ML20141D792

for Comment Draft Reg Guide,Task Fc 414-4, Guide for Preparation of Applications for Licenses for Medical Teletherapy Programs

ML20141D792
Person / Time
Issue date:	12/31/1985
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
References
TASK-FC-414-4, TASK-RE REGGD-10.XXX, NUDOCS 8601070431
Download: ML20141D792 (100)

Text

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/#poseh U.S. NUCLEAR REGULATORY COMMISSION Dictmbar 1985 Division 10 3 'r, OFFICE OF NUCLEAR REGULATORY RESEARCH j g Task FC 414-4 DRAFT REGULATORY GUIDE Afl0 VALUE/ IMPACT STATEMENT O o%, /

Contact:

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....* P. Vacca (301)427-4002 l

k GUIDE FOR THE PREPARATION OF

<<< ,ATIONS l FOR LICENSES FOR j TELETHERAPY 0 j

! (Second draft, previousi d as TM 608-4) l

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g*f 8601070431 051231 PDR REQQD 10.XXXR PDR This regulatory pide and the associated valve / impact statement are bef ng f ttued in draf t form to involve the pubitc in the early sta,es of the development of a reoutatory position in this area. They have not received compiete staff reste. and do not represent an official meC staf f position.

Public coasnents are being solicited on both draf ts, the gufde (including any implementation schedule) and the value/ impact statement. Cosaments on the valve / impact statement thould be accompanied by supporting data, tfritten to.unents may be submitted to the Rules and Procedures 6 ranch, Dee. A0ff. U.S. Nuclear Regulatory Conantstion. Washington DC 70555.~ Coasnents may also be delivered to Room 4000. Maryland National Sant tutiding. ??)5 Old ficorgetown Road. Sethesda. 'taryland from i Stil a.m. to 5:00 p.m. Coptes of coaments received may be enemined at the Pet Pubile Document poom.1717 N $treet IW.,

mathington, DC. Comuments will be matt helpful if received by February 21, 1986.

Dewests for single copies of draf t guides (which may be reproduced) of for placement on an automatic distributton Illt for slagle copfet of future draf t pides in speelfic divisions thould be nysde in writing to the U.S. leuclear Replatory Coannittion, Ifashington, DC 20$$5. Attention: Director. Olvistan of Technical Information and Document Control.

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} TABLE OF CONTENTS l Section P_ age i

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1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 i 1.1 Purpose of Guide. . . . . . . . . . . . . . . . . . . . . . . 1 1.2 Applicable Regulations. . . . . . . . . . . . . . . . . . . . 1 1.3 As Low As Is Reasonably Achievable (ALARA) Philosophy . . . . 2

{ 2. FILING AN APPLICATION. . . . . . . . . . . . . . . . . . . . . . . 3

! 3. CONTENTS OF AN APPLICATION . . . . . . . . . . . . . ... . . . . . 5 1

Item 1 License Information . . . . . . . . . . . . . . . . . . 6 Item 2 Applicant's Name and Mailing Address ......... 6 Item 3 Locations of Use. . . . . . . . . . . . . . . . . . . . 6 l Item 4 Person To Be Contacted about Application ....... 7 1

-Item 5 Radioactive Material ................. 7 5.1 Sealed Sources To Be Used in Teletherapy Unit . .... 7 j 5.2 Teletherapy Unit . . ................. 7 j Item 6 Purposes for Which Licensed Material Will Be Used . . . 8 Item 7'

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Individuals Responsible for Radiation Safety 4

l. Program--Their Training and Experience ........ 8 7.1 Proposed Authorized Users--Human Use. . . . . . . . . . 8 4 7.2 Proposed Authorized Users--Nonhuman use . . . . . . . . 11 i 7.3 Proposed Radiation Safety Officer (RS0) . . . . . . . . 12 <

j 7.4 Proposed Expert . . . . . . . . . . . . . . . . . . . . 13 Item 8 Training for Individuals Working in or Frequenting l Restricted Areas . . ................. 14

!' 8.1 Applicable Regulation . . . . . . . . . . . . . . . . . 14 8.2 Licensing Criteria. . . . . . . . . . . ........ 14 i

8.3 ' Response. . . . . . . . . . . . . . . . . . . . . . . . 15 i

! Item 9 Facilities and Equipment ........ ...... 15

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l 9.1 Description of Facility . . . . . . . . . . . . . . . . 15 <

9.2. Viewing System .................... 16 ,

( 9.3 Warning Systems and Access Controls . . . . . . . . . . 17 9.4 Beam Stops .......... ............ 18

9. 5 - Adequacy of Shielding . . . . . . . . . . . . . . . . . 19 1

h Item 10 Radiation Safety Program ............... 23  !

1 1 l 10.1 Personnel Monitoring Program ............. 23 10.2 Instrumentation . . . . . . . . . . . . . . . . . . . . 24

l \~ /' 10.3 Calibration of Portable Survey Instruments ...... 25 l

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TABLE OF CONTENTS (Continued)

Section Page 10.4 Leak-Test Program . . . . . . . . . . . . . . . . . . 27 10.5 Operating Procedures . . . . . . . . . . . . . . . . 30 10.6 Emergency Procedures . . . . . . . . . . . . . . . . 31 10.7 ALARA Program . . . . . . . . . . . . . . . . . . 32 10.8 Radiation Safety Committee . . . . . . . . . . . . . 33 Item 11 Waste Management . . . . . . . . . . . . . . . . . . 35 11.1 Applicable Regulation . . . . . . . . . . . . . . . . 35 11.2 Licensing Criteria. . . . . . . . . . . . . . . . . . 35 11.3 Response. . . . . . . . . . . . . . . . . . . . . . 35 Item 12 License Fees . . . . . . . . . . . . . . . . . . . . . 35 Item 13 Certification . . . . . . . . . . . . . . . . . . 36 Item 14 Voluntary Economic Data . . . . . . . . . . . . . . . 36

4. AMENDMENTS TO A LICENSE. . . . . . . . . . . . . . . . . . . . 38

5. RENEWAL OF A LICENSE . . . . . . . . . . . . . . . . . . . . . 38 G. IMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . 39 APPENDIKES Appendix Page A Discussion of Questions of Particular Interest to Applicants Requesting Human Use Authorization . . . . . . . . . . . . . . . . A-1 B Description of Sealed Sources, Teletherapy Units, and Proposed Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 C Training and Experience for Teletherapy Users. . . . . . . . . . . C-1 D Personnel Training l'rogram . . . .. ... . . . . . . . . . . . . D-1 E Discussion of Unrestricted and Restricted Areas For Teletherapy.

Applicants and Licensees . . . . . . . . . . . . . . . . . . . E-1 F Teletherapy Survey Reports. . . . . . . .. . . . . . . . . . . . F-1 G Procedures for Calibration of Survey Instruments. . . . . . . . . G-1 H Topics That May Be Included in Operating Procedures . . . . . . . H-1 I Emergency Procedures for Beam Control Failure or Malfunction. . . I-1 J Model Program for Maintaining Occupational Radiation Exposures at Medical Institutions ALARA . . .. . . . . . . . . . . . . . . J-l K Radiation Safety Committee. . .. . ........... . . . . K-1 L Requests for License Amendments, Renewals, and Terminations . . . L-1 EXHIBITS A NRC Form 313. . . . . . . . . . . . . . . . . . . . . . . . . . . EA-1 B Sample Teletherapy License. . . . . . . . . . . . . . . . . . . . EB-1 Draft Value/ Impact Statement . . . . . . . . . .. . . . . . . . . . . V/I-l iv

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1. INTRODUCTION 1.1 PURPOSE OF GUIDE The purpose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals that authorize possession of byproduct materic' (i.e.,

reactor produced radionuclides) in a teletherapy unit for the treatment of human beings. This type of license is provided for in S 35.13 of the Nuclear Regulatory Commission's (NRC's) regulations in Title 10, Chapter I, Code of Federal Regula-tions, Part 35, " Human Uses of Byproduct Material."

Usually the NRC will issue a single material license to cover an institu-

, tion's teletherapy program; the license will include the needed authorization for source material * (i.e. , depleted uranium) contained as shielding in many

' teletherapy units. An institution's other medical programs will be covered in  ;

p a separate license.

This guide is intended to provide you, the applicant or licensee, with information that will enable you to understand specific regulatory requirements and licensing policies as they apply to medical teletherapy licenses. Appendix A answers several questions frequently asked by medical teletherapy applicants and licensees.

After you are issued a license, you must conduct your program in accor-dance with (1) the statements, representations,-and procedures contained in your application and correspondence with NRC, (2) the terms and conditions of your license, and (3) NRC's regulations. The information you provide in your applicaticn should be clear, specific, and accurate.

I 1.2 APPLICABLE REGULATIONS ,

l NRC regulations applicai,le to medical teletherapy operations are in 10 CFR Part 19, " Notices, Instructions, and Reports to Workers; Inspections"; 10 CFR Part 20, " Standards for Protection Against Radiation"; 10 CFR Part 21, " Reporting

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• The term " source material" is defined in paragraph 20.3(a)(15) of 10 CFR 2(L/) Part 20.

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of Defects and Noncompliance"; 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR Part 35, " Human Uses of Byproduct Material"; 10 CFR Part 40, " Domestic Licensing of Source Material";

and 10 CFR Part 170, " Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy A:t of 1954, as Amended." It is your responsibility as an applicant and licensee to have copies of, to read, and to abide by each regulation. As a licensee, you are subject to all appli-cable provisions of the regulations as they pertain to medical teletherapy operations.  ;

This guide identifies the information needed to complete NRC Form 313 for applications for a license for a medical teletherapy program. The information collection requirements in NRC Form 313 have been cleared under OMB Clearance l No. 3150-0120.

1.3 AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY Paragraph 20.1(c) of 10 CFR Part 20 states "... persons engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation exposures, and releases of radio-active materials in effluents to unrestricted areas, as low as is reasonably achievable." Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable,"* provides the NRC staff position on this important subject.

Two other NRC documents may be of special interest to medical organiza-tions. Regulatory Guide 8.18, "Information Relevant to Ensuring that Occupa-tional Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable,"* describes ways of applying the ALARA philosophy in medical institu-tions. NUREG-0267, " Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions As Low As Reasonably Achievable,"* contains I information and references useful in establishing radiation safety programs to l

naintain exposures ALARA in medical institutions. l

• Copies of regulatory guides and NUREG reports may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.

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I You should consider the ALARA philosophy as described in Regulatory f7

) Guides 8.10 and 8.18 and in NUREG-0267 in developing plans for work with licensed radioactive materials.

2. FILING AN APPLICATION You, as the applicant for a teletherapy license,'should complete NRC Form 313 (see Exhibit A of this guide). You should complete Items 1 through 4 and 12 through 14 on the form itself. For Items 5 through 11, submit the infor-mation on supplementary pages. Each separate sheet or document submitted with  ;

the application should be identified and keyed to the item number on the appli-cation to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review. If larger drawings are necessary, they should be folded to 8-1/2 x 11 inches. Note that blueprints should not be submitted. Blueprints are too large and usually do not contain all the information needed for the NRC's review.

You should complete all items in the application in sufficient detail for the NRC to determine that your equipment, facilities, training and experience,

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5 and radiation safety program are adequate to protect health and minimize danger to life and property.

l Please note that license applications are available for review by the gen- [

eral public in the NRC Public Document Rooms. Do not submit proprietary infor-mation unless it is absolutely necessary. If you must submit such information, follow the procedure in S 2.790 of 10 CFR Part 2. Failure to follow this pro-cedure may result in disclosure of the proprietary information to the public or substantial delays in processing your application.

Do not submit personal information about your employees unless it is necessary. For example, the training and experience of employees should be submitted to demonstrate their ability to manage radiation safety programs or to work safely with radioactive materials. Home addresses and home telephone numbers should be submitted only if they are part of an emergency response plan.

Dates of birth, Social Security numbers, and radiation dose information should be submitted only if specifically requested by NRC.

You should file your application in duplicate. Retain one copy for your-self, because the license will require that you possess and use licensed material dj 3

in accordance with the statements and representations in your application and any supplements to it.

If you wish to possess or use licensed material on Federal property or in any State subject to NRC jurisdiction, you should file your application with the NRC Regional Office for the State in which the material will be possessed or used. (A list of NRC's Regional Offices and the States they cover is provided below.) The exceptions to the above are the United States Air Force and Navy and persons wishing to distribute exempt material under 10 CFR Part 32, Subpart A, who should file their applications directly with the Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Twenty-seven States have entered into agreements with the NRC that give them the authority 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 respon-sible officials) may be obtained upon requested from the Material Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or from NRC's Regional Offices, whose addresses are listed below. .If you are a non-Federal organization that wishes to possess or use licensed material in one of these Agreement States, your application should be filed with the State's radiation control program and 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 Regulatory Commission, Region I, Nuclear Material Section B, 631 Park Avenue, King of Prussia, PA 19406.

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

• An " Agreement State" is any State with which the NRC or, previously, the Atomic Energy Commission has entered into an effective agreement under Sub-section 274b of the Atomic Energy Act of 1954, as amended. A current list of Agreement States (including names, addresses, and telephone numbers of respon-sible officials) may be obtained on request from the Saterial Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or from NRC's Regional Offices, whose addresses are listed in this section.

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'O If you are located in Illinois, Indiana, Iowa, Michigan, Minnesota, t

Missouri, Ohio, or Wisconsin, send your applications to the U.S. Nuclear Regula-tory Commission, Region III, Materials Licensing Section, 799 Roosevelt Road, 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 Wyoming, send your applicat. ions to the U.S. Nuclear Regulatory Commis-sion, Region IV, Material F?.diation Protection Section, 611 Ryan Plaza Drive, Suite 1000, Arlington, TX 76511.

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

3. CONTENTS OF AN APPLICATION This portion of the guide explains, item by item, the information requested on NRC Form 313. Typically each item includes an " Applicable Regulations" sec-tion that identifies pertinent regulations, a " Licensing Criteria" section that lists criteria against which 7n applicant's response will be judged, and a "Re-sponse" section that describes acceptable responses.

This guide contains several appendixes that present sample procedures or sample progre.s. You may wish to adopt one or more of these samples as part of your program. If so, you may adapt the following paragraph as a response to the appropriate item in your application:

! Item _: We, (name of teletherapy applicant), have established and l agree to follow the procedures for as described in Appendix _

of Draft Regulatory Guide FC 414-4, dated December 1985.

j If you refer in your application to a section or appendix of this guide or j

of any regulatory guide, that section or. appendix will be incorporated as a part of-the terms and conditions of your license. You will be inspected against j the commitments contained in the referenced section, appendix, or document, l just as you will be inspected against your more detailed responses. Therefore, bi you must keep a ccpy of. the referenced guide on hand at all times so that you can review your commitments as necessary.

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The following comments apply to the indicated items of NRC Form 313.

Item 1 - LICENSE INFORMATION For a new license, check subitem A. For an amendment to an existing  ;

license, check subitem B. For a renewal of an existing license, check subitem C. If you check subitem B or C, be sure to enter the number of your license.

Item 2 - APPLICANT'S NAME AND MAILING ADDRESS If you are an individual, you may be the applicant only if you are acting in a private capacity and the use of the radioactive material is not connected with your employment with a corporation or other legal entity. Otherwise, you, the applicant, should_ be the corporation or other legal entity applying for the license.

Note that, in the case of teletherapy, paragraph 35.12(a)(2) of 10 CFR Part 35 provides that a license may be issued in the name of a physician (or group of physicians) if the unit and source are to be used in an office outside a medical institution. Otherwise the applicant should be the medical institu-tion in which the unit and source are to be located.

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 licensed material will be used, as specified in Item 3.

Item 3 - LOCATIONS OF USE Ycu should describe the actual location of use, specifying the street address (including building name, floor, wing, room number), city, and State or other descriptive address (such as 5 miles east on Highway 10, Anytown, State) to allow us to easily locate your facility. A Post Office box address is not acceptable. If licensed material is to be used at more than one location, pro-vide the specific address and other descriptive information for each location.

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t Item 4 - PERSON TO BE CONTACTED ABOUT APPLICATION a

You should name the individual who knows your proposed program and can answer questions about your application. Note his or her telephone number. If the contact person changes, notify the NRC. Notification of a contact change is for information only and would not be considered an application for a license amendment.

Item 5 - RADI0 ACTIVE MATERIAL You must provide certain details about each sealed source you are requesting and the teletherapy unit in which the' source will be housed. You may find it convenient to provide the information requested in Items 5 and 6 by-using the form shown in Appendix B of this guide.

5.1 Sealed Sources To Be Used in Teletherapy Unit N For.each sealed source to be used for teletherapy, specify:

[O 1. The radionuclide (e.g. , cobalt-60).

2. The manufacturer's name and model number.

3. The maximum amount of radioactive material in any one source; express this amount in curies.

4. The maximum output for a source containing the maximum amount of radioactive material. Note that the output should be expressed in terms of roentgens per hour at 1 meter'(RHM) or roentgens per minute at 1 meter (RMM).

5. The total amount of radioactive material to be possessed at any one time; express this amount in curies. Applicants usually request a total posses-sion limit that is-twice the amount of the source in use. This permits possession of a second source stored temporarily at the facility during source exchange.

5.2 Teletherapy Unit Specify the manufacturer's name and the model name and number of the tele-

-s_/ therapy unit in which each teletherapy source will be housed. Specify whether 7

the unit will have an integral beam absorber (beam catcher) or will have a counterweight.

The teletherapy units should be keyed to the sources listed in Item 5.1.

NOTE: To speed the review of your application by the NRC, you should verify with your supplier that your requested sealed source and teletherapy unit and your maximum activity per source and maximum source output combina-tions have been reviewed and approved for licensing purposes by NRC or an Agree-ment State. If your combination has not been approved, contact the NRC licensing staff for additional guidance.

Item 6 - PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED Specify whether the teletherapy source will be used for treatment of patients only or whether it will also be used for other purposes. If you request other uses, describe them (e.g., irra.diation of animals). The requested uses should be keyed to the sources listed in Item 5.1. You may find it convenient to provide this information using the form shown in Appendix B.

Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM--THEIR TRAINING AND EXPERIENCE Paragraph 30.33(a)(3) of 10 CFR Part 30 specifies that, before an applica-tion is approved, you must be qualified by training and experience to use the material for the purposes requested in such a manner as to protect health and minimize danger to life or property. Similar requirements that pertain speci-fically to teletherapy are found in SS 35.11 through 35.13 and 35.24 of 10 CFR Part 35. Accordingly, you should describe the training and experience of your proposed authorized users and proposed radiation safety officer (RS0).

