ML20245A781

Rev 1 to Reg Guide 10.9, Guide for Preparation of Applications for Use of Self-Contained Dry Source-Storage Gamma Irradiators. Related Documentation Encl,Including Copyright Matl

ML20245A781
Person / Time
Issue date:	12/31/1988
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
Shared Package
ML20245A615	List: IA-89-205, Rev 1 to Reg Guide 10.9, Guide for Preparation of Applications for Use of Self-Contained Dry Source-Storage Gamma Irradiators. Related Documentation Encl,Including Copyright Matl ML20245A613 ML20245A681 ML20245A684 ML20245A781 PNO-II-88-040C, on 880607,leak of Cs-137 Source Occurred.Nrc Met W/Mgt on 880609 to Discuss Recovery & Cleanup of Facility.Rsi Pool Last Sampled on 880429 & Determined to Be Clean
References
FOIA-89-205, TASK-FC-402-4, TASK-RE REGGD-10.009, NUDOCS 8906220178
Download: ML20245A781 (613)

Text

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8 U.S. NUCLEAR REGULATORY COMMISSION December 1988 i

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a. REGULATORY GUIDE 10.9 (Task FC 402 4)

GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSES FOR THE USE OF SELF-CONTAINED DRY SOURCE-STORAGE GAMMA IRRADIATORS I

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h The guides are issueo 6n the tosaow.ng ten broao aivessons:

USN AC ACGULATORV GUIDES Regulatory Guedes are issued to OescreDe and make availaDie to the L Power Reactors 6. Products CuDieC methods ac ceptable to the N AC staff of emplementeng 2. Research and Test Aeactors 7. Transportaceon i

specifeC Davis ot the Commisseon's regulations, to deteneste tech- 3. Fuels and Matersais Facehtees 8. Occupational Heatth l ns3 pes used by the Staff tn evalualene speCII.C problems or postu. a. Enveronntental and 5steng 9. Antstrust ano Fenancoat Reveew tats $ acceOents. De to provsGe quedance to apphcants. Regulatory 5. Matereass and Plant protection 10. General Gueges aec not substnutes f or regulations. and comphance wvth trvim #$ not eeovereo. Methoos ano solutions aittetent from those set out en the guides *'il be acceptapse et they provece a taases for the Copees of issuco guices may be purchased f rom the Government sens.ngs eeouessie to the muance or continuance of a permat os Printene Of fice at the current GPO prece. taformation on current egense by the Commession. GPO proces may De obtainea ey contacting the superintendent of Documents. U.S. Government pr ent eng Of rece, post othee som This gusoe was assued af tee cons'de'at on of comments received t'om 3 7082. Washengton, DC 2.0013 70 82, telephone (202)275 2060 or th@ puDhc. Comenents anc tugueshons f or emorovements m these (2021275 2871.

vueces are encourauco as asa temes, ano queces wm be eevised, as spoeopeeste, to accommuaate comments and to eetloct new ento <ma-toon os es peescoce.

in toe rna t eon Service on a siano.no oeace ba s es. Detaats on t hes tweetten comments may ue suunuttee to the feucicae ficoutatney fr egula f*uolications t ory commesseon, servoce enay De obtaenea by wrotene tvTts. 5285 Port Aoyal Road.

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TABLE OF CONTENTS Section Page

' 1. INTRODUCTION..................................................... 10.9-1 1.1 Genera 1.................................................... 10.9 1. 2 P u rpo s e o f Gu i de . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.9-2

1. 3 Applicable Regulations..................................... 10.9-2

1. 4 As Low As Is Reasonably Achievable (ALARA) Philosophy...... 10.9-4

2. FILING AN APPLICATION........................................... 10.9-4 2.1 Where To Fi1e.............................................. 10.9-4 2.2 How To File................................................ 10.9-4

3. CONTENTS OF AN APPLICATION...................................... 10.9-6 Item 1 - Li cens e In fo rmation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.9-6 Item 2 - Name and Mailing Address of Applicant.................. 10.9-6 I tem 3 - Locati o n of Us e. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.9-7 Item 4 - Person To Be Contacted About Application............... 10.9-7 Item 5 - Radioactive Material To Be Possessed................... 10.9-7 Item 6 - Purpose for Which Licen. sed Material Will Be Used....... 10.9-8 Item 7 - Individuals Responsible for Radiation Safety Program: Their Training and Experience............... 10.9-8 Item 8 - Training for Individuals Working In or Frequenting Restricted Areas................. ................... 10.9-9 Item 9 - Facilities and Equipment............................... 10.9-10 Item 10- Radiation Safety Program............................... 10.9-10 10.1 - Personnel Monitoring Equipment...................... 10.9-10

10. 2 - Radiation Detection Instruments. . . . . . . . . . . . . . . . . . . . . 10.9-11 10.3 - Leak Testing........................................ 10.9-12 10.4 - Operating and Emergency Procedures.................. 10.9-12 10.5 - Plans for Installation and Certain Repairs.......... 10.9-13 Item 11- Waste Management....................................... 10.9-14 11.1 - Authorized Disposa1................................. 10.9-14 11.2 - Transportation...................................... 10.9-14 I tem 12- Li c e n s e F e e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.9-14 Item 13- Certification.......................................... 10.9-14 i Item 14- Voluntary Economic Data..... ..... .................... 10.9-15 ]

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4. AMENDMENTS TO A LICENSE......................................... 10.9-16

5. RENEWAL 0F A LICENSE................................. .......... 10.9-16 iii s <

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• TABLE OF CONTENTS-(Continued) ,

l Section Page j 6 '. IMPLEMENTATION...................................... ........... 10.9 Appendix A - NRC Form 313............................................ 10.9-19 Appendix B - J.L. Shepherd Irradiators .............................. '10.9-21 Value/ Impact Statement............................................... 10.9 .

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1. INTRODUCTION ..

1.1 GENERAL The Nuclear Regulatory Commission (NRC) issues specific licenses that authorize the use of byproduct material in gamma irradiators. Gamma irradia-tors are. used for a variety of purposes in research, industry, and other fields.

-Typical uses are: .

1. Sterilization or microbiological reduction of medical and pharma-ceutical supplies

2. Preservation of foodstuffs

3. Radiation effects studies .

4. Chemic'ai and polymer synthesis and modifications

5. Insect eradication through sterile male release programs.

To obtain a specific license for a gamma irradiator, file an application on NRC Form 313, " Application for Material License." The application for a license will be approved if, among other things, (1) the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property and (2) the applicant is qualified by training and experience 1 - to use the radioactive material for the purpose requested in such a manner as

.to protect health and minimize danger to life or property.

For purposes of providing guidance to applicants for licenses, the NRC-divides gamma irradiators into two groups. The first group includes self-contained dry source-storage gamma irradiators and is the sub,iect of this Revi-sion 1 to Regulatory Guide 10.9. The second group includes all other irradia-tors, and licensing guidance for this second group is being developed'(see draft regulatory guide Task FC ~403-4, " Guide for the Preparation of Applications for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage.Irradiators, and Panoramic Wet Source-Storage Irradiators").

The American National Standards Institute (ANSI) has developed and pub-lished safety standards for gamma irradiators. Under the ANSI system for con- ,

sidering basic safety requirements, all gamma irradiators are divided into four )

general categories of irradiators. ANSI Standard N433.1, " Safe Design and Uce of Self-Contained, Dry Source Storage Gamma Irradiators (Category I),"* deals with the same type of irradiator that is dealt with in this Regulatory Guide .

10.9.

As defined in ANSI Standard N433.1, a Ca+r'.ory I irradiator is an irradia-tor in which the sealed source (or sources) 4 :ompletely contained in a- dry g

container constructed of solid materials and is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is not physically possible in its designed configuration.

Depending on the particular design, the radiation source within theInirradi- the ator may be in a fixed position or the radiation source may be movable.

latter case, interlocks are used to ensure that the source does not move into a ,

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

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position that, during normal use of the irradiator, may cause,a radiation hazard

, to any individual. Proper functioning of the interlocks ensures that shielding is.in place. Bypassing or failure of an interlock could cause persons to be

. exposed to very high levels of radiation.

Category I gamma irradiators typically contain several hundred to several thousand curies of Cs-137 or Co-60 and range in weight from several hundred to several thousand pounds.

1.2 PURPOSE OF GUIDE The pur. pose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals for the use of self-contained, dry source-storage gam'ma irradiators (also known as Category I irradiators).

It has been NRC's practice to issue licenses that provide only for the use of one or more Category I irradiators. This administrative practice conveniently permits consideration of the few, but important, items essential to the safe use of Category I irradiators. An exception to this practice is the author-ization for use of Category I irradiators under Type A specific licenses of

, broad scope. As provided in S 33.17 of 10 CFR Part 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material," devices containing up to 100,000 curies of byproduct material in sealed sources used for irradiation of materials may be included on Type A licenses of broad scope.

Section 3 of this guide describes the info,rmation that is expected in an application for use of a Category I irradiator under a Type A license of broad scope.

1.3 APPLICABLE REGULATIONS NRC regulations applicable to Category I Irradiators 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 of De-fects and Noncompliance"; 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR Part 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"; 10 CFR Part 71, " Packaging and Transportation of Radioactive Material"; and 10 CFR Part 170, " Fees for Facili-ties and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended."

Before preparing your application you should be acquainted with the appli-cable regulations. Single copies of a specific NRC regulation may be obtained without cost from the Division of Freedom of Information and Publications Serv-ices, Office of Administration and Resources Management, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or from your NRC Regional Office that is iden-tified in Figure 1. A bound volume of HRC regulations may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.

This guide identifies the information needed to complete NRC Form 313 when applying for a license for the use of a self-contained, dry source-storage gamma 10.9-2

irradiator. The information collection requirements in NRC Form 313 have been

. cleared under OMB Clearance No. 3150-0120.

1.4 AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY Paragraph 20.1(c) of 10 CFR Part 20 states "... persons engaged in activi-ties 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 radioactive materials in effluents to unrestricted areas, as low as is reason-ably 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. As an applicant, you should consider the ALARA philosophy as described in Regulatory Guide 8.10 in develop-ing plans for work with licensed radioactive materials.

2. FILING AN APPLICATION 2.1 WHERE TO FILE 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. The five Regional Offices and their respective areas for licensing purposes are given in Figure 1.

Twenty-nine States to date 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 and are shown in Figure 2. A current list of Agreement. States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional Offices or from the Medical, Academic and Commercial Use Safety Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555. If you are a non-Federal organization that wishes to possess or use licensed material in one of these Agreement States, you shculd contact the responsible officials in that State for guidance on preparing your application and your application should be filed with the State officials and not with the NRC.

2.2 HOW TO FILE

. You, as the applicant for a materials license issued by the NRC, should complete NRC Form 313 (see Appendix A to this guide). You should complete Items 1. through 4, 12 and 13, and Item 14 (if you so choose) on the form itself.

For Items 5 through 11, submit the required information on supplementary pages.

Each separate sheet or document submitted as part of the application should be identified and keyed to the item number on the form 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.

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

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

Please note that license applications are available for review by the general public in the NRC Public Document Rooms. Do not submit proprietary information unless it is absolutely necessary. If submittal of such informa-tion is necessary, follow the procedure in S 2.790 of 10 CFR Part 2. Failure to follow this procedure may result in disclosure of the proprietary infor-mation to the public or substantial delays in processing your application.

Do not submit personal information about your individual employees unless it is necessary. For example, the training and experience of individuals 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 not be submitted. Dates of birth, Social Security numbers, and i

radiation dose information should be submitted only if specifically requested l by NRC.

You should prepare your application in triplicate because you must file your application in duplicate. Retain one copy for yourself, because the license will require that you possess and use the licensed material in accor-dance with the statements and representations in your application and any supplements to it as well as with the requirements in the regulations.

3. CONTENTS OF AN APPLICATION 1

This portion of the guide comments, item by item, on the information  !

requested on NRC Form 313 (Ap'pendin A). If you have specific questions after reviewing this guide, contact the NRC material licensing staff at the appropri-ate Regional Office.

If you plan to use the irradiator under a Type A specific license of broad scope (defined in paragraph 33.11(a) of 10 CFR Part 33), subitems 10.1 about j personnel monitoring, 10.2 about radiation survey instruments, 10.3 about leak l testing, and Item 11 about waste management may be completed adequately by I referring to the comprehensive radiation safety program for the broad scope I license. This suggested action is particularly appropriate for a request for i amendment of a Type A specific license to add a self-contained irradiator.

Item 1 - LICENSE INFORMATION f l

For a new license for an irradiator, check subitem A. For an amendment of l an existing license for an irradiator or a Type A license of broad scope to add an irradiator, check subitem B. For a renewal of an existing license for an irradiator, check subitem C.

Item 2 - NAME AND MAllING ADDRESS OF APPLICANT The applicant should be the corporation or other legal entity applying for the license. If you are an individual, you may be an applicant only if you are acting in a private capacity and the use of the irradiator is not connected with your employment by a corporation or other legal entity.

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The address specified here should be your mailing addres's'for correspon-( dence. This may or may not be the same as the address at which the irradiator

.- will be used, as specified in Item 3.

Item 3 - LOCATION OF USE i

You should specify each location of use by the street address, city, and State or other descriptive address (such as 5 miles east on Highway 10, Anytown, State)~to allow us to easily locate your facilities. A Post Office box address is not acceptable. If irradiators are to be used at more than one location, you must give the specific address of each location. In Items 5 through 11 of the application, describe the intended use and the facilities and equipment at each location. -

Item 4 - PERSON TO BE CONTACTED ABOUT APPLICATION You should provide the name and telephone number of the person who knows your proposed program for the Category I gamma irradiator and can answer ques-tions about your application. This person, usually the radiation safety officer (R50) or a principal user of radioactive materials, will serve as the point of

. contact during the review of the application and during the period of the license.

If this person does not work for you full time, please specify his or her posi-tion and relationship to your firm. You should notify the NRC if the individual assigned to this function changes. Notification of a contact change is for informatfa1 only and would not be considered an application for license amend-ment. A license amendment would be needed if the new contact person also is to be added to your program as an R50 or a principal user.

Item 5 - RADI0 ACTIVE MATERIAL TO BE POSSESSED You should specify the radionuclides (e.g., Co-60), the number of curies per source (e.g., 750 curies), the name of the source manufacturer, the model number of the source (e.g., Able Company, Sealed Source Model Z-24), total number of sources in the irradiator (e.g., 8), and the maximum amount of Co-60 that will be possessed in the irradiator at any one time (e.g., 6,000 curies).

NOTE: You should be able to obtain the above information from the supplier of the irradiator. When contacting your supplier, you should determine whether safety information on the particular model source has been registered with the NRC or an Agreement State. Section 32.210 of 10 CFR Part 32, " Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Material,"

allows a manufacturer to register safety information about a product. That reg-istered information can then be used in NRC's consideration of license applica-tions from the manufacturer's customers. If your manufacturer has not registered information about the source and does not intend to register, then you as the applicant for a license are required (by S 30.32 of 10 CFR Part 30) to submit detailed safety information on the source as identified in paragraph 32.210(c).

If you need to prepare this detailed information, you are encouraged to follow the guidance in Regulatory Guide 10.11, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources :ontaining Byproduct Material."

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. Itam 6 - PURPOSE'FOR WHICH LICENSED MATERIAL WILL BE USED

. . Specify. the purpose for which the licensed material will be used (e.g. , to

.be used in a Baker Company Model B-25 gamma irradiator for insect eradication through sterile male release programs.)

NOTE:' As discussed above'in Item 5 for the source, if your supplier has not registered safety information about the irradiator with NRC or an Agreement State,- you must submit- the detailed information identified in paragraph 32.210(c) of 10 CFR Part 32. If you need to prepare this detailed information, you are encouraged to follow the guicance in Regulatory Guide 10.10, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material." -

Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM: THEIR TRAINING AND EXPERIENCE Among the general requirements for issuance of specific licenses (see S 30.33 of 10 CFR Part 30) is the requirement that your staff (the users, supervisors of users, and radiation safety officer for an institutional appli-

. cant),must be qualified by training and experience to use the material for the purpose requested in such a manner as to protect health and minimize danger to life or property. The information you present in Items 7 and 8 of your appli-cation should show how you will satisfy this requirement.

In Item.7, you should state the name, training, and experience of each person responsible for the radiation safety program for the irradiator. T. 4 qualifications of each person (who may have a title such as radiation protection officer, radiological protection officer, supervisor, senior operator) should show that he or she will be familiar with:

1. The basic design, operation, and preventive maintenance of the irradiator.

2. The principles and practices of radiation protection.

3. The biological effects of radiation.

4. The written procedures for routine and emergency irradiator operations.

5. Your application for a license, your license, and regulations of NRC.

A person with a background in radiation protection (e.g., a person appointed as a radiological safety officer under paragraph 33.13(c)(2) or 33.14(b)(1), or I as a user under Paragraph 33.15(b), or an individual meeting the training and experience requirements of paragraph 35.900(a) or (b) for a radiation safety officer) and specific instruction on the particular model irradiator to be obtained (or a similar model) should have adequate training and experience.

How the specific instruction was or will be obtained should be described for e'ach person named in Item 7. Specific instruction on the irradiator should show that, under the supervision of a knowledgeable person, the named person has used the irradiator or a similar irradiator to perform several irradiations of samples. This knowledgeable person might be the irradiator manufacturer's representative or another experienced operator.

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.., . Although unlikely, an applicant may designate in Itzm 7 a person who' has no previous training or experience. in radiation protection or irradiator opera-

. tion. In such case, the applicant should state where and from whom the individ-ual will receive training in radiation protection (e.g., a basic radiation pro-tection course of at least 3 days) and on-the-job training in operating an irradiator (e.g...a minimum of 2 days of supervised work at a licensed irradi-ator) prior to receipt of the irradiator by the applicant. Acceptable training.

and experience also may be obtained at an irradiator manufacturer's course con-sisting of a combination of radiation safety lectures, classroom exercises, written tests, and hands-on work on self-shielded irradiators.

Item 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS According to S 19.12 of 10 CFR Part 19, all individuals who work in or frequent restricted areas must be instructed in the health protection problems associated with exposure to radioactive material. In addition, persons who actually work with radioactive material should receive training in the safe use of radioactive material.

You should submit a general description of the training you will provide to all persons working in or frequenting your restricted areas and provide more specific information about the training of irradiator operators.

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Persons who will operate the irradiator under the supervision of a responsible individual (named in Item 7) do not need to be designet.ed by name; however, the following should be submitted.

1. An outline of the training program for these persons, including the topics that will be covered. Topics expected to be included in the training program are (1) the principles and fundamentals of radiation safety and good safety practices related to the use of radioactive materials, (2) the use of radiation detection instruments, and (3) the design and operation of the irradiator. This training usually is several hours long and may be covered in part by instructions provided to workers to meet the requirements of S 19.12 of 10 CFR Part 19.

2. A means of evaluating the understanding of the individuals who have complected the training program. One acceptable technique is to use a written J

examination of about 25 multiple-choice questions with all aspects of the train-ing program covered. You should describe in your application how you will deter-mine the trainee's understanding of the subject.

3. A discussion of the on-the-job training that will be given to trainees.

The training should consist of a minimum of several complete irradiation pro-cedures by the trainee under close supervision by a responsible individual spec-ified in Item 7.

4. The name of the training instructor. If this person is not a respon-sible individual specified in Item 7, submit this person's qualifications. The minimal qualifications for an instructor should be the same as those of an individual specified in Item 7.

5. A commitment that records documenting the training of each individual will be maintained. I 10.9-9 s

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• 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 equipment and facil-ities are adequate to protect health and to minimize danger to life or property.

As indicated above, information about the sealed source and irradiator should be presented in Items 5 and 6 of your application. Present information about the space where the irradiator will be located here in Item 9.

You should briefly describe the space where the irradiator will be located and comment on (a) control of access to the radioactive material by unauthorized persons and (b) fire protection considerations.

Regarding control of access to the radioactive material, if the irradiator will be located in a room that can be locked to prevent access by unauthorized persons, you need only repeat this statement in your application in a manner that constitutes a positive commitment. If the irradiator will not be located in a room that can be locked, you should explain how the requirements of S 20.207 of 10 CFR Part 20 will be met. Section 20.207 states that licensed materials in an unrestricted area must be secured from unauthorized removal from the place of storage and that licensed materials in an unrestricted area and not in stor-age must be under the constant surveillance and immediate control of the licensee.

Regarding fire protection, you should confirm that the room where the irradiator will be located will be equipped with an automatically operated fire detection and control system (sprinkler, chemical, or gas) that is adequate to ensure the integrity of the irradiator and source in a fire. Alternatively, you should describe the conditions (e.g., ground floor location in fire-resis-tant building with little combustible material) and other controls (e.g.,

coordination with and training of fire-fighting personnel) that ensure a very low level of radiation risk attributable to fires.

Item 10 - RADIATION SAFETY PROGRAM l 10.1 Personnel Monitoring Equipment Section 20.202, " Personnel Monitoring," of 10 CFR Part 20 requires that personnel monitoring equipment be used by individuals (other than minors) entering restricted areas who receive, or are likely to receive, a dose in excess of 25% of the dose specified in paragraph 20.101(a). The specified doses per calendar quarter are 1-1/4 rems to the whole booy, head and trunk, active l blood-forming organs, or gonads; 18-3/4 re,ms to the hands and forearms or feet and ankles; and 7-1/2 rems to the skin of the whole body.

Individuals under 18 yet s of age need to use personnel monitoring equip-ment if they receive, or are iikely to receive, a dose in excess of 5% of the specified doses in paragraph 20.101(a). The dose limits for minors are 10% of the specified doses in paragraph 20.101(a).

In determining the need for personnel monitoring equipment, you should con-sider both the doses related to the irradiator and the doses from other sources of radiation.

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For various reasons, including the requirements in S 20.202, most licensees

. require their personnel to wear either a film badge or a thermoluminescence dosimeter (TLD) when they use the irradiator. Assuming that you propose to use

. such equipment, state the type of equipment (film badge or TLD) you will use and the frequency at which the film badges or TLDs will be changed. The fre-quency of change should be at least monthly for film badges and quarterly for TLDs.*

Some licensees elect to use direct-reading pocket dosimeters. If you' propose to use this type of personnel monitoring equipment, you should state the range of the dosimeters and describe your program for their use. It is expected that the dosimeters have a range from zero to at least 200 milli-roentgens, be worn by only one individual between readings, and be checked at periods not to exceed one year for correct response to radiation. Acceptable dosimeters should read within i 30% of the true radiation exposure. If an individual's pocket dosimeter is discharged beyond its range, your program should prescribe action to evaluate the individual's dose.

10.2 Radiation Detection Instruments Paragraph 20.201(b) of 10 CFR Part 20 requires the performance of such

. surveys as are necessary to evaluate the extent of radiation hazards that may be present and to comply with regulatory requirements. In order to perform appropriate surveys, you need to have operable, calibrated instrumentation. l

! State that you will have available for use a calibrated, operable survey meter that can measure up to several hundred milliroentgen per hour. You do not need to name the manufacturer or the model number of the survey meter. The reasons for the survey meter are the need to determine normal radiation levels near the irradiator, in the room housing the irradiator and in adjacent unre- l stricted areas, and the need to detect radiation levels that may indicate safety l interlock and shielding failure, sealed source displacement, or sealed source i failure with a resultant spread of contamination.

In order to perform adequate surveys, instruments must be operable and l calibrated with an appropriate radiation source. State that the instrument will (1) be calibrated so that the readings are within 20% of the actual values i over the range of the instrument and (2) be calibrated at least annually and after servicing (other than a simple battery exchange). Also state that cali-bration records will be kept for a minimum of 2 years after each calibration, l and identify your selected means of calibration. There are three options for calibration:

1. If the instrument will be returned to the manufacturer for calibration, so state.

2. If a contractor will perform the calibration, state the name and address of the firm and its NRC or Agreement State license number.

• As of February 12, 1988, S 20.202 of 10 CFR Part 20 requires whole body I

personnel dosimetry devices such as film badges and TLDs to be processed by

( processors that have been accredited h the National Voluntary Laboratory Accreditation Program of the Nationa. Sureau of Standards.

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i 3. If ths instrument will be calibrated in-house, provide the experience

and training in instrument calibration of each named person who will perform the calibrations and the methodology to be used.

10.3 Leak-Testing

.As a licensee, you must perform such tests as the NRC. deems appropriate or necessary pursuant to S 30.53, " Tests," of 10 CFR Part 30. Tests to determine if there is any leakage from the sealed sources in the irradiator are necessary

- and must be performed at intervals not to exceed 6 months. The measurement of the leak-test sample should be a quantitative measurement and must be suffi-ciently sensitive to detect 0.005 microcurie of activity.

The options for leak-testing are: -

1. Engage the services of a consultant or commercial facility to take samples, evaluate the samples, and report the results to you.

2. Use a commercial leak-test kit. You take the sample and send the sample to the kit supplier, which reports the results to you.

3. You perform the entire leak-test sequence, including taking the sample and measurement.

For option 1, specify the name, address, and license number o.f the consul-tant or commercial organization. ,

For Option 2, specify the kit model number and the name, address, and license number of the kit supplier. State if the test samples will be taken by the individual specified in Item 7 who is responsible for the irradiator pro-gram. If another irradiator operator will take the test sample, instructions for taking the sample should be included in your operating and emergency pro-cedures. Include in the instructions a requirement that any indication of pos-sible source leakage should be reported to the individual responsible for the irradiator program for appropriate action.

For Option 3, state whether the test sample will be taken and measured by the individual specified in Item 7 who is responsible for the irradiation pro-gram. If another irradiator operator will take the test sample and make the measurement, instruction for those tasks should be included in your operating and emergency procedures. You should commit to use of an instrument capable of quantitatively measuring 0.005 microcurie or more activity; however, it is not necessary to identify the instrument in your application. If you also hold a specific license of broad scope issued pursuant to 10 CFR Part 33, state that the leak-test sequence will be performed by or under the supervision of the radiological safety officer (appointed pursuant to paragraph 33.13(c)(2) or 33.14(b)(1)) or by or under the supervision of individuals satisfying the requirements of paragraph 33.15(b).

10.4 Operating and Emergency Procedures You should provide your personnel with written operating and emergency procedures and you should state in your application that the written procedures 10.9-12 4

_.___.._.__.__._____________-_m_..__ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _

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will be provided to each person who uses the irradiator. The operating proce-dures should be maintained at the, control station,-and the emergency procedures

'should be conspicuously posted in the area. It is not-necessary to submit the detailed operating and emergency procedures to the NRC. However, you should list the topics covered in your procedures, and you should state that these pro-cedures include instructions in the following topics and will be available prior to use of the irradiator.

1. Step-by-step procedures for operation of the irradiator. Information may be extracted from the irradiator. manufacturer's manual.

2. Determination and recording of radiation doses to persons operating- -

the irradiator. ..

3. The methods to ensure that only authorized persons will use the irradiator.

4. Inspections, test procedures, and maintenance to ensure that all safety interlocks, devices, and components associated with the irradiator are functioning properly. Prohibited modifications (for example, changing the safety control system or removing the source) should be stated.

l 5. Emergency situations, e.g. , when a survey reveals abnormal radiation levels around the irradiator, personnel should leave the irradiator room, lock the door, and contact the individual responsible for the irradiator program.

Telephone numbers for the irradiator manufacturer's representative and the NRC should be included. In addition, your procedures should require that a survey be made with a radiation survey meter outside the irradiator room to determine whether further restriction of the area is necessary to ensure that no one can enter the area if the radiation level exceeds 2 milliroentgen per hour.

10.5 Plans for Installation and Certain Repairs

- You should discuss your plans for irradiator installation, pre-operational check-out, and repairs or alterations involving removal of shielding or access to the licensed material. Normally these plans indicate that the tasks will be performed by the supplier or other persons who are specifically licensed by the NRC or an Agreement State for such work. If your plans depart from the normal, you should clearly explain how these tasks will be safely and adequately .

performed.

Note that under current licensing practics, your license contains a condition that requires you to file a report with the NRC in Washington, DC, if you incur a failure of a safety lock mechanism or a failure of the shielding of the irradiator. Reports submitted under this condition will be evaluated for indical. ions of possible generic defects in your model irradiator and the need for NRC to alert other ucers of that model to take corrective action. Under this condition, you will be expected to report the failure of a door interlock on a moving source irradiator. You would not be expected to report routine maintenance, such as a burned out indicator bulb on the irradiator's control console (just replace the bulb).

x 10.9-13

. - W .[ r 1p ttem II - WASTE MANAGEMENT ,

-g g , J Authorized-Disposal Section 20.301 of 10 CFR Part 20 specifies the general requirements for h di'posal of licensed material. Because of the nature of the licensed material

.. g,nt.ained in irradiators, your only option for disposal is to transfer the radio-giive source to an authorized recipient as specified in paragraph 20.301(a) of You should state that disposal wi;i be by transfer of the radio-to CrR Part 20.

stive material to a licensee specifically authorized to accept it.

Authorized recipients are the original supplier of the irradiator source, a commercial firm licensed by the NRC or an Agreement State to accept radio- ~

stive waste from other persons, or another specific licensee authorized to -

No one else is authorized to dispose of your k,ossessthelicensedmaterial.

icensed material.

i 11,2 Transportation Jt should be noted that transportation of an irradiator for purposes of dh,posal or other reason must be done in accordance with 10 CFR Part 71, " Pack-e ing and Transportation of Radioactive Material." Prior to the adoption of 10 afR c

Part 71 in 1966, irradiators could be transported without being evaluated under the accident damage test requirements that are now incorporated in Pa*t n, Accordingly, a licensee may _have an irradiator that satisfied pre-1966 geansportation regulations but now requires special attention to meet Part 71 requirements.

If the irradiator cannot practically be transported in packaging that meets the requirements of Part 71, the licensee may request a one-time shipment in In applying for a one-time shipment, the accordance with SS 71.7 and 71.41(c).

iicensee must provide adequate controls so the shipment will not endanger life ce property. Guidance on preparing a one-time shipment request may be obtained f rom the Division of Safeguards and Transportation, Office of Nuclear Material safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

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

Naterials Licenses and Other Regulatory Services," to determine the amount of the fee that must accompany your application. An application received without a [ce or with an inadequate fee may be returned to you. All application fees mg be charged regardless of the NRC's disposition of the application or your withdrawal of the application.

Item 13 - CERTIFICATION Your application should be dated and signed by you if you are acting as an individual or by a representative of the corporation or legal entity who is authorized to sign official documents and to certify that the application con-tains information that is true and correct to the best of your knowledge and g,etiefs. Unsigned applications will be returned for proper signature.

10.9-14

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• 14.d Would You Be Willing To Furnish Cost Information on the Economic Impact of Currcnt Regulations or any Future Proposed NRC Regulations that May Affect You?

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 affected licensees.

4. AMENDMENTS TO A LICENSE l

After you are issued a license,.you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application, (2) the terms and conditions of the license, and (3) the Nuclear Regulatory Commission'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 the application 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 amend-ment to your li. cense.

An application for a license amendment may be prepared either on the application form (NRC Form 313) or in letter form and should be submitted in duplicate (see Section 2 of this guide for addresses). Your application should identify your license by number and should clearly describe the exact nature of the changes, additions, or deletions. References to previously sub-mitted information and documents should be clear and specific and should iden-tify the pertinent information by date, page, and paragraph.

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 befcre the proper fee is paid in accordance with S 170.12 of 10 CFR Part 170.

5. RENEWAL OF A LICENSE 1

Licenses are issued for a period of up to 5 years. You must send an application for renewal in duplicate (see Section 2 of this guide for the' address).

You may submit an entirely new application for renewal as if it were an applica-tion for a new license without referring to previously submitted information.

As an alternative, you may:

1. Review your current license to determine whether the information accurately represents your current and anticipated program. Identify any neces-sary additions, deletions, or other changes and then prepare information appropriate for the needed additions or changes.

2. Review the documents you have submitted in the past to determine whether the information in them is up to date and accurately represents your management control program, facilities, equipment, personnel, radiation safety 10.9-16 s

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FC 414-4' I"

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STANDARD REVIEW PLAN FOR APPLICATIONS FOR LICENSES FOR MEDICAL TELETHERAPY PROGRAMS  !

December 1985 i

This Standard Review Plan is for use with Draft l

Regulatory Guide FC 414-4, issued December 1985 (formerly DraftLTM 608-4, issued Maren 1982).

1 U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards j l -

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STANDARD REVIEW PLAN FOR APPLICATIONS FOR LICENSES FOR MEDICAL TELETHERAPY PROGRAMS i

TABLE OF CONTENTS Section Pace 1.

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 l 1.1 Purpose of Guide. . . . . . . . . . . . . . . . . . . . . . 1 1.2 Applicable Regulations. . . . . . . . . . . . ....... 2

1. 3 As Low As Is Reasonably Achievable (ALARA) Philosophy . . . . 2 2.

FILING AN APPLICATION. . . . . . . . . . . . . . . . . . . . . . . 3 3.

CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . 'S Item 1 Item 2 License Information . . . . . . . . . . . . . . . . . .

Applicant's Name and Mailing Address 6

... 6 Item 3 Locations of Use. . . . . . . . . . . . . ............. 5 Item 4 Person To Be Contacted about Application ....... 10 Item 5 Radioactive Material .................. 10 5.1 Sealed Sources To Be Used in Teletherapy Unit . . ... 11

5. 2 Teletherapy Unit ................... 11 Item 6 Purposes for Which Licensed Material Will Be Used . . . 13 Item 7 Individuals Responsible for Radiation Safety Program--Their Training and Experience ..... .. 13 7.1 Proposed Authorized Users - Human Use . . . . . . . . . 13 7.2 Proposed Authorized Users - Nonhuman Use. . ..... 19 7.3 Proposed Radiation Safety Officer . . . . . . . . . . . 20 7.4 Proposed Expert . ................... 21 Item 8 Training for Individuals Working in or Frequenting Restricted Areas ............. 23 8.1 Applicable Regulation . . . . . . . . . . . . . . . . . 23 8.2 Licensing Criteria. . . . . . . . . . . . . . . . . . 23 8.3 Response. . . . . . . . . . . . . . . . . . ...... 24 Item 9 Facilities and Equipment ............... 24 9.1 Description of Facility . . . . . . . . . . . . . . . . 25 9.2 Viewing System .................... 26 9.3 Yarning Systems and Access Controls . . . . . . . . . . 27 9.4 Beam Stops ...................... 28 9.5 Adequacy of Shielding . . . . . . . . . . . . . . . . . 30 iii

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TABLE OF CONTENTS (Continued) -1 Section-P' ace .

Item 10 Rai ton l Safety" Program .............. .

45

! 10.1 Personnel Monitoring Program ....

'45 10.2 Instrumentation . . . . . . . . . . .. .. .. .. .. .. .. .. . 46 10.3 Calibration of Portable Surve 47

-10.4 Leak-Test Program . . . . . .y Instruments . . . . .

............ 51 10.5- Operating Procedures ................ 56 10.6 Emergency Procedures . . . . . ... . . . . . . . . 57 10.7 ALARA Program . . . . . . . . . . . . . . . . . . . 58 10.8 Radiation Safety Committee ............. 59 Item 11' Waste Management .............. . . . . 60~

11.2 Applicable Regulation . . . . . . . . . . . . . . . .

11.2 Licensing Criteria. . . . . . . . . . 16 1 61 11.3 Response.~. . . . . . . . . . . . . .. .. ............. 61 Item 12 License Fees .......

61 Item 13-Item 14 Certification . . . . . . .............

... . . . . . . . . . . . . 62 Voluntary Economic Data . . . . . . . . . . . . . . . 62 4.

AMEN 0MENTS TO A LICENSE. . . . . . . . . . . . . . . . . . . . . 64 5.

RENEWAL OF A LICENSE . . . . . . . . . . . . . . . . . ... . . . 65

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6. IMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . 66 APPENDI 't .S.

Appendix Pace A- Discussion of Questions of Particular Interest to Applicants

- Requesting Human Use Authorization ............... A-1 8 Description of Sealed Sources Telethera Uses. . . . . . . . . . . . .,. . . . . py Units, and Proposed

............. 3-1 C Training and Experience for Teletherapy Users . . . . . . . . . . C-1 0 Personnel Training Program. . . . . . . . . . . . . . . . . . . . 0-1 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 Malfunctice. . . I-1 J Model Program for Maintaining Occupational Radiation Exposures at Medical' Institutions ALARA . . . . . . . . . . . . . . . . . . J-1 K Radiation Safety Committee ....... ........... K-1 L Requests for License Amendments, Renewals, and Terminations . . . L-1

-Checklist for Review of New Teletherapy Apoli ations M . . . . . . M-1 l N Checklist for. Review of Teletherapy Survey Resorts. . . . . . . . N-1 0- Checklist for Review of Teletherapy Renewal Applications. . . . . 0-1

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TABLE OF CONTENTS (Continued)

EXHIBITS Pace A NRC Form 313. . - - -

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Sample Ts.) therapy License. . . . . . . . . . . . . . . . . . . . EB-1 e

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'4 STANDARD REVIEW PLAN FOR APPLICATIONS FOR LICENSES FOR MEDICAL TELETHERAPY PROGRAMS l

1. INTRODUCTION 1.1 PURPOSE OF GUIDE j

f 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 material (i.e. ,

reactor produced radionuclides) in a teletherapy unit for the treatment of ifuman beings.

This type of license is provided for in 5 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 issua a single material license to cover an institu-tion's teletherapy program; the 'sicense will include the neeced 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 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 licar.se, and (3) NRC's regulations. The information you provide in your application should be clear, specific, and accurate.

Reviewers This standard review plan provides the reviewer on NRC's technical staff with guidance in the exercise of discretion  !

in the licensing process. Appendix M of this document is "The term " source material" is defined in paragraph 20.3(a)(15) of 10 CFR Part 20.

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a checklist that may be helpful in reviewing new teletherapy applications.

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1. 2 APPLICABLE REGULATIONS NRC regulations applicable 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 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 Sourca Material";

and 10 CFR Part 170, " Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act 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 No. 3150-0120.

1. 3 AS LOW AS IS NEASONABLY 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 saterials in affluents to unrestricted areas, as low as is reasonably achievable." Regulatory Guide 8.10, d0perating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable,"* provides the NRC staff position on this important subject.

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• 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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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 information and references useful in establishing radiation safety programs to '

maintain exposures ALARA in medical institutions.

You should consider the ALARA philosophy as described in Regulatory Guides 8.10 and 8.18 and in NUREG-0267 in developing plans for work with licensed radioactive materials. '

2. FILING AN APPLICATION fou, 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

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and 12 through 14 en the form itself. For Items 5 through 11, submit the infoi-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, and radiation safety program are adequate to protect health and minimize danger to life and property.

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.

" 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, OC 20013-7082. '

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-. , . i Do not submit personal information about your employees unless it is necessary. For example, the training and experience of employees should be i

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 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 tne NRC Regional Office for the State in which the material will be possessed or used (A list of NRC's Regional Officos,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, wtt; should file their applications directly with the Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulaury 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.

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' *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 -equest from the Material Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, OC 20555, or from NRC's Regional Offices, whose addresses are listed in this section.

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1 If you are located in Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, f

Rhode Island, or Ve,,nont, send your applications to the U.S. Nuclear Regulatory l Commission, Region I, Nuclear Material Section B, 631 Park Avenue, King of t Prussia, PA 19406. I j

If you are located in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee, Virginia, Virgin Islands,

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or West Virginia, send your applications to the U.S. Nuclear Regulatory Commis-sion, Region II, Material Radiation Protection Section, 101 Marietta Street, i Suite 2900, Atlanta, GA 30323.

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If you are located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wisconsin, send your applications to the U.S. Nuclear Requia-tory Commission, Region III, Materials Licensing Section, 799 Roosevelt Roa'd, Glen Ellyn, IL 60137.

If you are located in Arkansas, Colora,do, Idaho, Kansas, Louisiana, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas,

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

If you are located in Alaska, Arizona, California, Hawaii, Nevada, Oregon, Washington, or U.S. territories and possessions in the Pacific, send your applications to the U.S. Nuclear Regulatory Commission, Region V, Material Radiation Protection Section, 1450 Maria Lane, suite 2.10, Walnut Creek, CA 94596.

