pregnant.o minutes each day maximum for each visitor.SV-isitors must stay behind line on floor at all times.-

Nursing Restrictions:o Patient is restricted to room.o No nurses who are pregnant may render care.0 minutes each day per nurse in the room.

Patient Care:o Wear disposable gloves. Wash your hands after caring for patient.o Discard linen, bedclothes, plates, utensils, dressings, etc., in boxes in room." Collect urine in containers provided. Discard feces in toilet.o Discard urine and feces in toilet. Flush three times.o Housekeeping personnel are not permitted in the room.o Only RSO may release room to admitting office.o Wear your radiation monitor when caring for patient. Leave at nursing

station at the end of your shift. You may use the same monitor on your nextshift. Do not share. Call RSO for additional monitors if needed.

00

In case of emergency, or if you have a question, call:RSO: Work: Home: -

MD: Work: Home:- -

EXH-32

Pager:_-Pager:

EXHIBIT 17 (Example)Nursing Instructions for Patients Treated With Iodine-131,

rI-,spheruz 32, a! uid 1.98

Patient Name:.a A/6/• • Patient Number: A/ýý /Attending: 0,0 Phone-T Pager:,.0 Patient Room : C

Dose: /50..mCi of -/5/ aýa_/2!/was administered at LQ..:5Om.Signature: Z. A, te:_-

Radiation Exposure Rates

Unrestricted areas: door- ý.mR/hr; rm4 6.?' mR/hr; rm•hý 0.2- mR/hrPatient supine in bed c'--

Date Time

am: pm

am___pm

Bedside

__-__mR/hr

Z• mR/hr

mR/hr

3 ft from bed

_____mR/h

•"7mR/h

mR/h

Door

_Z. _9mR/hr

_!2- mRhr

mR/hr

mR/hr

mR/hr

2. mR/hr

mR/hr

mR/hr

Instructions

mR/h

7. mR/h"

mR/hr

Visitor Restrictions:o No visitors.V•No visitors under 18 or pregnant..Q'3jminutes each day maximum for each visitor.'Visitors must stay behind line on floor at all times.

Nursing Restrictions:7 atient is restricted to room.:4o nurses who are pregnant may render care.oV•.&minutes each day per nurse in the room.Pa ient Care:

Wear disposable gloves. Wash your hands after caring for patient.

e Discard linen, bedclothes, plates, utensils, dressings, etc., in boxes in room.o Collect urine in containers provided. Discard feces in toilet.e Discard urine and feces in toilet. Flush three times.V Housekeeping personnel are not permitted in the room.

;Only RSO may release room to admitting office.Wear your radiation monitor when caring for patient. Leave at nursing stationat the end of your shift. You may use the same monitor on your next shift.Do not share. Call RSO for additional monitors if ed.

0

Ir. case of eme g. or if you have a question, call:

RSO://v•. •_Work: HoamMDIv.Work: Ham

e :le: -

Pager:,__Pager,

...... •Tr

EXH-33

EXHIBIT 18

RADIATION SAFETY CHECKLIST FORIODINE THERAPY OVER 30 MILLICURIES

Patient: Room: Date:

PREPARATION

o Schedule a private room, with private sanitary facilities and withoutcarpet, in a low traffic area.

o Cover large room surfaces with absorbent paper and small surfaces withabsorbent paper or plastic bags.

o Prepare labeled boxes for used linen, disposable waste, and nondisposablecontaminanted items.

o Prepare urine collection containers if urine will be collected.

o Stock room with disposable gloves, absorbent paper, and "radioactive waste"labels.

o Mark a visitors' "safe line" on the floor.

o Order disposable table service.

o Notify housekeeping to not clean the room until further notice.

o Brief the nursing staff on radiation safety measures.

o Supply the nursing staff with personnel radiation dosimeters.

ADMINISTRATION

o Clear the room of unneeded personnel.

o Brief the patient on the clinical procedure..

o Administer the dosage.

o Measure dose rates at bedside, 1 meter from bedside, visitors' "safe line,"and surrounding hallways and rooms.

o Post the room with a "Radioactive Materials" sign.

FOLLOWUP

o Measure the thyroid burden of all personnel who were present for theadministration.

o Pick up waste for decay-in-storage or decontamination.

o Release the patient.

o Decontaminate and survey the room. Remove the "Radioactive Materials" sign.

o Call the Housekeeping Office to clean the room.

EXH-34

EXHIBIT 19

RADIATION SAFETY CHECKLIST FORTEMPORARY IMPLANT THERAPY

Patient: Room: _ _ Date:

PREPARATION

" Schedule a private room in a low traffic area.

o Mark a visitors' "safe line" on the floor.r

o Brief the nursing staff on radiation safety measures.

o Supply the nursing staff with personnel radiation dosimeters.

IMPLANT

o Clear the room of unneeded personnel.,

o Brief the patient on the clinical procedure.

o Insert the implant

" Measure dose rates at bedside, 1 meter from bedside, visitors' "safe line,"and surrounding hallways and rooms.

o Post the room with a "Radioactive Materials" sign.

FOLLOWUP

o Make a radiation survey of the patient to assure that all sources have beenremoved.

o Count the number of sources removed from the patient to assure that allsources have been removed.

o] Remove the "Radioactive Materials" sign.