7.1 Proposed Authorized Users--Human Use ,

1 7.1.1 Applicable Regulations S 30.33(a)(3)

S 35.3(b)

S 35.11(d)

S 25.12(a)(4)

S 35.13(b) 8

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) 7.1.2 Licensing Criteria You should propose as authorized users for human use only those physicians whose training and experience meet or exceed that described in Part I of Appen-dix C of this guide. An authorized user for human use must be a physician as defined in paragraph 35.3(b) of 10 CFR-Part 35.

7.1.3 Response for Previously Licensed or Certified Physicians In response to Item 7.1, list the full name of each individual who will use, or directly supervise the use of, the teletherapy unit and source for treat-ment of patients.

For each individual you name, document _ training and experience that is at least equivalent to Part I of Appendix C. You may find it convenient to present this irformation using Supplements A and B in Appendix C (these forms may be reprodu ed as needed). The NRC, with the assistance of its Advisory Committee on the (edical Uses of Isotopes (ACHUI), has determined that the following

. constitute evidence of adequate training and experience for physicians who are proposed as users:

? I U 1. Being.specifically named as a user (for treatment of patients) on a teletherapy license previously issued by the Atomic Energy Commission (AEC),

the NRC, or an Agreement State. In this case, submit only the previous license number (if issued by AEC or NRC) or a copy of the license (if issued by an Agree-ment State).

2. Being certified as listed below:

a. By the American Board of Radiology (ABR) in radiology or thera-peutic radiology. In this case, submit Supplement A with items 1 through 3 completed,

b. By the American Osteopathic Board of Radiology (A0BR) in radiation oncology. In this case, submit Supplement A with items 1 through-3 completed,

c. By the Canadian Royal College of Physicians and Sergeons (RCPS) in therapeutic radiology. In this case, submit Supplement with items 1 through 3 completed and a copy of the RCPS certification.

d. As a British " Fellow of the Faculty of Radiology" (FFR) or " Fellow of the Royal College of Radiology" (FRCR). In this case, submit Supplement A LM - with items 1 through 3 completed, a copy of the FFR or FRCR certificate, and evidence of specialization in radiation therapy.

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7.1.4 Response for Physicians Who Have Not Been Previously Licensed or Certified Physicians who have not been previously licensed by AEC, NRC, or an Agreement State or have not been certified by one of the organizations listed above must submit detailed descriptions of their training and experience that will be reviewed on a case-by-case basis with the assistance of the ACMUI. For each such applicant physician, submit:

1. Completed Supplement A form.

In Item 4 of Supplement A, document at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training in basic radioisotope handling techniques applicable to sealed sources that covered instruction in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, and radiation biology. State where the training was obtained, the dates, total number of hours, and type of training. Hours of training should be broken down into lec-ture, laboratory, or on-the-job training (0JT). OJT must have been received in a formal training program. Be sure that individual hours of training can be traced to the institution where the training was received. Each hour of training should be listed under the one most applicable subject category.

In Item 5 of Supplement A, document at least 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience with the types and quantities of radioactise material being requested that in-cluded review of initial source calibration and periodic spot-check measure-ments of teletherapy units, initial source calibration of sealed sources other thar. teletherapy sources that are used for treatment purposes, calibration of ion chambers and survey meters, preparation of treatment plans and treatment times for teletherapy and brachytherapy,* and knowledge of appropriate radiation safety, quality control, and emergency procedures for handling and using sealed sources.

2. Completed signed Supplement B forms.

Supplement B forms should document at least 3 years of active practice in therapeutic radiology, at least 1 year of which should have been spent in a formal training program accredited by the Residency Review Committee for A

Although brachytherapy procedures are not authorized on a teletherapy license, information on the applicant physician's. experience with these procedures is important because the normal method of treatment of some patients (e.g., patients with cervical cancer) involves use of both brachytherapy and teletherapy.

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O Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association.

This training must include therapeutic treatment of patients of both sexes, all ages, various organs, etc., using teletherapy or brachytherapy.* Separate Supplement B forms should be completed and signed by each preceptor. p.hysician under whom the applicant physician gained training or experience.

3. Letters of evaluation from each preceptor physician that (a) describe the scope and extent of the applicant physician's training and experience as known by the preceptor physician and (b) include the preceptor physician's eval-uation of the applicant physician's competency to independently use teletherapy or brachytherapy sources for patient treatment.

4. For applicant physicians who completed their training and experience more than 5 years before the date of application, evidence of (a) continuing clinical involvement in radiation therapy from the time the training was comp-leted to the data of the application (e.g., submit completed signed Suppl _ement B b forms) or (b) having taken continuing education or refresher courses in radiation therapy (e.g., submit completed Supplement A forms).

! 7.2 Proposed Authorized Users--Nonhuman _Use Only. applicants who will use the teletherapy unit and source for uses in addition to patient treatment need respond to Item 7.2.

7.2.1 Applicable Regulation S 30.33(a)(3)  ;

i 7.2.2 Licensing Criteria i

! If you will use the teletherapy unit and source for nonhuman uses, you i

should propose as authorized users for nonhuman use individuals whose training

• Although brachytherapy procedures are not authorized on a teletherapy license, information on the applicant physician's experience with these procedures is important because the normal method of treatment of some patient: (e.g., patients x with cervical cancer) involves use of both brachytherapy and teletherapy.

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and experience meet or exceed that-described in Part II of Appendix C of this guide.

7.2.3 Response In response to Item 7.2, list the full name of each individual who will use, or directly supervise the use of, the teletherapy unit and source for uses other than treatment of patients (i.e., nonhuman uses). Proposed users for nonhuman uses need not be physicians.

For each individual whose training and experience have not been documented as described in Item 7.1, submit a complete description of the individual's training and experience. You may find it convenient to present this information using Supplement A (in Appendix C).

In Item 4 of Supplement A, document at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training in basic radioisotope handling techniques applicable to sealed sources that covered instruction in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, and radia-tion biology. For each subject covered in Item 4 of Supplement A, state where the training was obtained, the dates, total number of hours, and type of training. Hours of training should be broken down into lecture, laboratory, or on-the-job training (0JT). 0JT must have been obtained in a formal training program. Be sure that individual hours of training can be traced to the institution'where the training was received. Each hour of training should be listed under only one subject category (i.e., the most applicable subject category).

In Item 5 of Supplement A', describe at least 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience with the types and quantities of radioactive materials being requested. This experience should include knowledge of appropriate radiation safety, quality control, and emergency procedures for handling and using sealed sources; cali-bration of ion chambers and survey meters and performance of operational checks of these instruments; and performance and evaluation of leak tests of sealed sources.

7.3 Proposed Radiation Safety Officer (RS0) 7.3.1 Applicable Regulation S 30.33(a)(3) 12

i l i

l l l

.g I i

1 7.3.2 Licensing Criteria

The individua1' proposed as RSO should have training and experience that meet or exceed that described in Part II of Appendix C of.this guide.

7.3.3 Response In response to Item 7.3, you should list the full name and title of the individual ~ designated by and responsible to your management for the coordi-nation of your radiation safety program (the RS0). If the on-site RSO is assisted by a consultant or part-time employee, also state the consultant's name and describe his or her duties, responsibilities, and the amount of time to be devoted to the radiation safety program. (Note that when a consultant is employed to assist the RSO, you (as the licensee) will still be responsible for the proper performance of your radiation safety program as required by the license, and your on-site RSO will be expected to review the consultant's work and sign the required reports and records.)

If the proposed RSO is not one of the proposed authorized users, you should j submit a complete description of the individual's training and experience. You l(g may find it convenient to present this information using Supplement A (in Appen-IN ,_ / dix C). If the on-site RSO is assisted by a consultant, provide similar infor-mation on the consultant's qualifications. Follow the guidance in Item 7.2 l when completing Supplement A.

7.4 Proposed Expert

• Only those applicants whose proposed expert does not meet the qualifica-tions specified in paragraph 35.24(a) or 35.24(b) of 10 CFR Part 35 need respond to this item.

7.4.1 Applicable Regulation Footnote 2 of S 35.24-

• As used in this guide, the term " expert" refers to the " qualified expert" described in S 35.24 of 10 CFR Part 35.

Ch

( /

v 13

l 7.4.2 Licensinq Criteria If your expert does not meet the criteria specified in paragraph 35.24(a) l or 35.24(b) of 10 CFR Part 35, your proposed expert should have training and experience at least equivalent to that specified in paragraph 35.24(b).

7.4.3 Response In response to Item 7.4, specify the full name of the proposed expert and describe the individual's training and experience, including all the information requested in Footnote 2 of S 35.24. The qualifications of your proposed expert will be reviewed with the assistance of NRC's medical physics consultants.

Item 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS 8.1 Applicable Regulation S 19.12 8.2 Licensing Criteria You must establish and agree to follow written procedures for instructing individuals as required by S 19.12 of 10 CFR Part 19. As a minimum, these writ-ten procedures should require:

1. That individuals who work in or frequent restricted areas (e.g, physicians, technologists) be instructed in the items specified in S 19.12 at the time of initial employment and at least annually thereafter.

2. That this instruction include all written procedures developed as a prerequisite for obtaining your NRC license and other terms of the license pertinent to radiation safety.

3. That other individuals whose duties may require them to work in the immediate vicinity of licensed material (e.g. , housekeeping, security, clerical personnel) be informed about radiation safety hazards and appropriate precautions at the time of their initial employment and at least annually thereafter.

4. That, until the NRC terminates your teletherapy license, you maintain records documenting initial and refresher training and that, as a minimum, these 14

/' records. identify.the individual who-conducted the training, the individuals who

!were-trained, the date and duration of the training, and the topics covered.

i

[ 8.3 Response In response to_ Item 8, you shculd submit one of the following:

1

1. A copy of the personnel training program that you have established

and that you agree to follow for instructing individuals as required by S 19.12 of 10 CFR Part 19.

2. A statement that you have adopted the training program described in Appendix D of Draft Regulatory Guide FC 414-4. The personnel training program in l Appendix D fulfills the criteria in Item 8.2.

I i

Item 9 - FACILITIES AND EQUIPMENT Paragraph 30.33(a)(2) of 10 CFR Part 30 states that an application will be approved if, among other things, the applicant's proposed facilities and

' j'~'(/ equipment are adequate to protect health and minimize danger to life or property.

\s_s In order for the NRC to evaluate the adequacy of your' proposed facilities 'and equipment, you must provide a detailed-description as discussed below. ,

9.1 Description of Facility

~ 9.1.1 Applicable Regulation.

S 30.33(a)(2)

. S 30.34(e)

- 9.1. 2 Licensing Criteria

Annotated plans and elevation drawings or sketches should provide sufficient information for the NRC staff to evalnate the proposed facility. As a minimum, the plans and elevation orawings or sketches of the teletherapy facility

• should show:

• Ar used in t5is guide, the term " teletherapy facility" means the treatment i room and its surroundings. The term " treatment room" refers to the room in

.which the teletherapy unit and source are located and patients are treated.

1 15 ,

1 l

1. The scale to which the drawings are made. Use the same scale for all drawings; the recommended scale is 1/4 inch = 1 foot.

2. The direction of north.

3. The location of the teletherapy unit and source within the treatment room.

4. The directions of primary beam usage and, in the case of an isocentric unit, the plane of beam rotation.

5. The type, thickness, and density of the shielding materials used on all sides of the treatment room, including the floor and ceiling.

6. The location of doors, windows, conduits, and other penetrations and voids in the shielding materials.

7. The nature of and distances to all areas adjacent to the treatment room (including above and below). Note that plans and elevation drawings are particularly helpful in showing the relationship among the treatment room, the roof, and the rest of the building.

8. The height of earth against outside walls, if applicable.

9. The type of use of all areas . adjoining the treatment room, including areas above and below. Note that areas should be described as restricted or unrestricted as defined in S 20.3 of 10 CFR Part 20.

9.1.3 Response You should submit annotated plans and elevation drawings or sketches of the propsed teletherapy facility that include the information listed above. Do not submit blueprints.

9.2 Viewing System 9.2.1 Applicable Regulations S 30.33(a)(2)

S 30.34(e) 9.2.2 Licer. sing Criteria You must provide a viewing system that permits continuous observation of the patient from outside the treatment room while the patient is being treated.

(See Condition 13 c>f Exhibit B.)

9 16 n

J j 9.2.3 Response A.s

' Describe the system you will use to view the patient continuously. If you will use a shielded viewing window, also specify the thickness, density, and type of material used. If you will use a closed circuit television system (or other electronic system) for viewing the patient, also describe the back-up system you will use in case the electronic system malfunctions or_specify that treatments will be suspended until the electronic system is repaired and func-tioning again.

9.3 Warning Systems and Access Controls 9.3.1 Applicable Regulations S 20.3(a)(14)

S 20.203 S 30.33(a)(2)

S 30.34(e) 9.3.2. Licensing Criteria Provide adequate equipment and controls to maintain exposures of radiation to workers within regulatory limits.

Condition 17 of the license requir u that each door leading into the treat-ment room be provided.with an interlock to control the "on-off" mechanism of the teletherapy unit. The interlock must cause the source to move to the "off" condition if the door to the treatment room is opened when the source is exposed.

~

The mechanism must be wired so that the source cannot be returned to the "on" condition until the door is closed and the system is reset at the control panel.

9.3.3 Response In response to Item 9.3, describe (1) warning systems (e.g., locks, signs,.

{

warning ' lights and alarms, interlock systems) for each teletherapy treatment room and (2) methods for controlling occupancy for each restricted area. If other radiation producing equipment (e.g., linear accelerator, x-ray machine) is located in the treatment room, describe the steps that will be taken to ensure that no two units can be operated simialtaneously.

l V'%

v) 17

9.4 Beam Stops It may be necessary to restrict use of the teletherapy unit's primary beam because the treatment room's walls, ceiling, or floor will not adequately shield adjacent areas from direct or scattered radiation. Electrical, mechanical, or other physical means (rather than administrative cont.rols) must be used to limit movement or rotation of the unit.

9.4.1 Applicable Regulations S 20.3(a)(17)

S 20.105(b)(1) and (2) 9.4.2 Licensing Criteria Equip your teletherapy unit with electrical or mechanical stops that limit use of the primary beam of radiation so as to ensure compliance with para-graphs 20.105(b)(1) and (2) of 10 CFR Part 20. (See Condition 15 in Exhibit B.)

9.4.3 Response In response to Item 9.4, you should describe the mechanical or electrical beam stops that are operational and restrict beam orientation, specify the direc-tion in which the teletherapy head can be moved, and describe the maximum angle (from vertical) of the beam orientation in each direction. Identify the angle orientation convention (e.g., 0 is vertical toward the floor, 90 is horizontal toward the east wall, 180 is vertical toward the ceiling, and 270 is horizontal toward the west wall). If the teletherapy unit has an integral beam absorber (also called a beam catcher), provide similar information for those orienta-tions in which (1) the primary beam is directed toward the integral beam absorber and (2) the primary beam is directed away from the integral beam absorber. You may use sketches to describe how beam stops limit the use of the primary beam.-

9.4.4 Sample Responses Some applicants have found it helpful to have a "sanple" response for guid-ance. The follo.4ing is an example of an acceptable response on the use of a rc,tational unit with an ir.tegral beam absorber; the angle orientation convention l

described above applies.

13

l 1

I l

,'"~'j + For the primary beam directed toward the integral beam absorber, elec-trical or mechanical stops are set so that the primary beam must be centered (within plus or minus 2 ) on the integral beam absorber and, in that configuration, the attenuated primary beam may be rotated 360* pointing toward the floor, east wall, ceiling and west wall.

+ For the primary beam directed away from the integral beam absorber, electrical or mechanical stops permit the unattenuated primary beam to be directed in a 95 arc from 5 toward the west wall to vertically down toward the floor to 90* toward the east wall.

Experience has shown that, given this type of example, many applicants can make changes to accommodate their own situations (e.g. ..use of a vertical unit, use of a rotational unit without an integral beam absorber).

9.5 Adequacy of Shielding 9.5.1 Applicable Regulations S 19.12 S.20.1(c)

S 20.101 S 20.105(a) s s ,f S 20.105(b)(1) and (2)

S 20.201 S 20.202 S 20.203 9.5.2 Licensing Criteria Based on an evaluation of shielding and the planned use of each area, you must have determined whether each area adjacent to the treatment room will be maintained as a restricted or an unrestricted area, and you must demonstrate compliance with NRC regulations. Accordingly:

1. Each area adjacent to the treatment room (including above and below) must be identified as a restricted or unrestricted area.

2. The maximum radiation levels ~ expected in each adjacent area must be calculated. The calculations should include:

a. Maximum anticipated workload data.

b. Your assigned values for each parameter used in the calculations

[f-~

I such as beam orientation, maximum field size, scatter angle, scatter ratio, O.

distance to scatterer, distance to area of concern, type and thickness of materials used in barrier, and transmission factor of barrier.

19 l

c. Contributions from primary, leakage, and scattered radiation.

d. Separate calculations for eacii area adjacent to the treatment room, including above and below the room. (Calculations need not be made for areas that have not been excavated.)

e. " Worst case" situations.

f. A consideration of continuous occupancy (i.e., occupancy factor of unity) for unrestricted areas unless you request authorization for higher radiation levels.

g. Results expressed in millirems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> and millirems in any 1 day.

3. For each unrestricted area, there must be a demonstration that the requirements of paragraphs 20.105(b)(1) and (2) will be met or you must have requested authorization for higher levels.

4. For each restricted area, you must have a program covering access controls, signs, personnel training and monitoring, and surveys as required by Parts 19 and 20.