3. CONTENTS OF AN APDL1 CATION 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 an 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 programs. You may wish to adopt one or more of these samples as part of your program. If so, you may adapt the follov ng paragraph as a response to the appropriate item in your application:

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Item __: We, (name of teletherapy applicant), have established and agree to follow the procedures for of Draft Regulatory-Guide FC 414-4, cateo December 1985.as described in Appencix __

If you refer in your application to a section or appendix of this guide or of any regulatory guide, that section_ or appendix will ce incorporated as a part of the terms and conditions of your license. You will be inspected against the commitments contained in the referenced section, appendix, or document,

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just as you will be inspected against your more detailed responses. Therefore, you must keep a copy of the referenced guide on hand at all times so that you can review your commitments as necessary.

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 ifcense, check subitam C. If you check subitam B or C, be sure to enter the number of your license.

Reviewers This item is for information only. No review is necessary.

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 te 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.

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1 Reviewers-Individuals may request ifcenses only.if they act for

~ themselves and not for'or witnin a legal entity. Othe r-wise, the applicant must be a legal entity such as a cor-poration, college, university,= medical institution, or research institution. An individual, division, or depart-ment within a-legal entity may not be a licensee.

If licensed materials are to be used on a hospital's

' premises, the application must be in the name of the medical institution. The American Hospital Association *

'(AHA) Guide to the Health Care Field may be used to check #

addresses that appear to be hospitals.

The name should be the legal name,of the applicant; abbre-viations of legal ~ names, e.g., "U.C. Medical Center" instead of " University of Cincinnati Medical Center," are not acceptable. However, "J. M. Jones, M.D., P.C." is acceptable.if this is the legal.name of a private physician's. organization.

The address specified here should be your mailing address for correspon-dance. This may or may not be the same as the address at which licensed material will be used, as specified in Item 3.

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Reviewers The address should be a. complete mailina address and may contain a Post Office box number, a department name, a mailing code, or other information that will assist in getting mail to the licensee. In general, if an "atten-tion" line is included in the address, that line should not specify a particular person's name but rather a title (e.g., ATTN: Director, Radiation Therapy Department).

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n The following are examples of acceptable names and addresses: l

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Veterans Administration Medical Center ATTN: Director (110) 1234 X Street Bronx, NY 10001 Note the use o' a title rather than the name of a specific person and tho use of a mail code (110).

Suburban Hospital Radiation Therapy Department P.O. Box 1234 ~

Arlington, VA 22000 Note the use of the department name and Post Office box numoer.

J. M. Jones, M.D., P.C. .

Suburban Hospital P.O. Box 1234 Arlington, VA 22000 This is acceptable only if Dr. Jones is using the hospital' address for mailing purposes and the teletherapy unit is actually to be located at his private office, outside of the hospital's premises. Check the entry in Item 3 before determining acceptability of this entry.

Item 3 - LOCATIONS OF USE You 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.

Reviewers Be sure to ebtain an address or description that clearly identifies each proposed location of use. A map of the hospital's property with an "X" marking the location of x

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)

the' teletherapy facility is not acceptable unless accom-1 panied by an address.

Se careful about the use of room numbers as shown on architectural crawings of facilities under construction. Sometimes the rooms are renumbered after construction is completed; sometimes the room numoers are not used on the rooms themselves. A Post Office box l or similar designation is not acceptable.

If the applicant is applying for more than one teletherapy unit and source, be sure to obtain a detailed description of the location of each.

.If each proposed location of use is not identified clearly, the application is deficient. Request clarification from the applicant. .

The following examples of responses to Item 3 may be -

helpful.

Suburban Hospital Radiation Therapy Department P.O. Box 1234 Arlington, Virginia This is unacceptable because a Post Office box number was used instead of a street address.

AECL Theratron 780 unit and source to be located in Roca 1 and AECL Eldorado 78 unit and source to be located in Room 3; both rooms are in the Department of Thereneutic Radiology, Henry Ford Hospital, 2799 West Grand Sculevard, Detroit, Michigan.

This is an acceptable identification of the location of two units and sources.

Suburban Hospital Room 21, Radiation Theracy Department 5678 South Drive Arlington, Virginia s

9

_ _ _ - - - - - _ _ - - _ _ _ - - _ _- .. -_. - -_ =_

. 4 j;

I This is acceptable if_ the appli, cation has been' filed in the name of:the hospital; it is not acceptable if the g

appiteation has been filed in the name of a physician.

L i

5255, Loughboro Road NW, Room 123, Washington, D.C.

This-is acceptable if the applicant is Sibley Hospital, which is located at this_ address. 'However, it is not acceptable if the applicant is a physician. In this-case, a reviewer in the Washington area may have been suspicious of the address used by a physician applicant. The previously ~

mentioned AHA Guide could be used to verify Sibley Hospital's-address. .

Item 4 - PERSON TO BE CONTACTED ABOUT APPLICATION 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.

I Reviewers This item is for information only and does not need review.

Item 5 - RADIOACTIVE MATERIAL

^ You must provide certain details about each sealed source you are requesting and the teletherapy unit-in which the source will be noused. You may find it convenient to provide the'information requested-in Items 5 and 6 by using the form shown in Appendix 8 of this guide.

s 10

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5.1 Sealed Sources To Be used in Telethersey Unit 1

For each sealed source to be used for teletherapy, specify:

l

1. The racionuclide (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-

. therapy unit in which each teletherapy source will be housed. Specify whether 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.

Reviewers Consider the information submitted in Items 5.1 and 5.2 together. Verify, through use of the sealed source and device registration sheets, that the requested sealed

source and teletherapy unit and the maximum activity per source and maximum source output combinations have been approved for licensing by NRC or an Agreement State.

11

f The 'following examples of responses to Item 5 may he helpful. An acceptable response is:

Cobalt-60 sealed sources supplied by Atomic Energy of Canada, Ltd. (AECL) Model C-146 or C-151; 2 sources not to exceed 6000 curies (or 90 RMM) each; to be used in an AECL Theratron 780 teletherapy unit (with beamstopper).

The following response is not acceptable:

Cobalt-60 sealed sources supplied by Advanced Medical Systems, Inc. (AMS) Model AMS 3802; 2 sources not to exceed 20,003 curies each; to be used in an Atomic ,

Energy of Canada, Ltd. (AECL) Theratron 780 tele-therapy unit.

This response is unacceptable because (1) AMS sources are not authorized.to be used in AECL units; (2) AECL's Theratron 780 unit has been evaluated for sources not to exceed 13,400 curies; (3) maximum output (in RHM or RMM) has not been specified; and (4) use of a beamstopper or counterweight has not been specified.

If tha requested source-unit-activity combination has not been approved for distribution, notify the applicant that possession and use of the teletherapy unit and source cannot be authorized until there has been a review by NRC or an Agreement State, as appropriate. Inform these applicants that they may either modify their applications to request a source-unit-activity combination that has been approved or reapply at a later date when the supplier notifies them that the appropriate regulatory agency's review is complete and the source-unit-activity cortination is acceptable for distribution.

If the teletherapy unit and source are custom designed, request ,

assistance from the Material Licensing Branch, NMSS.

s 12

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Item 6 - PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED Specify whether the teletherapy source will be used for treatment of L

patients only or whether it will also be used for other purposes. If you request other uses, describe them (e.g. , irradiation of animals). The requasted 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 8.

Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM--THEIR T 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-

~

fica 11y to teletherapy are found in 55 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 Procesed Authorized' Users--Human Use

_ 7.'1.1 Aeolicable Regulations 5 30.33(a)(3) 5 35.3(b) l 5 35.11(d) l 5 35.12(a)(4) l l

5 35.13(b) l 7.1.2 Licensino 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 Appendix C of this guide. An authorized use? for human use must bc a physician l' as defined in paragraph 35.3(b) of 10 CFR Part 35.

s 13

7.1.3 Resoonse for Previousiv Licensed or Certified Physicians

' In response to Item 7.1, list the full name of each individual wno 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 information using Supplements A and B in Appendix C (these forms may be reproduced as needed). The NRC, with the assistance cf its Advisory Committee on the Medical Uses of Isotopes (ACMUI), has determined that the following constitute evidence of adequate training and experience for physicians who are proposed as users:

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 (AOBR) in radiation oncology. In this case, submit Supplement A with items 1 through 3 completed.

c. By the Canadian Royal College of Physicians and Surgeons (RCPS) in therapeutic radiology. In this case, submit Supplement A 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 with items 1 through 3 completed, a copy of the FFR or FRCR certificate, and evidence of specialization in radiation therapy.

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 ,

s 14

U l[ .l<f 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 radioactive 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

- than 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 proceaures for handling and using sealed sources.

2. Completed signed Supolement B forms.

Supplement 8 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 Rev1ew Committee for Radio-logy of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This 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 patients (e.g. , patients with cervical cancer) involve: use of both brachytherapy and teletherapy.

15

1 1

l 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 physician under wnom 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 date of the application (e.g. submit completed signed Supplement B forms) or (b) having taken continuing education or refresher courses in radiation therapy (e.g., submit completed Supplement A forms).

Reviewers Verify that each applicant physician is licensed to prac-tice medicine (see paragraph 35.3(b) of 10 CFR Part 35).

Verification may be accomplished by examining a copy of the physician's license that is sometimes submitted by applicants, consulting the American Medical Directorv, or telephoning the Board of Medical Examiners (or other appropriate organization) in the State in which the physi-cian claims to be licensed. Licensure is a prerequisite to being named as a user (for human use) on a teletherapy license.

• Althougn 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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i 16 l

)

For previously licenseo physicians, check any referenced NRC license to verify that the physician was in fact scecificc11_v named as an authorized user. If the appli-cant does not send a copy of the Agreement State license, then ask the regional State Agreements representative to call the Agreement State and obtain the needed verification orally.

Be sure to make a written note to the file on the matter.

Verify that the physician is certified. Verification of .

ABR certification may be accomplished by checking the Directory of Medical _ Specialists, calling ABR, or reviewing a copy of the physician's certificate that some applicants send to NRC. Verification of AOBR certification may be accomplished by checking the American Ostecoathic Association Yearbook and Directory of Osteopathic Physicians, contacting AOBR by telephone, or examining a copy of the pnysician's certificate that some applicants submit to NRC.

Because you cannot verify the Canadian or British certifi-cation independently, the applicant must submit a copy of the certificate. In addition, FFR and FRCR certificates do not show the area of specialization (e.g. , diagnostic or therapeutic radiology). Thus, physicians who are FFR or FRCR must also submit information showing their area of specialization; the acceptable area is therapeutic radiology.

" Board eligible" is not equivalent to " board certified."

The medical specialty boards do not recognize the phrase

" board eligible." " Beard eligible" physicians must docu-ment their training and experience and have it reviewed by ACMUI.

Before sending to ACMUI the documentation on an applicant physician's training and experience, be sure to verify the following:

17

That the physician is licensed to practice medicine.

That Supplement A (or its equivalent) has been completed and that Item 4 shows that the physician has had 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 radio-isotope handling techniques in the subject areas described above. Also be sure tnat Item 4 of Supple-ment A has been completed following the advice shown above.

That Item 5 of Supplement A shows that the physician had at least 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience using radioactive material or radiation producing equipment similar to a teletherapy unit. Applicable experience may include the use of cobalt-60 or cesium-137 teletherapy units, an irradiator, other sealed sources such as those listed for therapy procedures in Group VI of 10 CFR Part 35, x-ray units, accelerators, er other equipment for therapy. .

That each Supplement B form has been filled out com-plately and signed by the pr.aceptor physician. These forms should document at least 3 years or active practice in therapeutic radiology and the other matters described above.

That letters of evaluation' signed by each preceptor physician have Leen submitted and include the infor-mation described above.

That the physician completed training and experience less than 5 years before the date of the application.

If the time interval'is more than 5 years, be sure that the applicant physician has documented either or both (a) continuing clinical involvement in radia-tion therapy or (b) continuing education or refresher courses in radiation therapy. -

4 w

18 1

l 1

i Because it takes some time to obtain responses from

{

ACMUI, it is important to obtain all the above infor- i mation before forwarding the occumentation to the appropriate ACMUI members. Requests for ACMUI appraisal that lack information usually result in the memcers r.rquesting the missing data, and this i

delays processing of the licensing action.

Request additional infomation about the qualiff-cations of proposed physician users whose training and experience do not include the information noted above.

7. 2 Procosed Authorized Users--Nonhuman Use Only applicants who will use the teletherapy unit and source for uses in addition to patient treatment need respond to Icem 7.2.

1 .

7.2.1 Aeolicable. Reeulation S 30.33(a)(3) 7.2.2 Licensinc Criteria

~

If you will use the teletherapy unit and source for nonhuman uses, you should propose as authorized users for nonhuman use individuals whose training and experience meet or exceed that described in Part II of Appendix C of this guide.

7.2.3 Resoonse 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.

19 u

4 a. .

a j!

I:

For each -individual whose training and experience have not been dec:.:mented as described in Item 7.1, submit a complate description of the individual's '

training and experience. You may find it convenient to present this information using Supplament 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 casic 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 whera 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). OJT 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 request'3d. This experience should include knowledge of appropriate radiation -sasety, 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 tources.

Reviewers Request additional information if all that is outlined above is not submitted.

7.3 Proposed Radiation Safety Officer (RS0) 7.3.1 Apolicable Reculation i 30.33(a)(3) 7.3.2 Licensino Criteria The individual proposed as RSO should have training and experience that meet or exceed that described in Part II of Appencix C of this guide.

s 1

20

7.3.3 Response I

In response to Item 7.3, you should list thi. full name and title of the individual designated by anc responsible to your management for the coordi- l nation of your radiation safety program (the R50). If the on-site R50 is l 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 R50, you (as th'e licensee) will still be responsible for the proper performance of your radiation safety program as required by the license, and your on-site R50 will be expected to review the consultant's work and sign the required reports and records.)

If the proposed R50 is not one of the proposed authorized users, you should submit a complete description of the individual's training and experience. You may find it convenient to present this information using Supplement A (in Appen-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 when completing Supplement A.

Reviewers Request additional information from applicants that do

, not supply all that is requested.

i 7.4 Prooosed 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 Aoplicable Reculation Footnote 2 of 5 35.24 "As used in tnis guide, the term " expert" refers to the "cualified expert" described in S 35.24 of 10 CFR Part 35.

s 21

7.4.2 Licensino Criteria If your expert does not meet the criteria specified in paragraph 35.24(a) 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 Resoonse 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 9 35.24. The qualifications of your proposed expert will be reviewed with the assistance of NRC's medical physics consultants.

Reviewers -

When applicants are not confident of their ability to judge a proposed expert's credentials against the require-ments in paragraph 35.24(b), or when the proposed excert does not have the required master's or doctoral degree or does not have the required 1 year of full-time training

• in therapeutic radiological physics, then the NRC, with the assistance of its medical physics consultants, can determine the acceptability of the proposed expert's qualifications.

Before sending the documentation to NRC's medical physics consultants, the reviewer should be sure the following information has been included:

Educational history, including highest degree received, name of college or university, and major and minor areas of study.

Description of training received in therapeutic radiological physics. This should include the locations and dates where training was received, subject areas covered, and number of hours devoted to each area.

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p . . ..

l 1

Description of work experience in therapeutic j radiological physics. This should include the name of the place where the experience was obtained, the dates of the experience, the number of hours per week, and a description of duties.

Reports of at least one full calibration measurement and one spot-check program based on measurements personally made by the proposed expert within the last 10 years.

- Written endorsement of the technical qualifications of the proposed expert from personal knowledge by a -

physicist certified by ABR in one of the specialties listed in paragraph 35.24(a).

Obtain as much of the information as possible before forwarding the documentation, to the consultants. Be sure to send to the consultants the applicant's original submission, any correspondence from NRC that identifies deficiencies on this matter, and the applicant's response.

Item 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS 8.1 Applicable Regulation l

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.

23 l l

- - _ - - - - - - - - - J

. , .o

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 records identify the individual who conducted the training, the individuals, who were trained, the date and duration of the training, and the topics covered.

^

8. 3 Rescense t In response tu Item 8, you should submit one of tne following:

1. A copy of the personnel training program that you. have established and that you agree to follow for instructing individuals as required by 919.12  ;

of 10 CFR Part 19. I

2. A statement that you have adopted the training program described in Appendix 0 of Draft Regulatory Guide FC 414-4. The personnel training program in Appendix 0 fulfills the criteria in Item 8.2.

Reviewers Review the applicant's response against the criteria described above. Ask the applicant to correct any deficiency.

Item 9 - FACILITIES AND EOUIPMENT 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 equipment are adequate to protect health ar.d minimize danger to life or property.

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

24

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

9.1 Description of Facility 9.1.1 Apolicable Regulations S 30.33(a)(2)

$ 30.34(e)- .

9.1. 2 Licensino Criteria Annotated plans and elevation drawings or sketches should provide sufficient information for the NRC staff to evaluate the proposed facility. As a minimum, the plans and elevation drawings or sketches of the teletherapy facility *-should show: ,

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 dirwetions of primary beam usage and, in the case of an isocentric unit, the plane of beam rotation. .

5. fThe 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, :enduits, 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 or 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 5 20.3 of 10 CFR Part 20.

• As used in this guide, the term " teletherapy facility" means the treatment 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.

25

V * *:

9.1. 3 Response i

h You should submit annotated plans and elevation drawings or sketches of the proposed teletherapy facility that include the inform'ation listed above. Do not submit blueprints.

Reviewers There is no one right response to this item and it is not possible to determine the final acceptability of any set of drawings until they have been considered together with information in Item 9.4 (Beam Stops) and Item 9.5 (Adequacy of Shielding). The reviewer must be able to understand where the teletherapy unit is located within the treatment room, how it is to be used (see also responses to Item 9.4),

what the relationship is between the treatment room and adjacent areas, and how the adjacent areas are used (e.g.,

restricted or unrestricted area, office, hall, cafeteria, newborn nursery). The drawings, sketches, or text of the ,

application must provide data on the types, density, and thickness of the materials used in each barrier and on distances to adjacent areas so that the reviewer can verify the adequacy of shielding in Item 9.5.

9.2 Viewino System 9.2.1 Apolicable Regulations 5 30.33(a)(2) 5 30.34(e) 9.2.2 Licensino criteria Y9u 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 of Exhibit B.)

9.2.3 Response 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 j type of material used.

If you will use a closed circuit television system (or 26

_ _ _ _ _ _ _ _ . . _ _ _ _ . - _ _ . . . - -- . .i

m: '.6.

other electronic system) for viewing the patienc, 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 fune-tioning again.

Reviewers If the applicant has not provided the information requested above, ask it to submit the needed information.

9.3 Warning Systems and Access Controls 9.3.1 Aoplicable Regulations -

S 20.3(a)(14) -

5 20.203.

5 30.33(a)(2)

$ 30.34(e) .

9.3.2. Licensina Criteria Provide adequate equipment and controls to maintain exposures of radiation to workers within regulatory limits.

Condition 17 of the license requires 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 simultaneously.

Reviewers ~

, The type of dcor interlock described above is standard practice for teletherapy. If any aspect of the door 27

l 7 interlock requirement is not addressed by the applicant, it is usually because the applicant has overlooked it. 1

-However, any discrepancies between the applicant's state-ments and the license condition should be clarified in a deficiency letter or, if a letter is not sent, 'should be brought to the applicant's attention in a cover letter sent with the license.

Other radiation producing equipment, although rarely located in the treatment room, may be present because an applicant converted an existing x-ray room to a combination "

x-ray and cobalt-60 treatment room. Acceptable responses have included (1) installation of electrical interlock systems and (2) putting the keys for the two units on one key ring. The reviewer must use professional judgment on this matter.

Applicants may describe access controls for restricted areas surrounding the teletherapy treatment room in their response to Item 9.5.

If the applicant has not provided the information requested above, it is a deficiency; ask for the needed information.

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

1 9.4.1 Aeolicable Regulations I 5 20.3(a)(17) ,

S 20.105(b)(1) and (2)  !

g 28

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

t c>= .. ,

' e 9.4.2 ' Licensina 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. , O' is vertical toward the floor, 90' is horizontal toward the east wall, 180' is vertical toward the ceiling, and 270* is horizental 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 wnich (1) the primary beam is dire,cted toward the integral beam absorter 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 " sample" response for guid-ance. The following is an example of an acceptable response on the use of a rotational unit with an integral beam cbsorber; the angle orientation convention described above applies.

For the primary beam directed toward the intecral beam absorber, elec-trical or mecnanical stops are set so that tne 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 intecral beam absorber, electrical-or mechanical stops permit the unattenuated primary beam to be directed in a 95* are from 5' toward the west wall to vertically down toward the floor to 90* toward the eest 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).

l s

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=

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Reviewers There is no one rignt response to this item. The reviewer 1

I must understand (1) the capabilities of the teletherapy unit as dercribed in the device registration sheet for the unit in question and (2) the applicant's description of the manner in which electrical or mechanical stops I limit use of the primary beam. The acceptability or the applicant's response to this item cannot be determined except in conjunction with its responses to Item 9.1 (Description of Facility) and Item 9.5 (Adequacy of Shielding). '

It may be that the treatment room has sufficient shielding and no beam stops are needed. However, scme stops are required for most applicants' facilities. After reviewing the shielding evaluation, it may be apparent that addi-tional electrical or mechanical stops are needed.

9. 5 Adecuacy of shielding ,

9.5.1 Apolicable Regulations S 19.12 5 20.1(c)

S 20.101 S 20.105(a)

S 20.105(b)(1) and (2)

S 20.201 S 20.202 S 20.203 9.5.2 Licensino Criteria t

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.

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t 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 such 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, and scattered radiation.

d. Separate calculations for each 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 nigher 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 cemenstration 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 bel'ow) as a restricted or unrestricted area.

2. Submit calculations of the maximum rddiation 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 calculations. These parameters include such factors as beam orientation, maximum field si:e, s:atter

. 31 A

.e . .

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angle, scatter ratio, distance to scatterer, distance to area of concern, type and thickness of materials used in barrier, and transmission factor cf 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, including above and below the room, and a statement as to whether the area will 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 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 ievels 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 any 1 day.

3. For each unrestricted area, state how you will meet the requirements of paragraphs 20.105(b)(1) and (2) g request authorization for higher levels 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 shoul.d 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. I

c. Your program for ensuring that personnel entering the restricted area receive proper instruction in accordance with 519.12 of 10 CFR Part 19.

d. Your program for ensur ing that personnel entering the restricted area are monitored in accordance with 8 20.202.

32

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

9.5.4 Discussion i

In the past, many applicants and licensees have had difficulty providing 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.

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) o,f 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 receive 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.'.05(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 /> or by Snowing 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-1-hour requirement and then count up the hours and show compliance with the less-than-100-m1111 rems-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 ..,a restricted area. Condition 18.A(fi)(a) of the tele-therapy license (Exhibit B) relates to this point. Licensees are expected, among other things, to identify each restricted 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 s

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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 limits in s 20.101 and that they are ALARA.

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

Conditions 18 and 19 of the teletherapy license require that certain surveys and tests ce made and the results reported to NRC. Appendix F of this guide describes the minimum information and measurements that should be incfuded in a survey report to meet the license conditions.

Reviewers In the past, the principal prob?em with these calculations has been the applicants' confusion between the recommenda-tions of the National Council on Radiation Protection and Measurements (NCRP) and the requirements of NRC's regulations.

The NCTP reports" suggest the use of a set of equations for primary, leakage, and scattered radiation that take into account workload, use, and occupancy factors. In the NCRP scheme,1:se and occupancy factors can be frac-tional values.

Note that the NCRP equations receramend maximum doses of 100 millirems per week for " controlled areas" and 10 milli-rems per week for "noncontrolled areas." The result of the NCRP calculations is a fractional transmission factor that is then used with a series of graphs to determine the thickness needed for a particular material as a barrier. i For example, a transmission factor of 3x10.s indicates the need for 100 centimeters of concrete (with a density

" National Council on Radiation Protection and Measurements, " Medical X-Ray'and Gamma Ray Protection for Energies Up to 10 MeV - Structural shielding Design and Evaluation," NCRP Report 34, Washington, D.C., 1970; and National Council

' on Radiation Protection and Measurements, " Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV,"

NCRP Report 49; Washington, D.C., 1976. NCRP Reoorts may be obtained from

. NCRP Publications, 7910 Woodmont Avenue, Bethesca, MD 20815.

34 l .

-__--____-D

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of 2.35 grams per cuoic centimeter) if cobalt-60 is being

{

considered. I The difficulty is that the NCRP calculations do not meet the requirements of NRC's regulations for unrestricted areas. The pertinent NRC regulation is found in para-graphs 20.105(b)(1) and (2) of 10 CFR Part 20.

This regulation contains a two-fold requirement and assumes continuous occupancy. The continuous occupancy assumption is not in line with the NCRP scheme. Also, because the NCRP scheme is based on weekly exposure rates in adjacent areas, the NCRP calculations do not necessarily show com-pliance with paragraph 20.105(b)(1), 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 />. It is this portion of paragraph 20.105(b) with which most applicants have difficulty.

With the requirement of 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 />, it is difficult, if not impossible, to average ,

fractional use factors. For example, suppose the appli- '

cant treats 4 patients per hour for 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> a day for a total of 32 patients per day. If the applicant states that a particular orientation is used 1/8 of the time, then 4 patients are treated in that particular orienta-tion in 1 day. On an hourly basis, how does one handle the use factor of 1/8? Is half of a patient's treatment given in each of 2 different hours?

How can one be sure that all 4 patients are not treated in that critical orientation within the same hour? Accordingly, fractional use factors cannot be used in showing compliance with the less-than-2-millirems-in-any-1-hour requirement.

However, fractional use factors probably do average out over a week and, if appropriate records are kept, can be

)

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used in showing compliance with the less-than-100-millirems-in-any-7-days requirement. This usually is not a problem because most teletherapy units are operated only 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week.

If radiation levels in unrestricted areas are at the maximum of 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 />, then in 1 week a person would only receive 80 millirems, less than 1

the specified 100 millirems in any 7 days. l l

If calculations are submitted in accordance with the ,

recommendations in the guide, they are fairly easy to ,

review. Keep in mind the drawings submitted in response to Item 9.1, the description of how electrical or mechan-ical stops will limit use of the ' primary beam of radia-tion (Item 9.4), and the capabilities of the teletherapy unit (i.e., data from the device registration sheet).

Verify the applicant's calculations and be sure that maximum radiation levels in each area have been presented.

Because they are familiar witn the NCRP scheme, many appli-cants use the NCRP calculations with the results expressed in te"ns of fractional transmission factors that, through ,

the use of graphs in NCRP documents, are then converted to " required" amounts of concrete. As mentioned before, applications with the NRCP scheme are not easily reviewed.

In these cases, it has been Headquarters' practice for the reviewer to perform sufficient calculations to identify prob-les areas to the applicant in a deficiency letter, rather than reject the submitted calculations without review.

One way of approaching the calculations is to rearrange the NCRP equations to selve for an exposure rata and to use special care in assigning values to certain factors.

The results of these "modiffec" equations could then be adjusted for "on time" to give answers 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 /> (or in any 7 days).

36

_ SUGGESTED MODIFICATIONS TO NCRP EOUATIONS To calculate contribution to exposure rate (mR/hr) from crimary radiation:

BucW (103 mR/R) 50pri)'

To calculate contribution to exposure rate (mR/hr) from leakace radiation (with the source in.the on position):

B), W (10 3)(103 mR/R) , B g W (usec) Idsec)

To calculate contribution to expc]ure rate (mR/hr) from scattered radiation:

a 8 3, W F (103 mR/R) 2.5 a B,, W F (d,,g)2 (esca) 400 (d,,g)2 (dsca) where: =

Bug' Elg, B,9 transmission factors (unitiess) for the useful beam of gamma rcys (Bug), leakage of gamma rays (B39 ) and scatter of gamma rays (0,g). Consult the graphs in the NCRP documents to determine the appropriate B value for the type and thickness of the material used in a given barrier and for the radionuclides of interest (e.g. ,

cobalt-60).

W= " workload" in terms of reentgens (R) per hoce at 1 meter. This is the maximug outout or .orkload possible.

37 i

e ,

(' .

d pri' d sec '= distance in meters from radiation source to person to

'be protected; to be obtained from facility drawings.

d,g, = distance in meters from radia-tion source to the, scatterer; to be obtained from device-registration sheet.

F = field area (in em2); obtain maximum field size in cm from device registration sheet. If maximum field is 36 x 36 cm, F = 1296.cm2 a = ratio of scattered to incident exposure; scattered radiation measured at 1 meter from phantom when field area is 400 caz at the phantos surface; incident exposure measured at center of field 1 meter from the source but without phantom.

See Table B-2 of NCRP 49.

For cobalt-60 and F = 400 cm2, the value for a for various scattering angles is:

Angle a 30' 6 x 10 3 45' 3.6 x 10 3 '

60' 2.3 x 10.a 90' O.9 x 10 3 135' O.6 x 10 2 38 l

e, ... '

e With information on maximum "on time," the above calculations can be adjusted to determine mR in any 1 l hour. For example, if the applicant presents data showing a maximum "on time" of 15 minutes, this means the unit is "on" for 25% of any hour. If the exposure rate in an unre-stricted area is 8 mR/hr with an "on time" of 25%, then:

8 mR , 0.25 hr ON = 2 mR in any 1 he nr hr This shows compliance with paragraph 20.105(b)(1) ,

for an unrestricted area. With similar types of informa-tion about maximum use and "on time" per week, compliance with paragraph 20.105(b)(2) can be determined.

Options for Aeolicants Not in Como11ance:

If applicants' calculations do not comonstrate compliance, clarification is needed. Appendix E of the guide outlines the applicants' options. These options are as follows:

1. Beam orientation may be restricted (e.g., using elec-trical or mechanical stops) to limit the anticipated raciation level. The applicant might decide to place additional limitations on the use of the primary beam beyond those specified in the response to Item 9.4

2. Accitional shielding may be added to the barrier in question, i.e. , modifying the facility description in Ites 9.1.

3. The applicant may request authorization for higher radiation levels and demonstrate that the require-ments of paragraph 20.105(a) of 10 CFR Part 20 are met. In this case, the applicant must include information on average radiation levels and antici-pated occupancy times for each unrestricted aree.

The applicant must also maintain, until the NRC termi-nates the teletherapy license, records to support 3?

e .- e the assumptions used in justifying the recuest for this permission.

4 The applicant may designate and maintain the area as restricted. If this cption is selected,'the-applicant must provide the information needed for restricted areas.

Example: Suppose the applicant proposes to use a rota-tional unit with an integral beam absorber. Atsume that in Item 9.4 the applicant says that the unattenuated primary beam may be directed in a 90' are from vertical to the floor to 90' toward the east wall. Further assume that the 90' orientation tcward the east wall causes suf-ficiently high radiation levels in the adjacent unrestricted area that.the applicant dess not ,show compliance with paragraphs 20.105(b)(1) and (2).

The applicant could select one of the above optinns and implement it as follows:

1. The applicant might state, in writing, that it will modify the electrical or mecnanical stops so that the unattenuated primary beam can be directed in a 20* arc (i.e., from vertical toward the floor to 20*

toward the east wall). Depending on the applicant's 1

revised beam stop limitations and the design of the i facility, it may or may not need to supply additional

! calculations to show that, with the revised beam stops, the unrestricted stea outside the east wall meets the requirements of paragraphs 20.105(b)(1) and (2). The feasibility of this option depends on which orientations of the primary beam are responsible for the high radiation levels, whether these orienta-tions are needed for patient treatment, and whether the proper electrical or mechanical stops can be installed.

L. _ _ _ _ _ - - _ _ _ - - - - - - - - - - - -

4

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2. The applicant might state that it will add a specified thickness of concrete, lead, steel, or other material to the entire east wall or to some part of the east wall. In this case the applicant must present a '

clear description of the materials to be used, state exactly where they will be installed, and provide additional calculations showing that, with the addi-tional shielding in plari, the unrestricted area outsice the east wall meets the requirements of paragraphs 20.105(b)(1) and (2). This option is not frequently used in existing cobalt-60 treatment rooms.

It is more commonly used in new treatment rooms still under construction or 'in old treatment rooms (e.g.,

x-ray rooms) being remodeled to accommodate a cobalt-50 unit. If the area in question is a roof, the appli-cant may not be able to add shielding because the building was not designed for, nor can it support, the additional weight of more shielding materials.

3. The applicant might indicate that the first two options are not feasible because it needs the criti-

_ cal orientation to treat patients and adding shield-ing to the wall would be too expensive. The app 11-cant might further state that the orientation in question is needed only occasionally to treat patients, so it requests authorization for higher radiation levels pursuant to paragraph 20.105(a).

To support its request, the applicant should provide calculations demonstrating compliance with paragraph 20.105(a). The calculations should consider average radiation levels in the unrestricted area (i.e.,

levels from all orientations of the primary beam, not just the contribution from the critical orienta-tien); specify frequency of use of the unit, parti-cularly the use of the " critical" orientation; 41

(

i estimate occupancy of the area and provide a commit-ment to maintain records, until NRC terminates the l-teletherapy license, showing that these assumptions are either accurate or at least conservative. In some cases, applicants commit to posting film badges or other devices on the wall of the unrestricted area to monitor the use of the unit and to show maxi- 1 mum accumulated exposure per week or month or year (i.e., without considering fractional occupancy factors). If fractional occupancy factors are used, use professional judgment about their validity; con-sider tr.e nature and use of the area in question as well as the fractional value proposed. An unrestric- -I L ted area used as an office probably should not be be assigned a fractional occupancy factor; an occupancy factor of 1/100 is exceptionally low for almost any area.

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Restricted Areas: These areas may have been initially designated by the applicant as restricted areas or, if s

the applicant was unable to show compliance with para-graphs 20.105(b)(1) and (2), they may have been reclassi-fied as a restricted area. In either case, the applicant needs to present the following information (also shown in Section 2 of Appendix E of this guide) regarding restricted areas:

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

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

3. The program for ensuring that personnel entering the restricted area receive proper instruction in accordance

.s with 5 19.12 of 10 CFR Part 19, l' i

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1 4 i The program for ensuring that personnel entering the restricted area are monitored in accordance with 5 20.202, S. The surveys that will be performed in accordance with 5 20.201.

Note that there are no maximum radiation levels that are acceptable for restricted areas; e.g., 10 mR/hr, 100 mR/hr, or 1 R/hr may be acceptable under some circumstances and not others. Again, judgment must be used in det* ding

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whether specific levels are acceptable--the higher a radiation level and the greater the use and occupamcy of the area, the more cautious the reviewer should be.

Discussion .

The acequacy of any one of these five points cannot be determined independently of the others. Instead, keep in mind the description of the facility, the magnitude cf the exposure rates in the restricted area, the location of the restricted area, etc., and evaluate as a whole the information on a given restricted area.

Physical controls may range from an electrical interlock that interrupts the primary beam if the door to the area in question is opened, to ensuring that doors to the area in question are locked with keys controlled by the tele-therapy unit operator, to fencas or ropes around the area in question making entry to the area difficult. Adminis-trative controls are usually signs, instructions, memo-randa, etc. , informing affected personnel of the pro-per procedure for gaining access to the area in question (e.g. , " consult therapy department before going on roof").

Signs must meet the requirements of 10 CFR Part 20. They may also contain the licensee's instructions regarding access. There must be a sufficient number of signs of s

43

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

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i sufficient size and in appropriate locations that persons approaching the restricted area "get the message." For example, if a person can approach the roof (the area in question) from four sides, there should be at least one sign on each of the sides.

The applicant must provide training (by memoranda, classes, meetings) to inform its personnel about the existence of the restricted area, the procedures to be followed to gain ac-cess, and the other topics included in S 19.12 of 10 CFR Part 19. For example, if the roof is a restricted area and .

if building engineers routinely go onto the roof to eneck heating, air conditioning, or ventilation systems, they must be given adequate instruction in the licensee's pro-cedures for gaining access to the roof and the reasons for the procedures. For example, they may be required to in-form the radiation therapy department staff or to obtain a key from the unit's operator.

Personnel entering a restricted area are usually required to wear personnel monitoring devices. However, these may not be necessary depending on the magnitude of the radiation levels, the time spent in the area, and steps taken to gain access. For example, if a person going to the roof needs to obtain a key from the unit's operator and that key is on the key ring that contains the only key to control the teletherapy unit, the primary beam cannot be turned on while the individual is on the roof and the individual would not need a personnel moni-toring device.

Surveys are usually those performed as required by Conditions 18 and 19 of the license. However, other surveys may be needed depending on the circumstances.

If the applicant has not provided all the information requested, ask that it do so. '

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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 incorporate in licenses such additional requirements anc conditions that it deems appropriate or necessary to protect health or to mini-

'). mite danger to life or property. Accordingly, you must provide information about your radiation safety program.

10.1 Personnel Monitorino Program 10.1.1 Aeolicable Reculation -

S 20.202 10.1.2 Licensino Criteria ,

You must establish-and agree to follow written procedures for personnel monitoring. As a minimum, these 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.

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

Reviewers Most teletherapy licensees do not use pocket dosimeters as a part of their personnel monitoring program. However, if these devices are used to measure exoosure from licensec activities, they must be operable and calibrated.

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10.1.3 Resoonse i 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 monitoring devices.

l l Reviewers Request additional information from applicants that do not supply all that is requested.

I NRC has been working with the National Bureau of Standards to establish NVLAP for personnel dosimetry processing services. Until that program is fully operational, it is difficult to judge the proficiency of any in-house dosimeter processing that a teletherapy licensee wishes to perform. This is why the use of a recognized commer- '

cial personnel dosimetry service company is stressed.

With NVLAP, any teletherapy organization that obtained accreditation could perform its own in-house processing.

10.2 Instrumentation 10.2.1 Aeplicable Regulations S 20.201(b) f 30.33(a)(2)

$ 35.23

$ 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 mourced 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 46

i providing a visible indication (e.g. , flashing light) of an exposed or partially exposed source, and the visibie indicator must ce observacle by a person entering )

the teletherapy room.

3. A dosimetry system for m& king 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 follcwing:

1. A description of the radiation detection and measuring instruments that you will use for radiation protection, including survey and monitoring 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 A14-4.

Reviewers Request additional information from applicants that do not supply all that is requested.

10.3 Calibration of Portable Survey Instruments 10.3.1 Applicable Regulations i 20.201(b)

$ 30.33(a)(2)

S 30.53 Paragraph 20.201(b) of 10 CFR Part 20 requi'res each licensee to make such surveys as are necessary to evaluate the extent of radiation hazards that may 47

i 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 Licensino Criteria for Aeolicants That Will Not Calibrate Their Own Survey Instrumeng

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

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

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3.

Records of each calibration should be maintained for at least 2 years after the calibration. These records should show the date and res'ults of the calibration and the name of the organization that provided the service.

10.3.3 Resoonse for Aeolicants 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 I will be returned to the manufacturer for calibration g provides the name, ad-dress, and the NRC or Agreement State license number of the organization that 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 survey instruments.

Reviewers A statement that the instrument manufacturer will perform the calibration is acceptable without further checking.

If any other organization will perform the_ calibration, 48

- ______- __ - - A

=.. ...

1 check whether NRC or an Agreement State has reviewed the organization's calibration procedures. If a determination cannot be made that the designated emsultant er organiza-tion is licensed, request the applicant to provide the i

specific procedure to be carried out by the designated consultant or organization and then review the procedure for its adequacy. It is acceptable to perform a "custem" review of the procedures used for calibration of survey instruments for a particular licensee or applicant.

Be aware of whether NRC reviewers have previously approved "

the procedure for calibrating survey instruments to be carried out by the designated consultant or organization.

Review the calibration procedure to determina its adequacy in light of the applicant's situation. Do not approve a procedure for calibrating survey instruments simply because it has been accepted in the past.

. Statements such as " instruments will be calibrated by a firm licens'ed by NRC or an Agreement State" or " instruments will be calibrated by XYZ Company or equivalent" should be considered deficient. Inform the applicant that the name, address, and license number of each firm other than the instrument manufacturer is needed.

Request additional information from applicants that do not provide all the information requested.

10.3.4 Mcensino Criteria For Aeolicants 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.

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

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' following minimum activities of typical radionuclides sources: 85 millicuries of cesium-137, 21 mil 11 curies of cocalt-60, or 30 mil 11 curies of radium-226.)

4. Survey instruments be adjusted to provide readings on all calibrated scales or ranges within 110%,of true value (or 220*4, provided a calibration chart or graph is prepared, attached to the instrument, and used to interpret readings).