EXH-35

EXHIBIT 20

NURSING INSTRUCTIONS FOR PATIENTS-TREATED WITHTEMPORARY IMPLANT SOURCES

Patient Name: Patient Number:Attending: Phone: Pager:__ Patient Room:__Dose: mCi of as individual sources •,:s loaded on -

amSources will be removed at approximately __:__pm on - -

RADIATION EXPOSURE RATES

Unrestricted areas: door- mR/hr; rm - mR/hr; rm mR/hrPatient supine in bed or

Date Time Bedside 3 ft from bed Door

am__:__pm __ mR/hr mr/h mR/hr mR/hr

Release certification: Patient may not be released from the hospital until thefollowing certification is signed and dated by the RSO or the attending physician.

I have removed and counted individual sources from this patient. A low-rangeGM survey of the patient failed to indicate any remaining sources in the patient.

Signature,: Date - -

INSTRUCTIONS

Visitor Restrictions:o No visitors under 18 or pregnant.o minutes each day maximum for eachvisitor.o VTsitors must stay behind line on floor at all times.

Nursing Restrictions:o Patient is restricted to room.o Patient is restricted to bed.o Patient must not move.o No nurses who are pregnant may render care.o minutes each day per nurse in the room.

Patient Care:o Wear your radiation monitor when caring for patient. Leave at nursing

station at the end of your shift. You may use the same monitor on your nextshift. Do not share. Call RSO for additional monitors if needed.

13 If a source appears dislodged, call the attending physician and the RSOimmediately.

o Omit bed bath.o No perineal care. Pad may be changed as necessary.o Save surgical dressings for disposal by attending physician or RSO.o See special oral hygiene care instructions.

13

In case of emergency, or if you have a question, call:RSO: Work: Home: - Pager:

MD: Work: Home: - Pager:

EXH-36


Nursing Instructions for Patients Treated WithTemporary Implant Sources'

Patient Name: Patient Number: 1,12562/O'!Attending: j. /one:• Pager:&Z Patient Room: 4:/5Dose: O___mci of Z.4-..2as individual sourc was loaded on

Sources will be removed at approximately :4 on &-,-46.

Radiation Exposure RatesUnrestricted areas: door-J•/ mR/hr; r.• 3 ,jmR/hr; J.•X 62,mRlhr

Patient supine in bed o" : :.

Date Time Bedside 3 ft from bed Door J/;.

J--AZ . ,L: m ______mR/hr "0mR/h /./ mR/hr './mR/hr

Release certification: Patient may not be released from the hospital until thefollowing certification is signed and dated by the RSO or the attending physician.

I have removed and counted individual sources from this patient. A low-rangeGM survey of the patient failed to indicate aP>,emaining sources in the patient.

Signature:/ Date 01?at

InstructionsViv itor Restrictions:

No visitors under 18 or pregnant.e/3yminutes each day maximum for each visitor.e Visitors must stay, behind line on floor at all tires.

Nursing Restrictions:o Patient is restricted to room.o Patient is restricted to bed.o Patient must not move.e No nurses who are pregnant may render care.9, & minutes each day per nurse in the room.

ient Care:Wear your radiation monitor when caring for patient. Leave at nursingstation at the end of your Shift. You may use the same monitor on your nextshift. Do not share. Call RSO for additional monitors if needed.

VIf a source appears dislodged, call the attending physician and the RSOimmediately.

o Omit bed bath.o No perineal care. Pad may be changed as necessary.V Save surgical dressings for disposal by attending physician or RSO.e" See special oral hygiene care instructions.00

,?4Zn case of emergency, or ifyou have e !uestion, call:

, 5 lwca!_•_,e__,_ Home: Pager:s

WO 7 Home: Pager: _

EX.4-37

EXHIBIT 21

SAMPLE CESIUM IMPLANT SOURCE LOG

Only the following individuals may handle these sources:

RSO: date:

Normal storageconfiguration

1A IB 1C

2A 2B 2C

3A 3B 3C

4A 4B 4C

Activity at

20mCi : IA1OmCi : 2B

l5mCi : 4A

5mCi : 4C

each storage point

lB IC 2A

2C 3A 3B. 3C

4B

in storageno MCidate time

taken outno mCi

returnedno mCi patient name mR/hr init

- - - --- --

- - ---- -

- - - --- - a

- - --- --

- a - --- -

- - - --- --

- - - - - - --

a a -

EXH-38

EXHIBIT'21 (Example)

SAMPLE CESIUM IMPLANT SOURCE LOG

Only the following Individuals may ha dle these sources: S.

Bea 14acchen, Therapy Technologist Z John ewitt, RSO

Hudd, M.D.

date: / A 4_•

Normal storageconfiguration

1A 1B IC

2A 2B 2C

3A 3B 3C

4A 4B 4C

Activity at

20mCi: 1AIOmCi : 2B

15mCi: 4A

5mCi: 4C

each storage point

lB 1C 2A

2C 3A 3B 3C

4B

in storageno mCi

taken outno mCi

returnedno mCidate time patient name mR/hr init

- - - -

12 [ /--,-12---

EXH-39

VALUE/IMPACT STATEMENT

A draft value/impact statement was published with the proposedRevision 2 to Regulatory Guide 10.8 (Task FC 415-4) when the draft guidewas published for public comment in August 1985. No changes were neces-sary, so a separate value/impact statement for the final guide has notbeen prepared. A copy of the draft value/impact statement is availablefor inspection and copying for a fee at the Commission's Public DocumentRoom at 1717 H Street NW., Washington, DC, under Task FC 415-4.

V/I-1

UNITED STATESNUCLEAR REGULATORY COMMISSION

WASHINGTON, D.C. 20555

OFFICIAL BUSINESSPENALTY FOR PRIVATE USE. $300

FIRST ClASS MAILPOSTAGE f,-FEES PAlE

USNRCWASH. D.C.

PERMIT No. G.67