9.5.3 Response

1. Identify each area adjacent to the treatment room (including above and below) as a restricted or unrestricted area.

2. Submit calculations of the maximum radiation levels expected in each adjacent area. Your calculations should include:

a. Maximum anticipated workload data (e.g. , maximum number of patients treated per hour and per week; maximum dose and treatment time per patient; maximum "on time" per hour and per week).

b. The value of each parameter used in your cal. s_; ions. These parameters include such factors as beam orientation,. maximum field size, scatter

~

angle, scatter ratio, distance to scatterer, distance to area of concern, type and thickness of materials used in barrier, and transmission factor of barrier.

c. Contributions from primary, leakage (with the source in the "on" position), and scattered radiation (including low-angle scatter that just misses the integral beam absorber).

d. Calculations for each area adjacent to the treatment room, i

including above and below the room, and a statement as to whether the area will 20

be maintained as a restricted or unrestricted area. Calculations need not be .

provided for areas that have not been excavated.

e. " Worst case" situations (e.g., use of maximum beam size; all l patients treated in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> using the critical orientation that produces high radiation levels in an adjacent area; if the integral beam absorber is not used for all patient treatments, calculations based on use of the unattenuated primary beam where appropriate; situations within the' capabilities of the teletherapy unit that are not prohibited by electrical or mechanical stops, regardless of the clinical usefulness of these orientations).

f. A consideration of continuous occupancy (i.e., occupancy factor of unity) for unrestricted areas unless you request authorization for higher radiation levels pursuant to paragraph 20.105(a).

g .. The results of each calculation expressed in millirems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> and millirems in ar.y 1 day.

3. For each unrestricted area, state how you wil m'eet the requirements of paragraphs 20.105(b)(1) and (2) or request authorizat'on for higher levels

/

O by providing the information specified in paragraph 20.105(a).

4. For each restricted area, describe your program for meeting the requirements of Parts 19 and 20. This description should include:

a. The physical and administrative controls used to restrict access to the restricted area.

b. The number, wording, size, and location of warning signs to be placed in the vicinity of the restricted area.

c. Your program for ensuring that personnel entering the restricted area receive proper instruction in accordance with 9 19.12 of 10 CFR Part 19.

d. Your program for ensuring that personnel entering the restricted area are monitored in accordance with 6 20.202. '

e. The surveys that will be performed in accordance with 9 20.201.

9.5.4 Discussion In the past,trany applicants and licensees have had difficulty providing A the information requested in Item 9.5. These difficulties arose, at least in part, because they did not understand NRC's regulations regarding unrestricted and restricted areas.

21

Unrestricted Areas: A treatment room should be designed so that the levels of radiation in any unrestricted area (as defined in paragraph 20.3(a)(17) of 10 CFR Part 20) adjacent to the treatment room meet the requirements of para-graph 20.105(b). This paragraph requires that radiation levels in unrestricted areas be such that a person in the area will receiva a radiation dose exceeding neither 2 millirems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> nor 100 millirems in any 7 consecutive days if the person were continuously present in the area. Conditions 15 and 18.A(ii)(b) of the teletherapy license in Exhibit B relate to this point.

Many applicants and licensees have thought that, because paragraphs 20.105(b)(1) and (b)(2) are separated by the word "or," they could choose to show compliance either by showing less than 2 millirems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> g by showing less than 100 millirems in any 7 consecutive days. However, the regu-lation does not permit this choice. The requirements of the regulation have been compared to a little box (i.e. , less than 2 millirems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />) inside a big box (i.e., less than 100 millirems in any 7 consecutive days). You must first show compliance with the less-than-2-millirems-in-any ' Sour requirement and then count up the hours and show compliance with the less-i.han-100-millirems-in-any-7-consecutive-days requirement.

Restricted Areas: NRC's regulations do not specify maximum exposure rates for restricted areas in millirems per hour or in a manner similar to paragraph 20.105(b). Rather, the regulations refer to the ALARA philosophy (in paragraph 20.1(c)) and specify (in S 20.101) certain maximum permissible doses that indi-viduals may receive in a restricted area. Condition 18.A(ii)(a) of the tele-therapy license (Exhibit B) relates to this point. Licensees are expected, among other things, to identify each restr'.cted area (e.g., by posting signs),

provide appropriate mechanisms to control access to each area (e.g., by locked doors), train personnel in methods to limit their radiation exposures, provide personnel monitoring for personnel entering each area, and perform adequate surveys or evaluations of radiation levels in the restricted area to ensure that personnel exposures do not exceed the li nits in S 20.101 and that they are ALARA.

Appendix E of this guide discusse:, the requirements for unrestricted and restricted areas and the calculations needed to show compliance with the regulations.

22

/ N Conditions 18 and 19 of the teletherapy license require that certain

}

surveys and tests be made and the results reported to NRC. Appendix F of this guide describes the minimum information and measurements that should be included in a survey report to meet the license conditions.

Item 10 - RADIATION SAFETY PROGRAM You, as the licensee, are responsible for the conduct of your teletherapy program and for all actions of your employees. Paragraph 30.34(e) of 10 CFR Part 30 permits NRC to incorpore*9 in licenses such additional requirements and conditions that it deems appropri or necessary to protect health or to mini-mize danger to life or property. Accordingly, you must provide information about your radiation safety program.

10.1 Personnel Monitoring Program 10.1.1 Applicable Regulation

/' S 20.202 N

10.1.2 Licensing Criteria You must establish and agree to follow written procedures for personnel monitoring. As a minimum, th2se written procedures must require:

1. That whole-body badges (i.e. , film or thermoluminescent dosimeters, also called "TLDs") be provided to personnel who enter restricted areas under the circumstances described in S 20.202 of 10 CFR Part 20.

2. That whole-body badges be exchanged for processing at intervals not to exceed 1 month.

3. That whole-body badges be processed by a commercial personnel dosi--

metry service company, preferably one accredited by the National Voluntary Laboratory Accreditation Program (NVLAP).

4. That any pocket dosimeters used to measure exposure from licensed material be operable, calibrated, and tested for drift at intervals not to exceed 1 year. Records of calibration and drift tests must be maintained as

/ described in paragraph 20.401(c)(1).

l 23

10.1.3 Response Your response to Item 10.1 should be a statement that, you have established and agree to follow written procedures for personnel monitoring that include as requirements the criteria specified in Item 10.1.2 of Draft Regulatory Guide FC 414-4. You do not need to name the commercial service company that will provide your personnel monitor :'m devices.

10.2 Instrumentation 10.2.1 Applicable Regulations S 20.201(b)

S 30.33(a)(2)

S 35.23 6 35.25 10.2.2 Licensing Criteria You must agree to have the following radiation detection instruments in your possession and available for use:

1. A portable low-range survey meter capable of detecting 0.2 milli-roentgen per hour.

2. A beam-on radiation monitor permanently mounted in each teletherapy room that is equipped with an emergency power supply separate from the power supply for the teletherapy unit. The beam-on monitor must be capable of providing a visible indication (e.g., flashing light) of an exposed or partially exposed source, and the visible indicator must be observable by a person entering tha teletherapy room.

3. A dosimetry system for making full calibration and spot-check measurements (or have access to it).

4. An instrument of sufficient sensitivity to count leak-test samples, e.g., a NaI(Tl) well crystal connected to a single or multichannel analyzer (or have access to it).

5. A high-range portable survey meter such as an ionization-type instru-ment capable of reading at least I roentgen per hour (or have access to it).

10.2.3 Response Your response to Item 10.2 should be one of the following:

24

1

1. A description of the radiation detection and measuring instruments

[' that you will use for radiation protection, including survey and monitoring l

' instruments and quantitative measuring instruments needed to monitor the ade-quacy of radioactive materials containment and contamination control. You do

not ,need to identify these instruments by manufacturer's name and model number.

2. The following statement:

Item 10.2: We, (name of teletherapy applicant), will have available for

use from the time we begin operation the instrumentation specified in

Item 10.2.2 of Draft Regulatory Guide FC 414-4.

10.3 Calibration of Portable Survey Instruments j 10.3.1 Applicable Regulations J S 20.201(b)

S 30.33(a)(2)

S 30.53 t

Paragraph 20.201(b) of 10 CFR Part 20 requires each licensee to make such i

surveys as are necessary to~ evaluate the extent of radiation hazards that may

\ be present during possession and use of licensed material. In order to perform

\' appropriate surveys, the instruments used.must be operable and calibrated. -

10.3.2 Licensing Criteria for Applicants That Will Not Ca sbrate Their Own Survey Instruments

1. Your survey instruments should be returned to the manufacturer for calibration or calibrated by a commercial firm licensed to perform calibrations for others.

2. Your survey instrunents should be calibrated at intervals not to exceed 1 year and after repair.

3. Records of each calibration should be maintained for at leas +

• years after the calibration. These' records should show the date and results / the calibration and the name of the organization that provided the service.

10.3.3 Response for Applicants That Will Not Calibrate Their Own Survey Instruments If you will not calibrate your own survey instruments, your response to Item 10.3 should be a statement that specifies (1) that'your survey instruments

, will be returned to the manufacturer for calibration or provides the name, 25

i 1

address, and the NRC or Agreement State license number of the organization that I will provide the service (and that is licensed to perform this commercial activ-ity), (2) the frequency of calibration, and (3) that you will maintain for at least 2 years after each calibration a record of the calibration showing the date and the results of the calibration and the name of the organization that provided the service.

A service company may not have a license, perhaps because it is located in a non-Agreement State and uses radium, a radioactive material not regulated by the NRC. It is also possible that a service company has a license, but the license does not specifically authorize it to provide instrument calibration services to other licensees. In these cases, you should also submit a descrip-tion of the radioactive sources and the procedures used by the company for calibrating servey instruments.

10.3.4 Licensing Criteria For Applicants That Will Calibrate Their Own Survey Instruments You must establish and agree to follow written procedures for calibrating your survey instruments. As a minimum, these written procedures must require that:

1. Survey instruments be calibrated at intervals not to exceed 1 year and after repair.

2. Calibration be performed with radionuclide sources at distances sufficient to approximate point sources.

3. Survey instruments be calibrated on every scale or range that the instrument offers, up to 1 roentgen per hour. (Note that calibration requires the follcwing minimum activities of typical radionuclide sources: 85 millicuries of cesium-137, 21 millicuries of cobalt-60, or 30 millicuries of radium-226.)

4. Survey instruments be adjusted to provide readings on all calibrated scales or ranges within 110% of tra value (or 120%, provided a calibrat.lon chart or graph is prepared, attached to the instrument, and used to interpret readings). I

5. A record of each instrument calibration, showing the date and the results of the calibration, be maintained for at least 2 years after the calibration.

O 26

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10.3.5 Response If you will calibrate your own survey instruments, your response to Item 10.3 should be one of the following:

1. A description of the standards, frequency, and procedures used to cali-brate your survey instruments. This description will be reviewed against the criteria in Item 10.3.4.

2. The following statement:

Item 10.3: We, (name of teletherapy applicant), will calibrate our own survey instruments in accordance with written procedures that include as requirements the criteria described 17 Item 10.3.4 of Draft Regulatory Guide FC 414-4.

3. A statement that you will calibrate your survey instruments in the

' manner described in Appendix G of Draft Regulatory Guide FC 414-4. The stan-dards, frequency, and procedures for calibrating survey instruments described in Appendix G fulfill the criteria in Item 10.3.4.

' For detailed information on survey instrument calibration, refer to

\s_- ANSI W323-1978, " Radiation Protection Instrumentation Test and Calibration."*

10.4 Leak-Test Program 10.4.1 Applicable Regulations S 30.34(e)

S 30.53 NOTE: Teletherapy licenses contain a leak-test condition (see Condition 14 of Exhibit B). You should be aware that distributors of sealed sources usually supply a certificate with each source giving the results and date of the last leak test performed on the source. If you do not receive such a certificate, you may not use the source until a leak test has been performed and the results of the test have been received showing that the source is not leaking or contam-inated. Thereafter, the source must be tested for leakage and contamination at intervals not to exceed 6 months.

e~'s r- k

'N '#

• Copies may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018.

27

10.4.2 Licensing Criteria for Applicants That Will Use a Consultant To Perform Leak Tests If you will use a consultant or commercial organization, the consultant or commercial organization (which should be licensed by the NRC or an Agreement State) should take the leak-test samples (smears), evaluate the samples, and report the results to you. Records of each< leak test should be maintained for at least 2 years after each leak test. These records must identify the sealed source (e.g.', manufacturer's name, model number, and serial number), the measured activity (in microcuries) of each test sample, the date of the test, and the name of the consultant or commercial organization that provided the service.

10.4.3 Response for Applicants That Will Use a Consultant To Perform Leak Tests In response to Item 10.4, state the name, address, and NRC or Agreement State license nutiber of the consultant or commercial organization that will perform the entire leak-test process for you. Also specify that you will main-tain records of leak tests for et'least 2 years after each test and describe the minimum information in these records.

10.4.4 Licensing Criteria for Applicants That Will Use Commercial Leak-Test Kits If you will use commercial leak-test kits, a person with adequate training and experience will use a commercial leak-test kit (in accordance with the sup-plier's instructions) for taking leak-test samples that are sent to the supplier for evaluation and the rescits will be reported to you. The leak-test kit should have been approved for licensing by NRC or an Agreement State. For at least 2 years after each leak test, records of each leak ~ test must be maintained that identify the source (i.e., manufacturer's name, model number, and serial number), the measured activity (in microcuries) of each test sample, the date of the test, the name of the person who took the samples, and the supplier's name and model number of the leak-test kit used to take the samples.

20.4.5 Response for Applicants That Will Use Commercial Leak-Test Kits In response to Item.10.4, identify the leak-test kit by supplier's name and kit model number. State that you will follow the supplier's instructions for taking the samples and sending them to the supplier and specify the name of the person who will use the kit. Also specify that you will maintain records 28

cf leak tests for at least 2 years after each test and that, as a minimum, your records will identify the source (by manufacturer's name, model number, and serial number), the measured activity of each test sample, the date of the test, the name of the person who took the samples, and the supplier's name and model number of the leak-test kit used to take the samples.

An individual identifiad in Item 7 who meets NRC's training and experience criteria as a user, radiation safety officer, or expert has adequate training cnd experience to use a commercial leak-test kit. If the individual who will use the leak-test kit is not one of those identified in Item 7, submit the per-son's name and a description of his or her training and experience, which the NRC staff will review on a case-by-case basis.

10.4.6 Licensing Criteria for Applicants That Will Perform the Entire Leak-Test Procedure Themselves If you will perform your own leak tests, you should establish and agree to follow written procedures for performing the entire leak-test sequence. As a minimum, these procedures should require that:

s

1. Samples be taken from locations where contamination, if present, is likely to accumulate.

2. Samples be taken with adequate precautions to minimize radiation exposure and spread of contamination.

3. Samples be evaluated or counted using a calibrated instrument of sufficient sensitivity and accuracy to measure 0.05 microcuries.

4. Counting data from samples be converted to microcurie units.

5. Individuals with adequate training and experience perform the leak-test sequence.

6. For at least 2 years after each leak test, records of each leak test be maintained and that these records identify the source (i.e., manufac-turer's name, model number, and serial number), the measured activity (in micro-curies) of each test sample, the date of the test, and the name of the person who performed the test.

10.4.7 Response for Applicants That Will Perform the Entire Leak-Test Themselves 1 In response to Item 10.4, you should:

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1. Descrite the materials to be used in taking the leak-test samples and the points on the equipment that will be tested. Samples are not normally taken directly from the surface of a source, but rather from the nearest accessible surface, e.g., collimator blades.

2. Describe the radiation safety procedures to be followed during the leak test and the method for handling and disposing of the samples.

3. Describe the instrument to be used to evaluate the samples and state its sensitivity and accuracy. Rather than specify the manufacturer's name and model number of the instrument, describe its characteristics (e.g., NaI(Tl) well crystal connected to a single-channel or multichannel analyzer). Survey instruments are not acceptable for evaluating leak-test samples.

4. Describe the calibration and standardization procedures and provide a sample calculation showing conversion of results to the required microcurie units.

5. Identify each individual who will take or evaluate the leak-test samples and describe each person's training and experience if tnis information was not submitted in response to Item 7. An individual identified in Item 7 who meets NRC's training and experience criteria as a user, radiation safety officer or expert has adequate training and experience to perform the entire leak-test procedure.

6. Specify that you will maintain records of leak tests for at least 2 years after each test and that, as a minimum, your records will identify the source (i.e. , manufacturer's name, model number, and serial number), the measured activity of each test sample, the date of the test, anc the name of the person who performed the test.

10.5 Operating Procedures 10.5.1 Applicable Regulations S 30.34(e)

S 30.53 10.5.2 Licensing Criteria You must establish and agree to follow written procedures governing the operation of the teletherapy unit. You should have written operating procedures directed to and given to specific groups of staff members (e.g., technologists) 30

l outlining the responsibilities of each group to ensure your compliance with NRC's regulations, the terms and conditions of the license, and the commitments made in license applications and correspondence with NRC. Many topics pertain-ing to radiation safety should be addressed in the operating procedures. As a minimum, these written procedures should:

1. Require that the teletherapy unit, room, and console be secured when unattended.

2. Describe the actions to be taken to ensure that only the patient is in the treatment room when the primary beam is turned on.

3. Require that safety devices be checked for proper operation (including identifying the devices to be checked and by whom, how the checks are to be performed and the frequency), that malfunctions or defects be corrected promptly, and that the dates and results of the checks and a notation of the date on which each malfunction or defect was corrected be maintained for at least 2 years after each check and each correction of a malfunction or defect.

A Appendix H contains a list of topics that may be addressed in a set of r b v operating procedures.

10.5.3 Response.

In response to Item 10.5, you should submit a copy of your operating procedures.

10.6 Emergency Procedures 10.6.1 Applicable Regulations S 20.1(c)

S 30.34(e) 10.6.2 Licensing Criteria Condition 16 of the teletherapy license (see Exhibit B) requires that emer-gency procedures be established and that the procedures be posted at the control console. You must establish and agree to follow written procedures for emer-gencies that may occur, e.g., the teletherapy source fails to return to the "off" position. These procedures, designed to minimize. radiation exposure to U patients, workers, and the general public, should as a minimum:

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1. Specify when they are to be followed.

2. Describe step-by-step actions that are to be taken by whom.

3. Give first consideration to minimizing the exposure to the patient, usually by removing the patient from the room (rather than using tools to attempt to return the source to the off position). If a first step of the emer-gency procedures specifies pressing the " emergency bar" on the teletherapy unit console, this action may cause the source to return to the off position but may also cut power to the entire teletherapy unit or to the gantry or the couch--

these possibilities must be considered in developing emergency procedures.

4. Instruct the staff to act quickly and calmly and to avoid the primary beam of radiation.

5. Require that, as soon as the patient and staff are out of the treat-ment room, the area be secured (i.e., door locked, guard posted) and a sign posted to alert others to the problem.

6. Specify who is to be notified. Provide the names of at least two individuals who can be notified and their on-duty and off-duty telephone numbers.