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.

10.3.5 Resoonse 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: Ve, (name of teletherapy applicant), will calibrate our own survey instruments in accordance with written procedures that include as requirements the criteria described in 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 cri+.oria in Item 10.3.4.

For detailed information on survey' instrument calibration, refer to  ;

ANSI N323-1978, " Radiation Protection Instrumentation Test and Calibration."* {

Reviewers Request additional information from applicants that do not provide all that is requested.

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

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l 10.4 Leak-Test Procram 10.4.1 Aoplicable Regulations 5 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 cate 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 leckage and contamination at intervals not to exceed 6 months.

10.4.2 Licensino Criteria for Aeolicants 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 i .

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 i,

name of the consultant or commercial organization that provided the service.

10.4.3 Response for Apolicants That Will Use a Consultant To Perform Leak Tests In response to Ites 10.4, state the name, address, and NRC or Agreement State license number 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 at least 2 years after each test and describe the minimum information in these records.

Reviewers Check whether the designated consultant or organization is specifically licensed to conduct a leak-test service.

A The applicant should have provided the license numoer.

51 l

If a determination cannot be made that the designated consultant or organi:ation is licensed, request the appli-cant to provide tha specific procedure to be carried out by the designated consultant or organization and then review the proceiure for its adequacy. A " custom" review of the leak-test procedures for a particular licensee or applicant is acceptable.

Determine whether NRC reviewers have previously approved the leak-test procedure to be carried out by the desig-nated consultant or organization. Review the leak-test procedure and determine its adequacy in light of the ap-plicant's situation. Do not approve a leak-test proce-dure simply because it has been accepted in the past.

10.4.4 Licensing Criteria for Acolicants That Will Use Commercial Leak-Test Kits If you will use commercial leak-test kits, a persan 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 opplier for evaluation and the results 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 nesie, 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 samoles.

10.4.5 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 of 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,

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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 samoles.

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 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.

Reviewers Check whether the kit has been reviewed by NRC or an Agreement State.

If the kit has been reviewed and accepted, no further information is needed on that subject. If the kit has not been accepted, request the applicant to provice details about the way the leak-test samples will be collected and analyzed.

Use professional judgment to determine whether an individ-ual not identified in Itam '7 has sufficient training and experience to use a commercial leak-test kit. Request additional information from applicants that do not supply all the requested information.

10.4.6 Licensing Criteria for Acolicants That Will Perform the Entire Leak-Test Procecure 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:

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.

s ,

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s 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.a., 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 Aoplicants That Will Perform the Entire Leak-Test Themselves In response to Item 10.4, you should:

1. Describe the materials to be used in taking the leak-tast 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 nam'a and model number of the instrument, describe its characteristics (e.g., NaI(T1) 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 this 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, and the name of the person who performed the test. "'

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Reviewers The responses given below are commonly. submitted accept-able responses from applicants. Use professional judg-ment to determine what variations are acceptable or to determine if an entirely different set of responses is acceptable.

1. Cotton swabs dipped in alcohol and held with tengs .

or forceps will be used to smear collimator blades and other areas where contamination, if present, might accumulate.

2. The use of long-handled tongs or forceps is required; the smears will be checked for gross contamination with an operable portable survey meter; and smears showing measurable activity will be disposed of with radioactive waste but negative smears will be disposed of as normal trash.

3. A NaI(T1) well crystal connected to a single-channel or multichannel analyzer will be used. This type of.

system is capable of providing results to within 210%

accuracy with a sensitivity well below the required 0.05 microcurie limit.

4. A standard source of cobalt-60 (or cesium-137 if used for teletherapy) of known activity (e.g..

0.1 microcurie) will be counted along with a "bacqtround" sample and with the leak-test samples.

l Counting times are sufficiently long to provide the required sensitivity. The not count rates for the standard and for the leak-test samples are calculated; the current activity of the standard is also calcu- -

1 lated to account for its physical decay. An acceptable formula is:

net count rate of sample current activity of activity on leak-test net count rate of standard standard (in microcuries) , sample (in mierecuries)

5. The leak tests will be performed by the RSO or an authorized user whose training and experience has been described previously.

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Item 6 (on records) has not been requested of applicants in the past. However, this will allow them to dispose of these records after 2 years.

10.5 Ooeratino Procedures 10.5.1 Applicable Regulations 9 30.34(e) 5 30.53 10.5.2 Licensino 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) 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.

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

10.5.3 Resoonse In response to Item 10.5, you should suomit a copy of your operating procedures, s

56

l Reviewers Request additional information from applicants that do not supply all that is requested.

10.6 Emercency Procedure,s, 10.6.1 Aeolicable Regulations 5 20.1(c)

$ 30.34(e) 10.6.2 Licensing criteria Condition 16 of the teletherapy license (see Exhibit B) requires that emer-gancy procedures be established and that the procedures be posted at the control console. You must establish ard agree to follow written procedures for emer-gencies that may occur, e.g., the teletherapy source fails to return to the "off" position.

Thes'e procedures, designed ta minimize radiation exposure to patients, workers, and the general public, should as a minimum:

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-j 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 10.5 should be one of the following:

l 57 J_____-____ -

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1. Submit a copy of your emergency procedures.

2. State that you will follow the emergency procedures described in

. Appendix I of Oraft Regulatory Guide FC 414-4 1

The emergency procedures shown in Appendix I fulfill the criteria established above.

Reviewers Request additional information from applicants that do not' supply all that is requested.

10.7- ~ ALARA Procram 10.7.1 Applicable Regulations 5 20.1(c) 9 30.34(e) 10.7.2 Licensino Criteria .

You should establish and agree' to 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:

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 ensure 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 5 20.101 of 10 CFR Part 20 and 4

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.

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

10.7.3 Resoonse 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.

Reviewers

• Request additional information from applicants that do not supply all that is requested.

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

10.8.1 Aeolicable Reculation S 35.11(b) 10.8.2 Licensino Criteria If you, the applicant, are a hospital or other medical institution, you must establish and maintain a Radiation Safety Connittee (RSC) to oversee the use of licensed material throughout your institution and to review your insti-tution's radiation ~ safety program. As a minimum, the membership of your RSC 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, paragraph 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 s

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need both'a medical isotopes ccmmittee and a radiation safety committee; insti- j tutions need only one committee, a radiation safety committee wnese responsi- '

bilities and required membersnip are specified in paragraph 35.11(b) of 10 CFR  :

L Part 35.

10.8.3 Resoonse l

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

1. A statement that specifies:

a. The name of each member of your radiation safety committee, pith

. 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 amendments wl.in 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 tne memoership 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.

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 chove and (2) specify that your existing RSC's duties and responsibilities have been amended to include teletherapy. ,

Reviewers Request additional information from applicants that do not supply all that is requested.

Item 11 '4ASTE 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 s

60

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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.

11.1 Aeolicable Regulation S 20.301 11.2 Licensino 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 tale-therapy units and sources.

Reviewers The most common acceptable response is that the sources or units will be transferred to a person authorized to receive them (e.g., the teletherapy unit manufacturer, source manufacturer, source supplier). Other responses will have to be considered in light of the requirements in 10 CFR Part 20.

Item 12 - LICENSE FEES An application fee paid in full is required by paragraph 170.12(a) of.

10 CFR Part 170 for most types of licenses, including applications for license amendments and renewals. You should refer to $ 170.31, ' Schedule of Fees for Materials Licenses and Other Regulatory Services," of 10 CFR Part 170 to s

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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.

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 OATA ,

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-tant 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 miti-gata the potential for a significant economic impact on a substantial number of small entities.

14.a Annual Recelets 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 these figures that pertain solely to the teacning hospital. ,

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• • * ' * ?. *

1. Holders of One NRC License. If your organization (named on' the license.

or application) holds one NRC Ifcense and operates from one address, check the.

4-box 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 receipts,: 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 approximates 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 Multiole NRC Licenses at Multiole Addresses. If your organization (named on the license or application) holds multiple NRC If eenses at 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 orl application and not for the entire corporate entity.

14.b Number'of Employees The number of employees 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 Requiations or Anv Future Proposed NRC Regulations That May Affect You?

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 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 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 licenso 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 1Iling or processing before the proper fee is paid in accordance with 5 170.12 of 10 CFR Part 170.

Reviewers Review any application for a license amendment in accor-dance with the criteria for review of a new application.

Check that the information provided by the licensee in-cludes all changes that need to be made in previously submitted documents. If the licensee does not provide all the documentation needed, ask it to correct the l

"In item 1 of NRC Form 313, check block B and enter the number of the license to be amended, s

64

[. s. ..

• L*

r deficiency by providing the appropriately amended documents.

See also the reviewers' notes in Section 1 of Appencix L.

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

1. The reference is mais 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 letter format and include the limited supporting documentation described in Section 2 of Appendix L.

If you file your application for license renewal at least 30 days before tne 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 dste and the NRC cannot process it before that date, you could be without a valid license when your license expires.

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

^In Item 1 of HRC Form 313, check block C and enter th'e numcer of the license to be renewed.

1 65 1

._____________O

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) recuesting termination of your license.

Your letter should reach the NRC before the expiration date on your license.

Reviewers The review of a renewal application should be straight-forward if the licar.see has kept its license up to date.

Check the inspection history of the licensee to determine whether additional information on a particular aspect of ,

the program is needed. An application for renewal should not be used as an occasion to solicit information from a licensee unless it is aosolutely necessary. The renewal process should be carried out expeditiously.

See also the reviewers' notes in Section 2 of Appencix L and the checklist in Appendix 0.

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-ticipation in its development. It represents the current position of the NRC staff, 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.

Until the final guide is published, this draft document represents the best &vailable 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 c.oose to request an amendment to your if cense to incorporate the less restri:tive guidance.

I 66

If the final guide is more restrictive than the craft guide, this will not affect licensing actions already completed since all required regulatory fincings will have been mace. However, more restrictive recommendations in the final guide may reflect items identified by the NRC staff as important to nealth and

, safety.

Such issues would be addressed for effective licenses by issuing an amendment or a rule change before 1 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.

O e

0 0

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_ _ - - _ - _ _ _ _ _ _ _ _ _ _ --.-.2..

APPENDIX A 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 numans" in the authorized use condition has been interpreted to include use of the teletherapy unit to (a) irradiate patients, (b) make physical measurements neeced for dosimetry purposes or treatment planning for patients, (c) make physical me'asurements 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 15 as "an individual licensed 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."

OUESTION 3:

The authorized user condition on a teletherapy ifcense (see Condition 12 of Exnibit B) may read in one of two ways: (1) " Licensed material shall be s

A-1 m._____ _ _ ._ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

used by

" or (ii) " Licensed material snall be usec by, or under the supervision of, .

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

ANSWER 3: ,

'1 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 l

." 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 become authorized users.

QUESTION 4:

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

.f' i

ANSWER 4: l i.

I 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 l still considered to be "the user." Authorized physician-users have certain responsibilities that may not be delegated to nonphysicians. I The authorized physician-user's responsibilities are- I l

I

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 '

I (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 3 originally prescribed dose as warranted by the patient's reaction to j l the radiation. '

A-2 l

.. l

l b

d.

Actual use of, or direction of technologists or other paramedical i personnel in the use of, the teletherapy unit, and

e. Provision of necessary followup medical care.

Items a through a 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 o,r herself that proper medical records are made of each use. It does not mean I

that the physician-user is necessarily present for each teletherapy treatment.

The authorized physician-user may delegate to properly trained tecnnolo-l 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 planning purposes; survey, full calibration, spot-check, and other 4

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.

s A-3

.,.1 APDENDIX 8 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 Radionuclides Number Source Model per Source of Source of (Element and Mass No.) Manufacturer Number (in curies) (in RHM) Sources (A) f -

(B)

(C)

Item Se2 TELETHERAPY UNITS NAME OF MANUFACTURER (include description, Beam Counter-if unit is custem made) Model Name Catcher Weight and Number (check one of these)

(A)

(B)

(C)

Item 6 PROPOSED USES A B C Check as appropriate Treatment of Patients Only Treatment of Patients and Other Use (as described below) s B-1

APPEN",IX C TRAINING AND EXPERIENCE FOR TELETHERAPY USERS PART I.

TRAINING AND EXPERIENCE FOR PROPOSED USERS--HUMAN USE

1. General Criteria Any human use of byproduct material (i.e. , the internal or external admini-stration of byproduct material, or the radiation therefrom, to human beings) must be e triad out vy or unour i.he 4 pervision of a physician. As defined in paragraph 35.3(b) of 10 CFR Part 35, a physician means an incividual 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 acequate 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 materials in teletherapy units.

2. Previous Aceroval 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 listed as an authorized user.

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

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

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9 . e b.

Certification by the American Osteopathic Board of Radiology (AOBR) 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 Supplement 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 Trainino and Experience The training and experience described below should have been received 1

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 Supple-ment 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 />) s C-2 2

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

(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 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:

(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 i emergency procedures for handling and using sealed sources.

c. Clinical training in teletherapy procedures: Active practice in 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 Itcensing agency (see Section 2) and who is not certified "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 brachy-therapy and teletherapy. '

C-3

(see Section 3) will be reviewed on a case-by case basis with the assistance of the ACMUI.

Most applicants use Supplements A and 8 to provide much of the needed information. The following is a checklist of materials that should be submitted, with suggestions on their preparation:

a. Completed Supplement A form.

In Item 4, document at leas't 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, as described in Section 4.a. For each subject covered in this basic training, state where the training was obtained, the dates, totaJ i

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. Se sure that hours of training can be traced to tne 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, {

l

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

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clinical involvement in radiation therapy from the time the training was com-pleted to the date of the application (e.g. completed signed Supplement 8 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 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 mtterial for the i 1

purpose requested in such manner as to protect health and minimi:e danger to l life or property." Proposed R50s and proposed users for nonhuman uses of tele-therapy units are expected to meet these requirements. Cutlined below are  !

training and experience criteria that have b' een found acceptacle for these two I 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 teletherapy unit and proposed R50s 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 f appendix.

b. Experience with the types and quantities of radioactive material for I 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 I include the following areas:

(1) Learning appropriate radiation safety, quality control, and emergency procedures for handling and using sealed sources. l (2) Calibration of ion chambers and survey meters and performance of operational checks of these instruments.

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

C5

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3. . Documenting Trainino and Excerience

'\

n;-

. Supplement A may be used to document ' training.and experience. See the c-discussion in Part I of this appendix.

e 4

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APPENDIX 0 PERSONNEL TRAINING PROGRAM

1. Schedule for Trainino 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 emoloyees, and

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

2. Description of the Trainino Prooram -

Training will be sufficient to ensure that:

a. Individuals who work in or frequent restricted areas are instructed in the items specified in 519.12 of 10 CFR Part 19, and

b. Individuals whose duties may require work in the immediate vicinity  !

of radioactive materials are informed about radiation hazares 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. I

b. Appropriate response to emergencies or unsafe conditions, including I l participation by appropriate staff in " dry runs" of emergency proce-dures conducted as a part of the initial and annual refresher training. l C. Areas where radioactive material is used or stored.

d. Potential hazards associated with radioactive material.

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1:,

I, e.

Radiological safety procedures coprocriate to the duties of the employee, f,

Pertinent NRC regulations.

g.

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

h.

The right of all personnel to be informed of radiation exposure and bicassay 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.

D-2

f APPENDIX E i

DISCUSSION OF UNRESTRICTED AND RESTRICTED APEAS 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 W ulations on restricted and unrestricted areas. After your license is issued a:td your teletherapy unit and source installed, you as a '

licensee must con u t, surveys (see Conditions 18 and 19 of Exhibit B) and use measured radiation levels in showing how you are complying with NRC's recuire-ments. The following discusses pertinent NRC regulations and factors to be considered in showing compliance with these, regulations.

1. Unrestricted Areas:

a. A standard teletherapy license requires that radiation levels in unrestricted areas meet the requirements of paragraphs 20.105(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 consecutive 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 (f.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-milliress-in-any-7-consecutive-days requirement.

b. In showing 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 "The pnrase " 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

'i, the primary beam is "on."

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(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 d regardless of the orientation of the beam).

, c. In showing compliance with paragraph 20.105(b)(1), you may not use a l

fractional use factor, i.e. , that fraction of the time during which the primary l 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.

a. 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 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 A!. ARA philosophy (in paragraph 20.1(c)) and specify certain maximum per-missible doses that individuals may receive in a restricted area ($ 20.101),

b. For each restricted area, you must describe:

(1) The physical and administrative controls used to restrict accass to the restricted area, 9

E-2

L . g ,. . ;,

it (2) The number, wording. . size, and location of warnir.g 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-519.12 of 10 CFR Part 19, (4) Your program for ensuring that personnel entering the restricted area are monitored in accordance with 5 20.202, and (5) The surveys that will be performed in accordance with S 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.

0 4

e a

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• * \

l APPENDIX F q

. I TELETHERAPY SURVEY REPORTS Conditions 18 and 19 of a standard teletherapy license (Exhibit B)-require you to perform 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.

Reviewers Appendix N is a checklist that may be helpful in review-ing a survey report.

CONTENTS OF SURVEY REPORT 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 numoer of the person or organi-zation that possesses the teletherapy unit and source..

Reviewers Make sure that this information corresponds with the entries on the license document. If it does not, you should get clarification from the licensee.

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

F-1

I

3. Describe the reason for the survey (e.g. , installation of a new source, j relocation of. the teletherapy unit). I Reviewers 4

This information is needed to clearly identify what cir-cumstances prompted the survey. Usually a reviewer has worked with a licensee to approve a relocation or source change and knows why a survey is being submitted. However, reviews of old license files indicate that sometimes more than one licensing action may have preceded the survey ,

(e.g., authorization to relocate, authorization to change sources) and that a survey may have been conducted after only one of these actions was taken by the licensee. If this information is not submitted or is unclear, ask for clarification. .

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

Reviewers .

ibis information is needed to assist inspectors in determining whether surveys were conducted and reports submitted in a timely fashion. If this information is not submitted, ask for it. If the report was not sub-mitted in a timely fashion, remind the licensee of the requirements in the license, either in a deficiency letter (if one is sent) or in a cover letter sent with the ifcense amendment.

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

Reviewers This information is needed primarily to assist inspectors.

If the information is not submitted, it should be obtained from the licensee.

F-2

l' 6.

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

a. The manufacturer's name and model number, b.

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

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

Reviewers Be sure that an appropriate icw-range meter is used that was calibrated within the previous 12 months in accordance with the criteria discussed under Item 10.2 of the guide.

Ask the licensee for this information if it is missing.

The licensee should provide the information requested in item 6 regarding the radiation detection instruments *(dosi-metry system) used to measure the intensity of the primary beam of radiation. Ask the licensee for this information if it is missing.

Note that the data on dosimetry system calibration usually show compliance with 5 35.23 of 10 CFR Part 35. However, the licensee need not have these data H it can show that it made two sets of measurements, one to fulfill the re-quirement of the license (see Condition 18. A(fi)(c) of Exhibit B) and the other to fulfill the requirements of SS 35.21 and 35.23 of 10 CFR Part 35--the licensee must have made both sets of measurements. If it appears that only one set of measurements was made and that the dosi-metry system calibration does not fulfill the requirements of 5 35.23, bring this point to the licensee's attention either in correspondence about the survey report or in a cover letter sent with the amended license. This will I s

F-3

alert the licensee of the need to correct tnis item of noncompliance and alert.the next inspector to a problem area.

7.

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

Reviewers Be sure that the teletherapy. unit described is authorized in Condition 9 of the license. ,

8.

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

Reviewers -

Be sure that the license authorizes the use of the described source in the unit described in item 7 of the survey report. .

9.

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

Reviewers Be sure that the license authorizes possession of a source of the specified activity in the teletherapy unit described in item 7 of the survey report. Occasionally a supplier provides a licensee with a source whose model number or activity.is not within the limits specified by the license.

When this is documented, you should refer the matter to the appropriate Regional Office (or in the case of an Agreement State, to the State Agreements Program) for appropriate enforcement action.

10. Specify the intensity of the primary beam of radiation at a specific distance (e.g., toentgens 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 j F-4

- __ - -_ _a

.' .. . l I

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 provice 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 5 35.27.

These records need not be suomitted with the required survey report.)

Reviewers If information on the intensity of the primary beam has '

not been submitted, you should request it from the licensee.

For the purposes of the survey report, the surveyor need not necessarily be a " qualified expert" as defined in S 35.24 nor must the dosimetry system necessarily be cali-brated as required by S 35.23; also see the Reviewers note for item 6 of the survey report.

11. Provide the maximum and average radiation levels measured at 1 meter from tne 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 location of the 14 primary points. Up to 25 points may be measured in accordance with NCRP Report No. 33. 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 evaluating the maximum exposure rate providing that the average over 100 square centimeters at one meter from the source does not exceed 10 millireentgens per hour.")

Reviewers The licensee should describe the locations of the 14 to 26 points and the radiation levels measured at each of these points. If this information is not provided, request i t. Check the data submitted by the ifcensee and verify that the stated values for maximum and average radiation levels are correct. Condition 18.A(1) requires that the maximum and average radiation levels at 1 meter from the F-5

-- --__--_ -___-- - b

i, ..

3 , . , ,

h source in_ the off position. not exceed 10 mR/hr and 2 mR/hr, respectively. If.the licensee presents data that exceed

• these-values,-ask for an explanation and for'the.correc-tive action to be taken.

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 diredon. Also specify the angle orientation t

(e.g. , 0* is vertical toward the floor; 90* is horizontal toward the east wall; 180* is vertical toward the ceiling; and UO' 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, provice this infor-mation for orientations with the primary beam directed (a) toward the integral beam absorber and (b) away from the integral beam absorber.

Reviewers

, The licensee's description should be logical and should correspond with information previously submitted (i.e.,

electrical or mechanical stops are set either in exactly the same fashion as previously described by'the licensee or are more restrictive). For example, suppose that the application stated that the 'unattenuated primary beam would be limited to a 90* arc (from vertical to the floor

-to'90* toward the east wall). It is acceptable if this item of the survey report makes the same statement or is more restrictive, e.g., a 50* are from vertical to the floor to 50* toward the east wall.

Obviously, this item must be reviewed in conjunction with, maximum reportesi levels in adjacent areas. Responses to this item are not acceptable unless the survey report clearly shows acceptable radiation levels in surrounding areas. Even so, you may wish to alert the licensee (in a x

F-S L _ .__ _ _ _ _ _ _ _ - -- - - - - - - - - - - - - - - - - -

I deficiency letter or cover letter sent with the license j l

amendment) of its prior commitment to NRC and of NRC's approval based on this submitted information.

\

13. For measurements of radiation levels in adjacent areas, which should 1 j

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 (fic1d size should be the maximum permitted by the collimators unless physical means are used to restrict field size).

Reviewers Note that some licensees perform their measurements with-out a phantom, which results in radiation levels in adjacent areas that are higher than they would be if a phantom were used. This manner of performing measurements is acceptacle if the radiation levels in adjacent areas are L acceptable. The licensee must submit the three items of

'information specified.

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,

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

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

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

F-7

e.  :, ' + . J.-

e Reviewers

, Orawings or sketches should be provided to facilitate review. !It has often been difficult to find up-to-date Ldrawings of the facility in the-license file. -Also, L licensees frequently refer to locations-where measure-ments were made by. the use of the area (e.g. ,' nursery,

cafeteria); previously submitted drawings often. do not indicate these~uses or the' licensee has made changes in the uses of surrounding areas (e.g., office converted to nursery).

If a licensee does not submit the requested drawings or sketches but clearly references previously submitted draw-ings and clearly describes where radiation measurements were made, this reference is acceptable. Otherwise obtain the requested information from the applicant. The submitted drawings or sketches should correspond to previously sub-mitted drawings, except perhaps-with respect to how ad-1 jacent areas are used.

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 s

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<r .

. - ,

a respect to;each barrier.

In general, measurements should be made at the maximum limits permitted by the beam stops as described in item 12'of the survey report.

Reviewers l

Make sure that maximum radiation levels have been measured.

For example, were measurements made only with the primary beam directed'toward the integral beam absorber? "Off--

beam-stop" measurements must also be made if such uses-are permitted by beam stops. If a range of "off-beam-stop" orientations is permitted, then it is not satisfac- -

tory to make' measurements in adjacent areas only.with the primary beam. vertical toward the floor. Radiation levels in adjacent areas must be investigated for the full range of "off-beam-stop" orientations that are l permitted. .

1 Were measurements made with the primary beam in its most adverse orientation with respect to each barrier? For example, if-not prohibited, radiation levels should be measured in the area above the treatment room with the head of the unit as close as possible to the ceiling and the head rotated 180* to point the primary beam toward the ceiling.

Be sure that measurements have been made in each adjacent area. An exception would be unexcavated areas under a treatment room. If walls are earthbacked, licensees should make measurements in the nearest area that can be occupied.

For example, if the east wall is backed by earth to ceiling height and a sidewalk is at the ceiling height, then

{

measurements must be made at the sidewalk with the unit in its most adverse orientation with respect to that area.

i If the licensee's report does not clearly show that it has measured maximum radiation levels in eacn area adjacent to the treatment room (including above and below with the F-9 ,

i

n F -

a exception noted above), obtain this information from the licensee.

i If the licensee has submitted previous survey reports for the same teletherapy unit in the same treatment room, compare the previous results with the new radiation

-measurements. Identify to the licensee any unexplained discrepancies and ask for clarification.

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 be made with a phantom in the primary beam and with the beam in its most adverse orientation with respect to I 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.

Reviewers See the notes for item 15.

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

Reviewers Unless the Itcensee provides other information, consider each adjacent area as a." restricted" or " unrestricted" area as stated in the licensee's previous correspondence.

Also, information from previous correspondence on "on time" may be considered accurate unless the licensee pro-vides new information or makes statements that suggest some changes have been made.

Unrestricted Areas: Usually maximum radiation levels in these areas, when adjusted for "on time," will meet the F-10

_ m

l 4

l less-than-2-millirems-in-any-1-hour and less-than-100-l millirems-in-7-consecutive-days requirements of para-graphs 20.105(b)(1) and (2). Unless permission pursuant to paragraph 20.105(a) has been grantec (or requestec),

obtain sufficient information from the licensee to cemon-strate compliance with paragraphs 20.105(b)(1) and (2).

1 If permission pursuant to paragraph 20.105(a) has been granted, a special condition to this effect should be on the license and the reviewer should verify that maximum radiaticn levels (in mR/hr) do not exceed the values specified in the authorization. Some adjustment in the authorized values may be necessary because measured radia-tion levels might be higher or lower than estimates basea on calculations. Consider the measured values in light of the licensee's previously subm'itted assumptions and determine whether the licensee will still comply with paragraph 20.105(a). If necessary, obtain sufficient additional information to demonstrate compliance with the regulation.

Restricted Areas: There are no maximum radiation levels that are considered acceptable for a restricted area.

The reviewer should be aware of the values expected (i.e. ,

from previously submitted calculations, correspondence, or survey reports), determine whether measured values are reasonably close to the expected values, and decide whether the licensee's control of the restricted area is adequate.

Any d2ficiencies or concerns in these matters should be identified to the licensee and clarifying information should be obtained.

18. Describe (1) the tests that were conducted and (2) the results of these tests that ensur3 proper operation of the safety systems described below.

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

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

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 l 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 the source returns to the off position at the end of the preset time, and that the source does not return to the on position untti the timer is reset.

Reviewers If the licensee's description of tests and results of the tests are not clear or do not address the matters identi- .

fied above, request additional details.

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.

Reviewers When a license amenoment is issued after review of the survey report, the reviewer can use the information in item 19 as a basis for deleting the authorization for a teletherapy unit or source that has been removed. However, be careful not to delete authorization for a source that the licensee may wish to use in the future. The informa-tion requested in item 19 should be obtainec from the licensee if it is not submitted.

s e

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20.

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

Reviewers Licensees should be encouraged to take positive action on surveyors' recommendations. However, the reviewer should insist on the licensee's taking action only on recommendations that effect compliance with NRC's regulations or the terms and conditions of the license.

When the licensee has presented satisfactory responses to each of these 20 items, the reviewer should institute action to amend the license. This usually involves amend-ing the " tie-down" condition to add the documents submitted

'by the licensee on the most recent survey and to delete the documents submitted regarding the previous survey.

Be careful not to delete documents that contain still-needed information, e.g. , a previous survey report might describe how the licensee controls access to the roof.

The license unendment is usually sent with a cover letter notifying the licensee that its survey report was accepted and reminding it when additional surveys must be conducted and submitted.

INSTRUCTIONS FOR FILING SURVEY REPORTS -

1. A report of the results of the required survey should te sent to the KRC. For specific instructions, see the conditten en your license that is eqhivalent to Candition 18,0 of Exhibit B.

These reports scat be sent no later than 30 days after the installation of a new scurce or completion of the changes requiring the survey.

2. Tha licensee should ket; a cepy of the survey repert in its files for at least 5 years from tna datn on which the survey was canducted.

F-13 3 _ _ . _ _ . _ - - - -

I

)

i Figure F-1 TELETHERAPY HEAD SURVEY (Source in "OFF** position.

Measurements taken one meter Top View Showmg from source) onentetson of Vows A througn D REAR Radiation Level i Position No. ImR/hrt

}

View A 1 A (left side) _

W B Geft fronti View 5 5 C ffronti n$'

7 8

View A-Vertical View B Verocal from left sade from left front View C 9 10 5

a View D 11

/ e 12 O -Q &

ts v 14

. W e e

REAR ' '

FRONT

(^

Average value Menimum weiue i I 1 f Instrument used View C.Verecel View D-Verticet from front from right front 7 "-. _' rds rwne it menW numtser of telethere9y sovere . g (

Osto ,eintmeieson N W M - g g

to -

9-nurrut _ L MW \ I. FRON1 REAR c_

e' r,ete , _

meecurerrent . .

t l ~

__e_ _ .

F-14

APPENDIX G PROCEDURES FOR CALIBRATION OF. SURVEY INSTRUMENTS 1.

Calibration of survey meters will be performed with racionuclice sources.

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 milliroentgen R&dionuclide per hour at 20 cm)

'desium-137 85 mil 11 curies Cobalt-60 21 mil 11 curies Radium-226 34 millicuries

c. The source activities or exposure rates at given distances will be traceable by documented measurements to a standard source certified within 5% accuracy to the U.S. National 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 i 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 withio 220% will be considered acceptable if a calibration chart, graph, or respcnse factor is prepared, attached to the instru-mert, and used to interpret meter readings.

2. A reference source (check source) that nas a long half-life, e.g. , casium-137 or racium D and E will also te read at the time of the calibration or as soon as the instrument its received from a calibra_ tion laboratory. The G-1

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

readings will be taken with the reference source placed in specific geometry relative to the detector. J. reacing of this reference sourcs 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 20% of the reading measured immediately after calibration, the instrument will be recalibrates.

3. Recores of items 1, 2.b, ano 2.c above will ce maintaine'd 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 Et other distances.

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

b. Inverse Squart Law f If R, is the exposure rate at distance 0, from a point so;;rce and j R3 12 the exposure rate; at distance 3b fecra the sate point s% rce, f

the n:  !

R,02=RDj G-2 l

(

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

1 milliroentgen per hour, reentgens per hour) anc D must be in a "" b the same units of distance (e.g., centimeters, meters).

If R,, 0,, and Ob are known, Rb can be calculated from:

02 R -

xR a b = D2b

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

t *EO**

=R0 * (b) where R

t is the exposure rate at a time t after the source calibration date

~

R O is the exposure rate on the date the standard source was calibrated t is the time elapsed since the calibration date T

g is the radionuclides half-life n is the number of half-lives through which the radioactive source has decayed and is equivalent to the quantity of NOTE: Rt an R O a.ust be in the same units of exposure rate (e.g. ,

uillf roentgens per hobt, roentguns per hour), and t and Tg must be h the salPe units uf time (e.g. , f eConds, days, years).

s

\ .T%

G-3

,s s ' .

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 whom they are directed. For example,'houst-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 incluced 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 numeer). (See items 6, 7, 8, and 9 of Exhibit B.) When radioactive materials are no longer needed, they may be transferred to a person or firm authorized to receive them as provided in 5 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).

Accordingly, operating procedures should be sufficient to ensure that radio-active materials received are within the limits specified in your license, that

, radioactive matarials are transferred to appropriately licensed persons in accordance with tne 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.

2. Use of ',he Telethersov Unit. The operating procedures should specify who may operate tae unit, how the unit may bd used (i.e., in what orientations, H-1

l F

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 wnen 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 include 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 retention 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 preceduras 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 procedures such as raquiring 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 Casium-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 procacures for makinp 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 or license condition.

"Capiis say be obtained feca the American Nattent1 Standards Institute,1430 '

Broadway, New York, NY 10018.

• • Copies may be obtained from RCRP Publications, 7910 Woodmont Avenue, Bethesda, MD 20815.

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.1 personnel Dosimetrv. Operatingproceduresshoukdrequireteletherapy 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 casa, it may be necessary for the film badge or TLD of the affected person to be processed immediately.

5. Procedures for Securine the Telethernov 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. ,

56 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 te sufficient to ensure compliance with 5 35.23.

7. Full Calibration of Teletherapy Units. Section 35.21 specifies what measurements must be made during a fall calibration; SS 35.23 and 35.24 require that a properly calibented dosimetry system be used and that an expert perform

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

B.

Monthly Scot-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 callbrated dosimetry system needed to make the' spot-check measurements.

The operating procedures should specify wnen, 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. Laak 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 o.f 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. - Inscoction and Servicina 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 5 35.26.

11. Limitations on Work Done on Teletherapy Unit. Condition 21 of the teletherapy license (see Exhibit 8) requires that only persons or firms specifically authorized by NRC or an Agreement State can:

' Install, relocate, or remove teletherapy units containing soureus, Perform source excnanges.

Perform any maintenance or repair of the teletherapy unit that involvet, work on the source drawer, the shutter, or other rechanism that could  !

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expose the source, reduce the shielding around the source, or compro-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.

l 12.. Survey Reports. i 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 fo,rmal 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 Telethersov Unit. Condition 19.8 of the teletherapy license requires that the NRC approvw 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. Recordkeepino. You must maintain certain records to comply with NRC's regulations, the conditions of your license, and commitments made in your licens, 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 HRC licenses, your license applications, and correspondence with the NRC in support of a license request 1 Record of results of safety device checks 2

' Maintenance of these records is required by $ 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.

RNaint. tin 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 enecks:

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  !

Records of calibration or intercomparison of the dosimetry system used for spot-check measurements Results of full calibration measurements Results of spot-check measurements -

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 personnels .

Records of full inspection and servicing of the teletherapy units 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 materials

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 be sure that they are clear and concise and that potential adverse consequences 3See 5 20.401 of 10 CFR Part 20.

• Maintenance of these records is required by 5 35.27 of 10 CFR Part 35. Because this regulation does not specify how long to kesp these records, you should maintain them until the NRC terminates yovr teletherapy license.

8See $ 35.27 of 10 CFR Part 35.

' Maintain until the NRC terminates your teletherapy license (see response to Item 8.2 of the guide).

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Maintain for at least 5 years from the date on which the survey was conducted.

sSee s 30.51 of 10 CFR Part 30. x H-6 '

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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 instructions 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 report 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 Procer 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 7tnd telephone numbers of individuals or organizations to be notified in each category of occurrence (e.g., radiation safety officer, hospital administrator, teletherapy unit manufacturer or service representative, and the NRC).

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l APPENDIX I EMERGENCY PROCEDURES FOR BEAM CONTROL FAILURE OR MALFUNCTI If the light signals or ceam-on monitor indicate that the beam control mechanism has failed to terminate the exposure at the and of the preset time (e.g., if the red light stays on and the green light is off, or if both the red

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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

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, ente,r 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 De contacted.

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APPENDIX J MODEL PROGRAM FOR MAINTAINING OCCUPATIONAL RADIATION EXPOSURES AT 9 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 radiation 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 proca-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 he 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, aPrivate practice physician ifcenses do not require an RSC. '

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2. Radiation Safety Committee (R?ffl2

a. Review of Proposed Users a J Uses (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 *he 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 and 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 ALA'RA 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,

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the RCS will record the basis for its action in the minutes of its quarterly seating.

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.

ZThe RSO 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 wnich 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 exceeoed (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 workers' as well as those of management.

3. Radiation Safety Officer (RS0)

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. -

(2) Quarterly review of occupational exposures. The RSO will review at least quarterly the external radiation 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 International Comm9ssion on Radiological Protection," serve as checkpoints above which the results tr2 considered sufficiently important to justify further investigation.

• The term " worker" as used in this acpendix refers to those individuals who work

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under the direction or supervision of authori:ed 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 j 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.

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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 authorizec users and workers in order to develop ALARA procedures for working with radioactive j

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.

1

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

4. Authorized Users I

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a. New Procedures Involving Potential Radiation Exposures (1) The authorized user will consult with and receive the approval l 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 a)1 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 These Supervised (1) The authorized user will explain the ALARA conc.ept 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 not being promoted on the job.

6. Establishment of Investigational Levels To Monitor Individual Occupational-

. External Raoiation Exposures This institution (or privata 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 (mress 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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i, The.RSO will review and record on Form NRC-5, " Current Occupational External Radiation Exposures," or an equivalent form (e.g., dosimeter processor's report) 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 actions 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.

l Quarterly personnel exposure equal to or greater than Investigational Level I, but less than Investigational Level II

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The RSO will review the exposure of each individual wnosa quarterly exposure equals or exceeds Investigational Level I and will report the results of such reviews at the first RSC meeting following the quartar 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 Investigation?

Level II The RSO will investigate in a timely manner the causes of all personnel exposures equaling or exceeding Investigational Level II and, if warranted, take action. A report of the investigation, actions taken, if any, 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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Establishment of ~an individual worker's Investigational Level II above that listed in Taole J-1 If a worker or a group of workers needs to exceed Investigational 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.

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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:

1.

Overseeing the use of NRC-licansed 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. Reviewthetrainingandexper$enceofallindividualswhouseNRC-licensed radioactive material (including physicians, technologists, and physi-cists) and determine that their qualifications are sufficient to enable them to perform their duties safely and in accordanca with NRC regulations and the con-ditions of the licenses.

3. Establish a program to ensure that all radiation workers" and all other individuals whose duties may require tbss to work in the vicinity ,of NRC-licensed radioactive material (e.g., rursing, security, and housekeeping

{

personnel) are properly instructed as required by 519.12 of 10 CFR Part 19. 1

4. Review and approve all requests for use of NRC-Itcensed radioactive material within the institution. I i

"The phrase "ractation workers" as used in this appandix 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 ceter-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 raof ation safety officer (R50),

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 R50).

Meeting Frecuency .

The Radiation Safety Committee will meet as often as necessary to conduct .

its business but not less than once each calendar quarter, s

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l APPENDIX L REQUESTS FOR LICENSE AMENDMENTS, 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-i 1 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 nas been paid.

1. LICENSEAMENOMENTREQUEShS*

a.

i-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:

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I (1) If Itce 7 of your licenso lists the pource to be fastalled by staufacturer's narue End model numoer a,,,nd if tne activity of the new source is less than or equel to the maximum activity per soures shown in item 8 of your i

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license, r.o amendment is needed.

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

of the guide.  !

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f- . 4 (2) If Item 7 of your license' does not list the source to be insta11ea by manufacturer's name and model number and if the activity of the new source

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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 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 creater than the maximum activity per source shown in Item 8 of your license, an amenoment 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 higher activity source is installed, 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.

Reviewers With regard to e above, note that most licensees' survey reports show that source-housing leakage rates (with the "old" source installed) are within the Ifmits specified in Condition 18.A(1) of the license. However, when these values are increased by the appropriate factor to estimate average and maximum values of leakage when the new higher activity source is installed, it is not uncos.oon for these estinates to excesc the Ifmits of the license condition even though the activity (or output) of the "new" source is within the limits stated on the registration sheet for the particular teletherapy unit. In these cases, it is "You neen not suomit another ALARA program if your ALARA program in connection with your teletherapy license has already been approved by the NRC.

L-2

necessary to bring this matter to the licensee's attention before the source is authori:ed and to find out how the licensee plans to comply witn Condition 18.A(i).