10.6.3 Response Your response to Item 10.6 should be one of the following:

1. Submit a copy of your emergency procedures.

2. State that you will follow the emergency procedures described in Appendix I of Draft Regulatory Guide FC 414-4. The emergency procedures shown in Appendix I fulfill the criteria established above.

10.7 ALARA Program 10.7.1 Applicable Regulations S 20.1(c)

S 30.34(e) 10.7.2 Licensing Criteria You should establish and agree te follow a written program for ensuring that occupational radiation exposures are maintained as low as reasonably achievable (ALARA). As a minimum, the ALARA program should:

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) 1. Contain management's formal commitment to the ALARA philosophy, recog-nizing the importance of keeping individual and collective doses ALARA.

2. Include periodic review of the teletherapy program and provide con-tinuing education and training for all personnel who work with or in the vicin-ity of the teletherapy facility. (This review and education program must cnsure that all personnel make every reasonable effort to maintain individual and collective doses ALARA.)

3. Specify the duties of various persons (e.g., technologists, authorized users, radiation safety officer (R50), radiation safety committee (RSC), licensee management) within the licensee's organization as they apply to ALARA.

4. Establish Investigational Levels (IL) at approximately 10% and 30% of the maximum permissible doses specified in S 20.101 of 10 CFR Part 20 and describe the actions to be taken if radiation exposures exceed the Ils (e.g.,

investigation by the RSO of the cause of the exposure; consideration of actions that might be taken to reduce probability of recurrence).

5. Specify that, at intervals not to exceed 3 months, radiation exposures of all personnel will be reviewed, compared to ILs, and appropriate actions taken.

r  ; 6. Include a formal annual review by management, the RSO, and the RSC of the entire radiation safety program, including ALARA considerations.

10.7.3 Response Your response to Item 10.7 should be one of the following:

1. Submit a copy of your ALARA program.

2. State that you have adopted the model ALARA program described in Appendix J of Draft Regulatory Guide FC 414-4. The ALARA program shown in Appendix J has been in use at many medical and teletherapy licensees' facilities since its development in 1980, and it fulfills the criteria established above.

10.8 Radiation Safety Committee Only applicants that are hospitals or other medica; institutions need respond to Item 10.8.

) 10.8.1 Applicable Regulation S 35.11(b) 33

10.8.2 Licensing Criteria If you, the applicant, are a hospital or other medical institution, you must establish and maintain a Radiation Safety Lommittee (RSC) to oversee the use of licensed material throughout your institu. tion and to review your insti- l tution's radiation safety program. As a minir.mm, the membership of your RSC j must include an authorized user for each type of use permitted by the license, a representative of the nursing staff, a representative of the institution's management, and the Radiation Safety Officer.

NOTE: Before October 12, 1982, pa agraph 35.11(b) of 10 CFR Part 35 required an institution to have a medical isotopes committee whose duties, responsibilities, and required membership were somewhat different from those of the currently required radiation safety committee. Medical institutions do not need both a medical isotopes committee and a radiation safety committee; insti-tutions need only one committee, a radiation safety committee whose responsi-bilities and required membership are specified in paragraph 35.11(b) of 10 CFR Part 35.

10.8.3 Response Your response to Item 10.8 should be one of the following:

1. A statement '. hat specifies:

a. The r,ame of each member of your radiation safety committee, with sufficient additional information to show that the RSC includes the individuals specified in paragraph 35.11(b) of 10 CFR Part 35. To prevent the need for future license emendments when RSC members are changed, also state that, if you change individual members of the RSC, you will (1) ensure that the membership includes all the personnel specified in paragraph 35.11(b) of 10 CFR Part 35 and (2) maintain records of the membership until the NRC terminates your tele-therapy license.

b. The meeting frequency and the responsibilities and duties of the RSC. As a minimum, the RSC should meet as often as necessary to conduct its business but not less than once in each calendar quarter.

2. A statement that your RSC's responsibilities, duties, and meeting fre-quency will be as described in Appendix K of Draft Regulatory Guide FC 414-4.

Appendix K meets the licensing criteria in Item 10.8.2.

34 1

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3. If you already have an RSC because you hold another NRC license (e.g.,

for nuclear medicine procedures), you may (1) submit the information on member-ship outlined in a above and (2) specify that your existing RSC's duties and responsibilities have been amended to include teletherapy.

Item 11 - WASTE MANAGEMENT Section 20.301 of 10 CFR Part 20 provides NRC's general requirements for disposal of radioactive material. Most teletherapy licensees dispose of unneeded sealed sources by transferring them to an authorized recipient (e.g., the source manufacturer). -You should note the provisions of Condition 21 as shown in the teletherapy license (Exhibit B). This condition requires that certain work, including source removal or source exchange, may be performed only by persons specifically authorized by the NRC or an Agreement State to do the work. Note also that some teletherapy units contain source material in the form of depleted uranium used as shielding material in the unit.

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~ 11.1 Applicable Regulation v

5 20.301 11.2 Licensing Criteria You must dispose of radioactive waste in accordance with the requirements of 10 CFR Part 20.

11.3 Response In response to Item 11, describe how you will dispose of unneeded tele--

therapy units and sources.

Item 12 - LICENSE FEES An application fee paid in full is required by paragraph 170.12(a) of N 10 CFR Part 170 for most types of licenses, including applications for license s cmendments and renewals. You should refer to S 170.31, " Schedule of Fees for 35

Materials Licenses and Other Regulatory Services," of 10 CFR Part 170 to determine the amount of the fee that must accompany your application. An application received without the required fee or with an inadequate fee may be returned to you. All application fees can be charged regardless of the NRC's disposition of the application or your withdrawal of the application.

l Item 13'- CERTIFICATION Your application should be dated and signed by a representative of the corporation or legal entity who is authorized to sign official documents and to certify that the application is true and correct to the best of your knowledge )

and belief. Applications filed in the name of a physician should be signed by the applicant physician. Unsigned applications will be returned for proper signature.

Item 14 - VOLUNTARY ECONOMIC DATA The Regulatory Flexibility Act of 1980 requires Federal agencies to consider 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, four categories of economic information are sought from applicants. These economic data will be used by the NRC in preparing regulatory analyses that contain, among other things, the anticipated economic burden a proposed rulemaking action will have on affected licensees. To the extent that it is possible and consis-tent with public health and safety, the NRC will consider the economic burden in light of the size of the entities affected by the rule in an attempt to mitigate the potential for a significant economic impact on a substantial number of small entities.

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

• If the applicant is a university with a teaching hospital that operates under a separate annual budget and has been issued multiple licenses, it should dis-tinguish the figures that pertain solely to the university from those figures that pertain solely to the teaching hospital.

36

1. Holders of One NRC License. If your organization (named on the license L- cr application) holds one NRC license and operates from one address, check the r

b:x that most closely approximates your annual receipts; in the case of hospitals, academic institutions, or other entities that do not operate on the basis of r:ceipts, check the box that most closely approximates the annual operating budget of your organization.

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

3. Holders of Multiple NRC Licenses at Multiple Addresses. If your organization (named on the license or application) holds multiple NRC licenses ct multiple addresses, check the box that most closely approximates the annual receipts or annual operating budget for the operations conducted at the address on this license or application and not for the entire corporate entity.

14.b Number of Employees The number of (7ployees reported should reflect all employees for the organization at the address listed on the license or application, excluding outside contractors. The number of employees reported should not be that of a single department or division within the organization.

14.c Number of Beds (Hospitals Only)

Enter the total number of beds in the hospital excluding bassinets and nursing-home-type units.

14.d Would You Be Willing To Furnish Cost Information on the Economic Impact of Current Regulations or Any Future Proposed NRC Regulations That May Affect You? o Indicate if you would be willing to furnish additional economic data to

, the NRC that would help the NRC evaluate the economic impact of a rule on J affected licensees.

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4. AMENDMENTS TO A LICENSE l

After you are issued a license, you must conduct your program in accordance l with (1) the statements, representations, and procedures contained in your application and correspondence with NRC, (2) the terms and conditions of the license, and (3) the NRC's regulations.

It is your obligation to keep your license current. You should anticipate the need for a license amendment insofar as possible. If any of the information provided in your application or other correspondence is to be modified or changed, submit an application for a license amendment. In the meantime, you must comply with the terms and conditions of your-license until it is actually amended; NRC regulations do not allow you to implement changes on the basis of a submission requesting an amendment to your license.

An application for a license amendment may be prepared either on the appli-cation form (NRC Form 313)* or in letter form and should be submitted in dupli-cate to the address specified in this guide in Section 2, " Filing An Application."

Your application should identify your license by number and should clearly describe the exact nature of the changes, additions, or deletions. References to previously submitted information and documents should be clear and specific and should identify the pertinent information by date, page, and paragraph.

Section 1 of Appendix L provides guidance on the most commonly requested license amendments; see also Section 3 of this guide.

You must send the appropriate fee for a license amendment with your appli-cation. The NRC will not accept an application for filing or processing before the proper fee is paid in accordance with S 170.12 of 10 CFR Part 170.

5. RENEWAL 0F A LICENSE Licenses are issued for a period of up to 5 years. You must send an appli-cation for renewal to the address specified in Section 2, " Filing An Application."

Renewal applications may be filed in either of two ways. First, you may submit a complete application, using NRC Form 313,** providing all the information

• In . Item 1 of NRC Form 313, check block B and enter the number of the license to be amended.

• • In Item 1 of NRC Form 313, check block C and enter the number of the license to be renewed.

l 38

requested on the form'(see Section 3 of this guide) without referencing pre-viously submitted-information (except for qual'ifications of previously approved users). However, certain references to previously submitted information are acceptable if:

1. The reference is made in response to a particular item on NRC Form 313,

2. The reference is clear and specific (e.g. , title of document, date of submission, page, and paragraph), and

3. The referenced document contains all the information required for a particular item at the time of renewal.

An acceptable alternative, preferred by most licensees, is to submit the renewal request in l'etter format and include the limited supporting documentation described in Section 2 of Appendix L.

If you file your application for license renewal at 1 cast 30 days before the expiration date of your license and send it with the appropriate fee for license renewal, your license will automatically remain in effect until NRC takes final action on your application. However, if you file an application less than 30 days before the expiration date and the NRC cannot process it before that date,.you could be without a valid license when your license expires.

It is "mportant that the appropriate fee accompany your application for license renewal. In accordance with 5 170.12 of 10 CFR Part 170, the NRC will not accept an application.for filing or processing before the proper fee is paid.

If you do not wish to renew your license, send a letter to the NRC (to the address specified in Section 2 of this guide) requesting termination of your license. Your letter should reach the NRC before the expiration date on your license.

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

This draft guide has been distributed for comment to encourage public par-L ticipation in its development. It represents the current position of the NRC 39

etaff, which is subject to change after the review of public comments. Comments received during the public comment period on this draft guide will be considered in developing the final guide, i.e., the guide that represents an official NRC staff position. l Until the final guide is published, this draft document represents the best available guidance, and you may use it when preparing requests for licens-ing actions. After the final guide is published, the NRC staff will use it in its review of requests for licensing actions.

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

If the final guide is more restrictive than the draft guide, this will not affect licensing actions already completed since all required regulatory findings will have been made. However, more restrictive recommendations in the final guide may reflect items identified by the NRC staff as important to health and safety. Such issues would be addressed for effective licenses by issuing an amendment or a rule change before a licensee would be required to conform. In unusual cases in which immediate action is required, you would be contacted directly by the NRC staff regarding any license amendments.

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s APPENDIX A J

DISCUSSION OF QUESTIONS OF PARTICULAR INTEREST TO APPLICANTS REQUESTING HUMAN USE AUTHORIZATION QUESTION 1:

What does the phrase " treatment of humans" mean as it is used in the authorized use condition on a teletherapy license (see Condition 9 of Exhibit B)?

ANSWER 1:

The phrase " treatment of humans" in the authorized use condition has been interpreted to include use of the teletherapy unit to (a) irradiate patients, (b) make physical measurements needed for dosimetry purposes or treatment planning for patients, (c) make physical measurements as required by license conditions or regulations for surveys, full calibration, or spot-checks, and (d) make comparisons or intercomparisons between dosimetry systems.

)

QUESTION 2:

Must a person named as an authorized user for " treatment of humans" on a teletherapy license (see Condition 12 of Exhibit B) be a physician and, if so, how do you define a physician?

ANSWER 2:

Each person proposed to be authorized to use a teletherapy unit and source to treat humans must be a physician. This term is defined in paragraph 35.3(b) of 10 CFR Part 35 as "an individual licersed by a State or territory of the United States, District of Columbia or Commonwealth of Puerto Rico to dispense drugs in the practice of medicine."

QUESTION 3:

The authorized user condition on a teletherapy license (see Condition 12 of Exhibit B) may read in one of two ways: (i) " Licensed material shall be A-1

used by " or (ii) " Licensed material shall be used by, or under the supervision of, .

What are the differ-ences between these two conditions and when is each used?

l ANSWER 3:

The first condition, " Licensed material shall be used by ,"

is used on licenses issued in the name of a physician or group of physicians.

The second, " Licensed material shall be used by, or under the supervision of

, " is used on licenses issued in the name of a medical insti-tution and provides a mechanism whereby nonapproved physicians can obtain the needed training and experience to enable them to beceme authorized users.

QUESTION 4:

How do these license conditions affect authorized physician-users and their relationships with physicians-in-training and technologists, physicists, and other paramedical personnel?

ANSWER 4:

The NRC recognizes that, in accordance with the traditional practice of medicine, physicians use technologists, physicists, and other paramedical personnel to perform some of the activities involved with the medical uses of radioactive material. In these instances, the authorized physician-user is still considered to be "the user." Authorized physician-users have certain responsibilities that may not be delegated to nonphysicians.

The authorized physician-user's responsibilities are:

a. Examination of the patient and his or her medical records to deter-mine if radiation therapy is appropriate.

b. Prescription of the radiation dose and how it is to be administered (e.g. , 5,000 rads to be delivered at the rate of 200 rads per day under specified conditions of field size, distance, angle, etc.),

c. Regular review of the patient's progress and modification of the originally prescribed dose as warranted by the patient's reaction to the radiation.

A-2

Actual use of, or direction of technologists or other paramedical

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personnel in the use of, the teletherapy unit, and

e. Provision of necessary followup medical care.

Items a through e may be delegated to physicians who are in training under the supervision of an authorized physician-user. The term " supervision" means that the physician-user (1) has adequately instructed the physicians-in-training in the specific human use, (2) has ascertained that they are receiving training in the safe use of these materials in humans, and (3) periodically reviews the work of those supervised and assures himself or herself that proper medical records are made of each use. It does not mean that the physician-user is necessarily present for each teletherapy treatment.

The authorized physician-user may delegate to properly trained technolo-gists, physicists, or other paramedical personnel the following activities:

a. Actual operation of the teletherapy unit,

b. Performance of physical measurements for dosimetry or treatment

'~'x planning purposes; survey, full calibration, spot-check, and other quality assurance checks and comparison or intercomparisons of dosi-

~

metry systems.

c. Administration of radiation to patients within the limits permitted by applicable Federal, State, or local laws.

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APPENDIX B

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DESCRIPTION OF SEALED SOURCES, TELETHERAPY UNITS,  :

AND PROPOSED USES Item 5.1 SEALED SOURCES TO BE USED IN TELETHERAPY UNITS Maximum Maximum Name of Source Activity Output Number Radionuclide Source Model per Source of Source of (Element and Mass No.) Manufacturer Number (in curies) (in RHM) Sources (A)

(B)

(C)

Item 5.2 TELETHERAPY UNITS

^

s NAME OF MANUFACTURER (include description, Beam Counter-

! if unit is custom made) Model Name Catcher Weight and Number (check one of these)

(A)

(B)

(C)

Item 6 PROPOSED USES t

A B C Check as appropriate Treatment of Patients Only Treatment of Patients and Other Use (as described below)

B-1

APPENDIX C

)

TRAINING AND EXPERIENCE FOR TELETHERAPY USERS PART I. TRAINING AND EXPEPIENCE FOR PROPOSED USERS--HUMAN USE

1. General Criteria Any human use of byrroduct material (i.e., the internal or external admini-stration of byprodLct matarial, or the radiation therefrom, to human beings) must be carried out by or under the supervision of a physician. As defined in paragraph 35.3(b) of 10 CFR Part 35, a physician means an individual licensed by a State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to dispense drugs in the practice of medicine.

Paragraphs 35.11(d), 35.12(a)(4), and 35.13(b) of 10 CFR Part 35 require that a physician designated as an authorized user have adequate training and experience. Outlined below are criteria for training and experience that the NRC, with the assistance of its Advisory Committee on the Medical Uses of Iso-

] '

topes (ACMUI), has found acceptable for physicians who will use, supervise, or direct the use of radioactive material; in teletherapy units.

2. Previous Approval by NRC or an Agreement State Physicians specifically listed as authorized users on a teletherapy license previously issued by AEC, NRC, or an Agreement State are considered to have adequate training and experience. Specify the number of the AEC or NRC tele-therapy license or submit a copy of the Agreement State license on which the applicant physician was specifically listea as an authorized user.

3. Medical Specialty Board Certification The following certifications will be accepted as evidence that a physicion has had adequate training and experience:

x a. Certification by the American Board of Radiology (ABR) in radiology or therapeutic radiology.

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b. Certification by the American Osteopathic Board of Radiology (A0BR) in radiation oncology.

c. Certification by the Canadian Royal College of Physicians and Surgeons (RCPS) in therapeutic radiology.

d. Certification as a British " Fellow of the Faculty of Radiology" (FFR) or " Fellow of the Royal College of Radiology" (FRCR).

Physicians holding one of the medical specialty certifications listed above should complete Items 1, 2, and 3 of Supplement A (a copy of Supple-ment A is included in this appendix and it may be reproduced as needed).

Physicians certified by RCPS or as FFR or FRCR should also submit a copy of their certificates and, in the case of physicians who are FFR or FRCR, evidence of specialization in radiation therapy.

4. Physicians Who Do Not Meet the Criteria in Sections 2 or 3--Minimum Training and Experience The training and experience described below should have been received within 5 years of the date of application or the applicant physician must provide evidence of (1) continuing clinical involvement in radiotherapy (e.g.,

completed signed Supplement B forms) (a copy of Supplement B is included in this appendix and it may be reproduced as needed) or (2) having taken refresher or continuing education courses in radiation therapy (e.g.,

completed Supplement A forms).

a. Training in basic radioisotope handling techniques applicable to the use of sealed sources (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) consisting of lectures, laboratory sessions, discussion groups, or supervised on-the-job training (0JT) experience (note that OJT must have been received in a formal training program) in the following areas:

(1) Radiation physics and instrumentation (110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br />)

(2) Radiation protection (40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />)

(3) Mathematics pertaining to the use and measure-ment of radioactivity (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) (

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(4) Radiation biology (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />)

J (The hours listed next to each of the four subjects above are suggested values and should not be interpreted as specific requirements.)

b. Experience with tre types and quantities of radioactive material for which the application is made or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). This experience should include the following:

(1) Review of initial source calibration and periodic spot-check measurements of teletherapy units, (2) Initial source calibration of sealed sources other than tele-therapy sources that are used for treatment purposes, (3) Calibration of ion chambers and survey meters, (4) Preparation of treatment plans and treatment times for tele-therapy and brachytherapy,* and (5) Learning appropriate radiation safety, quality control, and

'N emergency procedures for handling and using sealed so'irces.

)

c. Clinical training in teletherapy procedures: Active practir- . . ,

therapeutic radiology with a minimum of 3 years of experience, at least 1 year of which should have been spent in a formal training program accredited by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This training must include therapeutic treat-ment of patients of both sexes, all ages, various organs, etc., using teletherapy or brachytherapy, or both.

5. Physicians Who Do Not Meet Criteria in Sections 2 or 3--Documenting Training and Experience The qualifications of each applicant physician who has not been previously approved by a licensing agency (see Section 2) and who is not certified

• Although brachytherapy procedures are not authorized on a teletherapy a license, information on the applicant physician's experience with these

procedures is important because the normal method of treatment of some patients (e.g., patients with cervical cancer) involves use of both brachy-therapy and teletherapy.

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(see Section 3) will be reviewed on a case-by-case basis with the assistance of the.ACMUI. Most applicants use Supplements A and B to provide much of the needed informatiun. The following is a checklist of materials that should be submitted, with suggestions on their preparation:

a. Completed Supplement A form.

l In Item 4, document at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training in basic radioisotope handlir.g terbniques, as described in Section 4.a. For each subject covered in this basic training, state where the training was obtained, the dates, total number of hours, and type of training. Hours of training should be broken down into lecture, laboratory, or OJT. OJT must have been obtained in a formal training program. Be sure that hours of training can be traced to the institu-tion where the training was received. Each hour of training should be listed under only one subject category (i.e. , the most applicable subject category).

In Item 5, document at least 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience with the types and quantities of radioactive materials being requested as described in Section 4.b.

b. Completed signed Supplement B forms.

Supplement B forms are used to document clinical experience described in Section 4.c. Separate Supplement B forms should be completed and signed by each preceptor physician under whom the applicant physician gained training and experience,

c. Letters of evaluation from each preceptor physician.

These letters should describe the scope and extent of the applicant physician's training and experience as known by the preceptor physician and include the preceptor physician's evaluation of the applicant physician's competency to independently use teletherapy and brachytherapy sources for patient treatment.

d. For applicant physicians who completed their training and experience more than 5 years before the date of the application, evidence of (a) continuing l

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i clinical involvement in radiation therapy from the time the training was com-J pleted to the date of the application (e.g., completed signed Supplement B forms) or (b) having taken refresher or continuing education courses in radiation therapy (e.g., completed Supplement A form).

PART II. TRAINING AND EXPERIENCE FOR PROPOSED USERS--NONHUMAN USE AND RADIATION SAFETY OFFICER (RS0)

1. General Criteria Paragraph 30.33(a)(3) of 10 CFR Part 30 requires that the applicant for a license be qualified by " training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property." Proposed R50s and proposed users for nonhuman uses of tele-therapy units are expected to meet these requirements. Outlined below are training and experience criteria that have been found acceptable for these two categories of applicants.

Physicians whose training and experience meet the criteria in Part I

) have sufficient training and experience to be authorized to use a teletherapy unit for nonhuman use or to act as RSO or both. However, proposed users for nonhuman use (e.g., instrument calibration) of a teletnerary unit and proposed RS0s need not be physicians.

2. Minimum Training and Experience

a. Training in basic radioisotope handling techniques applicable to the use of sealed sources (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) as described in Section 4.a of Part I of this appendix.

b. Experienct with the types and quantities of radioactive material for which the application is made or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). This experience should include the following areas:

(1) Learning appropriate radiation safety, quality control, and emergency procedures for handling and using sealed sources.

(2) Calibration of ion chambers and survey meters and performance of l

operational checks of these instruments.

'~

(3) Performance and evaluation of leak tests of sealed sources.

C-5

3. Documenting Training and Experience g Supplement A may be used to document training and experience. See the discussion in Part I of this appendix.

I t

l I

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SUPPLEMENT A 9 TRAINING AND EXPERIENCE PROPOSED AUTHORIZED USER OR RADIATION SAFETY OFFICER s

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SUPPLEMENT B PRECEPTOR STATEMENT Supplement 8 must be completed by the nglocant php socian's preceptor. If more than one pire eptor os twessary to document esperence.

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APPENDIX 0 PERSONNEL TRAINING PROGRAM

1. Schedule for Training Training will be provided:

a. Before an employee assumes duties with or in the immediate vicinity of radioactive materials,

b. Annually as refresher training for all employees, and

c. Whetever a significant change occurs in duties, regulations, or the terms of the NRC license.

2. Description of the Training Program Training will be sufficient to ensure that:

a. Individuals who work in or frequent restricted areas are instructed in the items specified in S 19.12 of 10 CFR Part 19, and

b. Individuals whose duties may require work in the immediate vicinity of radioactive materials are informed about radiation hazards and appropriate precautions.

3. Content of the Training Program The program of instruction will include:

a. Pertinent terms and conditions of the NRC license, including procedures developed as a prerequisite for obtaining the license and commitments incorporated into the license by condition.

b. Appropriate response to emergencies or unsafe conditions, including participation by appropriate staff in " dry runs" of emergency proce-dures conducted as a part of the initial and annual refreshir training.

c. Areas where radioactive material is used or stored.

d. Potential hazards associated with radioactive material.

D-1

e. Radiological safety procedures appropriate to the duties of the employee.

f. Pertinent NRC regulations. l l

g. The obligation of all personnel to report unsafe conditions to the j radiation safety officer.

h. The right of all personnel to be informed of radiation exposure and bioassay results.

i. The locations where the licensee has posted or made available notices, copies of regulations, and copies of pertinent licenses and license conditions (including applications and applicable correspondence) as required by 10 CFR Part 19.

4. Records That Document Training Records of initial and refresher training will be maintained until the NRC terminates the teletherapy license and will include:

a. The name of the individual who conducted the training,

b. The names of the individuals who received the training,

c. The dates and duration of the training session, and

d. A list of the topics covered.

l 9

D-2

) APPENDIX E m

DISCUSSION OF UNRESTRICTFD AND RESTRICTED AREAS FOR TELETHERAPY APPLICANTS AND LICENSEES Each area adjacent to a teletherapy facility must be identified and main-tained either as an unrestricted or as a restricted area. As a part of your application for a new teletherapy license, you as an applicant have to use calculated values of maximum anticipated radiation levels to show how you will comply with NRC's regulations on restricted and unrestricted areas. After your license is issJed and your teletherapy unit and source installed, you as a licensee must conduct surveys (see Conditions 18 and 19 of Exhibit B) and use measured radiation levels in showing how you are complying with NRC's require-ments. The following discusses pertinent NRC regulations and factors to be considered in showing compliance with these regulations.

1. Unrestricted Areas:

F"') a. A standard teletherapy license requires that radiation levels in unrestrictsd areas meet the requirements of paragraphs 201.05(b)(1) and (2) of 10 CFR Part 20. This section of the regulations requires that a person continu-ously present in an unrestricted area will not receive a dose exceeding 2 milli-rems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> or 100 millirems in any 7 con ecutive days. The requirements of this regulation have been compared to a'little box (i.e., less than 2 milli-rems in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />) inside a big box (i.e., less than 100 millirems in any 7 consecutive days). You must first show compliance with the less-than-2-millirems-in-any-1-hour requirement and then count up the hours of "on time" and show compliance with the less-than-100-millirems-in-any-7-consecutive-days requirement.

b. In shcwing compliance with paragraphs 20.105(b)(1) and (2), you:

(1) Must use an occupancy factor

• of unity because the regulation assumes that a person is continuously present, and

~X *The phrase " occupancy factor" is used as in NCRP Report No. 49: a factor

) used to correct for the degree of occupancy of the area in question while s' the primary beam is "on."

E-1

(2) May take advantage of "on time" (i.e., that fraction of an hour or week during which the primary beam of radiation is "on" l regardless of the orientation of the beam).

c. In showing compliance with paragraph 20.105(b)(1), you may not use a fractional use factor, i.e., that fraction of the time during which the primary beam is directed at a particular barrier.

d. You may use a fractional use factor to show compliance with para-graph 20.105(b)(2) if you maintain records to support your assumptions about use of the teletherapy unit. You should keep these records until NRC terminates your teletherapy license.

e. If compliance with paragraphs 20.105(b)(1) and (2) cannot be demon-strated, you have several options:

(1) You may restrict beam orientation (e.g., by using electrical or mechanical stops) to limit the anticipated radiation level.

(2) You may add shielding to the barrier in question.

(3) You may request authorization for higher radiation levels and j demonstrate that the requirements of paragraph 20.105(a) are met. In this case, you must include information on average radiation levels and anticipated occupancy times for each un-restricted area. You must also maintain records to support the assumptions used in justifying your request until the NRC terminates your teletherapy license.

(4) You may designate and maintain the area as restricted.

2. Restricted Areas:_

a. NRC's regulations do not specify maximum exposure rates for restricted areas in a manner similar to paragraph 20.105(b). Rather, the regulations refer to the ALARA philosophy (in paragraph 20.1(c)) and specify certain maximum per-missible doses that individuals may receive in a restricted area (9 20.101).

b. For each restricted area, you must describe:

(1) The physical and administrative controls used to restrict access to the restricted area, E-2

l G

(2) The number, wording, size, and location of warning signs to be placed in the vicinity of the restricted area, (3) Your program for ensuring that personnel entering the restricted '

area receive proper instruction in accordance with $ 19.12 of 10 CFR Part 19, (4) Your program for ensuring that personnel entering the restricted I area are monitored in accordance with S 20.202, and l

(5) The surveys that will be performed in accordance with 5 20.201.

The details regarding controls, signs, training and monitoring programs, and surveys will vary depending on the magnitude of possible exposure rates and other factors that pertain to your teletherapy unit. The NRC will review each situation on a case-by-case basis.

G O

E-3

APPENDIX F l

/

TELETHERAPY SURVEY REPORTS Conditions 18 and 19 of a standard teletherapy license (Exhibit B) require you to perfctm a radiation survey and to submit a survey report each time your teletherapy source is replaced or whenever any changes are made in the shielding, location, or use of the teletherapy unit that could affect radiation levels in surrounding areas.

The radiation survey should be conducted by a person who is qualified by training and experience to measure ionizing radiation, to evaluate safety tech-niques, and to advise on protection needs and who has good knowledge and under-standing of the operating characteristics, including the limitations, of the radiation detection instrumentation and measuring devices that are used in the survey.

CONTENTS OF SURVEY REPORT i

To fulfill the requirement for reporting the results of the radiation survey to the NRC, the survey report should:

1. Provide the name, address, and license number of the person or organi-zation that possesses the teletherapy unit and source.

2. Provide the name and address of each person conducting the survey.

3. Describe the reason for the survey (e.g., installation of a new source, relocation of the teletherapy unit).

4. Provide the date on which the work described in Item 3 was completed.

5. Provide the date or dates on which the survey was conducted.

6. Provide the following information for each radiation detection instru-ment used for the measurements reported in items 10, 11, and 15 (or 16) of the survey report:

F-1

a. The manufacturer's name and model riumber,

b. The date of the last calibration before making these measurements, and

c. The standards (i.e., radionuclide, activity, and accuracy) and procedures used in the calibration.

7. Provide the manufacturer's name and the model name and number of the ,

teletherapy unit.

8. Provide the manufacturer's name and model number of the teletherapy source.

9. Specify the activity of the source (in curies) and the corresponding assay date.

10. Specify the intensity of the primary beam of radiation at a specific distance (e.g., roentgens per hour at a meter (RHM) or roentgens per minute at a meter (RMM)) as measured after the source has been installed in the protective l

source housing of the licensee's teletherapy unit and the date that this inten-sity was measured. (Note that SS 35.21 to 35.27 of 10 CFR Part 35 provide for full calibration measurements to be made by an expert using a properly calibrated dosimetry system, as well as for monthly spot checks. Records demonstrating compliance with these sections of NRC's regulations must be maintained by the licensee as required by S 35.27. These records need not be submitted with the required survey report.)

11. Provide the maximum and average radiation levels measured at 1 meter from the source in the off position. The average radiation level may be obtained by averaging measurements taken at 14 points on the surface of a sphere 1 meter in radius centered on the source; the diagram in Figure F-1 shows the locatior of the 14 primary points. Up to 26 points may be measured in accordance with NCRP Report No. :3. Describe the locations of the 14 to 26 points and the radiation levels measured at each of the points. (Note that NRC agrees with Section 4.2.2 of NCRP Report No. 33, "... small areas of reduced protection are acceptable in eraluating the maximum ex,osure rate providing that the average l

l F-2

i over 100 square centimeters at one meter from the source does not exceed 10 milliroentgens per hour.")

12. Describe the limits of beam orientation permitted by electrical or mechanical stops installed on the teletherapy unit. Specify each direction in which the teletherapy head can be moved and the maximum angle (from vertical) of the beam orientation in each direction. Also specify the angle orientation (e.g., 0 is vertical toward the floor; 90* is horizontal toward the east wall; 180 is vertical toward the ceiling; and 270 is horizontal toward the west wall). You may use sketches to describe the beam stops that limit the use of the primary beam. For units with an integral beam absorber, provide this infor-mation for orientations with the primary beam directed (a) toward the integral beam absorber and (b) away from the integral beam absorber.

13. For measurements of radiation levels in adjacent areas,.which should be made during irradiation of a phantom at the normal treatment distance using maximum field size, describe:

a. The phantom used, including the material of which it is made and its size,

b. The source-to phantom distance, and

c. The field size (field size should be the maximum permitted by the collirtators unless physical means are used to restrict field size).

14. Submit plan and elevation drawings or sketches of the teletherapy facility; a scale of 1/4 inch = 1 foot is recommended. The drawings or. sketches should:

a. Indicate the direction of north,

b. Show the location of the teletherapy unit and source within the treatment room,

.. Identify each area adjacent to the treatment room (including above and below),

'd. Indicate the directions _of primary beam usage and, in the case l of an isocentric unit, the plane of rotation, and 1

F-3

e. Identify the locations at which radiation levels were measured (see items 15 and 16 below). ,

15. Rotational units:

a. For the primary beam directed toward the integral beam absorber, determine the rotational position of the teletherapy unit that causes the maxi-mum radiation level in each area adjacent to the treatment room (including above and below the treatment room). Report the maximum levels measured with a phan-tom in the primary beam and specify the corresponding rotational position (i.e. ,

angulation toward each area). In general, the maximum levels will be encountered with the beam oriented 30 from the perpendicular to the barrier in question.

b. For the primary beam directed away from the integral beam absorber and for units without an integral beam absorber, report the maximum radiation levels that are measured in each area adjacent to the treatment room (including above and below) and specify the orientation (i.e., angulation toward each area) that produces these maximum levels. Radiation measurements should be made with a phantom in the primary beam and the beam in its most adverse orientation with respect to each barrier. In general, measurements should be made at the maximum l limits permitted by the beam stops as described in item 12 of the survey report.

16. For vertical units, report the maximum radiation levels measured in each area adjacent to the treatment room (including above and below) and specify the orientations (i.e., angulation toward each area) that produce the maximum radiation levels. Radiation measurements should he made with a phantom in the primary beam and with the beam in its most adverse orientation with respect to each barrier. In general, measurements should be made at the maximum limits permitted by the beam stops described in item 12 of the survey report.

17. For each measured radiation level reported in items 15 or 16 of the survey report that exceeds 2 milliroentgens per hour, explain how you are complying with NRC's regulations and the terms of your license. See Appendix E for further guidance.

18. Describe (1) the tests that were conducted and (2) the results of these tests that ensure proper operation of the safety systems described below.

F-4

, All tests should use a radiation detection instrument to confirm the "on-off"

status of the source. j

a. Teletherapy treatment room door interlock. The test should be sufficient to ensure that the door interlock operates in the manner described in Condition 17 of the license (Exhibit B).

b. Teletherapy "on-off" indicators, both mechanical and electrical (e.g., lights or mechanical indicator on protective source housing of teletherapy unit, over door to room, at console).

c. Electrical or mechanical stops installed to limit use of the primary beam of radiation. The test should be sufficient to ensure that beam stops operate in the manner described in item 12.

d. Teletherapy treatment timing device. The tests should be sufficient to ensure that the timer is accurate, that t he source returns to the off position at the end of the preset time, and that the source does not return to the on position until the timer is reset.

19. If a teletherapy unit or source was removed, provide:

a. The date of removal and

b. The name, address, and license number of the person or firm who took possession of the unit or source.

20. If the surveyor recommends any changes to improve the safety of the operation of the teletherapy facility, describe the recommendations and your response to these recommendations.

INSTRUCTIONS FOR FILING SURVEY REPORTS

1. A report of the results of the required survey should be sent to the NRC. For specific instructions, see the condition on your license that is equivalent to Condition 18.C of Exhibit B.

s These reports must be sent no later than 30 days after the installation

) cf a new source or completion of the changes requiring the survey.

F-5

2. The licensee should keep a copy of the survey report in its files for at least 5 years from the date on which the survey was conducted.