The licensee might state that the previously reported measurements were inaccurate and might supply new measure-ments upon which to base its estimates of source-housing leakage. Alternatively, it might state that the source supplier assures it that, based on the supplier's or manu-facturer's data, the licensee will be in compliance with ,

Condition 18.A(1). In either of these cases, Standard Condition 96 (in Enclosure 1 of Policy and Guidance Direc-tive FC 83-20, October 20, 1983) is usta11y added to the license, i.e., "Notwithstanding other authorizations and requirements of this license, the. licensee shall have the cobalt-60 source described in Subitem 7.A of this license removed from the teletherapy head and returned to the supplier if the radiation levels permitted by Condi-tion 18. A are exceeded."

When this problem is brought to the licensee's attention, its response may be to modify its amendment request, i.e.,

to reduce the maximum activity of the new source. In this case, Standard Condition 96 is not used.

d. To change or add teletherapy units and sources or to move an existing teletherapy unit and source to a new location, yea should complete Items 1-6, 12, and 13 of NRC Forn 313 and provide the information in Items 9.1 through 9.5, and 10.7* of this guide. You should refer to tne discussions of each of these items in $ection 3 of this guide.

In the situation in which (1) a new teletherapy unit and scurce will be installed in the exact name location within the sete treatment rcom (prs-viously occupied by the cid teletherapy unit and sourte) and (2) beam stcps

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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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will limit use of the primary beam of the new source in exactly the same manner that similar steps ifmited use of the primary beam of the olo source, calcula-  :

tions requested in Item 9.5 of the guide need not be submitted. In lieu of the i calculations, you may provide estimates of anticipated maximum radiation levels based on the results of the last radiation survey.

Reviewers Several other types of amendment requests have been received and granted that have not been discussed above.

These applications usually involve requests for exemp- ,

tions from the requirements of the regulations as permit-ted by 5 30.11 of 10 CFR Part 30. Requests of this type .

must be coordinated with and reported to Headquarters in accordance with the applicable Fuel Cycle Falicy and Guidance Directive.

• For each of these requests, the reviewer must determine that the exemption is authorited by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest.

Example 1:

Exemotion from Paracraoh 35.26(a) of 10 CFR .

Part 35 - Extend Interval for Inspection and Servicino.

Teletherapy units are required to be fully inspected and serviced at the time of source replacement or at intervals not to exceed 5 years, whichever comes first (see para-graph 35.26(a)). From about 1972 to March 1983, this requirement was contained in one of the preprinted condi-tions on teletherapy licenses. The staff has recognized that the timing of tource changes, availability of funds, decisions on whether to keep a teletherapy unit or change 1

sources, etc., sametimes make it difficult for licensees to have inspection and servicing work done within the 5 year me.ximum tine interval specified in the regulation 1 (or previous license concition). The cost of inspection knd servicing is estimated to be $2,000 to 57,000.

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In most cases, the critical question is whether inscection and servicing give sufficient added assurance of the tele-therapy unit's reliability to warrant performing inspection and servicing at 5 years if a' source change (including inspection and servicing) is plannec within a short time or if a unit and source may be removed within a short time. In many of these cases, the NRC staff has believed that the additional cost in person-rem exposure and dollars is not warranted. Accordingly, the staff has granted extensions up to 1 year (maximum of 6 years between inspec- ,

tions and servicings). The staff considers this interval (20% longer than that recommended in ANSI N449-1974,

" Guidelines for Monitoring Cobalt-60 and Cesium-137 Tele-therapy Equipment") to be a reasonable extension.

To request an extension, a licensee must request a license amencment and pay the appropriate amenament fee. In support of its request, a licensee should:

Describe the circumstances that prevent complying with the requirement; State when inspection and servicing was due and when l it plans to have the work done or to dispose of the unit and source.

It is helpful if a licensee provides some history of the functioning of the unit and descrdbes tests that were done (e.g. , those described in Condition 18.B of the license) and the results of those tests te ensure proper operation of the unit.

To authorire the extensfors, use Standard Condition 97 j

(in Enclosure 1 of Policy and Guidance Direct'.ve FC 83-20, October 20,1985), "Notwithstanding the requirements of 10 CFR 35.26(a), the licansee is authori:ed to extend until the time interval for inspection s

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and servicing of the teletherapy unit." Insert an appro-priate date, remembering that the maximum interval from one inspection and servicing to the next is 6 years.

The time interval may be extended for a few weeks beyond the date the licensee requests to provide flexibility in case the service company runs into some problem with scheduling. For example, if the licensee requests an extension to February 15, 1986, because the work is scheduled to be done on February 13-14, the licensee -

will be in violation of the regulations and may well request an emergency amendment if anything interferes with the scheduled cate. An extra 2 to 6 weeks may be granted to account for unforeseen problems if the total of 6 years is not exceeded. -

Example 2:

Exemotion from Paracraon 35.23(a) of 10 CFR Part 35--Extend Interval Between Calibrations of Desi-metry Svstems.

Paragraph 35.23(a) requires that dosimetry systems used to make full calibration measurements (see 5 35.21) must have been calibrated within the previous 2 years by the National Bureau of Stancards (NBS) or by a regional calibration laboratory (RCL) accredited by the American Association of Physicists in Medicine (AAPM).

Desimetry systems used to make spot checks (as described in 5 35.22) must have been calibrated as required by paragraph 25.33(a) or by dirert intercomparison with a system calibrated in accordznce witn parag'aph 35.23(a).

The staff has recegaized that some licensees have exper-l ienced long delays in having their syttems calibrated by l NBS or one of the RCLs. In fact, AAPM submitted s petitice

'or rulemakirg (PRM OS-2, 47 FR 4311, Jtnvary 29, 1982) l s

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outlining these problems, suggesting changes in the regu-l 1ations and requesting that, until the regulations are I changed, NRC " grant relief" to licensees experiencing problems. The rule enange will be included in the complete revision of 10 CFR Part 35, now under way. Relief has l

been granted in the form of license amendments; however, '

since PRM 35-2 was filed, AAPM has accredited several new  !

RCLs so licensees may not be experiencing delays as severe as before.

L The critical question with tnase requests is whether a Ifeensee who has difficulty having its dosimetry system calibrated in a timely manner by NBS or an RCL can rely on the measurements made with its dosimetry system. A request for an exemption may be granted if a licensee can show that (1) it has experienced difficulty scheduling

.the calibration, (2) the calibration of the dosimetry system has not changed from the time of the last calibra-tion to the time of the' request for the exemption, and (3) adequate steps will be taken to ensure the constancy of the calibration of the dosimetry system from the time of the request for the exemption to the time of the next calibration. The maximum interval between calibrations that has been authorized is 4 years, an interval consistent with PRM 35-2 and NCRP Report 69, " Dosimetry of X-Ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 kev to 50MeV."

To request an extension, a licensee must request a license amendment and pay the appropriate amendment fee. In support of this requast, a licensee should:

Specifically request an extension of the time interval specified in the regulations and include supporting information such as when the dosimetry system was

', last calibrated, actions taken attemoting to have s

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.. the system recalibrates in accordance with the regula-tions, and the date by which the system will be recalibrates.

Describe in detail the steps that have been and will be taken to ensure the constancy of the calibration of the dosimetry system. A licensee should provice information to support its assertion that the calibra-tion of the dosimetry system has not changed. Types of helpful information are results of constancy tests, results of third party measurements (e.g., NRC, ,

Regional Centers for Radiological Physics), and inter-comparisons with systems at other institutions. A licensee should describe not only the results of checks done between the time of the last calibration and the time of the amendment request, but also those actions that will be taken between the time of the amendment request and the date of recalibration.

See NCRP Report 69 for more details about constancy tests.

Note that Section 5.3 of NCRP Report 69 describes several constancy test procedures and states that the response of a dosimetry system "shall be verified by at least one of the constancy tests. . . shortly before and after an inter-comparison or the assignment of chamoer calibration fac-tors by a standardizing laboratory, and at least monthly thereaf ter." Note that the same section also requires recalibration and reassignment of chamber calibration factors if the user observes changes in instrument response that are greater than the fluctuations usual for the in-strument. The NRC staff understands that, if this latter situation were to occur, NBS or the existing RCLs would try to make arrangements to calibrate the dosimetry system on an emergency basis.

The requestea time extension has been granted by adding to the " tie-cown" condition the letters that include tne s

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information outlined above and by adding to the license a condition that reads as follows:

"Notwithstanding the requirements of 10 CFR Section 35.23(a),

the dosimetry system used for full calibation measurements shall have been calibrated within the previous (insert time interval not to exceed four years) by the National Bureau of Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine." -

Examole 3:

Other Recuests for Exemotions from the Recula-tions. Occasionally licensees experience unusual problems in complying with the regulations and seek advice from the licensing staff. Each exemption is decided on a case-by-case basis by considering the licensee's special circum-stances, the exemption sought, and the action the licensee proposes to take to accomplish the goals intended by the regulation. Each must be coordinated with Headquarters ia accordance with the applicable Fuel Cycle Policy and Guidance Directive.

One example is a children's hospital with a teletherapy unit that is used only a few times a year to give whole-body irradiation. The licensee stated that performing monthly spot checks as required by 5 35.22 of 10 CFR Part 35 was burdensome and proposed that it perform these measurements before each whole-body treatment. In this situation, the licensee's proposal seemed to provide the same assurances as monthly spot checks provided for licensees that use their units for many treatments each day. Accordingly, the licensee's request was granted.

2. LICENSE RENEWAL RE00ESTS To renew a license, you may submit a :smolete application using NRC Form 313 and provide all the information requested on the form without L-9

referring to previously submitted information (except for qualifications of previously approved users). Certain references to previously submitted.

information are acceptacle' 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 i

particular item at the time of renewal. -

An acceptable alternative is a-letter, 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.

Reviewers Appendix 0 is a checklist that may be helpful in reviewing these renewal applications.

a. The number of the license to be renewed.

Reviewers Be sure that the correct license number is referenced and that the renewal request was received by NRC before the expiration date on the license. Renewal requests received after the expiration date on the license should be handled as discussed in " Review of Special Cases" later in this section.

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

Reviewers Be sure the name is tne.same as that currently shown on the license or obtain clarifying information. A name change such as " Smith flemorial Hospital" to " Smith Memorial Medical Center" does not require any elaboration from the licensee. However, a change to " Hospital Corporation of l L-10

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l America" or "Humana Corporation" will probably necessitate l- further correspondence with the licensee and some input from Regional Counsel as to whether the license can be transferred to the new organization (see paragraph 30.34(b) of 10 CFR Part 30) or whether a new license must be issued.

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

Reviewers Compare the address in Item 2 of the license with the -

information submitted here.

d.

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

Reviewers This information should be the same as that shown in Condition 10 of the license and in the last survey report.

Discrepancies should be clarified by the licensee.

e. Verification that the location of the teletherapy unit is the same as that described in previous correspondence 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.

Reviewer If the licensee verifies that the location is unchanged, be sure that appropriate documents have been identified.

Any discrepancies should be clarified by the licensee.

If the licensee states that the location has been changed or that other changes have been made that affect radiation levels in surrounding areas, evaluate these using the inf:rmation and guidance provided in the appropriate items of the application. Obtain any necessary clarifications fr:m the licensee. A survey report may also be needec; see Conditions IS and 19 of the license. }fthelicensee L-11

1 l-states that its patient viewing system has been changed,-

be sure that it has provided the information requested in Item 9.2 or request the needed additional information.

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 l- correspondence on the report; identify these documents by date.

Reviewers If the licensee verifies that beam stops are still installed and operate as previously described to NRC, check whether the appropriate documents have been referenced. Any discrepancies should be clarified by the licensee. See also Item 9.4. .

If beam stops have been changed, be sure that the licensee has presented the information discussed in Item 9.4. No

. further information is needed if the new beam stop settings are more' restrictive than the old ones. If they are less restrictive, a new survey report may be needed; see Con-ditions 18 and 19 of the license.

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

Reviewers No further information is needed if the licensee confirms these matters. If the licensee identifies changes that need to be made in any of the authorizations in Items

{

6-9, consider these in light of the guidance provided in f

this document. I Occasionally licensees will indicate that they do not wish to continue using their teletherapy units and sources

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l to Ltreat patients, but wish to use them for nonhuman use ..

l only (e.g.,' irradiation of biological specimens). In '

these cases, the renewal applications snould be reviewed in accordance with the standard. review plan for irradiators f rather than teletherapy.

Occasionally licensees will request authorization for l

" storage only" because they plan to dispose of the unit and source and need more time to make the necessary arrange- '

ments. In these cases, the renewal applications should be '

handled as described in " Review of Special Cases" later.in this section.

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.

Reviewers occasionally licensees fail to list one or two individuals and it is not clear whether the individuals should be deleted or whether the licensee just forgot to list their names. In this case, the reviewer should call. or write for clarification.

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.

Reviewers Refer to Item 7.3 for guidance.

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

Reviewers

Refer to Items 8, 10.5, and 10.6 for guidance.

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k. i 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. I Submitting this less specific information will allow you greater flexibility. '

to make changes in these aspects of your program without amending your license.)

Reviewers Refer to Items 10.1,10.2, and 10.3 for guidance.

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.

Reviewers If the licensee verifies these points, no further action is necessary. However, if changes have Deen made, consider the impact of the changes on the licensee's program and its compliance with NRC's regulations and the terms and conditions of its license. Use professional judgment and the guidance found in this document to decide what additional information, if any, the licensee should be asked to provide (e.g. , whether a survey report is needed).

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

(1) Submit evider.:e 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).

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

Reviewers I Refer to Item 10.8 for guidance.

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. - i Reviewors Refer to Item 10.7 for guidance.

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.

Reviewers If a survey report is included with the renewal request, examine the license file to determine if the report had been submitted previously and reviewed and approved by the NRC staff. If it was previously submitted, reviewed, and approved, no further action is needed. If it was not, examine the report following the guidance in Appendix F.

If the licensee states that certain changes were made and a report submitted on a specified date, verify that the license file contains the referenced report and that it has been reviewed and approved by NRC. If the report is not in the file or if the report was not reviewed, the reviewer should obtain it from the licensee and review it as described in Appendix F.

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D.

If you wish to add authorized users or make any other changes in the teletherapy program, you should clearly describe the changes to be made and submit appropriate supporting documentation. You are advised to review this regulatory Caide carefully,~ especially Section 1 of this Appendix, to determine what information is to be submitted.

Reviewers If authorized users are to be added, see Item 7. For other requested changes, use professional judgment and the guidance in this document in deciding what additional -

information, if any, should be requested.

Renewal Recuests That Need Soecial Handling As mentioned previously, there are some renewal requests that need special handling.

Case No. 1: A " licensee" wants to " renew" an expired license and continue treating patients.

In this case, the teletherapy license has expired and the licensee has failed to file a timely application for renewal.

When the licensee finally realizes the problem, it becomes concerned about the need to continue treating patients.

These cases are handled in a two-stage process as described below.

Be sure to inform the inspection staff of the situation because they may wish to consider enforcement action.

Stace 1: The " licensee" should be instructed to submit a written request (e.g., letter, telegram, telecopy) signed by an appropriate person in management. This request should:

Outline the problem (i.e., expired license, need to continue treating patients), '

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q Request that a new license ce issued,

. j Confirm that the teletherapy unit, source, and facility J to be licensed are the same as were previously author-ized by the expired license, and Be accompanied by the appropriate fee for a new tele-therapy license.

)

On receipt of this information, the NRC tries to act quickly (within a few working days) to issue a new license for a short period of time.

Use as the expiration date the last day of the month about 3 months after the new license is issued. For example, if the new ifcense were issued on August 15, 1986, the expiration data would be November 30, 1986.

Reference the number of the expired license in Item 5 of the new license.

Obtain most other entries for the new license. from the expired license.

Include in the " tie-down" condition the request for a new license and appropriate correspondence listed in the " tie-down" condition of the expired license.

Send a cover letter with the new license informing the licensee that the license has sen issued for a short time; tell the licensee that in order to issue the license for the normal 5 year term, it must supply certain information before the expiration date on the new license. The information to be supplied is essentially the information requested in the section on renewals.

State in the cover letter that no additional fee need be sant with the above-requested information because the second stage of the process is considered to be a continuation of NRC's efforts to issue a new license for the normal 5 year term.

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._r' Administrative 1y, there are several steps that must be taken:

Be sure the needed back-up information is. transferred from the expired license folder to the new license folder.

Be sure the expired license folder is " retired."

Be sure the status of the expired license is changed to "4" in the computer.

Stace 2: When the response is received, review it in accordance with the guidance on renewals.

l 1 When all appropriate information has been received, issue an amencment to the new license to:

Extend the expiration date for an additional 5 years.

Make other changes in the license as needed.

Add appropiate correspondence to the " tie-down" condition.

Case No. 2: A " licensee" wants to " renew" an expired if cense to permit " storage only" of the unit or the source until these can be disposed of.

This situation is less urgent than Case No. 1. Again be sure to inform the inspection staff of the situation because they may wish to consider enforcement action.

The " licensee" should be instructed to submit a written -

request (e.g. , letter, telegram, telecopy) signed by an appropriate person in management. The request should:

Outline the problem (i.e. , expired license, need to continue license),

Request that a new license be issued, s

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Confirm that the teletherapy unit, source, and facil ' 1 ity are the same as were authorized by the expired license, Explain who will supervise the safe storage of the unit and source, and Be accompt.:nfed by the appropriate fee for a new license; consult ADM:LFMB for the appropriate fee cate-gory and amount.

The new license, when issued, should: "

+

uthorize og source, rather than two, Specify authorized use in Condition 9 as: "For storage only in the head of a (manufacturer's name, model name or number, or both) teletherapy unit,"

Specify in Condition 10 that " Licensed material shall be stored at (location, address),"

Specify in Condition 12 that " Licensed material shalibestoredunderthesupervisionof(named individuals)," and Include a condition equivalent to Condition 21 (see Exhibit B).

The administrative steps needed for Case No. I must also be followed for Case No. 2.

Case No. 3: A licensee files a timely application for renewal and requests " storage only."

This case is similar to Case No. 2 with regard to the technical information and needed fee.

3. LICENSE TERMINATION REQUESTS When you no longer wish to use your teletherapy unit and source and you have disposed of both, you should reouest 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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Reviewers-The following points should be considered during review of these requests:

Expired licenses cannot be terminated. Therefore, if what appears to be a termination request is received shortly before the expiration date of the license, review the request and determine whether the appropriate information has been submitted. If the proper information has been submitted, then the ,

amendment to terminate should be processed as quickly as possible so it will be issued before the license expires. If the proper information nas not been submitted, process the request as a renewal so the license will not expire unti} all the needed infor-mation is received. If this step is taken, be sure that, before final action.on the request, the action is changed back to " termination" and administrative steps are taken to ensure that the license folder is retired and'the status of the license is changed in the computer to "4."

If a termination request is received after the expira-tion date on the license, the information outlined above is still necessary. If the licensee did dispose j

of all Ifcensed material, no licensing action is '

needed. Simply have the ifcense folder retired and the license's status in the computer changed to "4."

However, if the licensee has not disposed of all licensed material, it will need a new license to authorize its continued possession of licensed material either for " storage only" or for continued authorization to treat patients, etc, In these cases, be sure to inform the enforcement staff because they may wish to consider enforcement action. See Sec-tion 2 of this Appendix for additional guidance.

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Review the license carefully to be sure that the unit and source that were removed were the only ones authorized by the license and possessed by the licensee. If they were not, find out wnether the licensee still has other units or sources authorized by its license.

If the licensee has authorized materials, the license should not be terminated. If the licensee does not have authorized materials, it needs to provide information regarding disposition of the materials (i.e., the date transferred and to '

whom or verification that the licensee never obtained the authorized materials).

Do not terminate a license on receipt of a completed NRC Form 314 without further checking. Experience has shown that some licensees submit NRC Form 314 to inform NRC of what happened to their old source follow-ing a source exchange; they are not trying to terminate their licenses.

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• APPENDIX M CHECKLIST FOR REVIEW OF NEW TELETHERAPY APPLICATIONS Item 1. Type of neolication: New license Item 2. Applicant's name and mailinc address Full name of legal entity Mailing address Telephone number (optional) .

NOTE:

A ifcense 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; see also the response to Item 3.

Item 3. Locations of use Full description, including such information as street address, building name, floor, wing, room number, etc.

Need similar information for the location of each teletherapy unit.

Item 4. Contact Name Telephone number Item 5. Radioactive material (May use format in Appendix B) 5.1 Sealed sources to be used in teletherapy unit -

Radionuclides Manufacturer's name and model number Maximum activity (in curies) in any one source.

Maximum output (in RHM or RM)

Total amount of activity (in curies) to be possessed at any one time.

If no registration sheet, need more details.

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1 5.2 Teletherapy unit Manufacturer's name Model name, number, or both

" Beam catcher" vs. counterweight If no registration sheet, need more details.

Consider together the responses to Items 5.1 and 5.2 and determine if the requested source unit-activity-output combination has been approved for licensing.

Item 6. Use (May use format in Appendix 8) ,

Human use only If human use and nonhuman use, describe nonhuman use ,

Itta 7, , Individuals responsible for radiation safety precram--Their trainino and exeerience -

7.1 Proposed authorized users--Human use Full name Physician licensed to practice medicine (paragraph 35.3(b))

Specifically named as user on an NRC/AEC or Agreement State tale-therapy license -- verify Certified by: .

1. ABR in Radiology or Therapeutic Radiology -- verify

2. AOBR in Radiation Oncology -- verify

3. Canadian Royal College of Physicians and Surgeons (RCPS) in Therapeutic Radiology -- Copy of certificate

4. British " Fellow of the Royal College of Radiology" (FFR) or

" Fellow of the Royal College of Radiology" (FRCR) -- Copy of certificate and evidence of specialization in radiation therapy If not previous user and not certified, send to ACMUI:

1. Supplement A -- 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience

2. Supplement B -- 3 years of full-time radiation therapy clinical experience s

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3. Letters of evaluation .

Description of training and experience as known by evaluator Evaluation of competency to use teletherapy and/or brachy-therapy independently 4.

If training and experience completed more than 5 years before the date of application, also need:

Evidence of continuing clinical involvement in radiation therapy from completion of training to date of. application (Supplement B) of ,

Evidence of having taken refresher or continuing education courses in radiation therapy (Supplement A) 7.2 Proposed authorized users--Nonhuman use Full name

• Physician whose acceptable qualifications were submitted in response, to Item 7.1 CR,R Documented training and experience ,

1. Supplement A--200 hours of training

2. Supplement A--500 hours of experience

7. 3 Proposed radiation safety officer (RS0)

Full name and title User whose acceptable qualifications were submitted in response to Item 7.1 or 7.2 _0R Documented training and experience

1. Supplement A--200 hours of training

2. Supplement A--500 hours of experience If consultant or part-time person assists on site RSO, need:

1. Full name

2. Documented training and experience (see Items 7.2 and 7.3)

3. Description of duties, time, etc.

7.4 Proposed expert - Submitted only if " expert" does not meet requirements j

in paragraphs 35.24(a) or 35.24(b); send to NRC's medical physics consultants for review:

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Full name  !

Educational history

. Training in therapeutic radiological physics Experience in therapeutic radiological physics Report of 1 full calibration (within last 10 yea-s)

Report of 1 spot check (within last 10 years) .

Endorsement by ABR-certified physicist (see 5 35.24)

Item 8.

Trainino for individuals workino in or frecuentino restricted areas Appendix 0 OR Minimum commitments:

1. Train workers initially, annually

2. Train in all procacures and terms of licanse pertinent to radiation safety (including " dry runs" of emergency procedures)

3. Train ancillary personnel initially, annually

4. Maintain records of initial and annual training until NRC terminates teletherapy license Trainer, trainees Date -duration Topics Item 9. Facilities and ecuiement 9.1 Description of Facility Annotated drawings -- Plan and elevation drawings showing:

1. Scale

2. Direction of north

3. Location of unit and source

4. Directions of beam usage; plane of rotation

5. Type, density,thicknessofallshieldingmaterials--walls, floor, ceiling.

6. Location of doors, windows, conduits, etc.

7. Nature of and distances to adjacent areas

8. Height of earth against outside walls -

9. Use of adjacent areas (restricted vs. unrestricted, hall, office, etc.)

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9. 2 viewing system Primary Backup or commitment to stop treatment 9.3 Warnino systems and access controls Door interlock -- Condition 17 on license Restricted area - access control; signs, lock, alarms, lights Other equipment interlocked?

9.4 Beam stops -

Electrical or mechanical controls, not administrative controls Direction of beam Maximum angle in eacn direction Angle orientation convention For units with beam stopper, all information above for:

1. Beam toward beam stopper

2. Beam away from beam stopper 9.5 Adecuacy of shieldina

1. Each area identified as restricted or unrestricted.

2. Calculations for each adjacent area.

a. Maximum anticipated workload data

b. Value of each parameter

c. Contributions from primary, leakage (source on), and scattered radiation

d. Calculations for each area

e. " Worst case" situations Maximum beam size Low-angle scatter Use of all permitted orientations regardless of clinical usefulness

f. Occupancy factor of unity

g. Results 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 in any 7 days l

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, 3. For unrestricted areas

a. With "on time" considered and occupancy = 1 12 mR in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />?

1100 mR in any 7 days?

b. Permission pursuant to 5 20.105(a)

_1500 mR/ year, consider average radiation levels, anticipated occupancy Records to support assumptions kept until NRC terminates license

4. For each restricted area:

a. Physical and administrative controls to restrict access-described

b. Signs -- location, numeer, wording

c. Training -

d. Personnel monitoring

e. Surveys Item 10. Radiation safety procram 10.1 Personnel monitoring program

1. Whole-body badges

2. Exchanged at least monthly

3. Commercial service or processor, preferably accredited by NVLAP

4. Pocket dosimeters: operable, annual calibration and test for drift, records maintained as described in paragraph 20.401(c)(1) 10.2 Instrumentation

1. Have low-range survey meter (to measure 0.2 mR/hr)

2. Have permanently installed beam-on monitor with visible indicator observable when entering room, emergency power supply

3. Have (access to) dosimetry system

4. Have (access to) instrument to count leak-test samples

5. Have (access to) high-range portable survey meter (to 1 R/hr) s M-6

i 10.3 Calibration of cortable survey meters 10.3.3 Applicants that will not calibrate their own instruments 1.

Return to manufacturer for calibration or name, address, and NRC (or Agreement State) license number of organization providing calibration service Calibration must meet criteria in 10.3.4 Calibration must be by licensed commercial service or applicant must submit description of source and procedures used by service organization

2. Calibrated annually, after repair

3. Maintain records at least 2 years '

10.3.5 Applicants that will calibrate own instruments Appendix G CR ,

Minimum commitments:

1. Calibrated annually, after repair

2. Use of radionuclides sources, point sources

3. Each scale calibrated, up to 1 R/hr

4. 10%; t20% if graph or chart prepared and used to interpret readings

5. Maintain records at least 2 years 10.4 Leak-test procram 10.4.3 Consultant used Name '

, Address License number Maintain records for at least 2 years 10.4.5 Leak-test kit used Name of supplier Model number of kit Follow supplier's instructions Name of individual using kit; qualifications Maintain records for at least 2 years M-7

~

10.4.7. Applicant does entire procedure How and where samoles taken Radiation safety procedures Equipment--its accuracy / sensitivity Calibration / standardization procedures; sample calculation Who will take samples; qualifications Maintain records for at least 2 years 10.5 coeratino erocedures Secure unit, console, room when unattended "

Only patient in room with beam on Check safety devices (frequency, by whom, which ones, how to check), correct problems promptly, maintain records for at least 2 years 10.6 Emercency erecedures Appendix I OR Minimum commitments

1. When to implement

2. Step-by-step actions, by whom

3. First consideration: minimize exposure to patient

4. Act quickly/ calmly, avoid primary beam

5. Secure area, post warning notice

6. Names and on-duty /off-duty telephone numbers of at least 2 people to be notified 10.7 ALARA program Appendix J OR Minimum commitments

1. Formal commitment to keep individual and collective doses ALARA

2. Review of activities for ALARA considerations, education and training on ALARA

3. Duties of personnel by categories 4 Investigational levels at approximately 10% and 30% of

. 5 20.101, actions .

M-8

1

5. -Quarterly' review of exposures

6. Formal annual review 10.8 Radiation safetv committee (institutions only)

1. Memeers Current names and information on positions Commitment that members are as specified in paragraph 35.11(b).

maintain records until NRC terminates teletherapy itcense

2. Meeting frequency at least quarterly, duties and responsibilities of Committee (Appendix K) '

3. If Committee already established:

Information as in 1 above Confirm that Committee's responsibilities / cuties amenced to include teletherapy Item 11. Vaste manacement Transfer to authorized recipient Other - Part 20 Item 12. License fees Item 13. Certification Signature of responsible individual Date Item 14. Voluntary Economic Data M-9

e.. * .

• APPENDIX N CHECKLIST FOR REVIEW OF TELETHERAPY SURVEY REPORTS (See alsn Appendix F)

1. Licensee's name, address, license number

2. Surveyor's name, address

3. Reason for survey

4. Date on which work on unit was completed

5. Dates on which survey was conducted

6. Instruments used

a. Manufacturer's name and model number

b. Date of last calibration

. c. Standards (i.e., radionuclides, activity, accuracy) and procedures

7. Teletherapy unit--manufacturer's name and model number

8. Teletherapy source--manufacturer's name and model name and number

9. Source activity (in curies) and the corresponding assay date

10. Measured output in RHM or RMM and date of measurement

11. Source housing leakage Location of each measurement, 14 to 26 points measured Value of each measurement Maximum: <10 mR/hr Average: <2 mR/hr N

N-1

l- . .

l' 1

1 1

12. Beam stops Electrical or mechanical controls, not administrative Direction of beam Maximum angle in each airection Angle orientation convention For units with beam stopper, all information above for:

1. Directed toward beam stopper

2. Directed away from beam stopper 13.

Conditions of survey for measurement of radiation in adjacent areas

a. Phantom material, size '

, b. Source-to phantom distance

c. Field size: maximum?

14. Plan and elevation drawings or referenced drawings

a. Direction of north b.

Location of unit and source in treatment room

c. Identification of each adjacent area

d. Directions of usage, plane of rotation

e. Locations where measurements were made 1

15, 16, 17: Maximum measured radiation levels in each adjacent area correlated with orientation producing each measured value

a. Beam toward beam stopper

b. Beam away from beam stopper

c. Include:

All areas including above and below

+

Most adverse orientations Unrestricted areas: - Paragraphs 20.105(b)(1) and (2)

Paragraph 20.105(a)

Restricted areas: - Control of access Signs Training Badges Surveys s

N-2

, m. .c . ,

18. Safety checks:

Procedures (must use radiation catection instrument) and results

{

a. Door interlock: As described in Condition 17 of license

b. On-off indicators: Correlate lights and mechanical indicators with instrument results

c. Beam stops:

Should correlate with information in Item 12.

d. Timer: Accurate? Beam off at and of preset time? Unable to turn b'eam on until timer reset?

19. Unit or source removed ,

a. Date

b. Name, address, license numcer of recipient

20. Recommendations of surveyor, licensee's action

'N N-3 1

. . . .  ; e. . 4 -

APPENDIX 0 CHECKLIST FOR REVIEW OF. TELETHERAPY RENEWAL APPLICATIONS (See Appendix L, Section 2)

a. Number of the license to be renewed

b. Licensee's full name l

c. Mailing address

d. Location of teletherapy unit

e. Location and viewing system unchanged, documents identified by date f.

Electrical / mechanical steps unchanged, documents identified by date

g. Authorizations in Items 6-9 unchanged?

(1) Radionuclides (2) Sealed source (3) Activity (4) Teletherapy unit (5) Authorized use

h. Authorized users same? Delete any?

1. Radiation safety officer (1) Name (2) Qualifications (see Item 7.3 of guide)

j. Provide information in:

(1) Item 8: Training Appendix C CR Minimum commitments:

a. Train workers initially, annually s

0-1

- _ _ _ - _ _ - _ _ _ _ _ - - __ r

'* c: ,

. b. Training in all procedures and terms of license pertinent to radiation safety (including " dry runs" of emergency procedures)

c. Train ancillary personnel initially, annually

d. Maintain records of initial and annual training until NRC terminates teletherapy license

. Trainer, trainees Date, duration Topics (2) Item 10.5: Operating procedures include:

Secure unit, console, room when unattended Only patient in room with beam "on" Check of safety devices (frequency, by whom, which ones, how to check), correct problems quickly, maintain records for at least 2 years (3) Item 10.6.: Emergency procedures Appendix I OR .

Minimum commitments:

(a) When to implement (b) Step-by-step actions, by whom (c) First consideration: minimize exposure to patient (d) Act quickly, calmly; avoid primary beam (

(e) Secure area, post warning notice 3 (f) Names and on-duty /off-duty telephone numbers of 2 people to be notified

k. Provide information in (1) Item 10.1: Personnel monitoring program (a) Whole-body badges (b) Exchanged at least monthly (c) Commercial service or processor accredited by NVLAP (d) Pocket dosimeters: operable, annual calibration and test for drift, records maintained as described in paragraph 20.401(c)(1)

N 0-2

is .a .. ,

(2) Item.10.2: Instrumentation '

(a) Have low-range (0.2 mR/hr) survey meter (b) Have permanently installed beam-on room monitor with visible indicator observable when entering room, emergency power supply (c) Have (access to) dosimetry system (d) Have (access to) instrument to count leak-test samples (e)~ Have (access to) high-range (to 1 R/hr) survey meter (3) Item 10.3: Calibration of portable survey meters Applicants that will NOT calibrate own instruments (a) Return to manufacturer for calibration or name, address, and NRC (or Agreement State) license number of organization providing calibration serv' ice.

Calibration must meet criteria in 10.3.4 Calibration must be by licensed commercial service or applicant must submit description of source and proce-dures used by service organization (b) Calibrated annually, after repair (c) Maintain records at least 2 years Applicants that will calibrate own instruments Appendix G OR Minimum commitments:

(a) Calibrated annually, after repair (b) Use of radionuclides sources, point sources (c) Each scale calibrated up to 1 R/hr (d) 110%; 120% if graph or chart prepared and used to interpret readings (e) Maintain records at least 2 years

1. Verify no th6nges in (1) Radiation safety program (2) Teletherapy program

m. Radiation safety committee (institutions only) (assumes committee already exists) 0-3

1

. r a a i

j I

i (1) Information to show membership per paragraph 35.11(b); if member-ship changes, will include people in paragraph 35.11(b); maintain records until NRC terminates teletherapy license (2) Duties and responsibilities of RSC' include teletherapy

n. Teletherapy ALARA program if not previously approved by NRC I

Appendix J OR

+

Minimum commitments:

_(1) Formal commitment to keep individual and collective doses ALARA (2) Review of activities for ALARA considerations, education and ,

training on ALARA (3) Duties of personnel by categories (4) Investigational levels: approximately 10% and 30% of 5 20.101, actions (5) Quarterly review of exposures

, (6) Formal annual review

~~

o. Survey up to date? If not, see Appendix N for checklist for review.

p. Add users? Any other changes to program?

628

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. Exhibit A (Continued)

PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 552 ate)(3), enacted into few by section 3 af the Privacy Act of 1974 (Public Law 93 579), th t Ing statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on NRC For' 313. This information is maintained in a system of records designated as NRC.3 and described at 40 Federal

. (October 1,1975). '

1. AUTHORITY: Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 220

2. PRINCIPAL PURPOSE (S):

The information is evaluated by the NRC staff pursuant to the criterie set for'th in 10 CFR Parts 30,32,33,34,35 and 40 to determine whether the application meets the requirements of the Atomic Energy 1954, as amended, and the Commission's regulatsens, for the issuance of a radioactive material ficanse or amencme thereof. * -

3. ROUTINE USES: The information may be (a) provided to State health departments for their information and and (b) provided to federal, State, and local health offici41s and other persons in the event of incident or exp 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 agencias in the event that the information indicates a violation or poten violation of law and in the course of an administrative or judicial proceecing, in addition, this information may be

• forred to an appropriate Federal, State, or local agency to the extent relevant and necessary for an NRC decision an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.

4. INGWHETHER INPCRMATICN: DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVI Diseforure of the recuested information is voluntary, if the reauested information is not furn.

'~' ished, however, the app!! cation for radioactive material license, or amendment thereof, will not be processed. A that information be held from public inspection must be in accordance with the provisions of to CFR 2.790. Withh ing from public inspection shall not affect the rignt,if any, of persons property and directly concemed need to the docurnent.

5. SYSTEM MANAGER (3) AND ADDRESS: U.S. Nuefear Regulatory Commission Director, Civision of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards Washington, D.C. 20555 N

EA-2 some somes:::

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l NRC Fonn lr14T E W 131T 3 tin er P ge I of 4 Page, k' U.S. NUCLEAR REGULATORY CDMMISSION

.j 4

MATERIALS LICENSE-TELETHERAPY '

i Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438)

Code of Federal Regulations. Chapter 1. Parts 30. 31. 32. 33. 34. JS. 36. 40 and ?O. and in reliance on statements

]

a

%)

heretofore made by the licensee. a license is hereby issued authonzmg the licensee to receive. acquire. possess, i!

source, and spec:al nucieu matenal designated below; to use such matenal for the purposets) and at the placetst designa

% deliver or transfer such matenal to persons authonzed to receive it in accordance with the regulations o import suen byproduct and source matenal. This license shall be deemed to contam the co Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the i' N Commission now or hereafter m effect and to any conditions specified below.

Ucensee j

ll 68 .

. 't

1. XYZ Hospital  :

3. Ucense number XX-XXXXX-XX

{

w g 2. 1234 A Street, H.W. - 't Washington, D.C. 20000. p

4. Expiration date 5

November 30. 1990 j l I . Docket Reference or No. 030 XXXXX 3

% 6. Byproduct, source, and/or 7. Chemical and/or physical 1

31 special nuclear material 3. Maxtmum amount that licensee 5 form I may possess at any one time E under this license E i B

} A. Cobalt 60 A. Teletherapy sealed A. 10,000 curies (2 sources

} a t Sources (ABC of not more than 5,000 Y Corporation Model eunes each) J 567)  :#

}

s E

!E

,E l

9. Authonzeduse

E A. One source to be usedin an ABC Corporation Nodel 89 teletherapy umt for the treatment of humans. One source in its shipping container to be in possession of thelicensee as neces.

j:E sary to the replacement of the source in the teletherapy unit only. g 3

I CONDITIONS

10. Ucensed material sha!! be used only st Room 103, XYZ Hospital,1234 A Street, N.W., Washington, j

E 0.C.

j 1

'E

11. The licensee shau comply wtth the provisions of Title 10. Chapter 1. Code of Federal Regulations. Part 19,'* Notices. Instructions l3 and Reports to Workers; Inspections ** and Part 20. " Standards for Protection Agamst Radiation."

,P E

12. Ucensed matenal sha!! be used by, or under the supervision of. John Jones , M.D. or Mary Smith . H.D.

I

B

B E

5 5

l 5 l u  :

13.ment Theroom, teletherapy facility shall be provided with a system permitting continuous observation of the panent fro]

dunng panent irradianon. s n {

9 1

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is2-ell U.S. NUCLEA3 C EGULATCRY COMMISSG N I page ; of 4 pstes MATERIALS LICENSE - TELETHERAPY ""*"""***

tContinued) XX-XXXXX-XX 5

030-XXXXX

$ 14 A.

3l Teletherapy sources shall be tested for !cakage at intervals not to exceed six months. Records of test results shd be

.]l kept in units of m2crocunes and mamtamed for inspection by the Commission. In the absence of a certificate from a transferor indicatmg that a test has been made withm stx 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 microcune of contamination on the test sample.

~

C. The test sample shall be taken from selected accessible surfaces of the teletherapy head. The selected accessible sur.

faces should be those surfaces on which one might expect contammation(if there were to be leakage) to accumu.

late and 2all include the inner surface of the most frequently used treatment eones 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 fl!e a report within five days of the test with the Material d

Licensing Branch. Divisica of Fuel Cycle and Matenal Safety. U.S. Nuclest Regulatory Comnussion. Washington.

f D.C. 20555. desenbing the test results and the corrective action taken. A copy of such report shall also be sent to

,g the Director of the appropnate Nuciear Regulatory Commission Regional Office of Inspection and Enforcement I hsted in Appendix D of 10 CFR 20.

i

'fi  ! $.