I I

(

l 1

F-6

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Figure F-1 TELETHERAPY HEAD SURVEY ISource in "OFF" position. Top View Showing Measurements taken one meter orientation from source) of Views A through D REAR Radiation Level Position No. ImR/hr)

View A 1 2 A (left side)-

3 45'

"  %' M*

B Deft front)  :

View B 5 C (front) fr t) 6 7

8 View A-Vertical View B-Vertical from lef t side from lef t front View C 9 10 5 8

45' View D 11 90'  %'

1

~

REAR 'x /

)FRONT L

x 45')

/

Average value Maximum value \ /

6 Date of survey View C-Vertical View D-Vertical instrument used from front from right front 11 Manufacturer's name Er model number g.

of teletherapy source W  %* g Date of installation , g 45' OUTPUT O RHM FRONT \ REAR N

O RMM Date of output measurement F-7

APPENDIX G PROCEDURES FOR CALIBRATION OF SURVEY INSTRUMENTS *.

l

1. Calibration of survey meters will be performed with radionuclide sources. l 1

1

a. The sources will be approximate point sources.  ;

b. The source used will be one of those listed in Table G-1.

Table G-1 SOURCES USED FOR SURVEY INSTRUMENT CALIBRATION Minimum Activity (To give at least 700 milliroentgens Radionuclide per-hour at 20 cm)

Cesium-137 85 millicuries Cobal t-60 21 millicuries Radium-226 34 millicuries

c. The source activities or exposur e rates at given distances will be traceable by documented measuremer.ts to a standard source certified within 5% accuracy to the U.S. Nati)nal Bureau of Standards (NBS) calibration sources,

d. Calibration will be performed at intervals not to exceed 12 months and after servicing.

e. Instruments will be calibrated on every scale or range of the instru-ment, up to 1 roentgen per hour.

f. The exposure rate measured by the instrument will differ from the true exposure rate by less than 110% at the calibration points (read the appropriate section of the instrument manual to determine how to make necessary adjustments to bring the instrument into calibration).

Readings within 20% will be considered acceptable if a calibration chart, graph, or response factor is prepared, attached to the instru-ment, and used to interpret meter readings.

2. A reference source (check source) that has a long' half-life, e.g., cesium-137 or radium 0 and E, will also be read at the time of the calibration or as soon as the instrument is received from a calibration laboratory. The G-1 o

readings will be taken with the reference source placed in specific geometry relative to the detector. A reading of this reference source should be taken:

a. Before each use and after each survey to ensure that the instrument was operational during the survey,

b. After each maintenance or battery change, and

c. At intervals not to exceed 3 months.

If any reading with the same geometry is not within x20% of the reading measured immediately after calibration, the instrument will be recalibrated.

3. Records of items 1, 2.b, and 2.c above will be maintained for a least 2 years after each calibration or check.

4. The use of the small check source that is in some survey meters is not appropriate or acceptable for calibration purposes.

5. The inverse square law and radioactive decay law may be used for calibration.

a. A calibrated source will have a calibration certificate giving its output at a given distance or its activity measured on a specified date by the manufacturer.

! (1) The inverse square law may be used with any point source to cal-culate the exposure rate at other distances.

(2) The radioactive decay law may be used to calculate the output at any time.

b. Inverse Square Law If R,is the exposure rate at distance D afr m a point source and R b is the exposure rate at distance Dbfrom the same point source, then:

R D2 = R D2 g aa bb G-2 4

l l

1 l

NOTE: R, and Rb must be in the same units of exposure rate (e.g.,

milliroentgens per hour, roentgens per hour) and D, and Db must be in the same units of distance (e.g., centimeters, meters).

If R,, D,, and Db are known, R b can be calculated from:

D2 Rb = xR a 02 b

c. Radioactive Decay Law The exposure rate of a standard source at a time t after a specified calibration date is given by

-(0.693 x )

R =R0*g

=R0 * (b)

I where R is the exposure rate at a time t after the source t

calibration date R is the exposure rate on the date the standard source was O

calibrated t is the time elapsed since the calibration date T

g is the radionuclide half-life n is the number of half-lives through which tae radioactive source has decayed and is equivalent to the quantity of t/T g NOTE: R and R must be in the same units of exposure rate (e.g.,

t 0 milliroentgens per hour, resntgens per hour), and t and Tg must be in the same units of time (e.g., seconds, days, years).

G-3 n

APPENDIX H TOPICS THAT MAY BE INCLUDED IN OPERATING PROCEDURES Good health physics practice dictates that you provide your personnel with operating procedures to give them clear and specific directions in their duties and responsibilities. These duties may include, but are not limited to, safety device checks, instrument calibration, monthly spot checks, and leak tests. Operating procedures should not contain information that does not apply specifically to persons to wh are directed. For example, house-keeping personnel would not follow the same procedures as therapy technologists.

The operating procedures should be designed for the program proposed in your application. Procedures should be complete and self-contained. Pertinent information contained in equipment manuals and other publications should be extracted and included in your operating procedures.

The following topics may be included in your operating procedures:

1. Receipt and Disposal of Radioactive Materials. Teletherapy licenses specify exactly the radioactive material by chemical and physical form (including manufacturer's name and model number) and the maximum activity that may be possessed and used in a specific teletherapy unit (manufacturer's name and model number). (See items 6, 7, 8, and 9 of Exhibit B.) When radioactive materials ate no longer needed, they may be transferred to a person or firm authorized to receive them as provided in S 30.41 of 10 CFR Part 30. Further, you must notify the NRC in writing when you decide to permanently discontinue all activities involving radioactive materials authorized by your license; see para-graph 30.34(f).

necordingly, operating procedures should be sufficient to ensure that radio-active materials received are within the limits specified in your license, that radioactive materials are transferred to appropriately licensed persons in accordan;e with the requirements of S 30.41, and that the NRC is notified in writing when you decide to permanently discontinue all activities authorized by your license. -

l

2. Use of the Teletherapy Unit. The operating procedures should specify who may operate the unit, how the unit may be used (i.e., in what orientations, l H-1

\

for what purposes), and how the unit is to be operated (i.e., the sequence of {

steps to be followed to turn the beam on and off). The operating procedures should include instructions to ensure that only the patient is in the room when the primary beam is on and may specify certain daily checks of the unit to ensure its proper operation.

3. Safety Device Checks. Safety devices should be checked periodically to ensure that they are operating properly. Such devices includa timers, mechanical and electrical interlocks, warning lights and alarms, safety switches, door interlocks, beam collimators, and other devices that actively warn of, limit, or prevent radiation exposure to either patients or personnel. The recommended frequency for safety device checks is at least once a week. A record of the results of the checks should be made. The operating procedures should include instructions for making the checks, the frequency with which they will be made, prompt correction of any malfunctions or defects noted, and reten,tjon of appropriate records (see Item 10.5 of this guide). A simple check-list may be used to complete the task and recordkeeping quickly and efficiently.

When checks of safety devices indicate defects or malfunctions, there may be some delay before the defects or malfunctions can be corrected. The operat-ing procedures should describe the steps that personnel will follow should a delay occur. For example, use of the teletherapy unit might be forbidden until the problem is corrected, or alternative equivalent proceaures such as requiring personnel to enter the room with an operable survey meter might be implemented.

Documents such as ANSI N449-1974, " Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment";* ANSI N449.1-1978, " Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment";* and NCRP Report No. 69, " Dosimetry of X-Ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 kev to 50 MeV,"** recommend frequency and procedures for making certain tests. If the recommendations in these documents conflict with NRC's regulations or license conditions, the minimum acceptable frequency is that specified in the regulation er license condition.

• Copies may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018.

C* Copies may be obtained from NCRP Publications, 7910 Woodmont Avenue, Bethesda, MD 20815.

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4. Personnel Dosimetry. Operating procedures should require teletherapy personnel to wear personnel monitoring devices (film or TLD badges); they should also contain instructions about the manner in which the devices should be worn and about proper storage of the devices when they are not in use. If pocket dosimeters will also be used, frequent reading should be required. The operating procedures should contain directions to be followed in the event that a person receives or suspects that he or she has received a high exposure.

In this case, it may be necessary for the film badge or TLD of the affected person to be processed immediately.

5. Procedures for Securing the Teletherapy Unit. The operating procedures should specify the actions to be taken to ensure that the teletherapy unit is secure when unattended. Such actions should include locking the treatment room and the control panel but may also include restricting access to the entire treatment area.

6. Instrument Calibration and Checks. Instruments must be calibrated and checked for proper operation in accordance with NRC regulations (e.g. ,

SS 35.23 and 35.25 of 10 CFR Part 35) and other commitments of the licensee (e.g., response to Item 10.3 of this guide). Operating procedures should identify who will calibrate survey instruments, specify the frequency of calibration, and describe the methods and radioactive standards used in the calibration.

Paragraphs 35.25(d) and (e) require that the beam-on monitor and survey instrument (or audible-alarm personal dosimeter) be checked daily for proper operation. The operating procedures should specify who is to make these checks and how they are to be made.

Section 35.23 specifies how and by whom dosimetry systems used for full calibration and spot-check measurements are to be calibrated and the frequency of calibration. Operating procedures should be sufficient to ensure compliance with S 35.23.

7. Full Calibration of Teletherapy Units. Section 35.21 specifies what measurements must be made during a full calibration; SS 35.23 and 35.24 require thet a properly calibrated dosimetry system be used and that an expert perform H-3 l

the full calibration measurements. Operating procedures should identify who will make the full calibration measurements and describe the procedures to 'be followed and the instruments to be used.

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8. Monthly Spot-Check Measurements of Teletherapy Units. Section 35.22 specifies that tests must be conducted as monthly spot checks and S 35.23 describes the characteristics of a properly calibrated dosimetry system needed to make the spot-check measurements. The operating procedures should specify when, how, and by whom the spot-check measurements will be made. If the spot checks are not done by the expert, the operating procedures should describe how and when the results of the spot checks are reviewed by the expert.

9. Leak Tests. Leak tests must be conducted in accordance with the requirements of Condition 14 of the teletherapy license (see Exhibit B) and the commitments in your response to Item 10.4 of this guide. Operating procedures should specify who will perform the tests, how often the tests will be conducted, and the procedures to be followed in taking and evaluating the samples. If commercial leak-test kits are used, the operating procedures should include the supplier's instructions.

10. Inspection and Servicing of the Teletherapy Unit. Section 35.26 requires that teletherapy units be fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first. This work to ensure proper functioning of the source exposure mechanism must be done by a person or firm specifically licensed to do so by the NRC or an Agreement State. Operating procedures should be sufficient to ensure compliance with S 35.26.

11. Limitations on Work Done on Teletherapy Unit. Condition 21 of the teletherapy license (see Exhibit B) requires that only persons or firms specifically authorized by NRC or an Agreement State can:

Install, relocate, or remove teletherapy units containing sources, Perform source exchanges, Perform any maintenance or repair of the teletherapy unit that involves work on the source drawer, the shutter, or other mechanism that could

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l expose the source, reduce the shielding around the source, or compro-D mise the safety of the unit and result in increased radiation levels.

Operating procedures should be sufficient to ensure compliance with the requirements of this license condition.

12. Survey Reports. Conditions 18 and 19 of the teletherapy license identify when a formal survey must be made, what measurements and tests must be performed..and when and to whom formal reports must be submitted. The operating procedures should specify who will perform the formal surveys, how and when they will be conducted, and when and to whom copies of the formal report will be sent. The operating procedures should require that, as a minimum, the survey reports contain the information identified in Appendix F of this guide.

13. Relocation of Teletherapy Unit. Condition 19.B of the teletherapy license requires that the NRC approve your plans and proposed location before a teletherapy unit is relocated. The operating procedures should ensure that the needed amendment to the NRC license is obtained before the teletherapy unit is relocated.

14. Recordkeeping. You must maintain certain records to comply with NRC's regulations, the conditions of your license, and commitments made in your license application and correspondence with NRC. Operating procedures should identify the individuals within your organization who are responsible for maintaining which records. Operating procedures should consider, but not be limited to, maintenance of the documents listed below.

- Copies of NRC licenses, your license applications, and correspondence with the NRC in support of a license request 1

- Record of results of safety device checks 2 IMaintenance of these records is required by S 19.11 of 10 CFR Part 19.

Because this regulation does not specify how long to keep the records, you should maintain them until the NRC terminates your license.

2 Maintain for at least 2 years from the date of each safety device check (see Item 10,5), survey instrument calibration and check (see Item 10.3),

and leak test (see Item 10.4).

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Personnel dosimetry records 3 Records of survey instrument calibrations and daily checks 2 Records of daily checks of beam-on monitor 4 Records of daily checks of audible-alarm personal dosimeters 4 Records of calibration of the dosimetry system used for full calibration measurements 5 Records of calibration or intercomparison of the dosimetry system used f.r spot-check measurements 5 Results of full calibration measurementss Results of spot-check measurementss Record of evaluation of the training and experience of the " qualified expert" as defined in S 35.245 Records of leak-test results2 Records of training of new personnel and annual refresher training of personne16 Records of full inspection and servicing of the teletherapy unit 5 Copies of reports of surveys conducted in accordance with Conditions 18 and 19 of the teletherapy license 7 Records of receipt and disposal of radioactive materia 18

15. Emergency Procedures. Condition 16 on teletherapy licenses requires that emergency instructions be posted at the teletherapy machine control and that these instructions inform the operator of procedures to be followed if the primary beam of radiation cannot be turned off by using the controls outside the room.

Emergency instructions should be developed that cover.not only the situation outlined above but any other unusual occurrence (e.g., source does not return to the fully off position). In developing emergency instructions, you must b sure that they are clear and concise and that potential adverse consequences aSee S 20.401 of 10 CFR Part 20.

4 Maintenance of these records is required by S 35.27 of 1C CFR Part 35. Because this regulation does not specify how long to keep these records, you should maintain them until the NRC terminates your teletherapy license.

SSee S 35.27 of 10 CFR Part 35.

CMaintain until the NRC terminates your teletherapy license (see response to Item 8.2 cf the guide).

7 Maintain for at least 5 years from the date on which the survey was conducted. j 8See S 30.51 of 10 CFR Part 30.

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have been considered. For example, the first step of some emergency instructions specifies pushing the " emergency bar" on the machine's console. Although this action frequently causes retraction of the source to the off position, it may also cut electrical power to the entire teletherapy unit or to the gantry or couch.

Operating procedures should require that written emergency instruct:ons be established, be posted at the teletherapy unit console, and be followed when necessary. The emergency instructions should specify when they are to be imple-mented and describe specific actions to be taken and specific persons to be notified. Operating procedures should also require that new teletherapy per-sonnel be trained in emergency procedures as soon as they raport for duty and that practice drills in emergency procedures be conducted with all appropriate personnel at least once a year.

See Item 10.6 for criteria used to evaluate emergency instructions.

16. Procedures for Notifying the Proper Persons in the Event of an Accident or Unusual Occurrence. The operating procedures should specify categories of occurrences (e.g. , teletherapy unit malfunction, misadministration) that require notification and the names and telephone numbers of individuals or organizations to be notified in sach category of occurrence (e.g., radiation safety officer, hospital administrator, teletherapy unit manufacturer or service representative, and the NRC).

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APPENDIX I EMERGENCY PROCEDURES FOR BEAM CONTROL FAILURE OR MALFUNCTION If the light signals or beam-on monitor indicate that the beam control mechanism has failed to terminate the exposure at the end of the preset time (e.g. , if the red light stays on and the green light is off, or if both the red and the green lights stay on for more than a few seconds), the source may still be in the on position. The following steps are to be carried out promptly and in a calm manner by the Radiation Therapy Technologist:

1. Open the door to the treatment room.

2. If the patient is ambulatory, tell him or her to get off the table and leave the room.

3. If the patient is not ambulatory, enter the treatment room but avoid exposure to the direct beam. Pull the treatment table as far away from the direct beam as possible. Transfer the patient to a stretcher and remove the patient from the room.

4. Close the door and secure the area by locking the door to the treatment room or posting a guard at the entrance.

5. Turn off the main switch at the control panel.

6. Notify the radiation therapist and radiation safety officer at once- .

7. Conspicuously post a sign in the area to warn others of the problem.

Radiation Therapist

• Phone No.. On Duty

• _ Off Duty

• Radiation Safety Officer

• Phone No.: On Duty

• Off Duty *

• Copies of emergency procedures posted at the teletherapy console will contain up-to-date information on the names and telephone numbers of personnel to be contacted.

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APPENDIX J MODEL PROGRAM FOR MAINTAINING OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL INSTITUTIONS ALARA

1. Management Commitment

a. We, the management of this (medical facility, hospital, private practice, etc.), are committed to the program described in this document for keeping exposures (individual and collective) as low as is reasonably achiev-able (ALARA). In accord with this commitment, we hereby describe an administra-tive organization for radiation safety and will develop the necessary written policy, procedures, and instructions to foster the ALARA concept within our institution. The organization will include a radiation safety committee (RSC)1 and a radiat.non safety officer (R50).

b. We will perform a formal annual review of the radiation safety program including ALARA considerations. This will include reviews of operating proce-dures and past exposure records, inspections, and consultations with the radia-tion protection 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 unless the cost, in our judgment, is considered to be unjustified. We will be able to demon-strate, if necessary, that improvements have been sought, that modifications have been considered, and that they have been implemented where reasonable. We will be prepared to describe the reasons for not implementing them.

d. In addition to maintaining doses to individuals as far below the limits as is reasonably achievable, the sum of the doses received by all exposed indi-viduals will also be maintained at the lowest practicable level. It would not be desirable, for example, to hold the highest doses to individuals to some fraction of the applicable limit if this involved exposing additional people and significantly increasing the sum of radiation doses received by all involved individuals.

1 Private practice physician licenses do not require an RSC.

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2. Radiation Safety Committee (RSC)2

a. Review of Proposed Users and Uses l

l (1) The RSC will thoroughly review the qualifications of each appli-cant with respect to the types and quantities of materials and uses for which that person has applied to ensure that the applicant will be able to take appro-priate measures to maintain exposure ALARA.

(2) When considering a new use of byproduct material, the RSC will review the efforts of the applicant to maintain exposure ALARA. The user should have systematized procedures to ensure ALARA and should have incorporated the use of special equipment.

(3) The RSC will ensure that the user justifies his procedures and that doses will be ALARA (individual ard collective).

b. Delegation of Authority The judicious delegation of RSC authority is essential to the enforce-(

ment of an ALARA program.

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

(2) The RSC will support the RSO in those instances in which it is necessary for the RSO to assert authority. When the RSO has been overruled, the RCS will record the basis for its action in the minutes of its quarterly meeting.

c. Review of ALARA Program (1) The RSC will encourage all users to review current procedures and to develop new procedures as appropriate to implement the ALARA concept.

2The RSu identified on private practice physician licenses will assume the responsibilities of the RSC.

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(2) The RSC will perform a quarterly review of occupational radiation exposure with particular attention to instances in which Investigational Levels in Table J-1 are exceeded. The principal purpose of this review is to assess trends in occupational exposure as an index of the ALARA program quality and to decide if action is warranted when Investigational Levels are exceeded (see paragraph 6).3 (3) The RSC will evaluate the institution's overall efforts for main-taining exposures ALARA on an annual basis. This review will include the efforts of the RSO, authorized users, and workers4as well as those of management.

3. Radiation Safety Officer (R50)

a. Annual and Quarterly Review (1) Annual review of the radiation safety program. The RSO will perform an annual review of the radiation safety program for adherence to ALARA concepts. Reviews of specific procedures may be conducted on a more frequent basis.

l (2) Quarterly review of occupational exposures. The RSO will review at least quarterly the external radiatinn exposures of authorized users and workers to determine that their exposures are ALARA in accordance with the pro-visions of paragraph 6 of this program.

(3) Quarterly review of records of radiation level surveys. The RSO will review radiation levels in unrestricted and restricted areas to determine that they were at ALARA levels during the previous quarter,

b. Education Responsibilities for an ALARA Program 3NRC has emphasized that the Investigational Levels in this program are not new dose limits but, as noted in ICRP Report 26, " Recommendations of the Internaticnal Commission on Radiological Protection," serve as checkpoints above which the results are considered sufficiently important to justify further investigation.

4The term " worker" as used in this appendix refers to those individuals who work under the direction or supervision of authorized users and who may receive an occupational dose as defined in paragraph 20.3(a)(10) of 10 CFR Part 20.

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

(2) The RSO will ensure that authorized users, workers, and ancillary personnel who may be exposed to radiation will be instructed in the ALARA philos-ophy and informed that management, the RSC, and the RSO are committed to imple- '

menting the ALARA concept.

c. Cooperative Efforts for Development of ALARA Procedures Workers will be given opportunities to participate in formulation of the procedures that they will be required to follow.

(1) The RSO will be in close contact with all authorized users and workers in order to develop ALARA procedures for working with radioactive materials.

(2) The RSO will establish procedures for receiving and evaluating the suggestions of individual workers for improving health physics practices and will encourage the use of those procedures,

d. Reviewing Instances of Deviation from Good ALARA Practices The R50 will investigate all known instances of deviation from good ALARA practices and, if possible, determine the causes. When the cause is known, the RSO will require changes in the program to maintain exposures ALARA.

4. Authorized Users

a. New Procedures Involving Potential Radiation Exposures (1) The authorized user will consult with and receive the approval of the RSO or RSC or both during the planning stage before using radioactive materials for a new procedure.

(2) The authorized user will evaluate all procedures before using radioactive materials to ensure that exposures will be kept ALARA. This may be enhanced through the application of trial runs.

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b. Responsibility of the Authorized User to Those Supervised (1) The authorized user will explain the ALARA concept and the com-mitment to maintain exposures ALARA to all of those supervised.

(2) The authorized user will ensure that workers under his or her supervision are trained and educated in good health physics practices and in maintaining exposures ALARA.

5. Workers

a. Workers will be instructed in the ALARA concept and its relationship to their working procedures and working conditions.

b. Workers will know what recourses are available if they believe that ALARA is nat being promoted on the job.

6. Establishment of Investigational Levels To Monitor Individual Occupational External Radiation Exposures This institution (or private practice) hereby establishes Investigational Levels for occupational external radiation exposure that, when exceeded, will initiate review or investigation by the RSC, the RSO, or both. The Investigational Levels apply to the exposure of individual workers.

TABLE J-1 Investigational Levels (mrems per calendar quarter)

Level I Level II Whole body, head and trunk, 125 375 active blood-forming organs, lens of eyes, or gonads Hands and forearms, feet and 1875 5625 ankles Skin of whole body

• 750 2250

• Not normally applicable to nuclear medicine or teletherapy operations.

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The RSO will review and record on Form NRC-5, " Current Occupational External {

Radiation Expostres," or an equivalent form (e.g., dosimeter processor's re; ort) the results of personnel monitoring at least once in any calendar quarter. The exposures will be compared with the Investigational Levels in Table J-1 and the following actionc will be taken:

a. Quarterly exposure of individuals less than Investigational Level I Except when deemed appropriate by the RSO, no further action will'be taken in those cases in which an individual's exposure is less than Table J-1 values for Investigational Level I.

b. Quarterly personnel exposure equal to or greater than Investigational Level I, but less than Investigational Level II The RSO will review the exposure of each individual whose quarterly exposure equals or exceeds Investigational Level I and will report the results of such reviews at the first RSC meeting following the quarter when the exposure

{

was recorded. If the exposure does not equal or exceed Investigational Level II, no action related specifically to the exposure is required unless deemed appro-priate by the RSC. The RSC will, however, consider each such exposure in com-parison with those of others performing similar tasks as an index of ALARA pro-gram quality and will record the review in the RSC's minutes.

c. Quarterly personnel exposure equal to or greater than Investigational Level II The RSO will investigate in a timely manner the causes of all personnel exposures equaling or exceeding Investigational Level Il and, if warranted, take action. A report of the investigation, actions taken, if anv, and a copy of the individual's Form NRC-5 or its equivalent will be presented to the RSC at the first RSC meeting following completion of the investigation. The details of these reports will be recorded in the RSC's minutes. The RSC's minutes will be sent to the management of the institution for review. The minutes, containing details of the investigation, will be made available to NRC inspectors for review at the time of the next inspection.

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d. Establishment of an individual worker's Investigational Level II above that listed in Table J-1 If a worker or a group of workers needs to exceed Investigational l Level II, a new, higher Investigational Level II may be established on the basis that it is consistent with good ALARA practices for that individual or group.

Justification for a new Investigational Level II will be documented.

The RSC will review the justification for, and will approve, all revisions of Investigational Level II. In such cases, when the exposure equals or exceeds the newly established Investigational Level II, those actions listed in paragraph c above will be followed.

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APPENDIX K RADIATION SAFETY COMMITTEE Responsibilities The Radiation Safety Committee is responsible for:

L Overseeing the use of NRC-licensed radioactive materials throughout the institution.

2. Reviewing the institution's radiation safety program to ensure that NRC-licensed materials are used safely and in accordance with NRC regulations, the conditions of all NRC licenses, and the ALARA philosophy (expressed in para-graph 20.1(c) of 10 CFR Part 20).

Duties

.The Radiation Safety Committee will:

1. Be familiar with all pertinent NRC regulations, the terms of the licenses, and information submitted in support of the request for the licenses and amendments.

2. Review the training and experience of all individuals who use NRC-licensed radioactive material (including physicians, technologists, and physi-cists) and determine that their qualifications are safficient to enable them to perform their duties safely and in accordance with HRC regulations and the con-ditions of the licenses.

3. Establish a program to ensure that alii radiation workers

• and all other individuals whose duties may require them to work in the vicinity of NRC-licensed radioactive material (e.g., nursing, security, and housekeeping personnel) are properly instructed as required by S 19.12 of 10 CFR Part 19.

4. Review and approve all requests for use of HRC-licensed radioactive material within the institution.

• The phrase " radiation workers" as used in this appendix means those individuals who may receive an occupational dose as defined in paragraph 20.3(a)(10) of

)

10 CFR Part 20.

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5. Review the entire radiation safety program at least annually to deter-mine that all activities are being conducted safely and in accordance with NRC regulations and the conditions of the licenses. (The review will include an examination of all records, reports from the radiation safety officer (RS0),

results of NRC inspections, written safety procedures, and management control system.)

6. Recommend remedial action to correct any deficiencies identified in the radiation safety program.

7. Maintain, until NRC terminates our licenses, written records of all Radiation Safety Committee meetings, actions, recommendations, and decisions.

8. Ensure that the NRC radioactive material license is amended, when necessary, before any changes are made in facilities, equipment, policies, procedures, and personnel (i.e., authorized user and RS0).

Meeting Frequency The Radiation Safety Committee will meet as often as necessary to conduct its business but not less than once each calendar quarter.

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l APPENDIX L REQUESTS FOR LICENSE AMEN 0MENTS, RENEWALS, AND TERMINATIONS Prepare requests for license amendments, renewals, and terminations in triplicate; retain one copy and submit the original and one copy to the NRC.

These requests may be prepared on NRC Form 313 or in letter form, and they must i be signed by an authorized representative of management (e.g., the hospital administrator.or applicant physician) and dated. The appropriate fee (see 10 CFR Part 170, " Fees for Facilities and Materials Licenses and Other Regulatory Serv-ices Under the Atomic Energy Act of 1954, as Amended") must be enclosed with amendment and renewal requests. Terminations do not require a fee. Review of an amendment or renewal request will not begin until the appropriate fee has been paid.

1. LICENSE AMENDMENT REQUESTS *

a. To add a new user, you should complete Items 1, 2, 4, 7, 12, and 13 of NRC Form 313. You should refer to the discussion on each of these items in Section 3 of this guide and to Appendix C of this guide for acceptable training and experience.

b. To change the radiation safety officer (RS0), you should complete Items 1, 2, 4, 7, 12, and 13 of NRC Form 313. You should refer to the discussion on each of these items in Section 3 of this guide and to Appendix C of this guide for acceptable training and experience.

c. To change sources in existing teletherapy units:

(1) If Item 7 of your license lists the source to be installed by manufactarer's name and model number.and if the activity of the new source is less than or equal to the maximum activity per source shown in Item 8 of your license, no amendment is needed.

• Unless you provide information to the contrary, the NRC staff will assume that you are making no changes to your teletherapy program other than the change identified (e.g., requesting authorization to change sources but not I to change other items such as leak-test program, requesting only the addition I of a new user). If other changes are requested, see the appropriate sections of the guide.

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(2) If Item 7 of your license does not list the source to be installed by manufacturer's name and modal number and if the activity of the new source is less than or equal to the maximum activity per source shown in Item 8 of your license, an amendment is needed. You should complete Items 1-6, 12, and 1

)

13 of NRC Form 313. You should refer to the discussions on each of these items in Section 3 of this guide.

(3) If the activity of the new source is greater than the maximum activity per source shown in Item 8 of your license, an amendment is needed.

You should (a) complete Items 1-6, 12, and 13 of NRC Form 313, (b) provide the information requested in Items 9.4, 9.5, and 10.7* of this guide, and (c) esti-mate the average and maximum radiation levels to be expected at 1 meter from the source with the source in the "off" position (i.e., show that, when the new h'igher activity source is insta'lled, you will comply with the requirements of Condition 18.A(i) of your license).

You should refer to the discussion of each of these items in Section 3 of this guide. If beam stops (discussed in Item 9.4) will not be changed when the new higher activity source is installed, you can use the results from your last survey to evaluate the adequacy of the shielding of the facility as well as to estimate the source-housing leakage levels.

d. To change or add teletherapy units and sources or to move an existing.

teletherapy unit and source to a new location, you should complete Item 1-6, 12, and 13 of NRC Form 313 and provide the information in Items 9.1 through 9.5, and 10.7* of this guide. You should refer to the discussions of each of these items in Section 3 of this guide.

In the situation in which (1) a new teletherapy unit and source will be installed in the exact same location within the same treatment room (pre-viously occupied by the old teletherapy unit and source) and (2) beam stops will limit use of the primary beam of the new source in exactly the same manner that similar stops limited use of the primary beam of the old source, calcula-tions requested in Item 9.5 of the guide need not be submitted. In lieu of the calculations, you may pruvide estirnates of anticipated maximum radiation levels based on the results_of the last radiation survey.

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• You need not submit another ALARA program if your ALARA program in connection with your teletherapy license has already been approved by NRC.

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2. LICENSE RENEWAL REQUESTS

-To renew a license, you may submit a complete application using NRC Form 313 and provide all the information requested on the form without referring to previously submitted information (except for qualifications of previously approved users). Certain references to previously submitted information are acceptable if:

- The reference is made in response to a particular item on NRC Form 313,

- The reference is clear and specific (e.g., title of document, date of submission, page, and paragraph), and

- The referenced document contains all the information required for a particular item at the time of renewal.

An acceptable alternative is a l_etter, signed by a representative of manage-ment, that specifically requests that the teletherapy license be renewed and that contains the following information in support of this request.

a. The number of the license to be renewed.

b. The name of the licensee to be used in Item 1 of the renewed license.

c. The mailing address to be used in Item 2 of the renewed license.

d. The location of the teletherapy unit by street address, building name, wing name, floor, room number; this information will be used in Condition 10 of the renewed license.

e. Verification that the location of the teletherapy unit is the same as that described in previous correspor.dence with NRC; identify these documents by date. Verify that no changes have been made that affect radiation levels in surrounding areas or that affect the patient viewing system.

f. Verification that electrical or mechanical stops that limit use of the primary beam of radiation are still installed and continue to operate as described in the last survey report submitted to NRC and in any subsequent correspondence on the report; identify these documents by date.

g. Confirmation that the current authorizations in Items 6 through 9 of the license (regarding radionuclide, description of sealed sources and tele-I therapy unit, maximum possession limit, and authorized use) are correct.

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h. Verification that the list of authorized users in Condition 12 of the {

license is correct or that a list of the names to be deleted is included.

i.

The name of the radiation safety officer (RS0) for the teletherapy program. If the RSO is not one of the authorized users or if the individual's qualifications have not been submitted to NRC with regard to the teletherapy license, submit a completed Supplement A. See Item 7.3 of this guide for additional information.

j. The information requested in Items 8, 10.5, and 10.6 of the guide.

k. The information requested in Items 10.1, 10.2, and 10.3 of the guide.

(This guide requests information that is less specific than previously requested.

Submitting this less specific information will allow you greater flexibility to make changes in these aspects of your program without amending your license.)

1. Verification that there have been no changes in the information previously submitted to NRC regarding other aspects of the radiation protection program or the teletherapy program.

m. If your teletherapy license is issued in the name of a medical institution:

(1) Submit evidence that your radiation safety committee (previously called the medical isotopes committee) includes the individuals specified in the current paragraph 35.11(b) of 10 CFR Part 35.

(2) Verify that the committee's duties and responsibilities have been amended to include teletherapy.

(3) Verify that records.on the membership of the radiation safety committee will be maintained until the NRC terminates your teletherapy license.

These records should demonstrate that, if committee membership is changed, the committee will continue to include the individuals specified in paragraph 35.11(b).

This commitment will permit you to change committee membership within the constraints of the regulation without requiring you to amend your teletherapy license.

n. If an ALARA program with regard to the teletherapy license has not been submitted and approved by the NRC, you should submit an ALARA program as requested in Item 10.7 of the guide.

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o. If a source change or any other change described in Conditions 18 and 19 of the license has occurred and the required survey report has not been sub-mitted to NRC, you must submit a copy of the required survey report being sure that, as a minimum, the report contains the information described in Appendix F.

p. If you wish to add authorized users or make any other changes in the l teletherapy program, you should clearly describe the changes to be made and 1

submit appropriate supporting documentation. You are advised to review this regulatory guide carefully, especially Section 1 of this Appendix, to determine 1 what information is to be submitted.

3. LICENSE TERMINATION REQUESTS When you no longer wish to use your teletherapy unit and source and you have disposed of both, you should request that NRC terminate your license.

Specify to whom the teletherapy unit and source were transferred, the recipient's NRC or Agreement State license number, and the date of the transfer.

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l i

D a SAC.FOnes 318 nA t0 CF m R.30.

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EXHIBIT A APPLICATION FOR MATERIAL LICENSE U S. seuCLE An stOULATomV comas 8SS804 AMaov'O *"a*

3196 0120 E- 53nr INSTRUCTIOseS: SEE THE APPROPRIATE LICENSE APPLICxTION GulCE FOR OETAILED INSTRUCTIONS FOR COuPLETING AP'L8 CATION. SEND T OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED 8tLOW IP VOU AAt LOCATEO 18e FEOtRAL AGE 8scitS PtLS AMUCATIONS WeTN:

ILLisso:S easOi Asea, eOWA aseCMsGAN, M'NesESOTA. asissouns. OMoo. Osl U S. MuCLEAm mEGuLATOmv COMMsSSION WESCONSiN. SENO APPUCAT508e8 TO OsvaS40se Of PutL CYCLE A8eO MATEme AL SAFETY, NMSS

> WASM48eGTON. OC 20868 U S NUCLEAA REGULATOsIV consM'SSiON. REGION su J M ATE #t ALS UCENSs4G SECTIOse ALL OT**G R PERSO8st P4LE APPUCATIOneS AS POLLOTft.1F YOU ARE F99 ROOSEVELT seO AO LOCATED tes: GLEN ELLv4 iL 80137 CDtssoECTICUT. Of Lausant. Deste*CT 09 COLunasaA, esAssus.M AAYLANO. AAR AntSAS COLOR AOO. IDAmeO. K AasSAS. LOusS8Assa, asOasTANA NEsa ASK A, saamaugemgTTS NEW JE RSE V, NEW voma, PtssNSTLWantA, RMODE ISLANO, asEW ME meCO, acoafes OAu GTA On LAseOMA. 00WTM OAACT A. YE KAS. UT Ase.

OR v5mm3ssT, Salso AMUCAT10ssS 70; OA WVOMoseG, SENO AMUCATioass 70 U S.*euCLEAA pfGut.ATORv COMMtBSIO88.REGIOes a U S NUCLE AR af 0uLATORv ConsuiSSIO8e REGION tV seuCLE AR WAftet AL SECTIOse S esATERI AL R ADe ATION P*OTECTION SECTION S31 Pams Avtsout 491 Rv Ase PLAZA O#4WE. SulTE 1000 E sseG OF PRUSSI A. PA 19400 ARLINGTO*e. Tx 76011 A A Aamaa, FLosttOA. 0EOmot A. stesTUCRV eisims#sMe, seOaTM CanOLs4A. ALASma, Ame20miA.CAUFOamsa Mawasa ssEVADA DAEGON WASMeseOTOes Pu't RTO ptCO. 90UTM cAnousea. Te assessSE E, vine:Nea, veaGeN sSLAseOS. On AseO u.L TEnasTomits Aae0 POSSEmaoses sq TMt PACIFIC,SEleO APPLICATIOsas WEST W1AGiassa, SEMO APPuCAT>Oses TO:

TO:

U S *suCLEAm mEGULATonv COMwe$$ ION REG 6088 H U $ NUCLE Am stEGULATOmv COMutSS80N REGIOpe v esATERI AL meOs ATIOss PeOTICTION SECTION M Af tas AL n AOi ATiO*e PmOTECTION SECTION tot tsanetTTA STaf ET.SutTE 2900 '450 naAnsA LANE. SueTE 2t0 ATLANT A. GA 30373 WAveUT CREEE. CA 94S98 PtR90sse LOCAf tO He AestEMENT ST AftS SEaso AppuCATIOnes TO TME U S NUCLEAR AEGULATORY COMMiSSnOss ONLY IP THEY WiSM TO POSSESS ANO USE UCtasSEO esaTEntAL ise ETAf ts susJECT TO W.i ssuCLEAR REGULATORY COhshs4SSsOss JumaSO*CTIOss.