Prior to initiation of a treatment program. exh teletherapy unit shall be equipped with electncal or mechanical stops

% limsting use of the pnmary beam of radiation so as to r.ssure compliance with i 0.10f(b) of 10 CFR 20. " Standards for f Protection Agamst Radiation." as evidenced by a radiation survey. Necessary use restnctions shall be fully desenbed in radiation survey reports submitted in accordance with Condition No. IS.

' 16. A set of wntten 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 pnmary beam of radiation "off" with the controls outside the treatment room.

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

I B. Each entrance to the teletherapy room shd be equipped with an electncalinterlock system that will turn the tele.

N therapy machine's pnmary beam of radiation off immediately upon opening of any entrance door. The interlock system shall be connected in such a manner dat the teletherapy machine's pnmary beam of radiation ennnot be tumed on until a!! treatment room entrance doors are closed and the ocam "on-off" controlis reset at de control panet l '

l C. Electncalinterlocks on entrance doors to the teletherapy room shall be tested for proper operation atleast once every stx months. Records of test results shn!! be maintained for inspection by the Commission. l l

D. In the event of malfunction of any door interlock, the teletherapy machine control shall be locked in the "off" j

condition and not used, except as may be necessary to the repair or replacement of the interlock system, until the .

interlock rystem is shown to be functioning properly. I

18. Prior to initiation of a treatment program, and subsequent to each installation of a teletherapy source. radiation surveys ,

and tests sha!! be performed in accordance with the following:

A. A radiation survey shall be made of: E (i) The teletherapy source housmg. 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 milliroent-gens per hour and 2 m Ilireentgens per hour, respectively.

]

(ii) All areas adjacr.nt to the treatment room. with the teletherapy source in the "on" pontion. Ths survey. except  !

J ltem (c) sha!! be performed with a phantom in se pnmary beam of radistionAh211jlearly estabiish: l anc 2 (a) The radiation levels in restncted . tress are not likely to cause personnel exposure in excess of the limits I spectiled in Sectson 0.101. Tit!e 10. Part :0 Code of Federal Regulations. Chapter 1. " Standards for l

Protection Agamst Radiation"(10 CFR 20). {

7

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MATERIALS LICENSE  !

XX-XXXXX-XX

'l SUPPLEMENTARY SHEET -

030-XXXXX i

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18. (Continued)

(b) That quantities of radiation in unrestricted areas do not exceed the limits specified in $20.105(b),10 CFR 20.

(c) The intensity of the primary beam of radiation at a specified distance from the teletherapy source.

B. Tests shall be made to detennine proper operation of:

(i) Electrical interlocks on entrance doors to the teletherapy treatment room.

4 3

(ii) The teletherapy source "on-off" indicators, both at the source housing and on the teletherapy macnine control panel.

g (iii) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiatinn (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam "on-off" mechanism.)

(iv) The teletherapy treatment timing device. **

C. A report of the results of the above surveys and tests shall be sent to the U.S. Nuclear Regulatory Comission, 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.

• 19. A. Any changes made in the treatment room shielding, location of the unit within lg the treatment room, or use of the teletherapy unit that could result in increased radiation levels in areas outside the teletherapy treatment room shall be 31 I

evaluated by a radiation survey made in accordance with Condition 18, and reported to the Comission within thirty (30) days following completion of the change (s).

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

approval and relocation, a radiation survey shall be made in accordance with Condition 18, and reported to the Comission within thirty (30) days after i comoletion of the move. '

I

20. The licensee shall comply with the requirements in Sections 35.21 through 35.27,  !

inclusive, of Title 10, Chapter 1, Code of Federal Regulations, Part 35, " Human Uses cf Byproduct Material." ly I, 21 . The following shall be perfonned only by persons specifically authorized by the Comission or an Agreement State to perform such services. {

g J

hJ A. Installation, relocation, or removal of teletherapy units containing sources. )

i B. Source exchange.

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, [ g j Lacarue number MATERIAI.S LICENSE l XX-XXXXX-XX SUPPLEMENTARY SHEET Dum or RmmunurnDer 030-XXXXX 3l

21. (Continued) l 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 3 and result in increased radiation levels.

22. pursuant to Title 10, Chapter 1, Code of Federal Regulations, Part 40, "Comestic Licensing of Source Material," the licensee is authorized to possess, use, transfer, and import the uranium contained as shielding material in the teletherapy units l$ authorized by this license.

g11 l 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 tems of this license,

{ provided the visiting physician:

fh) (a) Has the prior written permission of the hospital's Administrator and its Raciation Safety Comittee, and ,

31 gl (b) Is specifically named as a user on a Nuclear Regulatory Commission license authorizing human use, and (c) Performs only those procedures for which he is specifically authorized by a Nuclear Regulatory Comission license.

i The licensee shall maintain for inspection by the Comission, copies of tne written

j permission specified (b) and (c) above. Theseinrecords subitem (a)beabove shall and of maintained forthe fivelicense

5) years(s)(specified from the in s time the licensee grants its pemission under subitem (a) above.

4 24. Except as specifically provided otherwise by this license, the licensee shall possess I

and use licensed material described in Items 6, 7, and 8 of this license in acccrdance with statements, representations, and procedures contained in application dated September 2,1985; and letter with enclosures dated November 2,1985, both signed by Fred Green, Administrator. The Nuclear Regulatory Comission's regulations shall govern the licensee's statements in applications or letters, unless the statements are more restrictive than the regulations.

FOR THE U.S. NUCLEAR REGULATORY C0tiMISSION i Date November 2, 1985 By , Void s Material Licensing Branen 1 i

I Division of Fuel Cycle and I Material Safety 1

,"' Washington, D.C. 20555 l

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IAEA IAEA Training Course at*y ,W,s Safety and Regulation of Sealed Sources

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of Radioactive Materials

. .. 10 April-12 May1989 4 Lecture 42.3.10 General Inspection Procedures 6

by Darrel Wiedeman U.S. Nuclear Regulatory Commission Glen Ellyn, Minois

'4 21 April 1989 1

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( .6-x LECTURE 42.3.10 GENERAL INSPECTION FROCEDURES BY DARREL G. WIEDEMAN. CHIEF.

NUCLEAR MATERIALS SAFETY SECTION U.S. NUCLEAR REGULATORY COMMISSION L

REGION III

.- FRIDAY APRIL 21.1999 10:20-11:30 AM GOOD MORNING LADIES AND GENTLEMEN. ON BEHALF OF THE UNITED STATES. NUCLEAR REGULATORY COMMISSION I WOULD LIKE TO-PERSONALLY WELCOME YOU TO THE U.S. AND I- HOPE YOUR STAY IS ENJOYABLE'AND THE MAfERIAL THAT IS BEING PRESENTED-AT THIS YEARS IAEA INTERREGIONAL TRAINING COURSE IS INFORMATIVE AND.

. BENEFICIAL IN HELPING YOU SUPPLEMENT YOUR AGENCIES EFFORTS TO IMPROVE THE QUALITY OF YOUR REGULATORY PROGRAM.

l i

THE U.S. NUCLEAR REGULAIORY COMMISSION (NRC) REGULATES ABOUT S.OOO LICENSEES IHal USE RADIOISOTOPES IN MEDICINE.RESEARCH AND INDUSTRIAL. PURPOSES. MOST OF THE MORE THAN 5.000 LICENSING AC TIONS Il 1AKES PER YEAR INVOLVE EXISTING LICENSES THAT HAVE BEEN INSPEC1ED AT LEAST ONCE. THE NRC STAFF CONOUC1S APPROXIMATELY 2.800 INSPECTIONS PER YEAR AND ENFORCES CORRECTIVE ACTION BY THE LICENSEE WHEN VIOLATIONS OF THE REGULATIONS OR LICENSE CONDITIONS ARE FOUND. SINCE l

RADIOISOTOPES WERE FIRSr EMPLOYED IN MEDICAL RESEARCH UNDER 1

OUR A10MIC ENERGY ACT. lHElR USE HAS GROWN TO THE POINT WHERE THEY PROVIDE SUBSTANTIAL BENEFITS TO THE PUBLIC IN THE DI AG,,NOSIS AND 1RE41 MEN I OF DISEASES. RESEARCH. AND SAFETY IN THE HOME AND WORK PLACE AS NELL AS SUBSTANTIAL ECONOMIC s

BENEFIT.S. WITH RESPECT 10 ME.D1 CINE ALONE. APPROXIMATELY 7.000.000 DIAGNOSTIC NUCLEAR MEDICINE PROCEDURES AND 150.000

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WITH THE REMARKABLE GROWTH IN THE APPLICATION OF RADIOISOTOPE TECHNOLOGY THERE HAS BEEN A CONTINUING EVOLUTION AND DEVELOPMENT OF THE REGULATORY PROCESS WITHIN THE NRC TO ASSURE ADEQUATE PROTECTION OF THE PUBLIC HEALTH i

AND SAFETY. THE NRC DOES NOT HAVE THE HIGH LEVEL OF PRESENCE AND FREQUENT INSPECTIONS AT ITS. MATERIALS LICENSEES AS IT DOES AT OPERATING COMMERCIAL NUCLEAR POWER PLANTS. THE MATERIALS LICENSING AND INSPECTION STAFF HAS BEEN INCREASED SOME IN THE PAST SEVERAL YEARS TO SUPPLEMENT OTHER EFFORTS TO IMPROVE THE DUALITY OF ITS REGULATORY PROGRAM. WE ALSO RECOGNIZED THAT ADDITIONAL RESOURCES MAY BE NECESSARY TO i ADEOUATELY IMPLEMENT MANY INITIATIVES UNDER WAY TO PROVIDE FURTHER ASSURANCE OF PROIECTION OF THE PUBLIC HEALTH AND SAFETY. WITH THE STEPS 1 HAT HAVE BEEN TAKEN AND THOSE UNDER DEVELOPMENT. WE ANTICIPATE EARLIER IDENTIFICATION OF HEALTH.

SAFETY AND REGULATORY PROBLEMS IN BOTH THE LICENSING AND INSPECTION PROCESS.

TODAy I WILL ADDRESS HON UUR INSPECTIONS ARE SCHEDULED. PERFORMED AND DOCUMEN1ED.IN MY FIRST ATTACHMENT YDi l WILL FIND A COPY OF NRC INSPECTION MANUAL. CHAPTER 2900.

THE PURPOSE AND OBJECTIVE OF THIS DOCUMENT WAS TO ESTABLISH AN Ii1 SPEC 1 ION PROGRAM FOR LICENSEES AUTHORIZED TO POSSESS AND USE LICENSED MAlERIAL FOR RADIOGRAPHY. MEDICAL PROGRAMS.

ACADEMIC AND INDUSTRIAL USES. WASTE DISPOSAL OPERA 11UNS.

MANUFACTURING AND DISTRIBU110N OF PRODUCTS. LEAK

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+

TESTING. CALIBRATION SERVICES AND TRANSPORTATION ACTIVITIES RELATED TO THE ABOVE LICENSED ACTIVITIES.THE OBJECTIVES OF THIS MANUAL CHAPTER WAS TO ESTABLISH A GENERAL POLICY FOR THE MATERIALS PROGRAMS INCLUDING GUIDANCE ESTABLISHING PRIORITIES'FOR INSPECTION. DEFINE SPECIFIC REQUIREMENTS FOR INSPECTIONS AND AID IN THE ACHIEVEMENT OF A CONSISTENT PROCESS OF INSPECTION OF MATERIALS LICENSEES.AS-YOU WILL NOTE UNDER SECTION 03.01 " INSPECTION PRIORITIES" THE PRIORITY NUMBER ASSIGNED TO A LICENSEE IS BASED ON THE POTENTIAL HAZARD OF THE LICENSEE'S PROGRAM. FOR EXAMPLE A LICENSE WITH-AN INSPECTION PRIORITY I IS A PROGRAM IN WHICH i

THERE IS GREATEST PorENTIAL FOR HAZARDS IN HEALTH AND SAFETY. THIS PRIORITY REQUIRES MOST FREQUENT INSPECTION BECAUSE OF THE NAruRE OF THE OPERATIONS. EXAMPLES OF PRIORITY 1 PROGRAMS ARE RADIOGRAPHS. POOL 1RRADIA10RS AND HUMAN TELE 1HERAPY.ON IHE OTHER END UF iHE PRIORITY SPECTRUM. AN INSPECTION PRIORIlY 7 INVOLVES LITTLE POTENTIAL HAZARD TO-HEALTH AND SAFE 1Y AND REQUIRES LESS FREQUENI INSPECTIONS.

EXAMPLES OF A PR10R1'lY 7 PROGRAM HRE F1XED GAUGES. GAS CHROMAf0 GRAPH UNIIS AND INSIRUMEN'l CALIBRATION SERVICES.IN

SUMMARY

. INSPECTIONS OF LICENSEES IN PRIORITY I THROUGH 5 ARE CONDUCTED AT INTERVALS IN YEARS CORRESPONDING TO THE

-lNSPECTION PRIOki1V. AN EXAMPLE PRIORITY l'S ARE INSPECTED ANNUELLY. PRIORIiY 2'S ARE INSPEC1ED EVERy TWO YEARS AND PRIOR 1fY 3'S EVERi IHREE YEARS AND SD ON TO PRIORITY 5's EVERY FIVE YEARS. LICENSES IN PRIORITY 6 AND 7 ARE INSPECTED INITIALLN THEN THERE4FlER ONLV FOR RESOLUTION FOR COMPLAINTS

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Indicate here whether the inspection was routine, special, or closecut,

• whether it was anncunced or unannounced, the dates, and the report numbe r( s ) .

Areas Inspected: Licensee action on previous violations, licensee event reports, and NRC notices; organization and scope of licens protection procedures; receipt and transfer of material; personnel protection -

external; personnel protection - internal; effluent control and waste disposal; transportation; distribution licenses; notifications and reports; posting of notices; emergency preparedness. Additional information was obtained from the licensee by telephone on November 22, 1986.

This section lists the princioal subject or functional areas inscected.

The list must corresoond with the headines of the sectiotis in the recort, Include or delete sections as accrooriate and must be in the same secuence. If information was obtained oy te',eenone for your particular inspection.

af ter the end of the on-site phase of the inspection, or the licensee submittec acc1tional information by mail or facsimile wnicn was rev1 ewe 0 in the office as cart af the inspection. include the dates here.

Results: No violations were identified.

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See exarole beeineine en race 14 fe- bow te handle ar insee: tion wi . . .

viciations.

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5 DETAILS This part of the inspection report includes a brief description of the activities carried out during the inspection and a detailed discussion of inspection findines The to substantiate identified health and safety concerns, violations, etc..

report must be factual; findings must be clearly stated and must include Do notadiscuss' discussion of how the findings and conclus,ons i were determined.

severity level of violations.

Emphasize findinos or observations that may have an impact on safety, orAddr represent violations of NRC requirements.The report is not to be a lengthy discours overall safety.

carried out to justify the time spent or to demonstrate knowledce of a particular If no safety or manacement problems, violations or deviations technical area.

were ioentified, then succinctly identify the sogcific activities and items cDserved, and state your conclusions.

Insoection reports are intended to be technical reports and are to be written so tney car. ce uncerstood oy a person knowieoceabie in the cenerai area ccverec by the insoection.

1. Persons Contacted

" Daniel K. Ealker.ew, Health Dhysi:s Departrent Head and Radiation Safety Off'cer (RSC)

• Ed Truskowski, Health Physicist

• Larry Gaines, Health Physicist

• Larry Callan, Diagnostics Regulatory Affairs Manager

" George Thompson, Production Manager

" David M. Bartner, Distribution Services Manager

" Hank Eauer, Vice-president, Technical Operations

'J0hn Reinhardt, Operations DirectorInternational Quality Control

' Ernest A. Guscano, Vice President, j and Quality Assurance V. G. Russell, Health Physics Technician Leonarc M. Baum, Diagnostics Regulatory Operations Manager Jim Mannirg, Gros:

Leader Brian Swanson, Laboratory Director

• • Individual A

' denotes those present at exit interview

• • identity withheld in accordance with 10 CFR 2.790(a) i l

List all senior people contacted, and any person who furnished significant information. It is not necessary to list the rare of every person contacted. Include the functional title forthe eact person listed. lobitify tnose persons who were present at exit interview, if other NRC personnel participated (ciner inan as observers, e.c. HO licensino personnel) they should be listec. 100.

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!ht If' disclosure of information about a person is prohibited by the Privacy .

' Act or_would constitute an unwarranted invasion of the person's privacy (e.c.. Jn exposed person or information about a medical condition) or because the person is a confidential source, identify the person by aD pseudonym (e.c.. Individual-A. The in the list of Persons Contacted and in the body of the repor

. individual

-file and is disclosed only to those with a need to know.

2.

Licensee Action on Previous Violations, Licensee Event Reports, and NRC Notices-(Closed) MLER-RI-85-167, report by recipient d d for of pac Records of licensee surveys showed radiation limits not excee e package. See Section 11. " Transportation."

(Closed) MLER-RI-85-245, theft of licensee shipment from contract ca Report indicated that. licensee No actions reviewdid notinspection.

during contribute to theft, and no licensee personnel were involved.

(Closed) MLER-RI-85-254, theft of licensee ship No review during inspection. ,,

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licensee persenr.el were involved. i, i h General

.(Closed) Information Notice No. However, 86-37, licensee vendor represerta-communicati Licensees.

(See Section 13, " Distribution Licenses.")

tives. showed inspectors lett'ars sent to General Licensees in response to the Information Notice, explaining the requiremen material, and the necessity for proper disposal of the material.

This section is used to close out all coen items from erevious insoectiers, recorts of incidents that occurred since the last inspection, and licensee action on NRC Bulletins and Information Notices._

licensee-When violations were cited durine the orevious inspection, action must be inspected. For corrected items use the form in tne report becinnine on once 14, civino the status of tne item, tne o' the insoection number where cricinally cited. a brief statement violation, and your findines.

Make clear how the information was If the item is open.

obtained and why you feel the item is closed.

follow the above procedure, indicating section ofwhy the item the report is stillacoen.

(where recent

-You may ref er to a subsecuent violation or other information is described) to avoid repet tion.

Novemoer 1955

7 If an NRC Bulletin requiring licensee action has been issued since the last inspection, follow-up on licensee action on the bulletin is '

also documented here. This section is also used to show the If Comments here should be brief.

status an of items that remain open.

item is treated in more detail elsewhere in the report, refer to that section.

3. Organization and Scope of Licensed Activities The following information was determined by a review of the license and from statements by the radiation safety staff, and was verified by obser-vation: Licensed activities are conducted at three facilities, the main plant at North Brunswick, and laboratories at the corporate headquarters at Lawrenceville, and at Princeton House.

Fanciful manufactures and distributes molybdenum 99/ technetium-99m generators for use in nuclear medicine, kits for the pr diagnostic use, and as liquid and capsules for therapeutic use, ano a Fanciful variety of other radiopharmaceuticals containing iodine-131.

also makes radiopharmaceuticals containing chromium-53.

At the main plant, manufacturing activities are conducted in Building i ls. 124,

which is also the shipping and receiving area for all radioactive ater a

.Nuclides used in this building are molybcenum-99 (approximate'y 100-150 Ci per month), and 16C curies

[C1) per week)., iodine-131 (approximately Diagncstic chromium-51 (approximately 20 mil 11 curies [ mci] per month).

research and development is carried out in Building 80-84, where approx-imately 100 mci of iodine-131 per month is used, much of In Buildings 92 and 83, sterility and it for pyrogen iodinations (maximum 10 mci at a time). In Building 74, testing of products from Building 124 are carried out.researc technetium-99m, and rhenium-186, and 1-2 Ci of mo ,

done in Building 102.

1 In Lawrenceville, research is performed using up to 2 Ci of carbon-Ic, 500 mci of hydrogen-3, 3-4 mci per month of sulfur-2 mci per month of chromium-51.

l At Princeton House, a maximum of 2 mci each of hydrogen-3, carbon-Ic.

iodine-125, iron-59, and chromium-51 is used in the form of kits.

The Radiation Safety Officer (RS0) heads the Health Physics Depart =ert, whicr has a staff of four, and reports directly to the Vice He is thus actinis-President, International Quality Control and Quality Assurance.tne manufacturing t ies w-i:" and teat 4vely se;! rated fretTne R50 recorts that tnis g4ves nie indecencen:e in ma 't; ne reghiates.

ce:it :ns.

s November 19E2

i 8 I I'

At each remote location, an individual is designated as beingThis responsible -

for radiation safety, in addition to the individual's other duties.

person's activities are audited by monthly visits from the radiation safety staff.

Particularly in a large program, describe theGive organization some ideaand of function of the radiation safety operation.

• the staff, or staff hours allocated to the radiation safetyFor function, and how remote locations, if any, are manaced. See smaller procrams, include if pertinent to your findings.

also the second samole report.

including some indicator of the size Describ_e the operation briefly, of the operation (number of oatients per day or month, quantity of material used per unit time. area covered number of recort Since this pecole involved, concerns num:2r of radiographer and cameras, etc.).

a processor and distributor, this section is loncer that it woulo te for a smaller prooram.

No violations were identified.

A statement of findinos (violation, no violations) is recuired for each _section exceot Section 1 and the " Exit Interview" sectio . ,.

4. Licensee Ir.ted nal Audits The health physics staff stated that they conduct monthly surveys of the ent. ire freility, which consist of measurements of radiation and corta nation levels, interviews with personnel, and inspecti ings, were reviewed, and found to be in order.

thorough and effective.

No violations were icentified.

Brief , statement unless eroblems are found.

5. Trainine and Instruction to Emeleyees The health physics staf f stated that all employees are given a minimum t radiation safety indoctrination as required by 10 CFR 19.12 at the star of employment.

At that time the employee fills out a form with the l ee information reouired by Form NRC-4, and a certification that the emp oy These forms were reviewed.

has received the indoctrir.ation.

hovemDer 19E3

.a- ,

9 The health physics staff stated that employees working ir, the manufacturing -

areas are individually instructed in the radiation safety aspects of their Seminars, jobs by a member of the health physics staff upo discuss specific radiation safety topics. materials in other areas their employment. Housekeeping and maintenance personnel in the radio-pharmaceutical manufacturing areas are permanently The assigned to those a inspectors and are trained in the same way as other radiation worke information.

The health physics staff stated that security personnel do no.t enter In emergencies, they control traffic outside the restricted areas emergen:y :ene. The training of fire fighting and other emergencypreparedness."

response personnel is discussed'in Section 16, " Emergency No violations were identified.

Brief statement unless orobifms are found.

6. P.adiatien Protection Procedures The inspectors toured the manufacturing and research areas at all three

[ locatior.s, observec and interviewed many of the personnel working there, and made independent measurements of radiation levels and contamination.

No instances of poor radiation practices, contamination, high radiation levels, or unsecured licensed material were found.

Both the radiation safety office and the individual work areas were well equipped with survey instruments appropriate to the radioactive mate being used.

The inspectors noted that all the instruments they observed appropriate check sources were had current calibration stickers and tha: Several individuals questioned available to confirm insteurent response.

by the inspectors were familiar with the use of the instruments in their work area.

No violations were identified.

Brief statement unless problems are found.

7. Receiot and Transfer of Material The radiation safety staf f stated that all incoming radica:tive material is delivered to a special loading de:k in Building 124, where it is Surveys of incoming shipments are re:eived by trained personnel.re fo*med oy the health -'physics sta The inspe: tors cbserved the survey thea. pi: et up cy tr.e users. recoecs of package sur veys, wni:n aere ia:Lein; tacr.a;es, and examine:

f0une to be n orcer. s hCvemre" 1953

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The radiation safety staff stated that all orders for materials are -

l checked against a computerized list of customers which includes the i If the customer is not licensed customer's NRC license authorization. The inspectors for the material ordered, the order is not filled.

verified this information by interviewing personnel in the department and requesting them to check the authorization of a customer selected at random.

No violations were identified.

Brief statement unless problems are found.

8. Personnel Protection - External Notations on Film badge records were reviewed and found to be complete.

the reports and memoranda and records of reviews indicated that the records were. reviewed each reporting period by the health physics staffThe and that records anomalous results were promptly identified and investigated.

indicated tnat in the manufacturing areas, badges are exchanged weekly, otherwise monthly. Approximately ten employees in the manufacturer;,

packing, and distribution areas get between oneVery and two rem a year, whole few cosimeters are body, and up to 15 rads per year to the hands.

1 cst, and doses are assigned for periods where dosimeters are missing, g ,,,

after an investigation.

Include some idea of doses received by personnel at facility, ard whetner or not results are reviewed by manacement.

The inspectors selected one of the employees with an annual exposure above one rem, Individual A. Individual A stated that he had worked for the licensee for four years, and had had intensive training on hiring, and confirmed that he attended safety meetings and seminar month.

film badge, and answered that he had on one occasion, and her.e to get it.

his whole bocy and extremity doses, and had been observed at work by the health ohysics staff in an attempt to identify the sources of his high exposures. Individual A stated that he had not yet been informed of the results. .

i This section demonstrates the recordino of an interview Note tne ouestion-answer format.

A eseuctofyma cac employee by an inscector.

is used to orotect the emoloyee's identity, and is also used in Se::::- 1 of the report (c.v.).

No violations were identified.

i a-e fou-d.

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N0vencer 1935

3 11

9. Personnel Protection - Internal .

The radiation safety staff stated that they conduct an extensive urinalysis and thyroid-inonitoring program, which includes all workers in Building The124 (the manufacturing building), and selected workers in other areas.

basis for selecting workers for inclusion in the program was discussed with Methods of analysis and calibrations the RSO and appeared appropriate. Very few cases of missing assays were reviewed and found to be in order.

were found, and were too infrequent to compromise the program in an Records of results were reviewed.

gation level (20 MPC-hours intake in one week) have occurred since the last inspection.

Air samplers with activated charcoal cartridges were observed in virtually every room in Building 124, and in other areas where radiciodine is used.

The radiation safety staff stated and records confirmed that these cartridges are changed daily. The results of the analysis of these air samplers were reviewed, and found to be well below the maximum permissible concentrations (MPC).

The inspectors reviewed records that showed that flow rates through hoods were checked monthly.

Ne violations ws-e ide.tified.

B*ief statement un'ess e-oblems are found.

10. Ef fluent Cortrol . k'aste Discosal Records snowed that the three high-level. hot cells in Building 12a, w9ere therapeutic deses of iodine-131 are prepared, are releasing 100 m:i cuant-Filter ities of volatile iodine-131, requiring frecuent filter changes. to breaitnroughs had caused releases for the week prior to the insoection average 90'. of MPC, triggering the ALARA investigation recuired by tne license. Tre 52 week running average, and the year-t:-dats ave-a;e are both less than 20P. of MPC. A graph showing the licensee's data is includec as Attacnment 1.

The licersee's procedures for radioactive waste disposal were reviewed.

The radiation safety staff stated that waste is seg-egated in areas w7ere it, compacting it it if appropriate, and transferring it to a con disposal. This was confirmed by observation.

Neverber 1555 j

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The health physics staff stated that they survey cold waste during routine '

tours of the facility, to assure that no hot waste has inadvertently been In addition, dumpsters are surveyed with a placed in the cold trash. The inspectors.

micro-R meter before they are emptied, as a final check.

surveyed a dumpster with a NRC micro-R meter and found no trace of radioactive material.

No violations were identified.

Brief statement unless problems a-e found. .

II. Traescortation The packaging and shipping of licensed materiel were reviewed, No including the observation of the preparation of several packages for tran problems were found. tion (DOT) Specification 7A have The packages been tested were as re furnished copies of the test results to the insoectors. The packed by trained indi$icuals, and sealed and labeled as. required.

packages were monitored at the surface and at three feet on all six sices The inspectors reviewed written precedures that es a DDT Yellow-III label. '

^

The circumstances surecer. ding a transportation incicent NPI reported repcrted by Na Pnarmacy, Inc. (NPI) in Woburn, Mass.. were investigat liquid form, which eead 240 mR/hr at the surface, and 5 mR/hr at ore mete Licensee representatives prodJced the shipping and survey documents f d maximun i this package, showing maximum surface dose rates of 99 mR/hr anThe in i i dose rates at three feet of 2.6 mR/hr.to accept Fanciful's survey L

' procedures. This item is considered closed.

Nc violations were identified.

Note that LER'S had been received reoardino this area and are out in tne reocrt. More cetail is reovired to close out an item su:n as an LER.

12. Distribution Licenses h the i

Tne statuses of the four distribution licenses were discussed witIn most c inMdviduals responsible for these programs.

l have been reduced to a minimum, or are being The maintained organization to service of ex j

customers, and no new material is being distributed. RC app-oval, tne programs is such that no changes which would reovire Ngoing inrou;n re sa:r Ks modification cf a proo*1:

lacei. can de made witnout Cire:* or of tre re sce"* d Novem:er 1955

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13 No violations were identified. This .

This describes the scope of a procram, similar to Section 3.

Information is important to the NRC, and will also belo the next inspector.

13. Notifications and Reports All required reports and notifications had been made.

No violations were identified.

Brief statement unless problems are found.

14 Postine of Notices Required notices, such as Form NRC-3, were posted, ho violations were identifiec.

Brief statement unless oreblems are found.

1

15. Enercercy Preparedness h

' The litersee's c;ntin;er:y p'an and emergency plan wer radiation safety staff.

local police fcree, and other off-site agencies, had been hel:

one year acc.

Inspectors reviewed a report of this crill.

i The radiation safety staff stated that the licensee maintains l rs, a*:

a fire on site, consisting of two full-time personnel, i augmented eateriais. b equipped with a truck.in the proper response to fires in areas containing ' +;

The radiat'en safety staff stated that pact of the ity ofcontinget:y ra:icactive clan i l the presence of stack monitors which alarm if the quant b ptly. Ine mcnit:-

l material being released to the environment increases a ru consists of a particulate filter and a charcoal The radiat'on filter, safetyeach radiation monitor. l i the quantity of radion:tive material in the filters. in l te *re staff stated that, while the monitor serves The its fu j

rea:ings with data from their recular effluent monitoring syster.*he j":* esse " l inspe: tor suggested that a differential readout, wj /

activity, would give more meaningful data.

{

they wou d consider modifying the instrume.ntation.

l a recommenta*ica

• • a* is *:t a 1*~

.N0te here tre in50s *oes coturen*

'reCuiat-ry r e O u i

• e r+ r,; , 0;; 5*oglC alert tne 3* tic" *as*est *C5ct*

ste" *.ise*  :"1:

• 0ss**cIy a II t*5e re'.* ewer to see if a*y a:*ress tee 155We. h ver:e* .355 l

14 .

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During their tour of the facility, the inspectors were alert for nonradio- "

logical hazards that could give rise to a release of radioactive material.

No hazards of this type were observed.

This paracraph refers to a current NRC ceneric concern.

No violations were identified.

16. Exit Interview I

The inspection findings were discussed with the individuals indicated in Section 1.

1

• This is-suf ficient. unless some specific concerns were Any discussed, manace-ent in which case the concerns should be descriDed here.

response should be recorded, as well.

a m.

Never:er 1955 i

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%, UNITED STATES

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pi NUCLEAR REGULATORY COMMISSION i WASHINGTON, o C. 20555 f l i  ! . ,

/ NRC INSPECTION MANUAL ttPe R

INSPECTION PROCEDURE 9770?

FOLLOWUP ON CORPECTIVE ACTIONS FOR VIOLATIONS AND DEVIATIONS 1

l PE0 GRAM APPLICABILITY: 2500, 2600, 7700, 2800 l 9770?-01 th5PECT10H OBJECTIVES Establish that adequate corrective actions have been taken for violations and deviations, that their root causes have been identified, that their ceneric implications have been addressed, and that the licensee's quality assurance (0A) program procedures and practices have beert dpuropriately strengthened to prevent recurrence.

9270?-0? NSPECTION REQUIREMENTS 07.01 Documentation Review. Conduct a review of licensee responses to Notices of V1olation. end Deviations to ascertain that the licensee responses and stated corrective actions were timely and appropriate, that the licensee has conducted an indepth root cause analysis (andgeneric implemented any appru-implications were priate changes in training or procedures), that addressed, anc that the licensee's 9 program practices and procedures, Also, reviewwhenper-appropriate, were strengthened tc Jrevent recurrence.

tinent 0A/0C records, audits, reports end both onsite or offsite review committee minutes to determine if the licensee's OA oversicht practices shoulc have identifico the violation (s) or prevented such violation (s).

l Determine which responses are to receive onsite follcwup inspection based on their hafety significance end con.plexity , their apparent inadecuacy, weaknesses in licensee administrative or management controls.

or apparent 02.02 Onsite Inspection. Ccnduct an onsite inspection of the selected viole- ano tions one deviations with respect to the timeliness, completeness Where appropri6t2, doecuacy of licensee actior.s in the following areos.

these inspections should be dtual physical Wfications of equipment and processes.

o. Corrective Actions in futwarded copies of their response

1. Has licensee manacement the form of onsite tuskina (as appropriate)?

~

Issue Date: 09/30/8C

7. Have responsibilities bun assigned for effecting the identified i

changes in procedures and proctices?

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3. Were corrective actict.s fully implemented?

4 Did the licensee post copies of radiological working condition ,

related enfo-cement correspondence as required by 10 CFR 19.117

5. Did the licensee's OA department conduct any recent audits of the the inspection area in which violations /ceviations were identi-fied, ono whet, if any, deficiencies were noted, and what follow-up actions were initiated?

b. Root Cause Analysic

c. Generic Iniolicaticns Analysis 0A Progrom Frocedures and Practices Changes. Did the licensee's re-d.

view of the QA program evaluate the program's scope and effectiveness?

97702-03 INSPECTTON Gl'IDANCE 03.01 General Guidance

a. 10 CFR 50 Append a B may form the regulatory basis for n.any enforce-have been made during the licensing ment acticos. Commitments may process (e.g. the information contained in the plants FSAR represents commitments to the hRC) or niay have been made in written correspon-dence to the NRC after receipt cf the plant's operating license.

f.,

b. In acccrdance with 10 CFR ?.201, enforcement letters require written explanations and statements of reply concerning cor Other specific responses or act-corrective and preventive actions. The irspector assigned ions may be required in enforcement letters.

to followup on the licensee's actions should therefore le addition, conduct areport inspection care-ful review of enforcement letters, transmittal letters may contain statements consisting of regional Such state-perceptions of, and concerns with, licensee performance.

ments are valuable background information for the inspector,

c. The NRC Inspection Program places strcu.g emphasis on the inspection of licensee performance os the basis for determining the overall adecuacyThus, wh of the implementation ficier.cy in licensee of qu611ty assurance programs.perfomance is id repetitive the failurt deficiencies occur, a key element to be review and correct the oeficiency.

For selected areas, this will involve focusit.g on the individuals, procedures and practices targetedInataddi- ver-ifyinn that specified quality objectives have been achieved.

tion, the region may want to consider conducting a performance based regional initiative inspection to reinspect the deficient area and verify that the licensee's corrective action was effective.

-T- s 9270? [

lasue Date: 09/30/8P

\

cf .

The intent of this procedure is to ensure the early identif1 cation of i-potential problems in the effectiveness of the licensee's OA program implementation. Where licensee enrrective actions for NRC tdentif1ed def1ciencies are not adequate, additional regional initiative may be warranted te assess the adecuacy of licensee corrective actions for internally identifiod problems. IP 92720, Ccrrective Action shall be .

considered when such regional initi6tive is cor.templated.

03.0? Specific Guidance

a. Inspection Pecuirement 02.01. Whether immedidte NRC followup to a routine inspection is needed would depend on the regions estimation of the safety significance of a deficient QA program'in the area of the inspection findings. NPC inspectors will very likely havE developed ir. formation as to the probable root cause of safety significant' Similarly,find-the ings as a result of normal inspection activities.

inspector will typically have a general (or in the case of a resident inspector, a detailed) understanding of the audit. inspection and sur-veillance practices of the licensee's OA organization and en opinion as to whether the licenste's quality However, assurance the verification licensee willactivities normally may require addit 1oncl attention.have been requested, as part of the e own determination of quality assurance adecuacy unless, due to safety There-i significance, fore, immediate NRC inspection followup is warrente his managerrent will ideally assess the adequacy of the licensee's evaluation and corrective actions, rather than cunducting an onsite followup inspection.

The regional documentation review ny involve extensive communication with the licensee for the purposes of clarification, elaboration or the provisior. cf further documentation.

b. Inspection Requirement 02.02. For the same sample selected for an crisite inspection, the assigned inspector should review pertinent documents such as:

1. inspection reports

?. inspectinn report transmittal lettu s

3. t:ctices of V1oiation (t:0Vs) 4 licensee response letters

5. minutes of meetings with the licensee

6. regional records of cornmunications with the licensee.

The onsite inspection should examine whether the licensee's evaluations in-cluded a review of internal audtt/ inspection fir. dings in arrivino at deter-minations on the repetitive and generic nature of a NPC finding and the Where an item is identifiec os repeti-effectiveness of licensee prngrams. f the tive in nature, the licensee shculd have conducted an indeDth analysis o

-s-

' Issue Orte: 09/30/EO 92700

effectiveness Uf mdnagement- control systems. . This entails the determination-

' of root ~ causes 'of ' deficient managernent controls and. their potential generic implications. It should t,e noted that this is: considered to be the most ,

important item in inis inspection procedure.

92702 04 REFERENCES- .

10 CFR 2.201 Notice of Violation

. 10 CFR 19.11 Posting of hotices to Workers

'10 CFR 50, Appendix 8 IP 97720, Corrective Action v

END 4

l.

52702

.4 Issue Date: 09/30/88 h

- l s ,

l I

I j,# *'%

e UNITED STATES y' '; NUCLEAR REGULATORY COMMISSION j WASHINGTON. D. C. 20555 e

NRC INSPECTION MANUAL ItR3 .

f l

CHAPTER 0330 I.

GUIDANCE FOR NRC REVIEW OF LICENSEE DOCUMENTS 0330-1 PURPOSE This chapter provides guidance for staff review and handling of licensee draft documents which have been submitted to HRC for review and comment.

0330-2 OBJECTIVE The ebjective of this chapter is to ensure that a review or discussion of a licensee draft document would not have a real or perceived appearance of impropriety.

0300-3 APPLICABILITY All NRC licensing and inspection staff reviewing licensee draft documents during conduct of an inspection or other review of documents submitted by the licensee to NRC offices sball comply with the policy identified in this manual chapter.

0330 4 BASIC REQUIREMENTS 04.01 General. As a regulatory agency, the NRC staff has the obligation of overseeing licensee activities to ensure they are being. conducted safely ano in compliance with conditions cf e license and with the regulations and In the course of conducting regulatory activities, orders of the Commission.

licensees may request staff review ano comment on draft licensee documents before they are formally submitted to the agency. A review cr discussion of a draft document by the NRC would be inappropriate if the review would have the real cr perceived appearance of impropriety (such as where the staff member stept, cut of the role of regulator and into the role of ac' visor) nr of giving rc.re of an advantage to one licensee than to another. The decision whether it is . proper for the NRC to review a drait of a particular licensee documen+ j should be baseo solely _on thf reed for the NRC to review the draft in carryino '

out its regulatory obligations.

The policies containec in this chepter supersede all previous cuidance on this subject. -

i

!stue Cate: 10/?1/87

.04.02 Sp:cific Guidance .

a. Any document obtain:d froa a licensee which the licensee indicates is a

' draft, should be clearly marked and handled as such.

p t

b. It is the Commission's policy to address all matters of safety in pub-lic. Consequently, it is the Commission's policy generally that any document, including those labeled " drafts," considered by the staff in reaching a regulatory decision should generally be placed in the appro-priate docket file and the Public Document Room (PDR) unless the docu-

• ment labeled " drafts" falls within one of the exempt categories listed

.below,

c. Consistent with this chapter, NRC review of drafts of the following licensee, applicant, or vendor enforcement-related documents, would be inproper:

1. Licensee documents arguing that violations did not occur.

2. Licensee documents arguing the appropriateness of sanctions in-posed on it; e.g., c,ivil penalties.

3. Licensee documents arguing whether or not an order should be im-posed.

4 Responses to 50.54(f) letters and similar requests for information specifically requested under cath or affirmation (excluding appro-priate technical licensing documents).

d. In other cases, an examination nf draft documents from a licensee, (

applicant, or vendor which the NRC desires and which is in the interest ..

of the NRC in carrying out its public health and safety responsibili-ties es contrasted to purely assisting the licensee, may be proper.

Included in this category are draft documents that:

1. Could assi.st sn inspection or an assessment or corrective actions.

2. Could form the basis for a confirmatory order.

3. Could form the basis for a settlement agreement,

e. Labeled " drafts" considered by the staff in reaching a regulatory de-cision shculd generally be placed in the appropriate docket file and the Public Dncument Room (PDR) unless the document falls within one cf the exempt categories listed in f. below.

f. Categories exempt from this general policy are:

1. Documents or portions of dccuments that fall within the exempt categcries of 10 CFR 2.790 (e.g., proprietary information and in-vestigatory material). These should be placed in the appropriate docket file only. If a proprietary document is involved, to the extent possible a non-proprietary version should be placed in the PDR .- However, if such a proprietary document is requested by the public. OGC sheuld review the determination for proprietary treat-

. cent.

s b

0330 l Issue Date: 10/21/07

l

!., s...

~

l'

2. Documents that resident inspectors and others examine durine onsite insp;ction and oversight. In conducting an onsite in:pection a substantial number of documents, including draft documents, may )

have to be examined to provide background information regarding the facility. Placirg all such documents in the PDR would place an unnecessary burden on the agency, and might hamper the necessary flow of background information from the licensee to the inspectors.

For these reasons, the meterial need not be placed in the PDR if .

the material does not leave the licensee's premises or is returned to the licensee upon completion of the inspection.

3. All draft material relied upon by an inspector to prepare en in-spectinn report or to make inspection findings must be retained by the inspector because a draft document by its nature may be changed or destroyed by the licensee. Draft material retained for such purposes must be placed in the appropriate docket and placed in the PDR if the material does not fall within one of the exempt cate-gories of 10 CFR 2.790.

4. Draft proposals concerning a confirmatory order or settlement agreement if an Office Director determines that it is in the interest of the public health and safety to consider such proposals in preparing the final regulatory document.

04.03 Additional Guidance The essence of the specific guidance discussed in 04.02 f.2 and f.3 above is that the review of background information relative to an area of inspection

- (f.2) would not necessarily recuire the inspector to retain draft documents of

- that category unless the draft document itself will be the basis of or'will be

', needed to support a finding (f.3). Additional guidance in this regard is provided by the following examples.

1. Inspector reviews draft procedure change to assure connitted changes are included.

Need not retain; final procedure will form basis for finding.

I 2. Inspector examines work in progress on electrical modification and I.

reviews related rarked-up drawings and proposed procedure changes to be sure appropriate modification and work control procedures are beinn followed.

Need not retain; work observation is inspection ob..iective.

3. Situation as in enmple 2 above. Inspector notes marked-up i

drawing (draft) violates electrical separation requirements.

l Retein; may be basis for enforcement.

4. Inspector reviews electrical anaiyses in progress to ascertain cuality of licensee's corrective action plan.

Need not retain; inspectior objective was observation ci analyticel process.

End l

Issue Date: 10/21/87 l 0330

i

". , o-c, ,

'i

/*p%fIt UNITED STATES

.S NUCLEAR REGULATORY COMMISSION i )[-

5  ! OFFICE OF INSPECTION AND ENFORCEMENT Washington, D.C. 20555 ];

4 ,/

INSPECTION AND ENFORCEMENT MANUAL DI CHAPTER 2800

.J MATERIALS INSPECTION PROGRAM

. 2800-01 PURPOSE To establish the inspection program for licensees authorized to possess and use licensed material for radiography, medical prograrr.s , academic and industrial uses, waste disposal operations, manufacturing and distribution of products, and leak testing, calibration, other types of services, and transportation related thereto.

2800-02 OBJECTIVES 02.01 To establish general policy for the materials inspection programs, including priorities for inspection.

' 02.02 To define specific requirements for inspection of materials licen-ses.

To aid in the achievement of a consistent process of inspection for 02.03 materials licensees.

2800-03 DEFINITIONS licensee R 03.01 Inspection Priorities. The priority number assigned to For a example, R is based on the potential hazard of the licensee's programs. R a license with an ir.spection Priority 1 is one in which there is the great- the R est potential for hazards in health and safety; this priority requires On the R most frequent inspections because of the nature of the operations. hazard to R other hand, an inspection Priority 7 involves little potential R health and safety and requires less frequent inspection.

03.02 Telephonic Contacts.

These are contacts done by telephone using a R These con- R questionnaire to determine the status of licensees' activities. Priorities 6 and 7, and R tacts are only used for the low orioritv licenses, R under certain conditions, Priority 5 licenses (see Enclosure 1 for instruc- R tions).

R 03.03 Telephonic Inouiries. These are inquiries done by telephone reminding the R to de-termine (1) some facts about the licensed program such as licensee that its license is near expiration, (2) if there is sufficient RR activity to conduct an inspection (radioactive material may beunder in storage),

its R or (3) if the licensee actively possesses radioactive material Issue Date: 04/08/87

, m\. 4 r

R  ! l license. Th2se are only exampics; there cay be oth'Ir reascns to make t21e- R ' /' ..

.  ; i L'

phonic inquiries of licenses regarding license expiration, decommissioning, R and so forth. Telephone inquiries generally do not involve direct inspec- R l* tion effort, whereas telephone contacts do (03.02 above).

l~ 2800-04 INSPECTION PRIORITIES

• 04.01 Routine, Periodic Inspections _. (Also see 2800-05 and 2800-06.) In-spections of licenses in Priorities-1-through 5 shall be. conducted.at Priority 1 = in-tervals in years corresponding to the inspection priority:

each year; Priority 2 = each 2 years; Priority 3 = each 3 years; Prior-ity 4 = each 4 years; Priority 5 = each 5 years. t Licenses in Priorities 6 and 7 are inspected initially (04.03, below) and thereafter only for reso-lution of complaints, allegations, or incidents, or in connection with an inspection of another specific license; Priority-W (as needed) is for walk-in or pool-type irradiators under construction (see IE 2815). ,

R 8ecause considerable travel is required, inspectors may telephone licensees R located in Puerto Rico, Guam, American Samoa or other island locations undertaking to R such R

verify travel.

that a routine inspection can be performed beforeWe R have ex such locations, have found that licensees did not possess and use radio- R active material.

When a new license is 04.02 Initial Assignment of Inspection Priority.

issued by the regional office, it shall be assigned an initial These actionsinspection should be priority and scheduled for an initial inspection.The initial inspection priority is ass uses (

taken as soon as possible.

e comparing the types, quantities, and forms of material andIfauthorized a license

' with the descriptions of the priority system in Table 1.

involves more than one type of use, the type associated with the highest priority (most frequent inspection) shall establish the initial inspection priority.

04.03 Initial Inspections. These shall be conducted of licenses in In-spection Priorities 1 through 5 within 6 months Initialafter material isofreceived inspections li- ,

and operations under the license have begun. Initial censes in Priorities 6 and 7 shall be conducted within 1 year.

inspections of new licenses may be announced.

04.04 Expired and Terminated Licenses. Notification that a license has expired cr is being processed for termination has will disposed been properly require prompt action to of and areas ensure that licensed wasmaterial used can be safely released to unrestricted use.

wherein materialincluding inspection and confirmatory survey, if necessary, Final action, should be conducted as soon as possible, but no later than 6 months after the notification is received (see Procedure No. 83895.)

Returned, undeliverable mail to R 04.05 Abandonment of Licensed Activities. The followup R licensees should be included as a weekly routine followup.

~

If no response is R should include a telephone call to the licensee. The returned R R

received, mail an inspector should be sent to the licensee' site.shou R

the license, such as shown in the example, Enclosure 5.

2800 Issue Date: 04/08/87 -- - - - _ _ _ _ _ _ _ _ _ _ _ _

y , , .-

The following R- 'i c 04.06' Inspectirn Activities and Licensea Inspectien Fees. )

guidance is baing provid::o to assist. in determining when activitics con . RR l

j stitute an inspection and ~ when fees applicable to those activities will be R 1

• - charged to'the licensee. .

a.

Before scheduling an initial insoection, An determine if the licensee finitial inspection should RR possesses any radioactive material. R. I

. not be attempted if it is determined that the licensee does not R- I An inspection should not be considered R possess licensed material. if, after arriving on an announced initial R to have been performed I

inspection, it is found that no radioactive material is possessed. R-Before attempting an initial inspection, the licensee should be con- R tacted by telephone.

b. An inspection should not be considered to have been performed (1)R.R if, after arriving on an unannounced inspection,.it is found that no radioactive material 1s possessed or used because of disposal or R

' storage of the material and no inspection activities are performed RR the licensee or licensee's representatives are not avail-or-(2)if able to assist with the inspection andother the inspector On the hand, if itisisunable possibleto RR perform inspection activities. R to inspect records or other items according to Rlicens R as an inspection whethe the radiation safety officer (RS0) is pre- R sent or not, including those licenses that have been terminated.

c. For any situation where an inspection was not performed as defined RR above, the region should not prepare an NRC form notificati licensee or other type R

rf the region should not record the attempted inspection in the Li- R

' cense Management System.(LMS) as "an inspection." However, a note RR' should be placed in the docket file to record the reason an inspec- R

'- tion could not be performedThe and giving a date when the next inspec- R "next inspection date" data element tion should be performed. R in the LMS should be changed to reflect the new date.

Telephone contacts are not inspections. Therefore, the results of R

d. R these activities shouldThe be recorded on an NRC-591 form or in a R notfact that a telephone contact of a licen-Notice of Violation. be entered into the LMS as an inspection. R see was made should not Information Tracking System (RITS) allows R However, the Regulatory factual material to be charged against R the time spent in gathering R the time budgeted for performing routine inspections.

Unannounced Inspections. With the exceptions provided in the above RR 04.07 of this manual chapter, all other materials inspections should be R sections performed on a strictly unannounced basis.

2800-05 TELEPHONE CONTACTS R

As defined in 03.02, contacts by telephone are a useful means of maintain- infre- R ing contact with licensees who are never inspected or are inspected quently. - Such contacts may be performed by an adequately trained pe s

Issue Date: 04/08/87 2800

wh3 would nst ordinarily ccnduct field inspections. Telephone contacts of R

• low priority licen'.,ees also gay be dsne by a junior inspector. Other more -R experienced inspectors may do telephonic contacts only if the region has R t

L* . completed inspections of the higher priority licensees (Priorities 1 - 5), R allegations, and special inspections. Contacts shall be limited Priority to general R (-

licensees and Priority 6 and;7,licentS s with small programs. 5 R

' licensees may be included if the prt ums are small and the potential for R ~

j for health and safety hazards is remote. Procedures for using the tele- R j phonic contacts are included as Enclosure 1. A telephone questionnaire R is attached as Enclosure 2 and standard responses back to licensees con- R R

tacted by telephone are included as Enclosures 3 and 4.

2800-06 CHANGE IN PRIORITY BASED ON CHANGE IN TYPE OF PROGRAM A change to a lower or higher inspection priority shall be made when it is determined that the licensed activity being carried out is of a priority different from that initially assigned and is one which warrants a lower or higher inspection priority under the system in Table 1. T h rocram prior-ity codes shall be changed _in the LMSz Any changes from the usual priori-ties shall'be authorized by the Section Chiefs and a note placed in the j docket file, but the program code shall not be changed.

A reduction to a Priority 6 may be done if: R

a. it is not likely that radiation workers will exceed 10% of the air- R borne radioactivity limits listed in 10 CFR 20, Appendix B, Table 1 R

b. it is not likely that a radiation worker will exceed 25% of the R g

radiation dose limits listed in 10 CFR 20.101(a) or will not need to RR use personnel monitoring devices

~

c. it is not likely that any work with radioactive material will result R R

in a spill causing spread of contamination R

d. complex surveys are,n,ot, ot required R

e. waste disposal is noi required 2800-07 EXTENSION OF INSPECTION INTERVAL The interval between inspections may be extended (lengthened) beyond that specified by the priority system on the basis of exemplary performance on the part of the licensee. The governing consideration in extending the inspection interval should be evidence of a level of performance in safety and compliance on the part of the licensee that provides a greater-than-normal assurance of a well-managed, safe operation. The determination to extend the inspection interval shall be made on the basis of an inspection, considering current and prior findings. The extension shall be valid only until the next inspection, but may be renewed on the basis of repeated favorable findings. The extension shall be limited to a maximum of 6 months for licensees in Priorities 1 and 2, and to a maximum of 2 years for licensees i'n other priorities. For computer entry, the letter E shall be used for licensees on an extended inspection interval.

s 2800 Issue Date: 04/08/87

l

?, ?

~

for .these ~ licensees . sh uld not be j

- .The ' designattd inspection priorityHowever, - the "next inspection date" ' data eleme

•  : changed in : the LMS.the LMS should be changed to contain the inspections, a Rextende tion. -To. support the extension in the interval. between the basis for the extension, approved .R.

brief note should be written giving R

by the Section Chief, and placed in the docket file. .

E 2800-08 REDUCTION OF INSPECTION INTERVAL.

The interval between' inspections may be reduced.(s basis . of minimally satisfactory performance on the part of the licensee. should The governing consideration in reducing .the inspection. interval be a lack of confidence in.the level of performance in safety and compli-ance on the part of the licensee that indicates conti

- attention by the licensee and the NRC. -

inspection interval shall be made on the basis of an inspection, co ing current'and' prior findings.

- entered for licensees on a reduced inspection interval.

The designated inspection priority for these licensees shoul'd not be R l

However, the "next inspection date" data elementon in RR changed in the LMS.

LMS should be changed to contain the date for the next A brief note inspection should be based R-a reduction of the interval between inspections. Section Chief, R written giving the basis for the reduction, approved by the R and placed in the docket file.

2800-09 SCHEDULING OF INSPECTIONS

& The month in which an inspection is actually 09.01 Basis for Scheduling.

performed may be completed earlier or later than scheduled (by its plac ment in the priority system) for the purpose of the efficiency inspector travel time.

against the basic purpose of the inspection priorities, that is, effective use operation. of an inspector's time versus the potential haz cause an NRC inspector is in the area of the facility.high purposes.

For radiography licensees that are autho-09.02 Radiography Inspections._ an inspection of a rized to conduct radiography at temporary job sites, temporary job site should be attempted for audit at least 25 of those licensee auditors during a quarterly made to accompany sites. The accompaniment of auditors may be on an announced basis.

09.03 Combining Inspections. If a licensee holds more than one kind of license (that is, of different priorities), a single inspection may be scheduled whenever practicable to aid in more effective use time spent in travel status.

on a continuing basis, consideration should be given to "over inspecting" a lower priority license versus the need and desirabili Issue Date: 04/08/87 2800

q

,y , , . -e j (y

o ;.

p I compliance performance. The priority designations of the lower priority ' '

licenses 'sha11f not beLchanged in - these cases; the more frequent inspec-

- tions._ of : lower priority licenses shall be handled only in .the scheduling _

process. . (.

( 09.04 Performance Indicators. These are defined in' Inspection Procedure RR, L .89100, that, when finalized shall be used by inspectors to determine if the licensee is. conducting ~its operation in a way, that may, if not corrected. R I or changed,~1ead to violations. There is .no regulatory basis for most per- R .)

formance. indicators, but there is a basis for sound radiation protection by.-R {

the industry. Several of these practices are included in the inspection R

)

procedure. j 09.05 Permissible Frequency of Inspection. To achieve the goals of cost saving and efficient use of staff time as described 'in 09.01 and 09.03, inspections (other than initial inspections) may be performed at a frequen-cy other than that defined by the priority system. However, the frequency of inspection for a licensee should not fall outside the ,following points:-

Type of Inspection Permissible Frecuency Initial inspections of new licensees. See 04.03.

Inspection of licensees in Interval between inspections may Priorities 1,'2, 3. vary by i 25%.

Inspection of licensees in Interval between inspections may Priorities 4 and 5. vary by i 1 year.

I 1 ~i If escalated enforcement action has taken place, an inspection should be conducted within 1 year following closecut of the escalated enforcement w action.

09.06 Inspection Before License Renewal. Before renewing a license in R Priorities 1, 2, or 3, the compliance / inspection requirements history of the licensee R should be R should be checked to determine whether additional

'made a part of the license, particularly for those licensees that have a R history of marginal performance. In some cases, it may require an on-site R inspection to determine if the license should be renewed, based on prior RR performance and up-to-date information on the licensee.

Notification to Non-Agreement States. Notify in a reasonably time- R R

4 09.07ly manner by telephone or in writing non-Agreement State radiation control program personnel of planned NRC materials inspections and enforcement R cases in their wn States. Inform the States of the type of materials in- R spections, enforcement cases applicable for participation, and the number For inspection accom- RR of such personnel that may participate in each case.the non-Agreement StateR radia paniments at Federal program director mustfacilities, seek permission from the Federal agency licensee. R R

Personnel interested in participation may do so as observers as long as inspection program. The NRC R their presence does 'not impact on NRC's that may be R assumes no responsibility for injuries or radiation exposures R received by participating non-Agreement State personnel.

4 ~

2800 Issue Date: 04/08/87 - - - - - - - _ _ _ _ - _ _ _ _ _ _ _ _ _ _

te- ja

2800-10 REGIONAL' RESPONSIBILITY FOR LICENSES.

General. ;When a-license authorizes-~ operations in more than ona re-- 'i

~10.01

• ' gion, the responsibility. for inspection shall Thereside main office with means. the, regiona fice in which the licensee's main office is located.

-the corporate office, normally the. address given on the license.

In the interest of efficiency in travel

• 110.02 . Assistance in Inspections.

time and funds, the responsible regional office shall. request another re .

gional' office to conduct inspections (assist inspections) of the activ L

" of such licensees. when the licensee is - operating outside the area of the responsible region. inspection report) and recommend enforcement plate documentation (draft The responsible region should distribute--

. action to the responsible region. initiate enforcement action, and take other followu the documentation, actions, as appropriate to the case. These last two actions shall be completed by mutual agreement of the regional offices involved.

When ' requesting assist inspections, the regional offices shall take into consideration the sample size of inspections for which they are request -

In this effort, the regions should differentiate between large assistance.

and small companies and establish different inspection progr general class of licensee.The strength of the licensee's internal inspection pro-others have few.

gram -is another factor in determining the sample size of the lice I

field operations.

Notwithstanding the above (10.01 and 10.03 Transfer of Responsibility. an address that places the inspection 10.02), when a license carries responsibility in one region and operations under the license occu f pally within- another region, the inspection responsibility This transfer may be. tra ferred to the -region in which the operations are performed. The

~

shall be done with mutual agreement of the regional offices involved.

regional offices should ensure that the appropria

~

enforcement.

2800-11 INSPECTION OF GENERAL LICENSEES With the exceptions specified in 11.01 Routine Inspection Not Required._

11.02, inspections of general licensees are not required on a rcutine b sis. However, inspections shall be made to resolve allegations, com-plaints, or other indications of an unsafe practice or a case of noncom pliance, or when such anAny inspection inspections is directlyunder conducted pertinentthe above to an ins involving a specific license.done during activities conducted in areas of NRC provisions should be jurisdiction.

The NRC region in which 11.02 Inspection of Activities Under Reciprocity.

an Agreement State is located is the recipient of the NRC-241 form from a State licensee of its proposed activities in non-agreement State The regional office receiving the NRC-241 form shall take action on t report, including prompt notification of the NRC regional i

.(

jurisdiction in the area in which the Agreement State licensee's a take place. The responsible regional effort to conduct inspections of Agreement State' licensees at the sam quency as the NRC licensees.

Issue Date: 04/08/87

'2800

3 4 ,

2800-12' CONSTRUCTION AND PREOPERATIONAL INSPECTIONS ~ 0F IRRADIATORS' .

Construction- and preoperational inspections of ~ new walk-in :or pool . type R irradiator . facilities shall- be a regular part of..the inspection program; .R .

The. inspections will invoive the use of engineering ~ inspectors and: will R-1 require that the materials staff' identify the parts of the facility that R; R-are especially important to safe operations ~ of irradiators. MC 2815 des-cribes the inspection program for these. facilities. R-R 2800-13 'SPECIAL INSPECTIONS Special inspections are reactive in nature and cannot be scheduled on'a R routine' basis. ' Occasions for which a special . inspection should be per- R formed include, but are not necessarily limited to, the following: R 13.01 Licensee report of an incident where onsite inspection is needed to R determine the facts of the case, the cause of the incident, and adequacy of R the licensee actions to correct the cause of the incident, mitigate its R consequences, and prevent recurrence. (See IE 2820 for criteria and R R guidance.)

R 13.02 Followup within 1 year of escalated enforcement to determine whether the licensee has taken the actions to which it committed itself in its re- RR sponse to the enforcement order.

13.03 Obtain information as to the validity and significance of the al- R A

leged unsafe _ operations.

l^ R 2800-14 INSPECTION METHODS

- To the maximum extent practicable, inspectors should ascertain whether a R licensee is in compliance with specific provisions of the license and the R regulations by direct observation of work activities, . demonstrations of how R.

the licensee performs an NRC-required test or other activity, interviews R of licensee employees ~, and, in appropriate cases, by. independent measure- R ments' of radiation'and air concentrations. Less reliance should be placed. R R

on determining compliance based solely on information in licensee records.

2800-15 INPUT INTO THE LMS SYSTEM AND ASSIGNMENT OF INSPECTION PRIORITIES 15.01 Table 1 provides a listing of license program codes with the associ- R ated inspection priorities. We have adopted these codes as the exclusivs R system ._for determining the insDection prinri_tv for each Mcense. However, R

~it may be necessary to continue usirig a "subpriority" code (inspection RR category code) from the previous system to satisfy an edit in the LMS.

While the IE staff has tried to eliminate all problems that have been R identified in the use of the license program code system for assigning R inspection priorities, it is possible that other problems remain or may be R encountered in the future. In any such case, the inspection staff should R make a judgment about the proper inspection priority for the license based RR on past practice and should insert that priority into the LMS.

i l

l 2800 Issue Date: 04/08/87

w -- - . _ - . _ - _ _

+. .. * 'R 0

• ' b3 cnttred ' pr:rptly into the LMS at the time a' new li-  :.1 15.02 censaData sh:uld or an insp:ction has been performed, including the is issu:d R dates !

for initial inspections of new licensees, the'last insp;iction date, and R the l1 next inspection date. for licensees' already inspected.

f' R

2800 INSPECTION PROCEDURES FOR THE MATERIALS PROGRAM R .

procedures that should be used in the mate-

' Table 2 lists' the inspection: R.

rials inspection program and the frequency for use of each procedure.

END

Enclosures:

1. Tables

2. Appendix

.J l

4 N

Issue Date: 04/08/87 2800

b( . 't ..-

7, , . Enclosure'1 x.

' Inspection Priority by. Program Codes .

Program Priority Category Title Remarks Code ,

• Academic Type A Broad Connittee approved users 2 >

01100.- RSO approved users 2 R 01110 Academic Type B Broad 5 Academic Type C Broad Named users 01120- Classroom teaching-01200 Academic Other (Secondary Code)

Physics, Biology, or i Chemistry code'03620 ()see program Hospitals only 1R 02110 Medical Institution Broad 3

- 02120 Medical Institution Other - Group Hospitals only

' 02121 Medical Institution Other -

GroupsI,II(includes. Diagnostic- 4 R LimitedTherapeutic) 4 R 02200 Medical Private Practice - Group Medical Prsvate Practice - Lixiscopes by podia-02201 trists, physicians GroupsI,II(includesLimited (bonemineralanalysis)

. Diagnostic,LimitedTherapeutic)

Also iodine-131 for

' diagnostic / therapeutic 4 R 02209 Users of Materials Formerly Under General Licenses and General 4 R Medical Use for In Vitro studies r

02210- Eye Applicators Strontium-90 Hospitals or physician's offices 4 R 2' R 02220 Nuclear Medical Vans Human use only 1 R 02300 Teletherapy 5 02400 Veterinary Nonhuman 5 02410 In Vitro Testing Laboratories 1 R 02500 Nuclear Pharmacies 5-02510 Medical Product Distribution-32.70 3 02511 Medical Product Distribution-32.72 Radiopharmaceuticals 5

02512 Medical Product Distribution-32.73 Reagent Kits Mo/Tc generators 3 02513 Medical Product Distribution-32.74 Group VI materials, calibration and references sources 3 03110 Well Logging Byproduct and/or SNM 3 Tracer and Sealed Sources 03111 Well Logging Byproduct and/or SNM 3 Sealed Sources Only

~

03112 Well Logging Byproduct Only-Tracers 3 Only El-1 Issue Date: .

2800/16 I

---

- q j, .

')

• - Program .

Priority' - l Cetigtry' Title Remarks Code 7

i; 03122 3 -Measuring Systems Analytical 6

r Instruments 7 j L 03123 Measuring Systems' Gas Chromatography .

7 03124 Measuring Systems Other .

03211 Manufacturing and Distribution -

1 Type A Broad 03212- Manufacturing and Distribution 3

Type 8 Broad-Manufacturing and Distribution .)

03213 5 l Type C Broad 03214 Manufacturing and Distribution 6 R

. Other 3 03218 ' Nuclear Laundry

' Leak Test Services Only 7

,03220 03221 Instrument Calibration Services Only ^

7

<100 Curies 03222 Instrument Calibration Services Only 3

>100 Curies-03223 Leak-Test and Instrument Calibration 7 Services <100 Curies 03224 Leak Test and Instrument Calibration 3 Services >100 Curies 03225 Other Services' Soil and water analysis 7 Repairing tele-

• therapy units, irradiators, and f

,_.. gauges 4 R (

i 2 03232 Waste Disposal Service Prepackaged Only 1

s. 03233 Waste Disposal Service Incineration 03234 Waste Disposal Service Processing and/ 1 or Repackaging Incineration-Noncommercial (Secondary Licenses issued 03235 (Code) for decontami-nation and con-taminated equip-ment storage 03240

• General License Distribution - 32.51 Generally licensed gauges, other 4 R

• General License Distribution - 32.53 H-3, PM-147 signs 03241 4 R or markers 03242

• General License Distribution - 32.57 Am-241 calibra- 4 tion sources R 03243

• General License Distribution - 32.61 Sr-90 ice detec-tion 5 R 3

03244

• General License Distribution - 32.71 In vitro kits

- 32.11 Includes broad, 03250

• Exempt Distribution exempt concen-trations 5

• If expedient, may be inspected at the same time that the manufac- R R

turing/ processing license is inspected. s T1-2 2800 Issue Date: 04/08/87

Prierity Remarks C+de Cetecory Title 03251

• Exempt Distribution Time H-3, Pm-147, and

'/ Pieces - 32.14 other isotopes in 30.15 5 R Sc-46 resins 5 R.

03252

• Exempt Distribution - 32.17 Byproduct material 03253

• Exempt Distribution - 32.18 in processed chemical elements, compounds, mixtures, tissue samples, bio-R assay samples, etc. 5

• Exempt Distribution - 32.22 Self-luminous R 03254 products 5 5 R

• Exempt Distribution - 32.26 Smoke detectors 03255 1

03310 Industrial Radiography Fixed 1

03320 Industrial Radiography Temporary Job Sites 3

03510 Irradiators Self Shielded <10,000 Curies Animal teletherapy 3 03511 Irradiators Other <10,000 Curies <1000 curies from which no beam can R 6

be extracted W

03511 Irradiators Under Construction 3

'f.

03520 Irradiators Self Shielded >10,000 Curies Pool type, other 1 t

03521 Irradiators Other >10,000 Curies gamma cells 3 R W

03521 Irradiators Under Construction Committee approved 03610 Research and Development Type A Broad 2 Users RSO-approved users 3 03611 Research and Development Type B Broad 5 Research and Development Type C Broad Named users 03612 and nonBroad Small Multisite-Multiregional Type A Broad -

(Secondary Code) Teaching, non-03620 Research and Development Other routine in vitro, Program Code 01200, and other 5 R )

1 7

03710 Civil Defense 3

11200 Source Material Other <150 Kilogram 7 R 11210 Source Material Shielding 7 Source Material Military Munition Indoors / R 11220 outdoors 3 Testing 11230 Source Material General License 5 R

~ Distribution - 40.34 l

Issue Date: 04/08/87 T1-3 2800 w_-__-_______ _-

g

' :,x

/-

ProgramI

,))" '

Remarks Priority -

, :C-de- ' Category-Title N Includes munition 11300: -SourceLMaterial Other >150 Kilograms. .

.: ~

-production subcriti- -

_i

' cal assembly, and; {e j Jother 3-Rare. Earth Extraction and Processing. 3-

'11700 SNM Plutonium - Neutron Source PuBe 21310

. Greater Than 200 Grams at 51 Universities 21320 SNM Plutonium - Neutron Source-Greater Than 200 Grams Other Than Universities 5-

,SNM Plutonium Unsealed, Less Than 2 '

22110 R' Critical <15 grams 3 2

22111 SNM U-235:and/or U-333 Unsealed .

" Less Than Critical <15 grams' 3 R

,, 22120 SNM Plutonium - Neutron Source PuBe, non-critical, Less than 200 Grams and others 6 Power Sources Byproduct and/or-SNM Snap Generators, 7

>22130 SNM Plutonium - Sealed Sources'in Gauges, but no PuBe 22140 6 Devices

'Not PuBe (

[~ 22150 SNM Plutonium - Sealed Sources 6 Less Than Critical 22151 SNM U-235 and/or U-233 Sealed

~'

Sources:Less.Than Critical 6 Mass 22160 Pacemaker Byproduct and/or SNM 7.

-Medical Institution 22161 Pacemaker Byproduct, SNM and/or' 7

Individual 22162 Pacemaker Byproduct, SNM and/or 1

Manufacturing and Distribution 5 R 22170 -SNM General License Distribution-70.39 4

i w

T1-4 2800 Issue Date: 04/08/87

'Id

'~..: ...

Table 2 Insp;cticn Pr:c';dures t:ble co:.: prise the inspecticn progrcm for The procedures listed in list thisof procedures is divided into two parts, The materials licensees. The programmatic procedures specify the inspec- l

1. programmatic and generic.

tion see activities; the requirements for operational and radiological safety  ;

I applicable to all licensees. "

. Inspection Frequency

• Procedure Number Title PROGRAMMATIC PROCEDURES I, P 83822 Radiation Protection R W

87100 Manufacturing and Distribution Relicensing I, P R 87100 Manufacturing and Distribution Postlicensing I, P 87100 Multisite Broad License I, P R 87100 Radiography I, P R 87100 Radiography - Field Sites I, P R 87100 Waste Disposal 87100 All other Special Nuclear Material,

/. Industrial, Academic, Environmental, I, P R and Other Specific Licenses I, W

1. MC 2810 Multisite/Multiregional Broad Licensees Construction and Preoperational Inspection of W R MC 2815 Panaramic Wet Source Storage Gamma Irradiators I, P R 87100 Medical I, P R 87100 Medical Teletherapy I, P **

84850 Inspections of Waste Generator Requirements I, *** R 89100 Performance Indicators GENERIC PROCEDURES W R 0517 Management of Allegations (proposed MC)

X 30703 Management Meeting--Entrance and Exit Interviews i

• See footnotes at end of table. s Issue Date: 04/08/87 T2-1 2800

_ _ _ _ _ _ _ - _ _ - _ - _ - _ _ _ _ _ ____ __- _ _ _ _ _ _ _ _ - _ - - _ _ _ _ - _ _ _ _ _ _ _ __-_a

Proc; dure Insp2ction ,

".. Frequency.

Number Title ,

'30800 Initial Management Meeting I I , P **

( '

86740 Transportation Activities MC 1330 Response to Transportation Accidents Involving '

Radioactive Materials W MC 2820 Followup Actions to Incidents Involving Fuel Facility or Materials Licensees W R 83890 Closeout Inspection and Survey W 83895 Followup on Expired Licensees W In-Office Review of Event Reports W .

90712 92700 Licensee Event Followup W Followup on Inspector-Identified Problems W .

92701 Followup on Noncompliance and Deviations W 92702 92703 IE Bulletins /Information Notices / R Confirmatory Action Letter Followup W.

Review of 10 CFR Part 21 Reports W 92715

,r" 93710 Followup on Significant Event Occurring During an Inspection W

. .a

" Codes for inspection frequencies:

I = initial inspection W = when required P = by priority of license X = each inspection

• • As applicable to the activities of the licensee being inspe'cted.

• • • When procedure become effective.

~

04/08/87 T2-2 2800 Issue Date:

L_._______________________.__

k ,, . .: E -Enclosure 1

, y 4

Telep' hone Contact Procedures for Priority 5, 6, and 7 Licenses I ', ,

Program Ob.iectives:

In the past there have been times when manpower limita- i tions by the : NRC..

have required exempting lower priority To licensees ^

improve from number of licensees many of which had never been inspected.of th general performance was developed so each licensee would be . interviewed at least once

.procedure during the duration of.the license and at some periodic frequency thereaft to be determined by the regional staff.

2800-05) from the' computer 1.- Select license to interview at random (seeAfter this is done, select.11-listing of. licenses never inspected.'consees that have had in inspected infrequently (Priority 5).

Pull the license file and review the file to determine the person to

2. contact for. information needed to complete interview questionnaire-(Enclosure 2).

Note that not all licen-

3. Telephone licensee and complete questionnaire.

ses require each procedure mentioned in the questionnaire.

4. If the licensee reports any problems, namely:

personnel exposures in excess of 1.25 rems for a calendar quarte

'/' a.

b. lost licensed material f c. leak tests indicating source leakage or

d. any event the licensee considered unusual The person filling in the questionnaire Provide the Sectionshould Chief with promptly the appropriate notify . the Ma terials Section Chief.

draft letter (Enclosure 3).

1

5. If the licensee responses confirm no problems Section Chief.

6. Send package to Section Chief for review.

NOTE: of the backlog of overdue materials inspection ties (1, 2, 3, 4).

1 Issue Date: 04/08/87 El-1 2800

.+ . . .,

Enc 1csure 2 EVALUATION OF POSSESSIONS AND USE OF BYPRODUCT MAT License Number:

Name:

. Phone Number:

Address: _

Name and Title of person responsible for radiation safety program:

Describe how this material is used:

from use by unauthorized Describe how you safeguard the byproduct material personnel:

A..

i

?!?

Describe how you safeguard the material from loss or theft:

Describe controls which prevent individuals who work in the area around the material from becoming exposed to radiation:

Do you have a personal monitoring program No for your employees such a Yes badges, dosimeters, ;

If yes, were there any exposures to individuals? in excess of 1.25 rems fo any calendar quarter for the year (s)

No Yes k

Issue Date: 04/08/87 E2-1 2800

-=-_________- _ _ _ _ _ _ _ _ __ _ _ _

.y ..

'Da y u p rferm surv:ys- to datcct external radiatien in the area' creund the , i bypr: duct material? Yes No -l If'yes, how often are the surveys performed? l

.(.-'

What instrument is.used to perform the surveys?

4 When was this instrument last calibrated?

On. what date was the last physical inventory of all byproduct material in your possession performed?

Yes No Do you perform: leak tests on the sealed source?

If yes, how often are these. leak tests performed?

i Who evaluates the' leak test results?

If no, describe the provisions you have made to have the leak tests done:

Describe your provisions for repair. and maintenance of your device or source holder:

(

- (.

m Describe any unusual events involving the byproduct material or device (s) in which it is used:

Name of person filling in questionnaire Title Date s

2800 Issue Date: 04/08/87 E2-2

Enc 1csure 3 License No.

Gentlemen:

, 19 _.

This refers to a telephone contact conducted on The contact was an examination of activities The contact con- conduct and regulations and with the conditions of your license. .

sisted of discussions with As a result of this examination of activities, regulatory concer and are specified below.

your facility in the near future.

As you described on the telephone, the following apparent regulatory conce were identified.

(examples) '

at the required intervals leak test sealed sources

/" #

1. failure to rems to an individual during the third quarter of

' 2. an exposure of 1986* curies of

- 3. an apparently lost gauge containing l

• (If apparently serious enough (such as overexposure), add the follo You should examine your license and NRC regulations to determine how you c correct the apparent regulatory concerns that you dis  !

should pay particular attention to as follows:

l

a. maintaining awareness and control of licensed material b.

c. proper transfers and disposal of radioactive sourcesp If you have any questions regarding this contact, you may contact us at Sincerely, j

_, Chief Nuclear Materials Safety and Safeguards (Branch or Section) bCC x i DCS/RSB (RIOS)

Issue Date: 04/08/87 E3-1 2800 j

~

,* Enclosure 4

. i-License No.

Gentlemen:

, 19 _.

This refers to a telephone contact conducted on The contact was an examination of activities conducted under your license as they relate to radiation safety and to compliance of the Commission's

• rules and regulations and with the conditions of your license. The contact .

consisted of discussions with No regulatory concerns were identified.

. If you have any questions regarding this contact, you may contact us at Sincerely, I , Chief Nuclear Materials Safety and

(

Safeguards (Branch or Section) en DCC DCS/RSB (RIDS)

E4-1 Issue Date: 04/08/87 2800

ps ma,q i

.$ I' UNITED STATES

~-

i' .Y .S NUCLEAR REGULATORY COMMISSION 5

! OFFICE OF INSPECilON AND ENFORCEMENT Washington, D.C. 20555 g.....,/ -

INSPECTION AND ENFORCEMENT MANUAL DQASIP CHAPTER 0611 ,.

REVIEW AND DISTRIBUTION OF INSPECTION REPORTS 0611-01 PURPOSE To identify the steps and procedures for reviewing inspection reports to guard against inappropriate release of exempt information and for the subsequent distribution of final inspection reports to other NRC offices, other government agencies, and the public.

l 0611-02 POLICY 02.01 To the extent possible, all final inspection reports will be l made available to the public after the reviews identified in Section 05 of this manual chapter have been completed.

02.02 Under no circumstances shall draft inspection reports or por-tions of such reports be reviewed with licensees or given to l licensees, their agents, or any member of the public without the express permission of the Executive Director for Operations.

This does not preclude IE or regional management from discussing inspection findings with licensee management or their agents for the purpose of effecting corrective action relating to safety or security matters before' the time the report is in final form. (See IE Manual Chapter 0610 and EDO Policy Letter

" Policy on the Distribution of Draf t Inspection and Investi-l gation Reports," dated October 7, 1983.)

02.03 Proprietary review of draft inspection reports will be accom- It plished by the NRC staf f without licensee or vendor review.

is the responsibility of the licensee or vendor, in the first instance, to identify and/or tell the inspector that the mate- If rial provided in the course of an inspection is proprietary.

significant doubt arises regarding the proprietary nature of material in the report, licensee / vendor review may be requested of the final inspection report before distribution.

02,04 All reports will be reviewed by the NRC staff to ensure that the reports do not contain exempt information within the meaning of 10 CFR 9.5(a). Once reports are cleared by this review process all nonexempt portions will be placed in the Public Document Room (PDR)(see Section 05.01 and 05.02).

Issue Date: 09/14/84

v- o .

' REVIEW AND DISTRIBUTION 0F INSPECTION REPORTS 0611-02.05 i

Those portions of inspection reports deemed by staff

~

to contain f 02.05 (safeguards), i

'f sensitive information as in 10 CFR 73.21 information that meets the test of 10 CFR 2.790(d)(1) (physical -

protection), or classified information (e.g. , NstionalTherefore Security)a will be routinely withheld from public disclosure.

review of those portions of the report by licensees and vendors, is not necessary. All safeguards and/or classified information is required to be contained in an enclosure to the inspection report (see IE Manual Chapter 0610-06).

0611-03 DEFINITIONS Draft inspection report. All versions of the inspection report 03.01 before the published version. It is to be considered a draft

-inspection report from its initial development, and throughout the period of supervisory and management review, until final signature, publication and distribution in accordance with this manual chapter.

03.02 Exempt information. Information not releasable to the public and normally not to be included in inspection reports. This information includes:

a. The personal advice, opinions, and recommendations of the inspector as opposed to an NRC position, opinion, or recom-mendation or the inspector's presentation of technical

(

positions on items and areas inspected (ref. 5 U.S.C.