1. TMt3 68 AN APPUCATIO91 POR fQtere espropree , sees 2. N AME ANO MaaV8eG ADORESS OF APPUCANT HaeNeole Casse A. asEW UCENSE

.u-0 AMEseOMENT TO UC1NSE NUMGER C. RENEWAL OF UCtesSE NuMSER

3. ADOMESStesi WMept LeCENSEO esATEptAL mLL SE usto DA P0538151O.

TEttP=ONE*swMSEA A NAast OF PERSO8e TO SE CONT ACTEO AsOut Tiens APPUCATiose SugMtf ITEnsS S TasseOuGM 11 One sin e it PAPEm THE Tvet ANO SCOPE Of SNFORMAT:04 TO SE pmOvtOEO ts OSSC81'eEO ine Y=8 UCENSE AMUCATiON GunOf S m AOsOACTfvt esATEneAL A E ernene one meses aumeur, h. c*essemes ordrer phences term. and 4. 84semuen emeunt E PUMPOSE(Si FOR wmCM UCENSED MATER 1 AL mLL SE USED essuna mise te et one one ome T 18eOlve A S I S LE FOA R ACIATIOae SApETv PnOGnAM AND THEin S TA As *NG FOR #NOtvlOU ALS WOmo4G '8s Om f st0uf 4 TING mEStanCTEO ARE AS 9 P ACIUTIES A8sO EOuaPMENT. 10 RAQs ATsons SA8ETv PeOGn AM 12 LiLENSet FE ES asse #0 C#4 f /0 ens sere,e= tro m S t. W ASTS MA8sAGEMENT. CSEO S FEt CA TEGOmv lEN IS CimVipeCar Ops ram,sr se eeMsweesd ay apspeone TME AMuCANT useOtmSf ameOS TMAT ALL ST ATEME*eTS Asso Re P*ESENT ATIONS M ADE IN TMa3 APPUCA TLON AME tessOenG uPose THE AMuCANT THE APPUCANT AND ANY OFreCI AL E Rf CUTiesG TheS CERTIFICAT109 Oas SEM alp 08 YME APPUCANT, NAMED ise ITEM I CERTIFY THAT TMs3 AMUC ATION IS PetEPAAEO eN CO*eFOmWify WtTM TsTLE 80. f'OCE OF PEOER AL MEGuLAflONS.PAATS30. 32. 33. 34 35. Asso 40 A8ec TN AT AL'. INFORMAflON CONT AeNEO MEREtN.

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Exhibit A (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 Form 313. 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(o) 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 CFR Parts 30,32,33,34,35 and 40 to determine whether the application meets the requirements of the Atomic Energy Act of 1954, as amended, and the Commission's regulations, for the issuance of a radioactive material license or amendment thereof.

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 potential violation 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 to an 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 voluntarv. If the requested information is not furn-ished, however, the application for radioactive material license, or amendment thereof, will not be processed. A request that 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 inspect the document.

5. SYSTEM MANAGER (S) AND ADDRESS: U.S. Nuclear Regulatory Commission Director, Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards W-(nington, D.C. 20555 EA-2 l l

NRC FORM 313

- - ----- - - - ---mu.------ m m = ----1EWN!T5fi r ELmansr.eqa m 9 l NRC Form 374T EXHIBIT B page~ I of 4 Pages lN p

g ts 2-8 s) U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE-TELETIIERAPY Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g g

Code of Federal Regulations, Chapter 1, Parts 30,31,37,33,34,35,36,40 and 70, and in reliance on statements and representations g

g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p(

4 source, and special naclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to P 4 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s); and to

. port such bfproduct and source material. This license shall be deemed to contain the conditions specified in Section 183 of the g l Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory i g

g Commission now or hereafter in effect and to any conditions specified below. l Ucensee l j

4

1. XYZ Hospital 3. Ucense number XX-XXXXX-XX l

4 I

g 2. 1234 A Street, H.W.

Washington, D.C. 20000 4. Expiration date November 30. 1990 g 5. Docket or g Reference No. 030-XXXXX

$ 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum a nount that licensee 5 special nuclear material form may possess at any one time under this license

, A. 10,000 curies (2 sources y A. Cobalt 60 A. Teletherapy sealed sources (ABC of not more than 5,000 6

N Corporation Model curies each) 4 567) l 8 6

4 4 '

4 Fj N 9. Authorized use

(

I A. One source to be usedin an ABC Corporation flodel 89 >k teletherapy unit for the treatment of humans. One source in its shipping container to be in possession of the licensee as neces-lq sary to the replacement of the source in the teletherapy unit only. b CONDITIONS l

N 10. Ucensed material shall be used only at Room 103, XYZ Hospital, 1234 A Street, N.W., Washington, >l k

N D.C.

8 i Fl h

N g i1. The licensee shall comply with the provisions of Title 10, Chapter 1, Code of Federal Regulations, Part 19 " Notices, Instructions b and Reports to Workers;lnspections" and Part 20," Standards for Protection Against Radiation." PI

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12. Ucensed material shallbe used by,or under the supervision of, John Jones, M.D. or Mary Smith, M.D.

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13. The teletherapy facility shall be provided with a system permitting continuous observation of the patient from outside the taat. p g

ment room, during patient irradiation.

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(psawwzzTETEEmiN?EFETETrmaa NRC Form 374TA sussa U.S. NUCLEAR REGULATORY COMMISSION xwwsrAnaxxuaeTTiwwww Page 2 of 4 Pagesg%

MATERIAL.S LICENSE - TELETilERAPY XX-XXXXX-XX 1 (Continued) 3 030-XXXXX y 4 Y a

4 14. A. Teletherapy sources shall be tested for leakage at intervals not to exceed six months. Records of test results shall be k t

4 kept in units of microcuries and mamtained for inspection by the Commission. In the absence of a certificate from '

% a transferor indicating that a test has a' cen made within six months prior to the transfer, the source shall not be used until tested for leakage.

& B. The test shall be sufficiently sensitive to detect 0.05 microcurie of contamination on the test sample.

A C. The test sample shall be taken from selected accosib!c surfaces of the teletherapy hea<!. The select ?d accessible sur-Y Af faces should be those surfaces on which one might expxt contamina: ion (if there were to be leakage) to accumu-3 >:

K late and shall include the inner surface of the most frequently used treatment cones or beam collimating device.

The test sample shall be taken with the source in the "off' position.'

% D. If the test reveals the presence of 0.05 microcurie or more of removable contamination, the licensee shall promptly  ;

% take action to prevent spread of contamination and shall file a report within five days of the est with the Material j h Ucensing Branch, Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission. Washington, f

I D.C. 20555, describing the test results and the corrective action taken. A copy of such report shall also be sent to g g the Director of the appropriate Nuclear Regulatory Commission Regional Office of Inspection and Enforcement listed in Appendix D of 10 CFR 20. hf

{ 15. Prior to initiation of a treatment program, each teletherapy unit shall be equipped with electrical or mechanical stops limiting use of the primary beam of radiation so as to assure compliance with 120.105(b) of 10 CFR 20," Standards for E{

4 Protection Against Radiation," as evidenced by a radiation survey, Necessary use restrictions shall be fully desenbed in fpj y radiation survey reports submitted in accordance with Condition No.18.

pf 4  ;

fd 16. A set of written emergency instructions shall be posted at the teletherapy machine control. These instructions shall

$ inform the machine operator of the procedure to be followed should he be unable to turn the machine's primary beam

$ , l of radiation "off' with the controls outside the treatment room.

'i

17. A. Access to the teletherapy room shall be controlled by a door at each entrance. Such doors shall be normally closed.

B. Each entrance to the teletherapy room shall be equipped with an electrical interlock system that will turn the tele- b y therapy machine's primary beam of radiation off immediately upon opening of any entrance door. The intericek system shall be connected in such a manner that the teletherapy machine's primary beam of radiation cannot be gl turned on until all treatment room entrance doors are closed and the beam "on-off"controlis reset at the control panel.

C. Electricalinterlocks on entrance doors to the teletherapy room shall be tested for proper operation at least once p h; every six months. Records of test results shall be maintained for inspection by the Commission. b!

I D. In the event of malfunction of any door interlock, the teletherapy machine control shall be locked in the "off" k condition and not used, except as may be necessary to the repair or replacement of the interlock system, until the

$! interlock system is shown to be functioning properly, b,

$ Ei

18. Prior to initiation of a treatment program, and subsequent to each installation of a teletherapy source, radiation i.urveys I and tests shall be performed in accordance with the following:

1. A. A radiation survey shall be made of:

A P

(i) The teletherapy source housing, with the teletherapy source in the "off' position. The maximum and average >

radiation levels at one meter from the teletherapy source in the "off' position shall not exceed 10 rnilliroent- >l>

gens per hour and 2 milliroentgens per hour, respectively.

g (ii) All areas adjacen. to the treatment room, with the teletherapy source in the "on" position. The survey, except f

k ffl item (c), shall be performed with a phantom in the primary beam of radiation /ha!! clearly establisti: E i

p and >

(a) The radiation levels in restricted aren are not likely to cause personnel exposure in excess of the limits >

4 specified in Section 20.101, Title 10, Part 20, Code of Federal Regulations, Chapter I, " Standards for E, Protection Against Radiation"(10 CFR 20). {

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lI NRC Form 374A U.S. NUCLE AR REGULATORY COMMISSION Pact 3 OF 4 PAGES l,

1. License number i

XX-XXXXX-XX MATERIALS LICENSE D SUPPLEMENTARY SHEET O - U h

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1. li N

18. (Continued) F l'I

$ (b) That quantities of radiation in unrestricted areas do not exceed the g limits specified in~ 520.105(b), 10 CFR 20. p l

4 (c) The intensity of the primary beam of radiation at a specified distance 8; p

a' from the teletherapy source. F hi B. Tests shall be made to detemine proper operation of:

}

(1) Electrical interlocks on entrance doors to the teletherapy treatment h

.l room.

(ii) The teletherapy source "on-off" indicators, both at the source housing and en the teletherapy machine control panel. g (iii) Electrical or mechanical stops installed for the purpose of limiting f;p t use of the primary beam of radiation (restriction of source housing

'j angulation or elevation, carriage or stand travel and operation of bl

,l the beam "on-off" mechanism.)

(iv) The teletherapy treatment timing device. f I C. A report of the results of the above surveys and tests shall be sent to the l1 U.S. Nuclear Regulatory Commission, Region I, 631 Park Avenue, King of Prussia, ,

PA 19406, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch not ',

more than 30 days after each installation of a teletherapy source. j

! 19. A. Any changes made in the treatment room shiciding, location of the unit within f

.j the treatment room, or use of the teletherapy unit that could result in increased j!

4 radiation levels in areas outside the teletherapy treatment room shall be  :

hi evaluated by a radiation survey made in accordance with Condition 18 and reported '

to the Commission within thirty (30) days folicwing completion of the change (s).

l 4

B. Relocation of the teletherapy unit to a new facility is not permitted without prior approval of the plans and details by the Comission. Following such f

approval and relocation, a radiation survey shall be made in accordance with #p N

Condition 18, and reported to the Commission within thirty (30) days after b)

% completion of the move. B

% e 4

f 20. The licensee shall comply with the requirements in Sections 35.21 through 35.27 j,'i g inclusive, of Title 10. Chapter 1, Code of Federal Regulations, Part 35 " Human Uses t q! of Byproduct Material ." {)

.\

The following shall be perfomed only by persons specifically authorized by the h lkl 21. Comission or an Agreement State to perform such services, y l A. Installation, relocation, or removal of teletherapy units containing sources. f 4! R

% B. Source exchange. B

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C Form 374A U.S. NUCLEAR REGULATORY COMMISSION ,,gg 4 4 License number g, ,,gt, p),

MATERIALS LICENSE oockei or Reference n be SUPPLEMENTARY SHEET Y

21. (Continued) i g C. Any maintenance or repair operations on a teletherapy unit involving work on the source drawer, the shutter, or other mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels.

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I

22. Pursuant to Title 10, Chapter 1, Code of Federal Regulations, Part 40, " Domestic kj Licensing of Source Material." the licensee is authorized to possess, use, transfer, and import the uranium contained as shielding material in the teletherapy units authorized by this license. (h 4

23. For a period not to exceed sixty (60) days in any calendar year, a visiting physician is authorized to use licensed material for human use under the tenns of this license, -

j provided the visiting physician:

[h (a) Has the prior written permission of the hospital's Administrator and its y Radiation Safety Comittee, and f,

@4 (b) Is specifically named as a user on a Nuclear Regulatory Commission license

.h authorizing human use, and h (c) Performs only those procedures for which he is specifically authorized by a Nuclear Regulatory Comission license. l q The licensee shall maintain for inspection by the Commission, copies of the written y permission specified in subitem (a) above and of the license (s) specified in subitems y (b) and (c) above. These records shall be maintained for five (5) years from the g, g! time the licensee grants its pennission under subitem (a) above. p i

pt

' 24. Except as specifically provided otherwise by this license, the licensee shall possess and use licensed material described in Items 6, 7, and 8 of this license in accordance j with statements, representations, and procedures contained in application dated b .

September 2,1985; and letter with enclosures dated November 2,1985, both signed by N i

Frtd Green, Administrator. The Nuclear Regulatory Commission's regulations shall h govern the licensee's statements in applications or letters, unless the statements f p

1. are more restrictive than the regulations. p hl FOR THE U.S. NUCLEAR REGULATORY COMMISSION F

Date Nove ter 2, 1985 By Void h Material Licensing Branch h Division of Fuel Cycle and >

Material Safety >;

l Washington, D.C. 20555 y 4 >

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DRAFT VALUE/ IMPACT STATEMENT

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1. BACKGROUND In March 1982, the Nuclear Regulatory Commission (NRC) published for public comment a draft regulatory guide, " Guide for the Preparation.of Applications for Licenses in Medical Teletherapy Programs," Task TM 608-4. The guide was intended to provide license applicants with information and guidance concerning the type and scope of information needed in an application for a license to use sealed sources for medical teletherapy. The draft guide reflected the use of Form NRC-313T. In July 1984, the NRC issued a new application form, NRC Form 313, which superseded Form NRC-313T. It was decided to revise the draft guide in conformance with NRC Form 313.

2. PROPOSED ACTION 2.1 Description An applicant for a license to use radioactive sealed sources in medical teletherapy is required to develop a program that complies with NRC regulations and to describe this program in the license application. The proposed action is to take into account comments received on the draft guide and to update the guide so the guidance will be in conformance with NRC Form 313.

2. 2 Need The need to reflect public comments and the change from Form NRC-313T to NRC Form 313 necessitate changes in the guidance provided for teletherapy license applications.

2.3 Value/ Impact 2.3.1 NRC The instructions and guidance to applicants contained in the proposed guide would facilitate orderly staff review of applications for a license for medical D teletherapy. The proposed action clearly lists the regulations to be followed i 1

v/I-1

and the information required for licensing and implementing an acceptable pro-gram for the use of sealed sources for t ;ical teletherapy. Staff review time would be shortened because less correspondence would be needed to compensate for a lack of sufficient detail in license applications.

2.3.2 Other Government Agencies Other government agencies would not be affected.

~

2.3.3 Industry The proposed action would contribute to a reduction in the time required for preparing licensa applications and help eliminate the need for preparing answers to NRC's inquiries for additional information. Applicants would spend less time trying to interpret NRC regulations and requirements for information.

More importantly, the proposed action would provide information for the design and implementation of a more effective radiation safety program, thereby mini-mizing the exposure of workers to radiation.

2.3.4 Public No impact on the public is foreseen.

2.3.5 Worker i The worker would benefit from the proposed action through reduced radiation exposure as discussed in Item 2.3.3.

2.4 Decision on Proposed Action A revised draf t regulatory guide should be prepared to reflect public comments and to conform the guidance to the application form, NRC Form 313.

TECHNICAL APPROACH Not applicable.

G V/I-2

4. PROCEDURAL APPROACH 4.1 Alternatives A draft regulatory guide presently exists. A revision of the draft guide is necessary to reflect public comments and a change in the application form.

The only alternative is to write individual letters to applicants, l 4.2 Discussion A regulatory guide is the most effective way to transmit information about regulations and licensing requirements. A regulatory guide ensures uniform transmission of information to applicants. Individual letters would be ineffi-cient and, depending on the reviewing official, may not uniformly convey the same information to each applicant. Revision of the guide is the most effec-tive alternative.

5. STATUTORY CONSIDERATIONS 5.1 NRC Authority Authority for the proposed action is derived from the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended, and implemented through the Commission's regulations.

5.2 Need for NEPA Assessment Issuance or amendment of guides for the implementation of regulations in Title 10, Chapter I, of the Code of Federal Regulations is a categorical exclus-ion under paragraph 51.22(c)(16) of 10 CFR Part 51. Thus, an environmental impact statement or assessment is not required for this action.

6. RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES The NRC staff is working on a complete revision of 10 CFR Part 35. If the D proposed revision of 10 CFR Part 35 is approved for publication in effective form, the NRC staff will revise this guide again.

V/I-3

7.

SUMMARY

AND CONCLUSIONS

{

The proposed guide will assist the NRC in its review of applications for licenses to use sealed sources for medical teletherapy and will provide industry with guidelines for submitting applications tnd implementing optimum radiation safety programs. The draft guide should be prepared and issued.

l I

V/I-4

UNITED STATES .instetassmat NUCLEAR REGULATORY COMMISSION Po S * ',* "c' ' '*

WASHINGTON, D.C. 20555 wasa o e PERMIT he 0 57 OFFICIAL BUSINESS j PENALTY FOR PRIVATE USE. $ RIP C 5 ES 0( 4 2 I] ISC P I S 0 l r r, US fir C ',

CM-DIV Cr TIC O h0CUMENT CONpog c.c 3 g ,p7 W a S H P4 6 T 0*g I' C p c g rg I

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