552(b)(5)).

b. Identity of persons providing information to the NRC under an express pledge of confidentiality or under such circum-stances that confidentiality can be inferred and any de-tails of the confidential information that would reveal the identity of such persons (ref. 5 U.S.C. 552(b)(7)).

c. Names of individuals who have received exposure to radia-tion or other identifying information and other personal and medical information, ,the disclosure of which would constitute a clearly unwarranted invasion of personal privacy (ref. 5 U.S.C.552(b)(6)).

d. Excerpts from NRC or other government agency documents that have not been disclosed to the public (ref. 5 U.S.C.552(b)

(5)).

e. Information exempt from mandatory public disclosure pur-suant to 5 U.S.C. 552(b)(4) - trade secrets, commercial or financial information.

f .' Safeguards information pursuant to Section 147 of the Atomic Energy Act.

Exempt information in accordance ith this manual chapter g.

also includes:

09/14/84 2 Issue Date: I i--__ -_ _- _ --- _ l

. l

..

• l l

REVIEW AND DISTRIBUTION .

0611-03.02g1 l OF IRSPECTION REPORTS  !

. i

1. Information exempt from mandatory disclosure under 10 CFR 2.740, " General Provisions Governing Discovery;"

and 10 CFR 9.5, " Exemptions." .

2. Information received by the Commission as set forth in  !

10 CFR 21.2, submitted to this agency pursuant to a claim for withholding from public disclosure, relating that a facility or activity or basic component sup-plied to a facility or activity; I (a) contains substantial safety hazards, or (b) contains defects which could create a substantial safety hazard.

3. Information submitted in confidence to the NRC by a foreign source and which is determined by-NRC to be exempt from public disclosure pursuant to 10 CFR 2.790(d)(2).

Final inspection report. The report of inspection which has 03.03 received concurrence and signature by all appropriate levels of management and has been published and distributed in accordance with this manual chapter.

Proprietary information. Information that is a trade secret, 03.04 commercial or fissancial information or other information exempt from mandatory public disclosure (see Section 03.02 above).

i 0611-04 RESPONSIBILITIES IE/ Regional management. To guard against inappropriate release 04.01 of exempt information in inspection reports by ensuring that all steps and procedures identified in this manual chapter are followed in the conduct of the inspector's proprietary review of inspection reports and the subsequent distribution of the reports.

04.02 IE/ Inspection staff. To guard against release of exempt infor-mation in inspection reports by following the steps and proce-dures identified in this manual chapter.

0611-05 REVIEW OF INSPECTION REPORTS 05.01 A review of draf t inspection reports will be contuJted at the branch chief or section chief level to determine if the report

- contains exempt information. This type of information is not releasable to the public and normally is not to be included in inspection reports. However, there may be cases where despite j

3 Issue Date: 09/14/84

y * .

REVIEW AND DISTRIBUTION 0F INSPECTION REPORTS 0611-05.01 efforts of the report writer, some information, which is [

the considered exempt, may be acquired and inadvertently appear in a report If exempt information must be included, such information is to be contained separately in an enclosure to the report or, if this is not possible, the inspector should ensure that sections that have exempt information in them are clearly marked in If the accordance with NRC Manual Chapter 2101, Part XVI. 1 after review, does not appear to contain exempt '

report, information, the procedure for distribution of inspection reports (Section 06 below) will be followed.

05.02 Inspection reports containing safeguards information will be Before controlled in accordance with NRC Manual Chapter 2101.

placing these reports in the PDR or making general distribution, The summary shall all safeguards information will be deleted.The description of subjects contain no safeguards information.

examined shall normally present no particular problem in draft-ing the description to exclude exempt information, but care and deviations must be should be exercised. Violations described in general terms to preclude disclosure of exempt information.

.- 05.03 If the report contains proprietary information, those portions will be marked in accordance with NRC Manual Chapter 2101, Part I

XVI, and distributed (see Section 06 below). If there isis significant doubt as to whether or not the material proprietary, then a copy of the suspected final _ report will be sent to the licensee / vendor for proprietary review purposes only. The letter transmitting the report for review will review and contain a paragraph which provides specific An example is given below.

notification instructions.

"In accordance with 10 CFR 2.790(a), a copy of this letter and the enclosure will be placed in the NRC Public Document Room unless you notify this office, by telephone, within 10 days of the date of this letter, andcontained submit written therein application to withhold information promptly thereaf ter. Such application must be consistent with the requirements of 10 CFR 2.790(b)(1). If we do not hear from you in this regard within the specified periods noted above, this report will be made available to the public and placed in the Public Document Room."

05.04 If the licensee / vendor does not notify the regional office or IE headquarters in the case of IE conducted inspections within 10 calendar days from the date of the NRC transmittal letter that it intends to file a request for withholding, the report will be distributed in accordance with Section 06 below.

l 05.05 In the event a licensee / vendor fails to file a timely (25 calendar days from the date of transmittal letter) application, following notification to the region or IE headquarters that one 4

Issue Date: 09/14/84

_ _ . _ _ _ __ _ _____-__________-__________-______-_-___L__-

REVIEW AND DISTRIBUTION ^

0611-05.06 OF INSPECTION REPORTS will be forthcoming, the region or headquarters (at least at the branch chief level) shall notify the licensee / vendor - tele-phonically and in writing that the report in question is being '

released to the public unless extenuating reasons dictate otherwise.

05.06 Following receipt of an application from a licensee to withhold infomation, the regional office must make a decision as to whether the' claim appears to be justified. All such claims must be reviewed by the Regional Counsel. In the case of claims

- relating to IE inspection reports, the Director, IE will review these claims with the Office of the Executive Legal Director (ELD). The Regional Administrator or Director, IE is authorized to approve an application to withhold information from public disclosure.

05.07 If the Regional Administrator maintains that the claim should be rejected, the matter will be reviewed by the Regional Counsel.

In the case of claims relating to IE headquarters inspection reports, the matter must be forwarded to ELD. Such discus-sion or tranmittal should include a discussion of the reasons why the licensees' or affected parties' claim should be rejec-ted., The affected licensee ce party should be notified that the matter has been referred to ELD and that public disclosure of e the particular inspection report or portions thereof will be i held in abeyance pending resolution.

05.08 If the Regional Administrator or Director, IE approves the licensee's claim to withhold exempt information, IE or the region must ensure that all copies of the report to be distributed outside the NRC by IE or the region are treated This is to be done by to delete the exempt information. information, cutting the adding the blackening or out designation " exempt informationIEdeleted" or the region in the margin must retain and reproducing the treated pages.

an untreated version of the report with the cover sheet and pages of the inspection report clearly marked that the report exempt from public disclosure under contains information 10 CFR 9.5(a)(4).

0611-06 DISPATCH OF REPORTS After the review process identified in Section 05 above is completed, inspection reports should be distributed promptly by IE headquarters or be the region. Distribution patterns for inspection reports shall established as follows:

06.01 . For each licensee and vendor, a distribution list should be established, as appropriate, to provide copies to the licensee's site and/or corporate headquarters, state and local governments, other entities as appropriate, and internally within the region and IE.

5 Issue Date: 09/14/84

REVIEW AND DISTRIBUTION 0F INSPECTION REPORTS 0611-06.02 06.02 Distribution of inspection reports to the Public Document Room, (

Local Public Document Room, and to other offices within NRC will be accomplished through placement of the report in the0232,"

Chapter NRC .

Control System. See NRC Manual Document Placement of Documents in the NRC Document Control System."

The original final report will be filed in ~ the region or IE in accordance with NUREG-0910.*

06.03 ' Certain U.S. Government agencies have asked the NRC .to send copies of inspection reports to their agency coordinators for inspections. Exhibit 1 identifies the agencies and provides the addresses of the coordinating offices.

06.04 All materials inspection reports prepared in accordance with IE f Manual Chapter 0611 must be placed in the NRC Document Control System (DCS). Formal reports are written only for (1) inspec-tions of Priority I licensees -(2) inspections conducted in response to allegations which are significant to-public health and safety (3) inspections which will result in escalated enforcement actions and (4) inspections of special incidents such as overexposure, large release of radioactive material, etc. For all other. materials inspections only the cover page of the report needs to be entered into the DCS. The cover page with the field notes attached are to be maintained on file at the regional cffices for as long as the regions wish but not l ,,

less than 5 years after review for retirement in accordance with l'

NUREG-0910.* Formal reports, Notices of Violation (NOVs),

(including Form 591 NOVs clear or not clear) and licensee responses to NOVs, are to be forwarded to IE headquarters.

These will be reviewed by IE to assess the materials inspection program implementation in the regions.

Commission, NUREG-0910, "NRC Comprehensive "U.S. Nuclear Regulatory Records Disposition Schedule," dated July 1982.

END s

09/14/84 6 Issue Date:

je REVIEW AND DISTRIBUTION EXHIBIT 1, 0611 4 0F INSPECTION REPORTS Distribution of Inspection Reports to Coordinators of U.S. Government Agencies A. Department of the Navy Licensees Whenever inspection reports are sent to

1. Nonmedical Licensees.

the Department of the Navy nonmedical licensees, copies of the reports shall be sent to the folinwing two coordinating offices:

a. Officer-in-Charge Naval Energy and Environmental Support Activity Port Hueneme, CA 93043

b. Head Radiological Affairs Support Program Department of the Navy Naval Facilities Engineering Command 200 Stoval Street Alexandria, VA 22332 Medical Licensees. Whenever correspondence is sent to the Depart-2.

ment of the Navy medical licensees, copies of the correspondence shall be sent to the following coordinating office:

Department of the Navy

/

Bureau of Medicine and Surgery Code 3C222 Washington, DC 20372 B. Department of the Army Medical Licensees Whenever inspection reports are sent to the Department of the Army medical licensees, copies of the reports shall be sent to the following coordinating office:

Of ficer-in-Charge ATTN: DASG-PSP Department of the Army Office of the Surgeon General Washington, DC 20310 E-1 Issue Date: 09/14/84

.a;+w ~

REVIEW AND DISTRIBUTION EXHIBIT-1, 0611 0F INSPECTION REPORTS F ,

U.S. Environmental Protection Agency (EPA) Licensees i

C.

Whenever inspection reports are sent to the EPA licensees identified

• below, a copy of the report shall be sent to the following coordi-

.nating office: ,

Mr. J. S. Coogan U.S. Environmental Protection Agency P.O. Box 15027 Las Vegas, Nevada 89114 List of EPA licensees:

License Number Location 01-07317-01 Montgomery, AL 04-12703-01 Alameda, CA 05-14892-01 Denver, CO 05-14892-02 Denver, CO 08-14907-01 Washington, DC 09-10672-02 Gulf Breeze, FL 10-10146-01 Athens, GA 19-14125-01 Annapolis, MD Needham Heights, MA 20-14039-01 22-13390-01 Ouluth, MN I

23-15096-03 Bay.St Louis, MS 24-13753-01 Kansas City, MO 27-05861-01 Las Vegas, NV 27-05861-02 Las Vegas, NV 29-12946-01 Edison, NJ Research Triangle Pk, NC 32-14048-04 34-12736-02 Cincinnati, OH 35-11581-02 Ada, OK -

36-12343-02 Corvallis, OR 38-11957-01 West Kingston, RI 42-15778-01 Houston, TX Redmond, WA 46-10100-02 47-13313-01 Wheeling, WV Denver, CO SNM-693

0. Department of Health and Human Services Whenever inspection reports are sent to Indian Health Service, a division of the Department of Health and Human Services (formerly HEW), copies of the reports shall be sent to the following coordinating office:

Indian Health Service -

ATTN: ISH Institutional Environmental Health Officer ,.

c/o Phoenix Indian Medical Center s 4212 N 16th Street Phoenix, AZ 85016 09/14/84 E-2 Issue Date:

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-Training Course Safety and Regulation of Sealed Sources of Radioactive Materials 10 April-12 May1989 Lecture 42.3.10 General Inspection Procedures SUPPLEMENT A Medical Teletherapy Inspection Field Notes by Darrel Wiedeman U.S. Nuclear Regulatory Commission Glen Ellyn, Illinois O4  % 21 April 1989

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UNITED STATES '

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j MEDICAL TELETHERAPY INSPECTION FIELD NOTES

'- Inspection Rep -' No. License No.

Licensee (Name and Address) 1 i e Telephone No.

Licensee Contact License No.

Date of Amendment Last Amendment No.

Priority: 3 Program Code: 02300 Date of Inspection I'

Type of Inspection: ( ) Announced ( ) Initial

( ) Unannounced ( ) Special

( ) Reinspection Next inspection Date ( ) Normal ( ) Reduced ( ) Extended Summary of Findings and Action:

( ) No violations, Clear E91 issued ( ) Action on previour violations

( ) Violations, SSI issued ( ) Regional Action Letter with NOV

( ) Reinspection Persons Contacted

• Atterded exit interview Inspector (Date Signed)

(Signature)

Approved (Date Signed) L[gv ce (Signature) Date: 03/16/88

_ _ _ _ _ _ _ _ ___-______ -__-_ _ ______ _ 1

3

1. ORGANIZATION A. Material used by or under supervision of authorized users. "

( ) Yes ( ) No Remarks B. " Visiting physician" condition on the license or 35.27.

( ) Yes ( ) No If so, has licensee complied with all requirements of license condition or regulation. ( ) Yes ( ) No C. Name of consulting physician if not listed under persons contacted.

( ) N/A

7. INSPECTION HISTORY A. Violations or deviations noted during last inspection conducted on . ( ) Yes ( ) No 4

f Corrective Action Taken Status B. Recuirteent Violetion ( ) Yes ( __

) No ( ) Open ( .) Close Remarks C. If any violations or deviations noted during last inspection were not corrected, explain V

2

3. SCOPE OF PROGRAM

4. TRAINING A. Status of individual designated as " teletherapy physicist".

Certification by Education & Experience ( ) Yes ( ) No (10 CFR 35.961 or 35.606(e))

B. Training program for personnel implemented ( ) Yes ( ) No

( ) 35.25(a)(1)(?)and(3)

C. Retraining program implemented. ( ) Yes ( ) No ( ) N/A Remerks D. Training records maintained for 2 years (35.610(c))

( ) Yes ( ) No

5. RADIOLOGICAL PROTECTION PROCEDURES A. Emergency procedures posted. ( ) Yes ( ) No -

Remarks. (35.610(a))

3

l-l .

l B.

Individuals(

adequate. understanding)of

) Yes ( No operating and emergency procedures (35.610(b))

Remarks .

6. MATERIALS, FACILITIES, AND INSTALLMENTS A. Amount and use of material as authorized. ( ) Yes ( ) No B. Possession and use of depleted uranium as shielding as authorized, if needed.

( ) Yes ( ) No '

C. Facilities as described in License Application (35.606).

( ) Yes ( ) No Remarks D. Inspection and servicing perfomed during source replacement or at intervals not to exceed 5 years (35.647) ( ) Yes ( ) No Remarks 1i E.

Perfomed

(- ) Yes by(

) Nopersons specifically authorized to do so (35.647(b

1. Any work (other than in D. above) done. ( ) Yes ( ) No If so, done by authorized personnel. ( ) Yes ( ) No Remarks F. Facility providec' with system to pemit e.ontinuous observation of the patient (35.615(e)) ( ) Yes ( ) No Remarks G. Facility provided with interlock system to control access to treatment room (35.615(b)(1)(2) and (3)). ( ) Yes () No s

I 4

H.

Interlock

( ) Yes sy(stem

) No tested at 1-month intervals (35.634 (d)(1))

Remarks I. Records of interlock tests (35.634(f)) ( ) Yes ( ) No .

Remarks J. Leak tests performed as required (35.59(a)) ( ) Yes ( ) No Remarks K. Leak test performed by authorized individual. ( ) Yes ( ) No Remarks L. Results of leak tests recorded (35.59(d)). ( ) Yes ( '

No Remarks

( M. Postino of area, rooms and teletherapy unit is adequate.

( ) Yes ( ) No Remarks N. Facility maintained locked daring malfunction when access to an area is required (35.C36(b)).except during p(eriods

( ) Yes ) No

0. Survey instruments calibrated as required (35.620).

( ) Yes ( ) No Remarks P. Dosimetry system calibrated by NBS or ac' credited lab within 2 years (35.630). ( ) Yes ( ) No Remarks Q. Permanent radiation monitor in accordance with 35.615(d).

( ) Yes ( ) No R. Records of daily monitor check (35.615(d)(a)). ( ) Yes ( ) No 5

i S. If radiation monitor nonfunctional, was survey meter used (35.615(d)(5)). ( )' Yes ( ) No l

Radiation monitor repaired promptly? (35.615(d)(6)) -

( ) Yes- ( ) No T. Facility equipped with functioning beam condition indicator light (35.615(c)). ( ) Yes ( ) No

7. RECEIPT OF MATERIAL A. Transfer of licensed material in accordance with Part 30.41.

( ) Yes ( ) No Remarks B. Record of transfer and receipt maintained (30.51(c)(3)).

( ) Yes ( ) No ( ) N/A Remarks PERSONNEL RADIATION PROTECTION - EXTERNAL ,,

B.

A. Film or TLD badge supplier Frequency Reports reviewed by Frequency

. B.

C. MRC inspector, reviewed personnel monitoring records for period i

to D. NRC form or equivalent (1)NRC-4( ) Yes ( ) No Complete ( ) Yes ( ) No (2) NRC-5 ( ) Yes ( ) No Complete ( ) Yes ( ) No Remarks E. Maximum quarterly whole body exposure .

F. Maximum quarterly extremity exposure .

G. Licensee has implemented an ALARA Program (35.20).

Remarks II 6

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I I

9. SURVEYS l

1 A. Surveys have beca conducted in accordance with 35.641. ,

(1) before first patient treatment ( ) Yes ( ) No

.(2) after new source installation ( ) Yes ( ) No (3) after any changes in room shielding ( ) Yes ( ) No Remarks B. Surveys of areas adjacent to treatment room were conducted (1) before first treatment ( ) Yes ( ) No Remarks (2) after new source installation ( ) Yes ( ) No Remarks (a) after any changes in room shielding, location of the unit within the treatment room or use of the unit.

( ) Yes ( ) No Remarks (b) survey results of console area and entrance to treatment roem with beam "on".

(c) measurement cf radiation levels in areas adjacent to teletherapy room w'Ith beam on.

Remarks

10. NOTIFICATIONS AND REPORTS A. Licensee in compliance with 10 CFR 19.13 (reports to individuals).

( ) Yes ( ) No Remarks s

7

A B. Licensee in compliance with 10 CFR 20.405 (overexposure).

( ) Yes ( .) No Remarks C.. Licensee in compliance with 10 CFR 20.403 (incidents).

l- ( -) Yes ( ) No Remarks D. Licensee in compliance with 10 CFR 35.33 (misadministration).

(. ) Yes ( ) No Remarks

11. POSTING OF NOTICES Notices to workers post.ed (19.11). ( ) Yes ( ) No Remarks e

12. BULLETINS AND INFORMATION NOTICES A. Bulletins and Information Notices issued during current year.

B. Bulletins and Information Notices received by licensee.

( ) Yes ( ) No F.emarks C. Licensee took appropriate action in respot.se to Bu11stins and Information Notices.

( ) Yes ( ) No Remarks

13. TELETHERAPY CALIBRATION 8

l A. Full Calibration (35.632).

(1) Performed: .

(a) prior to first use on humans (35.632(a)(1)).

( ) Yes ( ) No Remarks (b) after source change, relocation, major repair 35.632(a)(2)(ii). ( ) Yes ( ) No Remarks (c) annually (35.632(a)(3). ( ) Yes ( ) No Remarks

- (d) whenever spotchecks indicate output change 25%

1 (35.632(a)(2)(1)). Remarks (2) Full Calibration (35.632(q)(3)).

(a) exposure rate or dose rate to an accuracy.A3% (35.632 (b)(1)).

( ) Yes ( ) No Recarks l

(b) for all field sizes and treatmentRemarks distances (35.632 (b)).

( ) Yes ( ) No i

1 (c) congruence ( ) Yes ( ) No Remarks 1

(d) timer accuracy (35.632(b)(4)). s (e) accuracy of all distance measuring devices (35.632(b)(6)).

9

1

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(3) Proper procedure followed - American Association of Physics-in Medicine (AAPM) (35.632(d)). ( ) Yes ( ) No Remarks (4) Performed with' instrument calibrated by NBS or accredited lab within previous 2 years (35.630(a)). ( ) Yes ( ) No Pemarks (5) Records of full calibration (35.632(g)). ( ) Yes ( ) No Remarks i

(6) Performed by therapy physicist (35.632(f)).

Remarks B. Monthly Spot Checks (35.634) ,

(1) Performed monthly (35.634(a)). ( ) Yes ( ) No Remarks (2) Perforned by or in accordanca with proceo'ures established by the teletherapy physicist (35.534(b)). ( ) Yes ( ) No If teletherapy physicist oces not perform spot checks, results checked by teletherapy physicist within 15 days (35.634(c)).

( ) Yes ( ) No  !

(3) Spot Checks include (35.634(a)(1 thru 6)).

(a) timer accuracy ( ) Yes ( ) No Remarks ]

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,  : -. 3 (b) Coincidence ( ) Yes ( ) No Remarks i

(c) accuracy of distance measuring device ( ) Yes ( ) No Remarks (d) output ( ) Yes ( ) No Remarks (e) difference between measured and expected output

( ) Yes ( ) No Remarks (f) spot checks performed using NBS/ regional lab calibratet' instrument or direct intercompairson with same (35.630).

( ) Yes ( ) No (g) records of monthly spot check (35.634(f)).

( ) Yes ( ) No Remarks

.s e

11

'14. PROTOCOL.

A. Does licensee participate? -

(- -) Yes - Complete Section- 16 only

(- ) No - Complete Sections 15 and 16 B. If "Yes" . protocol is part of:

( ) NBS

( ) National Cancer Institute Center for Radiological Physics

( ) AAPM - Radiological Physics Center C. Date of last intercompairson .

D. Were results with.!5% ? ( ) Yes ( ) No Remarks

15. OUTPUT VERIFICATION A. Type of Unit Co-60 Cs-137  ; Curies as of (date) , , . .

Machine make Model Shutter Type Type of machine mount: Vertical Isocentric Other(specify)

B. Licensee's Data laken from ( ) monthly spot check

( ) full calibration x h i

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2 mR/hr average 2 mR/hr average ind 10 mR/hr maximum ind 10 mR/hr maximum at 1 meter at 1 meter

( ) Yes ( ) No

()Yes ( ) No . .

16. APPARENT VIOLATIONS FOUND

17. OC/QA PROGRAM A. Has the licensee iglimented a QC/QA Program ( ) Yes ( ) No B. Description of qurlity assurance program to prevent misadministration for therapy patients.

(1) Havesecondary)checksofthedosecalculatinsbeendone7

{

( ) Yet ( No l l

(2) Do the second party checks of the dose calculations provid5 assurance that the final treatment plan will provide the dose prescribed on the patient chart ? ( ) Yes ( ) No (3) Do technologist consult with the doctor if the prescription 4 or other orders are unclear ? ( ) Yes ( ) No Remarks  !

N j

13

C

• C. Followup on therapy misadministration (1) 10 CFR 35.33 properly implemented ? ( ) Yes ( ) No .

(2) Was proper medical care given for the patient pursuant to the NRC medical consultant recommendations ? ( ) Yes ( ) No (3) Were appropriate actions implemnted to prevent recurrence ?

( ) Yes ( ) No (4) Were the technologist and dosimetrist made aware of these actions ? ( ) Yes ( ) No (5) Does the licensee's OA/QC procedures address these actions to prevent recurrence ? ( ) Yes () No Remarks

• Inspect the QA Pitgram and misadministration when the rule becomes final.

i 96 l

x l

14

4 Attachment 3 PERFORMANCE EVALUATION FACTORS Licensee:

License No.:

Date of Inspection:

Inspector (s):

1. Does the Radiation Safety Committee appear to be functioning adequately to successfully implement the licensee's radiation safety program? (e.g., Is membership and attendance at meetings adequate? Are adequate reviews of users and/or facilities being conducted? Are meaningful issues being discussed at the meetings?)

l

( ) Yes ( ) No ( )N/A

2. Is the Radiation Safety Officer (R50) able to perform his or her duties adequately without being burdened by other duties?

( ) Yes ( ) No ( ) N/A

3. Is sufficient staffing available to manage the licensed prograr workloac?

( ) Yes ( ) No ( ) N/A 4, Does licensee renagement prtvide support for the radiation sa'ety aspects of the licenscd program?

i

( ) Yes ( ) No ( )N/A

5. Does the licensee have the resources to operate the facility safely and support decortanination of the facility if necessary?

( ) Yes ( ) No ( )N/A

6. Is it evident that the licensee is capable of respondire to a radiological event?

( ) Yes ( ) No ( ) N/A s

Attachment 3 . ..

7. Are periodic audits conducted of the radiation safety program by the licensee and/or a contractor and do the audits appear adequate? 3

( )Yes ( )No ( ) N/A

. 8. Are licensee's radiation exposures in accordance with ALARA?

( )Yes (- ) No ( )N/A

9. Are reportable events (10.CFR 20.402, 20.403, 20.405) kept to a level commensurate with the licensee's workload?

( ) Yes ( ) No ( ) N/A

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( ) Yes ( ) No ( )N/A t

11. Are safety-related allegations kept to a minimum level? Does the licensee have an adequate system to follow up on complaints?

( ) Yes ( ) No ( ) N/A

12. Are licensee's reports and responses to violations complete, candid and ,,,

timely?

( ) Yes .( ) No ) N/A

13. Are misadministration (diagnostic or therapeutic) kept to a level con:ner.surate with the licensee's work 1 cad?

( ) Yes ( ) No ( ) N/A 14 Oce: the licentee have sufficient instrumentation to safely manage *he program and are those instruments properly maintained? (e.g., Is there a preventive maintenance / quality assurance program?)

( ) Yes ( ) No ( )N/A

15. Does the licensee have an adequate program in place to store radioactive waste safely? (e.g., Are materials properly labeled and inventoried? Is exposure to the elements contro11et?)

( ) Yes ( ) No ( )N/A h

2

Attachment 3 Inspector's Coments: (Required for any factor given a. negative response)

{

Action Recuired: (As deemed by Region III management, i.e., telephone contact, licensee management meeting, increased inspection effort, etc.)

~

(

Action laken:

Section Chief Signature: Date:

3

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IAEA l IAEA Training Course l Safety and Regulation of Sealed Sources of Radioactive Materials 10 April-12 May1989 h- Lecture 42.3.10 General Inspection Procedures SUPPLEMENT B:

Industrial - Academic Inspection Report y - ,.

Darrel Wiedeman U.S. Nuclear Regulatory Commission Glen Ellyn, Illinois

1. 1. 21 April 1989 V

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INDUSTRIAL - ACADEMIC INSPECTION REPORT

o ~

Inspection' Report No. License No.

Docket No.

Licensee (name and address)

I Telephone No.

Licensee Contact Date of Amendment Last Amendment No.

Category Priority Program Code Date of Inspection

( ) Announced ( ) Unannounced ( ) Normal Type of Inspection: ( ) Special ( ) Reinspection

( ) Initial Ntxt Inspection Date

( ) Normal ( ) Reduced ( ) Extended

{

l Summary of Findings and Action:

( ) No Violation, Clear 591 issued ( ) Actiori on Previous Violation

( ) Violation (s), 591 issued (.) Regional Action

( ) Headquarters Action

( ) Violation (s), Appendix Inspector: (Date Signed) l (Signature) l Approved: (Date Signed)

(Signature) l s

{

2.- INSPECTION HISTORY .

a. Items of noncompliance or safety items noted during last inspection conducted on Yes N o___, ,

Corrected by letted dated -

q

b. Requirement Corrected Not Corrected .

c. If any items of nonco,mpliance or safety items noted during the last inspection were not corrected, explain:

?- .

2. Creanization

a. Organizational structure as described in application or letter 2 Dated

, Or

b. List primary licensee contact: Telephone No.

c. Comments: .

3.

SUMMARY

OF LICENSED PROGRAM (Kind of program, number of people, rate of use or quantities on hano, places and frequency of use, type, quantity and l .

J useasauthorized).

6 W

e p

e 2

J 1

. .. 1 1

i i

4 INTERNAL AUDITS OR INSPECTIONS

a. Required by L/C or application: Yes No If "Yes":

1 By whom -

2 Frequency Announced: unannounced:

3 Scope i 4 Records maintained: Yes No 5 Records reviewed: Yes No 6 Period Reviewed:

b. Comments (responsibility of auditor or committee, management control): ,,

v

5. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS

a. Training program specified in L/C or application: Yes No

b. If training program is required, describe scope of program:

,e.

n r

~

c. Retraining required: Yes No Complete Incomplete

~

If "Yes" is retraining:

1 Are tests and/or examinations required: Yes No .

2 If "Yes" are records available: Yes No /

3 Reviewed test results: Yes C' -

?

4) Period reviewed:

5) Conments (per cent completec, test results, etc.):

I Training provided, but not covered above:

d.

e. Instructions to workers in accord with 10 CFR 19.12: Yes No 3 .. .

. .. g - .

-6. - RADIOLOGICAL PROTECTION PROCEDURES

a. erating and Emergency Procedures  !

Required by L/C or application: Yes No ,

0p)p 1

2 Provided, but not Norequired by L/C or applicat Yes No 3 i Procedures reviewed: Yes r 4h Appeared adequate: Yes No

5) Coments (personnel's uncierstancing of procedures):

c Changes in procedures since last inspection: Yes No

b. No

1) Were changes authorized: Yes

2) Coments:-

b

, 1 INSTRUMENTATION Type (s) of radiation' survey instruments on hand as per L/C. applica-

.' ' '_ a.

tion or equivalent: Yes No

1) If "No" list changes:

f.. ,

b. Capability of radiation survey instruments adequate for program: ,' ,

Yes No  ;

c. Calibration of instruments required: Yes No

d. If "Yes", instruments calibrated in accord with requirements:

Yes No '

e. Coments:

9 4

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O 4

=

4

~

8. MATERIALS _

a. Radioactive material secured to prevent unauthorized removal from:

1) Restricted area: Yes No .

2) Unrestricted area (20.207): Yes .,

b. Methodofcontrolappearadequ$te: Yes No 1

c. Coments:

9. FACILITIES

a. Facilities described in letter or application: Yes No

b. Facilities inspected: Yes No ,

c. Coments:

10. POSTING AND LABELING

a. Posting and labeling in accord with 10 CFR 20.203: Yes No

b. Coments:

11. RECEIPT AND TRANSFER OF MATERIAL l

a. Procedures for picking up and receiving packages (10 CFR 20.205[b)[c]l Yes No 1 Incoming shipments monitored: Yes No 2)) Records of monitoring maintained (10 CFR 20.401Lej): Yes No~~

3) Records reviewed by HRC inspector: Yes No 4J Period reviewed:

b. Proceduresforopeningpackages(10CFR20.205[d)): Yes No .,

c. Coments: _

5

~

l

s

.t

. , 3

d. Records of receipt and transfer of seterial available (30.51[a);

40.61[a);70.51[b3[1]): Yes No If "Yes", review of records was made by inspector: .Yes No .

1 .

2 Period reviewed:

3 Comments: ,

i

e. Packages on hand meet labeling requirements (49 CFR 173.399):

Yes No

. Comments:

f. Reports to connission required by L/C or regulation submitted:

Yes No' .

Comnents:

-. I2. PERSONNEL RADIATION PROTECTION - EXTERNAL

.1 s. Film or TLD badge supplier

<~b

b. Badge exchange frequency

c. Reports reviewed by

d. Records reviewed for period to by NRC inspector

[

e. NRC forms or equivalent

1) NRC-4(20.102',b)): Yes No Complete: Yes No No Complete: Yes No  :

2) NRC-5 (20.401.a)): Yes '

Maximum whole body quarterly exposure- i Maximum extremity quarterly exposure

3) Comments:

f, Pocket dosimeters used: Yes No

1) Type used:

2) Frequency of recharging:

3 Frequency of reading:

4 Comments:

. g. Direct radiation surveys of restricted and/or unrestricted areas being made: Yes No 1 Records of surveys being maintained: Yes No Records of surveys reviewed: Yes No b 2 ~~ ~

j 3 Period reviewed:

4) Comments: ,

A A _ _ . . _ _ _ _ _ _ . _ _ _ _ _ _

. - ... l

13. PERSONNEL RADIATION PROTECTION - INTERNAL

a. Potential for exposure of individuals to airborne radioactive mate-rial exists: Yes No .

1) If "Yes" does program for monitoring and control exist: '

Yes No

2) Program for monitoring and control appears adequate:

Yes No

b. Comments:

c. Respiratory protection program required by L/C or application:

Yes No

1) If "Yes" were respiratory protection procedures reviewed:

Yes No

2) Respiratory protection procedures appear adequate:  :

Yes No

3) Comments:

1 i- ~

l .

,n ., d. Bioassay program required: Yes No l 1) If "Yes" was bicassay program reviewed: Yes No

2) Bioassay program appears adequate: Yes No

3) Comments:

e. Smears and air samples: f .

. 1) Monitoring for airborne radioactivity is conducted (20.103):  ; '

Yes No

a. Records of monitoring reviewed: Yes No

b. Period reviewed: -

c. Records of monitoring appears adequate: Yes No

2) Smearsurveysbeingconducted(20.201.b): Yes No

a. Records of smear surveys reviewed: Yes No

b. Period reviewed:

c. Records appeared adequate: Yes No

3) Comments:

.14. LEAK TESTS

a. Leak tests required: Yes No

b. If "Yes" leak tests conducted: Yes No .

c. Records of leak tests maintained: Yes No I

d. Leak tests records reviewed: Yes ho )

N

e. Period reviewed:

f. Records of leak tests appear adequate: Yes_

No

g. Coments:

i I

.15. RADIOACTIVE EFFLUENT CONTROL AND WASTE DISPOSAL ,

i

s. Byproduct material released to atmosphere and/or sewer (20.106 and 20.303):

Yes No -

b. Recoros of releases or radioactive effluents maintained (20.401):

Yes No

1) Period reviewed:

2) Records appear adequate: Yes No ,

c. Solid waste disposal method:

1 Records of disposal maintainea (30.51): Yes No ~

i 2)J Surveys of waste prior to disposal made (20.201):

(es No

3) Period reviewed:

4) Records of surveys appear adequate (20.401): Yes No

d. Coments:

,e Ig r

4

\

t 8 .

INDUSTRIAL / ACADEMIC

16. TRANSPORTATION (10 CFR 71.5a and 49 CFR 171-178) Yes g g

a. Licensee makes shipments of RAM? ( )( )( )

Such shipments are:

(

( l delivered to common carriers? . transported in licensee's own vehicle as '

carrier?

4

( )both?

If above is yes, complete items below:

b. Areauthoriz'edpackagesused?[173.415-416] ( )( )( ) .

Packabetypesusedk[173.415(a)

( ) OT-7A, Type performance test records on file? ( )( )( )

( )00T-55[173.416(a))

licensee aware of 6/30/85 cutoff on use?

Excepted, Instruments / articles [173.421-424]

( )( )( )  :

(

( LSA-strongtight[173.425(b)(1)]

. (

NRC-Certified]173.416(b)])(1)]

NRC COC's on file? [71.12(c (

k)))

,, {

. Registered with NRC as user? [71.12(c)(3) (

~ . Documented NRC-Approved Q/A Program? [71.17(b)] (

NRC Q/A Approval No.:

( )Other:

c. Special Form Material performance test records available ( )( )( )

for each source design? [173.476(a)]

d. Par,kages Labeled as required? [172.403(a)3 ( )( )( )

( ) Excepted ( )WI ( )YII ( )Yll!

Surveys performed to select correct label category and compliance with, Rad. Limits? {173.475(i)3

( )( )( ) >

e. Packages name, ID No.Marked as required,

, Spec. No. , COC No. ,i.e.,

etc. prop [er shipping 172.300)

)( )(

)(

( )

f.

Shippingpaperspreparedforeachshipment?(172.200])]

Such papers contain required information? [172.203(d ( )( /

g. For Licensee private carrier shi xnents:

Yehicles placarded as required? '172.500* 172.504 Table 1)

( ( )

Cargo blocked, braced, tied down in vehicle? [177.842(d)3 ( (

( (

h.

Any incidents reported to DOT 7 [171.15-16)

Does Licensee ship any radwaste? ( ( [))

If yes, are shipments:

( tendered to common carriers by licensee?

( p) tendered through a Radwaste Broker?

. ( )(

)( )(

)( )

( )

If yes, name of Broker

( )( )(

l Is licensee aware of 10 CFR 61 waste generator ,

)

requirements? [10 CFR 61)

Has licensee classified and characterized waste? ( )( )( ) l

[20.311(d))

p .

tt ,

- 17. NOTIFICATIONS AND REPORTS

a. Licensee in compliance with 10 CFR 19.13 (reports to individuals):

Yes- No .

• b. Licensee in compliance with 10 CFR 20.405 (over exposure): i Yes No ,

- c. Licensee in compliance with 10 CFR 20.403 (incidents):

. Yes No

d. Licensee in compliance with 10 CFR 20.402 (theft or loss):

Yes No .

e. Comments

- I

18. POSTING OF NOTICES .

[~ a. Licenseeincompliancewith10CFR19.11(a)or(b): Yes No Licenseeincompliancewith10CFR19.11(c): Yes No e'"

b.

[ c. Comments:

1

19. ENVIRONMENTAL MONITORING PROGRAM ,' ,

s. Environmental Monitoring Program required: Yes No

b. If "Yes" records reviewed: Yes No

c. Period reviewed:

d. Records appeared adequate: Yes No

e. If Environmental Program is not required, briefly describe any existing program:

4 0

10 -- ..

- . .. j , .

1

. CONF 1RMATORY MEASUREMENTS Independent measurements made by inspector: Yes No a.

b.- Coments (describe type, results, comparison with licensee results): -

E

~

21. INDEPENDENT INSPECTION EFFORT

a. Coment on type of independent inspection effort conducted: ,

~

0

• e

22. CONTINUATION FROM PREVIOUS PARAGRAPHS - USE BACK OF PAGE 1F NECESSARY sw,,

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___---_________ __ 0

7, c

Attachment 3 PERFORMANCE EVALUATION FACTORS Licensee:

License No.:

Date of Inspection:

Inspector (s):

1

1. Does the Radiation Safety Comittee appear to be functioning adequately to successfully implement the licensee's radiation safety program?

Are adequate (e.g.,ofIs reviews membership and attendance at meetings adequate?

- users and/or facilities being conducted? Are meaningful issues being discussed at the meetings?)

( ) No ( ) N/A

( ) Yes

2. Is the Radiation Safety Officer (RS0) able to perform his or her duties adequately without being burdened by other duties?

( ) No ( ) N/A

( ) Yes

3. Is sufficient staffing available to manage the licensed program workload?

( ) No ( ) N/A

( ) Yes

4. Does licensee management provide support for the radiation safety aspects of the licensed program?

( ) No ( ) N/A

( ) Yes

5. Does the licensee have the resources to operate the facility safely and support decontamination of the facility if necessary?

( ) No ( )N/A

( ) Yes

6. Is it evident that the licensee is capable of responding to a radiological event?

( ) No ( ) N/A

( ) Yes

(

N.

(

\

Attachment 3

'. l

7. Are periodic audits conducted of the radiation safety program by  :

the licensee and/or a contractor and do the audits appear adequate? . J l

( )Yes ( )No ( ) N/A

8. Are licensee's radiation exposures in accordance with At. ARA?

( ) No ( ) N/A l

( )Yes

9. Are reportable events (10 CFR 20.402, 20.403, 20.405) kept to a level commensurate with the licensee's workload?

( ) Yes ( ) No ( ) N/A

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( ) Yes ( ) No ( ) N/A

11. Are safety-related allegations kept to a minimum level? Does the licensee have an adequate system to follow up on complaints?

( ) Yes ( ) No ( ) N/A

"" 12. Are licensee's reports and responses to violations complete, candid and timely?

( ) Yes ( ) No ( ) N/A

13. Are misadministration (diagnostic or therapeutic) kept to a level cornensurate with the licensee's workload?

( ) Yes ( ) No ( )N/A 14 Dees the licensee have sufficient instrumentation to safely manace the procram and are those instruments properly maintained? (e.g., Is there a preventive maintenance / quality assurance program?)

( ) Yes ( ) No ( ) N/A

15. Does the licensee have an adequate program in place to store radioactive Is waste safely? (e.g., Are materials properly labeled and inventoried?

exposure to the elements controlled?)

( )Yes ( ) No ( )N/A 2

' ~

Attachment 3- .

f . ..

0 Inspector's Comments (Required for any factor-given a negative response)

J .

Action Recuired: (As.deemedby'RegionIIImanagement,i.e., telephone

' contact, licensee management meeting, increased inspection effort, etc.)i A t.,

l A: tion Taken:

Date:

Section Chief Signature:

~

[

3

,:~

- < v- ..

IAEA'

_ i IAEA Training Course Safety and Regulation of Sealed Sources of Radioactive Materials i 10 April-12 May1989

. ~. .

I Lecture 42.3.10 General Inspection Procedures SUPPLEMENT C:

Nuclear Medical Inspection Field Notes I

by Darrel Wiedeman

~ U.S. Nuclear Regulatory Commission Glen Ellyn, Illinois

- 21 April 1989

(

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NUCLEAR MEDICAL INSPECTION FIELD MOTES \

Inspection Report No. License No. ,

Docket No.

Licensee (name and address)

Telephone NJ.

Licensee Contact Date of Amendment

. Last Amendment No.

Category Priority Prograr Codes: ( ) 02110 - Broad ( ) 02201 - Private Practice - Li 'te

. ( ) 02120 - Group Hospital ( ) 02220 - N.M. Van

( ) 02121 - Non-Group Hos.( ) 02209 - InVivo Testir;

( ) 02200 - Private Prac- ( ) 02500 - Pharmacy tice - Group ( ) 02210 - Eye Application Date of Inspectior. ( ) Other

( ) Announced ( ) Unannounced ( ) Normal Type of Inspection: ( ) Special ( ) Reinspection

( ) Initial Next Inspection Date l ( ) Normal ( ) Reduced ( ) Extended Summary of Findings and Action:

( ) No Violation, Clear 591 issued ( ) Action on Previous Violation

( ) Regional Action

( ) Violation (s) 591 issued ( ) Headquarters Action Persons contacted:

Those present at exit interview:

f Inspector '

(Date Signed)

(SignatureJ i

1

+ > __ m >

<j i

l 1.. ORGANIZATION Organizational structure meets license requirements. ( ) Yes a.

( ) No (L/C)

Remarks: .

. 1 I

Use by authroized individuals. ()Yes ( ) No (L/C) l b.

Remarks:

( ) Yes ( ) No

c. Radiation Safety Committee meets at required intervals.

(35.22 (a)(2))

Membership in accordance with 35.22 (a)(1) L/C ( ) Yes ( ) N:

Record of Conmittee meetings. ( ) Yes ( ) No (L/C or 35.22 (a)(4))

d. ,,

Remarks:

2. INSPECTION HISTORY

a. Item (s) of violations or deviations noted during last inspectior

( ) Yes ( ) No.

conducted on Response letter dated

b. Corrective Actier.Taken Statt

( ) hc Oce7 ?Ti Type of Violation ( ) Yes Reovirement Icontinue b. paragrapn 20, if neeced) g

c. If any item (s) of violations or deviations noted during last inspe F s

were not corrected, explain.

o9o _-_ -

3

3. SCOPE OF PROGRAM

(

l l

4 INTERNAL AUDITS OR INSEPCTIONS

a. Required by license condition. ( ) Yes ( ) No Audits or inspections conducted ( ) Yes ( ) No (L/C) b.

c. Records maintained. ( ) Yes ( ) No (L/C)

Remarks :

5. TRAINING, RETRAINING, AND INSTRUCTION TO WORKERS

( ) No

a. Training program required by license condition. ( ) Yes Training program implemented. ( ) Yes ( ) No (L/C) b.

Remarks:

( ) Ne

c. Retraining program required by license condition. ( ) Yes Retraining program implemented. ( ) Yes ( ) No (L/C) d.

Remarks:

l i

e. Instruction to workers in accordance with 10 CFR 19.12 ( ) Yes

( ) No (19.12)

Remarks:

s

A

6. RADIOLOGICAL PROTECTION PROCEDURES

( ) No f

a. Procedure referenced in license condition. ( ) Yes i Used in accordance with referenced procedure. ( ) Yes ( ) No

b. '

Remarks:

s Individuals understanding of procedures adequate. ( ) Yes ( ) No

c. l Remarks: l

d. Examples of key procedures:

( ) Inadecuate (1) ordering and accepting packages RAM ( ) Adequate

( ) Inadequate (2) general rules for safe use of RAM ( ) Adequate

( ) Adequate ( ) Inadequate (3) emergency procedures

/

survey procedures ( ) Adequate ( ) Inadequate (4)

^

(5) handling of volatile RAM (e.g., 'Xe-133,1-131)

( ) Adequate ( ) Inadequate (6) precautions for use of RAM (sealed and unsealed) for therapy

( ) Adequate ( ) Inadequate

7. MATERIALS, FACILITIES AND INSTRUMENTS

( ) Yes ( ) No (L/C)

a. Facilities as described in license application.

Remarks:

Isotope, chemical form, quantity and use as authorized. ( ) Yes ( ) No (L-b.

Remarks:

c. Tests required by license condition or regulations.

(1) molybdenum-99 breakthrough. ( ) Yes ( ) No (35.204(a))

- .( ) No h (2) performed as required. ( ) Yes (L/C and/or 35.204(b))

( ) No (35.204(c))

(3) records maintained. ( ) Yes Remerks:

t. -

t

. (4) leak tests ( ) Yes ( ) No (5) leak tests performed as required. ( ) Yes ( ) No (L/C)

(35.59'(b)(i), 35.59 (b)(2), 35.59 (c)(1)) ,

Remarks:

! (6) other tests required (e.g., physical inventories; surveys to ensure that patients contain 30 mi11(curies of Au 198, I-131 before leaving hospital) (L/C or 35.75)

d. Inventory of sealed sources.

(1) Inventory of Group VI sources. ( ) Yes ( ) No (35.59(g))

Inventory of calibration sources. ( ) Yes ( ) No (35.59 (g))

(2)

e. Areas for storage and use of radioactive materials.

(1) Hethod used to prevent an unauthorized individual from entering a restricted area is adequate. ( ) Yes ( ) No (2) Radio 6ctive material secured to prevent unauthroized removal frorr an unrestricted area. ( ) Yes ( ) No (20.207)

Remarks:

f. Instrumentation.

(1) Operable survey instruments are as described or equivalent to those decribed in license application. ( ) Yes ( ) No (L/C or 35.123, 35.220, 35.330, or 35.420)

Remarks:

(2) Capability of radiation survey instruments is adequate for program

( ) Yes ( ) No Remarks:

Calibration of survey instruments required. ( ) Yes ( ) No (3)

(4) Performed as required. ( ) Yes ' ( ) No (L/C or 35.51)

Remarks:

~

(5) Dose calibrator checks required. ()Ys ( ) No (6) Performed as required. ( ) Yes ( )'No (L/C or 35.50)

8. RECEIPT AND TRANSFER OF RADI0 ACTIVE MATERIAL Receipt of incoming packeye's during "off-duty" hours by whom?

Where stored?

Security?

a. Survey of incoming packages. ( ) Yes ( ) No (20.205(b)(1)) - L/C) '

Remarks:

Record of survey. ( ) Yes ( ) No (20.401(b))

b.

Remarks:

( ) Yes ( ) No (L/C;20.205(d))

c. Procedure for opening packages.

Remarks:

( ) Yes ( ) No

d. BPM transferred in accordance with 10 CFR 30.41.

(30.41 )

Remarks:

( ) Yes ( ) No

e. Records of receipt and transfer maintained.

(30.51 )

Remarks:

I

~

.6-1 - - - - - - - - - - - _ - - - - - _

1 i

- 9. PERSONNEL RADIATION PROTECTION - EXTERNAL (Obtain information regarding whole body and extremity monitors)

Film or TLD badge supplier Frequency a.

Reports reviewed by Frequency b.

(Are badges assigned to personnel as per licensee's correspondence ,

with NRC7) l

c. MRC inspector reviewed personnel monitoring records for period to

d. NRC forms or equivalent.

(1) NRC-4: ( ) Yes () No Complete: ( ) Yes ( ) No

() No Complete : ( ) Yes ( ) No (2) NRC-5: ( ) Yes (20.401 (a))

Remarks:

I

e. Maximum quarterly whole-body exposure.

f. Maximum quarterly extremity exposure.

g. Licensee has implemented an ALARA program. ( ) Yes ( ) No (35.20)

Remarks:

I Radiation survey of unrestricted areas. ( ) Yes ( ) No

h. 35.415(a)(4),35.315(e)(<

(2C.201(b) to show compliance with 20.105 (b),

Re arks:

1. Record of ' surveys maintained. ( ) Yes ( ) No (20.401 (b) to show '

l compliance with 20.105(b) 35.315(a)(4) or 35.415(a)(4)) i Remarks:

l l \

l

j. Radiation survey of use areas (hot lab, therapy treatment area,(L/C or 35.

( )_No patient's room, etc.). ( ) Yes 35.315(a)(.))

4 Remarks:

( l

k. Record of survey maintained. ( ) Yes ( ) No (L/C,35,70(h),

35.415(a)(4))

10. PERSONNEL RADIATION PROTECTION - INTERNAL

a. Potential for exposure of individuals to airborne radioactive .

material exists. () Yes ( ) No Remarks:

( ) No b.

Monitoring)for (20.201(b) airborne radioactivity conducted. ( ) Yesto sh Remarks:

Records of monitoring maintained. ( ) Yes ( ) No (20.401(b) or L/C on c.

35.205(d))

Remarks:

e-

d. Bioassay program implemented as described in correspondence with NRC

( ) Yes ( ) No (L/C or 35.315(a)(B))

11. RADIOACTIVE EFFLUENT AND WASTE DISPOSAL Radioactivity in effluents to unrestricted areas. ( ) Yes ( ) Ne a.

Release in accordance with regulatory limits. ( ) Yes ( ) No b.

(20.106(a))

Recarks:

c. State solid waste disposal method,

d. State liquid waste disposal method.

~

l

e. Disposal of solid and liquid waste in accordance with regulatory I requirements (decay in storage). ( ) Yes ( ) No (L/C or 35.92)

Remarks:

L___________________________________ ,

L .

( ) No (30.51 or 35.92(b))

f. Records of disposal.

Remarks:

( ) Yes ,

Survey of waste prior to disposal. ( ) Yes ( ) No

p. 35.92(a)(2))

(20,201(b) to show compliance with 20.301 Remarks:

Records of surveys maintained. ( ) Yes ( ) No (20.401(b) or 35.92(b)'

h.

Remarks:

12. NOTIFICATIONS AND REPORTS

a. Licensee in compliance with 10 CFR 19.13 (reports to individuals).

( ) Yes ( ) No (19.13)

Remarks:

b. Licensee in compliance with 10 CFR 20.405 (overexposure).

f

( ) Yes ( ) No (20.405(a))

Remarks:

c. Licensee in compliance with 10 CFR 20.403 (incidents).

( ) Yes ( ) No (20.403)

Remarks:

d. Licensee in compliance with 10 CFR 20.402 (theft or loss).

( ) Yes ( ) No (20.402(a)or20.402(b))

Remarks:

i

^

. _2 __--__--.- _____------- _ - - - _ . - _ _ _ - - _ _ , _ _ . 0-

e. Licens e in compliance eith 10 CFR 35.33 and

( ) No(35.33a,b.c or d) 35.44 (misadministration). ( ) Yes

f. and 35.44)

Remarks:

l I

I

13. POSTING OF NOTICES Notices to workers posted. ( ) Yes ( ) No (19.11(a) or (b))

(19.11(c))

Remarks: .

14 CONFIRMATORY MEASUREMENTS / INDEPENDENT MEASUREMENTS

( ) No

a. Measurements made by inspector. ( ) Yes Survey instrument NRC Serial No.

b.

c. Describe type and results of measurements and compare with licensee's measurements.

1

15. POSTING AND LABELING

( ) Yes ( ) Nc Posting and labeling in accordance with 10 CFR 20.203.

(20.203 or 35.60 or 35.66)

Remarks:

16. LICENSE CONDITIONS All license conditions reviewed'during inspection. ( ) Yes ( ) No a.

b. Activities were conducted in accordance with license conditions, except at noted elsewhere in this report ( ) Yes ( ) No l

N

~,

17. BULLETINS AND INFORMATION NOTICES

a. Bulletins and Information Notices issued during current year.

. b. Bulletins and Information Notices received by licnesee. ( ) Yes

( ) No.

Remarks:

c. Licensee took appropriate action in response to Bulletins and Information Notices. ( ) Yes ( ) No Remarks:

18. TRANSPORTATION ( 10 CFR 71.5a and 49 CFR 171-178)

Yes Violation

-a a. License makes shipments of RAM? () ()

If "Yes", complete the following items.

b. Such shipments consisted of:

( ) radwaste

( ) sources / products

( ) other .

c. For radwaste, shipments are:

( ) by licensee, using common carrier

( ) through Radweste Broker name of Broker

d. Licensee is aware of 10 CFR 61:

Radwaste requirements for generators? () ()

Licensee has classified and characterized its radwaste? (20.311(d)) () ()

l 11

L y; ,

L 19. LIST OF VIOLATION (S) i.

l

20. CONTINUATION OF REPORT' ITEMS - USE BACK OF PAGE IF NECE55 r

Os, th

- 12 -

7 Attachment 3 4

PERFORMANCE EVALUATION FACTORS l-Licensee:

License No.:

Date of Inspection:

Inspector (s):

1. Does the Radiation Safety Comittee appear to be functioning adequately to successfully implement the licensee's radiation safety program? (e.g., Is membership and attendance at meetings adequate? Are adequate reviews of users and/or facilities being conducted? Are meaningful issues being-discussed at the meetings?)

( ) Yes -( ) No ( ) N/A b ' 2. Is the Radiation Safety Officer (RS0) able to perform his or her duties adequately without being burdened by other duties?

( ) Yes ( ) No ( ) N/A

3. Is sufficient staffing available to mar. age the licensed program workicad?

( ) Yes ( ) No ( ) N/A 4 Does licensee management provide support for the radiation safety aspects of the licensed program?

( ) Yes ( ) No ( ) N/A

5. Does the licensee have the resources to operate the facility safely and support decontamination of the facility if necessary?

) Yes ( ) No ( ) N/A

(

6. Is it esident that the licensee is capable of respondire to a radiological event?

( ) Yes ( ) No ( ) N/A

~

~n - . ~ . . - . , . - - _ _ , - _ . ~ . . _ _- -_- - - . _ - - - - - - - . _ - - - - _ - - - _ . - - _ - - _ . . _ . - . _-_-- -_ - -- -- _ __

Attachment 3

7. Are periodic audits conducted of the radiation safety program by -

the licensee and/or a contractor and do the audits appear adequate?

( ) Yes ( ) No (' ) N/A B. Are licensee's radiation exposures in accordance with ALARA?

( ) Yes ( ) No ( )N/A Are reportable events (10 CFR 20.402, 20.403, 20.405) kept to a level

~

9. '

commensurate with the licensee's workload?

( ) Yes- ( )No (. ) N/A

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( ) No ( ) N/A

( ) Yes 9

11. Are safety-related allegations kept to a minimum level? Does the licensee

+

have an adequate system to follow up on complaints?

( ) No ( ) N/A

( ) Yes '

i 12.

Are licensee's reports and responses to violations complete, candid and -

timely?

( ) No ( ) N/A

( ) Yes

13. Are risedministrations (diagnostic or therapeutic) kept to a level d

consensurate w th the licensee's workload?

) Yes ( ) No ( )N/A

(

14 Dees the licensee have sufficient instrumentation to safely(e.g., manage the a Is there procrar and are those instruments properly maintained?

preventive maintenance / quality assurance program?)

( ) No ( ) N/A

( ) Yes

15. Dees the licensee have an adequate program.in place to store radioactiveIs waste safely? (e.g., Are materials properly labeled and inventoried?

exposure to the elements controlled?)

( ) No ( ) N/A

( ) Yes

\

b 2

s .. :. ...

Attachment 3 l l

). .

- Inspector's Consnents: (Required for any factor given a negative response)

I p

Action Recuired: -( As deemed by Region III management, i.e. , telephone contact, licensee management meeting, increased inspection effort, etc.)

, n. .

'l.

Action Taken:

s Date:

Section Chief Signature:

3

I. e .

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-r v ..

IAEA IAEA Training Course Safety and Regulation of Sealed Sources

' L: of Radioactive Materials 10 April-12 May1989

a. ..

' Lecture 42.3.10

'~

General Inspection Procedures SUPPLEMENT D:

Well Logging Inspection Field Notes by Larrel Wiedeman U.S. Nuclear Regulatory Commission Glen EDyn, Illinois 21 April 1989

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l WELL LOGGING INSPECTION FIELD NOTES Inspection Report No. License No. .

. Licensee (nameandaddress) Docket No.

Temporary Site Inspection, 1

Approximate Location i

Licensee Contact Telephone No.

License No.

Date of Inspection Last Amendment No. Date of Amendment.

Priority III.

() 03110 03111 ( ) 03112 Programs Codes Type of Inspection: ) Announced

()jInitial

(

( )- Unannounced i Special Reinspection Next Inspection Date. ( ) Normal ( ) Reduced ( ) Extended Summary of Findings and Action.

()NoNoncompliance, Clear 591 issued ( ) Action on Previous N/C

( ) Noncompliance. 591 issued ( ) Regional Action

( ) HQ Action Persons Contacted.

I

• Those present at exit interviews.

~

(5ignature) (cate sig'ed)

Approved (Signature) (Date Signed) l

- - - - - - m_ _m

1. ORGANIZATION

a. Management structure. )

Telephone No.

b. List primary licensee contact.

c. Individuals identified as responsible for radiation safety  !

still hold those positions. ( ) Yes ( ) No Remarks.

2. INSPECTION HISTORY

a. Items of noncompliance or deviations'noted during last inspec-tion conducted on ( ) Yes ( ) No Corrected by letter dated Requirement Severity Corrected Status b.

(continue b. paragraph 31, if needed)

c. If any items of noncompliance or safety items noted during the last inspection were not corrected, explain. .e .

(continue c. paragraph 31, if needed)

3. SCOPE OF PROGRAM (Number of people, rate of.use or quantities on hand, places and freguency of use, type, quantity and use as author-ized, proper users) [.10 CFR 39.13(b)]

(continue 3. paragraph 31, if needed)

4. INTERNAL AUDITS OR INSPECTIONS

a. Required by 10 CFR 39.13(d) or application: ( ) Yes ( ) No If "Yes":

(1) By whom (2) Frequency Announced Unannounced (3) Scope 5

(4) Records maintained. ( ) Yes ( ) No [

(5) Records reviewed. ( ) Yes ( ) No (6) Period Reviewed.

2 Attachment 87100 Issue Date: 05/20/86

b. Comments (responsibility of auditor or comittee, management 1 control). f Remarks.

5. TRAINING, ANNUAL REVIEWS, INSTRUCTIONS TO WORKERS 10 CFR 39.13(b)

a. Training program specified in L/C or application. ( ) Yes ( ) No (1) Verify records of test results, including field exams of supervisors.[39.13(b)and39.61]

b. Describe scope of training program.

c. Annual reviews examined. Records maintained. ( ) Yes ( ) No

[39.13(b)and39.61]

d. Period reviewed.

Remarks (percent completed, tests results, etc.).

e. Training provided, but not covered above, such as on-the-job

'l training.

\

Remarks.

f. Instructions to workers in accordance with 10 CFR 19.12 and l 39.61(a)(2). ( ) Yes ( ) No Remarks.

6. RADIOLOGICAL PROTECTION PROCEDURES

a. Operating and Emergency Procedures .0 CFR 39.63)

(1) Required by L/C or application. ( ) Yes () No (2) Procedures reviewed. ( ) Yes () No (3) Appeared adequate. ( ) Yes ( ) No i (4) Remarks (personnel understanding of procedures).

b. Equipment such as remote handling tools, gloves available and used. ( ) Yes ( ) No

c. Changes in procedures since last inspection. ( ) Yes ( ) No Were changes authorized? () Yes ( ) No '

Remarks.

3 Issue Date- 05/20/86 Attachment 87100 l_

^

[ ,.]

7. INSTRUMENTATION (10CFR39.33) ,

a.

Type (s) of or application radiation survey )(instruments equivalent. Yes ( ) No on hand as per L/C, l .

If "No," list changes.

1 i b. Capability and availability of radiation survey instruments ade-quateforprogram(39.33(b)]

( ) Yes ( ) No

c. Calibration of instruments required. ( ) Yes (-) No

d. If "Yes," instruments calibrated in accordance with requirements.

( ) Yes ( ) No Remarks.

8. MATERIALS

a. Radioactive material locked and secured to prevent unauthorized removal from.

(1 Restricted area. ( ) Yes ( ) No [39.31(b)]

(2 Unrestricted area (20.207). ( ) Yes ( ) No (3 Licensed material stored with explosives. ( ) Yes ( ) No

[39.31(b)(1)] c.,

If "Yes," describe violation.

b. Method of control appears generally adequate. ( ) Yes ( ) No

c. Remarks.

9. FACILITIES

a. Facilities (or field office) described in letter or application.

( ) Yes ( ) No

b. Facilities (or field office) or temporary job sites inspected.

( ) Yes ( ) No

c. Materials stored only at locations authorized by the license.

( ) Yes ( ) No

d. Remarks.

10. POSTING AND LABELING

a. Posting and labeling in accordance with 10 CFR 20.203 and 39.31.

( ) Yes ( ) No Issue Date: 05/20/86 4 Attachment 87100

lg

. b. Uraniumsinkerbarsproperlylabeledorstamped[10CFR39.49)

( ) Yes ( ) No

c. Remarks. .

11. RECEIPT AND TRANSFER OF MATERIAL

a. Procedures for picking up and receiving packages [10 CFR 20.205 (b)(c)] ( ) Yes ( ) No (1) Incoming shipments monitored. ( ) Yes ()No (2) Recordsofmonitoringmaintained[10CFR20.401(b)].

( ) Yes ( ) No (3) Records reviewed by NRC inspector. ( ) Yes ( ) No (4) Period reviewed.

b. Proceduresforopeningpackages[10CFR20.205(d)].()Yes

( ) No

~

c. Remarks.

m b d. Records of receipt, transfer and inventory of material available

[30.51(a);40.61(a);70,51(b)(1)]. ( ) Yes ( ) No (1) If "Yes," review of records by inspector.

(2) Period reviewed.

(3) Remarks,

e. Packages on hand meet labeling requirements (49 CFR 173.399).

()Yes ( ) No Remarks.

f. Reports to Commission required by L/C or regulation were submit-ted. ( ) Yes ( ) No Remarks.

g. Semiannaul physical inventory conducted. [10CFR39.37]

( ) Yes ( ) No ~

Remarks.

_ o onom ranc>no ra MIurM

V .

'12. PERSONNEL RADIATION PROTECTION - EXTERNAL

a. -Film or TLD badge supplier-

b. Badge exchange frequency c .- Reports reviewed by .

d. Records reviewed for period to __, by NRC inspector

e. NRC forms or equivalent:

(1) NRC-4 ;20.*;02(b? (( )) Yes ( ) No Complete ()Yes ( ) No (2) NRC-5 20.401(aJ Yes ( ) No Complete ( ) Yes ( ) No Maximum whole body quarterly exposure Maximum extremity quarterly exposure (if applicable)-

(3) Remarks.

f. Pocket dosimeters used. ( ) Yes ( ) No (1 Type used 2 Freque?cy of recharging 3 Frequency of reading

4) Remarks.

r' g.

Direct radiation being made. survey)No[39.67]

( ) Yes (s of restricted and/or unrestricted areas 1 Records of surveys being maintained. ()Yes ( ) No (2

( Records of surveys reviewed. ( ) Yes ( ) No 3 Period reviewed.

4 Remarks .-

13. PERSONNEL RADIATION PROTECTION - INTERNAL

a. Potential for exposure of individuals to airborne radioactive material exists. ( ) Yes ( ) No (1) If "Yes," does program for monitoring and control exist.

( ) Yes ( ) No (2) Programs for monitoring and control appear adequate.

( ) Yes ()he

b. Remarks.

c. Smears.

(1) Smearsurveysbeingconducted[20.201.b].()Yes()No

a. Records of smear surveys reviewed: ( ) Yes ( ) No

b. Period reviewed. I

c. Records appeared adequate. ( ) Yes ( ) No Issue Date: 05/20/86 6 Attachment 87100

r j

l (2) Remarks.

d. Bioassayprogramrequired[10CFR39.45) ()Yes ( ) No (1) If "Yes," was bioassay program reviewed? ( ) Yes ( ) No (2) Bioassay prograr, appears adequate ( ) Yes ( ) No (3) Remarks.

14. LEAKTESTSOFSEALEDSOURCES~[10CFR39.35]

a. Records of leak tests maintained. (-) Yes ( ) No

b. Leak tests records reviewed. ( ) Yes ( ) No

c. Period reviewed,

d. Records of leak tests appear adequate. ( ) Yes ( ) No

e. Remarks.

15. UTILIZATION RECORDS [10CFR39.39)

a. Utilization records contain all pertinent information. ( ) Yes

( ) No

,,,. 16. RADIOACTIVE LIQUID CONTROL rf

a. Radioactive material unintentionally released to groundwater or k aquifersand[20.303]. ( ) Yes () No

b. Exemption granted for unintentional releases. [39.45(b))

c. Records of releases or radioactive effluents maintained [20.401].

( ) Yes ( ) No

17. DESIGNANDPERFORMANCECRITERIAFORSEALEDSOURCES[10CFR39.41]

a. Sources meet design criteria. ( ) Yes ( ) No

b. Remarks.

18. INSECTION, MAINTENANCE AND OPENING OF SOURCES OR SOURCE HOLDERS LIO CFR 39.43J

a. Licensee has program for inspection and maintenance of equip-ment. ( Yes ( ) No

b. Equipment inspected both daily and semiannually. ( ) Yes ()No

c. Records of inspection maintained. ( ) Yes ( ) No

d. Stuck sources in source holders or repair, opening, modification done only by persons specifically licensed. ( ) Yes ( ) No l

e. Use of radioactive markers in wells only if individual markers contain quantities of licensed material not exceeding exempt quantities. (-) Yes ( ) No [39.47]

Remarks.

___ a onom anono mam#m

Documents and records required at field stations [10 CFR 39.73]

~

19. . .

J

a. Utilization records and other documents located at' field sta- '

tions as required by regulation. ( ) Yes- ( ) No

b. Remarks. q

20. Documents and records required at temporary job sites [10 CFR 39.75)

a. Documents and records maintained at job sites as required by -

regulation. ( ) Yes ( ) No

b. Remarks.

21. NOTIFICATION OF INCIDENTS AND LOST SOURCES; ABANDONMENT PROCEDURES FOR IRRETRIEVABLE SOURCES L10 CFR 39.77J; SOURCE RECOVERY MONITOR-ING REQUIREMENTS. [10CFR39.69(a)]

a. Contamination checks made during source recovery operations.

( ) Yes ( ) No

b. NRC notified of ruptured sources. (()Yes Yes ( )( No No

c. NRC notified of abandoned sources.

d. Abandoned wells properly placarded. ()) Yes ())No

e. Procedures for (using) sealed sources in wells without surface casing. ( ) Yes No [39.51]

f. Remarks.

22. TRANSPORTATION [10 CFR 71.Sa a'nd 49 CFR 171-187] Yes N/A Vio. ,

a. Licensee makes shipments of RAM? () () ()

Such shipments are:

delivered to comon carriers? () () ()

transported in licensee's own vehicle as private carrier? () () ()

If above is "Yes," complete items below.

b. Areauthorizedpackagesused?[173.415-416] () () ()

Package types used:

DOT-7A,TypeA[173.415(a)]

performance test records on tele? () () ()

00T-55[173.416(a))

licensee aware of 6/30/85 cutoff on use? () () ()

Excepted, instruments / articles [173.421-424] ,

LSA-strongtight[17!,.425(b)(1)]

NRC-Certified NRCC0C'sonfile?[71.12(c [173.416(b)] )(1)] () () () ()

RegisteredwithNRCasuser?[71.12(c1(3)] () ()

DocumentedNRC-ApprovedQ/AProgram?[71.17(b)] () () ()

NRC Q/A Approval No.

i Other:

s b

8 Attachment 87100 Issue Date: 05/20/86

)

]

Yes N/A Vio,

c. Special Form Material performance' test records availableforeachsourcedesign?[173.476(a)] (' ) () ()

d. Packages Labeled as required?-[172.403(a)]

() () () *

(-) Excepted-( ) WI ( ) YII ( ) YIII Surveys performed to select correct label j

category and compliance with rad. limits?

.[173.475(1)]

e. Packages marked as required, i.e., proper shippin name,IDNo., Spec.No.,COCNo.,etc.[172.300]g f.

Shipping]paperspreparedforeachshipment?

'( ) () ()

[172.200 Such papers contain required information? () () ()  !

[172.203(d)]

Such papers carried in vehicle and readily () () ()

available.

g. For licensee private carrier shipments:

Vehicles placarded as required? [172.500,

() () () l

'172.504 Table 1]

Cargo blocked, braced, tied down in vehicle? () () ()

[177.842(d)]

AnyincidentsreportedtoDOT?[171.15-16] () () ()

" h. Does licensee ship any radwaste? () () ()

If yes, are shipments:

/ . tendered to common carriers by licensee? () () ()

( tendered through a Radwaste Broker?

If "Yes," name of Broker

() () ()

Is licensee aware of 10 CFR 61 waste generator requirements? [10CFR61] () () ()

Has licensee classified and characterized waste? () () ()

[20.311(d)]

i. Proper disposal reacords for decay-in-storage () () ()

wastes.

j. Remarks.

23. NOTIFICATIONS AND REPORTS

a. Licensee in compliance with 10 CFR 19.13 (reports to indivi-duals). ( ) Yes ( ) No

b. Licensee in compliance with 10 CFR 20.405 (overe vosure).

( ) Yes () No

c. Licensee in compliance with 10 CFR 20.403 (incidents).

( ) Yes ( ) No

d. Licensee in compliance with 10 CFR 20.402 (theft or loss).

( ) Yes ( ) No

e. Remarks.

- o- w w am oma

l 24, POSTING OF HOTICES

a. Licensee in compliance with 10 CFR 19.11(a) or (b). ( ) Yes f

( ) No

b. Licensee in compliance with 10 CFR 19.11(c). ( ) Yes ( ) No i

c. Remarks. .

25. BULLETINS AND INFORMATION NOTICES

a. List Bulletins and Information Notices issued during current year.

b. Bulletins and Information Notices received by licensee. ( ) Yes

( ) No

c. Licensee took appropriate action in response to Bulletins and Information Notices. ( ) Yes () No .

26. ENVIRONMENTAL MONITORING PROGRAM

a. Environmental Monitoring Program required. ( ) Yes ( ) No

b. If "Yes," records reviewed. ( ) Yes ( ) No

c. Period reviewed.

d. Records appeared adequate. ( ) Yes ( ) No

e. If Environmental Program is not required, briefly describe any existing program. , . .

27. CONFIRMATORY MEASUREMENTS

a. Confirmatory measurements made by inspector. ()Yes ( ) No

b. Remarks (describe type, results, comparison with licensee results).

28. INDEPENDENT INSPECTION EFFORT Remark on type of independent inspection effort conducted.

29. SECURITY Direct surveillance maintained by loggino supervisor / designee when source is not below ground or in shipping container. ( ) Yes ( ) No

30. ITEMS OF NONCOMPLIANCE 1

I 10 Attachment 87100 Issue Date: 05/20/86

A l

. 31. ' CONTINUATION FROM PREVIOUS PARAGRAPHS-USE BACK OF PAGE IF NEC 1.

/

d

.e*.

- - - - - - .- - noorve~co avsvam 11 1ssue Date: 05/20/86

g Attachment 3'-

t.

r-PERFORMANCE EVALUATION FACTORS

_ Licensee: .

License'No.:

Date of Inspection:

Inspector (s): -

1. Does the Radiation Safety Committee appear to be functioning adequately to successfully implement the licensee's radiation safety program? (e.g., Is membership and attendance at meetings adequate? Are adequate reviews of users and/or facilities being conducted? Are meaningful issues being discussed at the meetings?)

( )Yes- ( ) No ( )N/A e 2. Is the Radiation Safety Officer (R50) able to perform his or her duties i adequately without being burdened by other duties?

(; )Yes ( ) No ( )N/A

3. Is sufficient staffir.g available to manage the licensed peceram workload?

( -) Yes ( ) No ( ) N/A

4. Does licensee management provide support for the radiation safety-aspects of the licensed program?

( ) Yes ( ) No ( ) N/A

5. Does the licensee have the resources to operate the facility safely and support decontamination of the facility if necessary?

( )Yes ( ) No ( ) N/A

6. Is it evident that the licensee is capable of respondinc to a radiological event?

( ) Yes ( ) No ( ) N/A

' ~ ' Attachment 3 4

7. Are' periodic audits conducted of the radiation safety program by the licensee and/or a contractor and do the audits appear adequate?

( )Yes ( )No ( , ) N/A

8. Are licensee's radiation exposures in accordance with ALARA?

( )Yes ( ) No ( ) N/A

9. Are reportable events (10 CFR 20.402, 20.403, 20.405) kept to a level commensurate with the licensee's workload?

( ) Yes ( )No ( ) N/A

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( )Yes ( ) No ( ) N/A

11. Are safety-related allegations kept to a minimum level? Does the licensee have an adequate system to follow up on complaints?

( ) Yes ( )No ( ) N/A

12. Are licensee's reports and responses to violations complete, candid and timely?

( ) Yes ( ) No ( ) N/A

13. Are misadministration (diagnostic or therapeutic) kept to a level commensurate with the licensee's workload?

( ) Yes ( ) No ( ) N/A 14 Does the licensee have sufficient instrumentation to safely manage the program and are these instruments properly mainteir.ed? (e.g., Is there a preventive maintenance / quality assurance program?)

( ) Yes ( ) No ( ) N/A

15. Does the licensee have an adecuate program in place to store radioactive waste safely? (e.g., Are materials properly labeled and inventoried? Is exposure to the elements controlled?)

( ) Yes ( )No ( ) N/A s

2

y _ - _ . _ _ _

-Attachment 3 4

.=s.

Inspector's Comc.ents: (Required for any factor given a negative: response) .

t Action Reouired: (As deemed by Region III management, i.e., telephone contact, licensee management ineeting, increased inspection effort, etc.)

1 ..

Action Taken:

1 Section Chief Signature: Date:

3

4

,.(.#-

,v .

IAEA IAEA  ;

Training Course 1 2 Safety and Regulation of Sealed Sources of Radioactive Materials 10 April-12 May1989 Lecture 42.6.8 Safety & Licensing Program for Brachytherapy Sources by NormalL McElroy Medical and Academic Section,6H3 j -' pt U.S. Nuclear Regulatory Commission q*o Washington, D.C. 20555 ~

g a, ,

. . . , . . . . . . .,1 ,;

'+ 26 April 1989 L

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if W -- -- ------- - ----- -- - _ - - - - - - _ - _ _ _ _

A

,. (. <

o-Lecture 42.6.8

-SAFETY AND LICENSING PROGRAM FOR BRACHYTHERAPY SOURCES Norman L. McElroy. -

Medical and Academic Section -

US Nuclear Regulatory Commission .

LECTURE OUTLINE o Brachytherapy: shortdistance(cm)treatmentbyinsertionorsurface application of sealed radioactive sources o Sources used

' Isotope Activity Half-life Ra or Cs-137 .5 mci to 30 mci 30 y 20 MBq to 1 GBq Ir-192 .5 mC1 to 1 mci 74 d 20 MBq to 40 MBq I-125 .5 mC1 to 30 mci 60 d 20 MBq to 1 GBq Ir-192 10 Ci 74 d 400 GBq Sr-90 50 mCf 29 y 2 GBq o- Examples of clinical procedures Cesium-137: 5 seeds total 50 mci (2 GBq) for 60 hr

- Iridium-192: 50 seeds total 25 mci (1 GBq) for 60 hr Iridium-192: 1 source of 10'C1 (400 GBq) for 15 min o Examples of problems

- Loss (e.g. Luther, Memorial, Veterans)

- Damage (e.g. Notices 86-84and88-52, Providence)

High radiation levels (e.g. Notice 82-33) o Safety measures Perform physical counts and surveys Follow manufacturer's handling instructions, perform leak tests

- Perform surveys l - _ _ . - ---

. Cuperfisicitrmtmonts Strontium-90 ophthalmic applicators {

t Beta applicatorforthe treatment of "**

pterygia The applicator contains a strontium-90 compound incorporated j ,' ~

to rolled silver disc with a face thickness of 0 05mm. The disc is sealed in a welded stainless steel holder having a winoow

%, um thcknessof 005mm.

The steel holder is attacned to a handle which allows the active head to be rotated tnrougn 180* and whch is fitted with a sneld to protect the operator.

The active area can De reduced by fitting a metal mask over the _

s active face. Eacn appicator is suppled witn one kidney-shaped  ; __

~-' ~

mask and one blank mask for users to shape to their own 9-re( uirements. The box in whch the applicalor is suppled is equipped with a mask Changing plate to simplify this operation.

J i;r  ;,,,,.Jorit;nr- A;i;;;i;;,;;;;s;;.- oo =c e, ',a%

- earnecer actsety eene rete sitsssu' '

moness ici

• '" GB4 "C' WGY'S '

_ _. 805'8. . . . -

s 2 04 55 500 g,,,,, ,$,A 20 see.eyp.rvorm nceto. tine Recommended workinglife 10 years seoeisneinassen " ~ ~ ~ ~ ~ ~

AvailabilityonreQuest c6n QualitycontrolWipetest A Immersion test L Measurement The surface dose rate in tissue-equivalent matenalis measured for each appliance (without mask) either by an extrapolation chamber or by using a scintillation probe to compare the dose rate from the appliance with that from a similar one calibrated by ,

an extrapolation chamter. A certifcate is issued.

References \ \ N'*

vanoenBRENK.H A s \ \ ./

Resuitsof propr ,4sucpostoperativeirramatonin 1300 cases ototarypum Amer J \' ., .

Aosntponot 103, r23-733.1968 ,  ? /

BAOSNAN.J o Pterypum Resectonpluscetatraccon Trans Obntnarnat. Soc Nr.21

' NC ,

-N 107-113.1969 d^ '

MSON.B Betarramatonof plerygia frans Opninarnat Soc. Austrahs.23,96-100.19ti3 j ,

VIONEA.V..BRAMBIER. A L.BOTEZ N and BOERAS F Betatherapy untn **Srin tne treatment of pterygium Opntnarnoopea. ite, _ ' -

I11-116.1969 TONG.E C G .ZARET.M M andRue[NFiELD.S a,,m.n

• Cellusar enanges ri the conunctwa after strontium 90 treatment for pterypum ,,,oy i,n,,  %, ,. .* * -

g- '

j Amor J A3entgenot.100,848-8s3.1969

\

CASTRCMEJO.R Newrnaskstoimttheactwesurface of rasaionnbeta rayappacators Trans Amor Acaa Ophtharnar ancotowyngar.80,486.t956.

gn,,gng . '< . . \

CAsTROviEJO.R. #\ r !

Atlas ot keratectomy arc keratoplasty.pubiisned Dy w B Saunoers Co , 49'l Phdaoelphia.1966. 462pp Thas product is manufactured by Amersham International plc Amersham UK Mindustries, Idc.

7643-8 FULLERTON ROAD SPRINGFIELD._ __VA 22153

par NARY NOTIFIC TION 0F EVENT OR UNUSUAL OCCURRENCE PN0-III-89-20 Date March 21, 1989 This preliminary notification constitutes EARLY notice of events of POSSIBLE '

. 'cafety or public interest significance. The information is as initially ceived without verifiestjen or evaluation, and is basically all that is i Inown by the Region IINff on this date.

1 '

Fac1111y: I .uther Hessi2 11 Licensee' Emergency J.au Claire, Wisconsin Classification:

Unusual Event License No. 48-02122-05 Alert Site Area Emergency

- General Emergency

,X Not Applicab"e

Subject:

LOST BRACHYTHERAPY SOURCE On March 17, 1989, thelicenseereportedthelossofa33millicurie(approximate) cesium-137 brachytherapy source. The loss was discovered during a ohysical inventory on the same date.  ;

The source, which is three quarters of an inch long, and slightly wider than cil lead,.

was one of 15 stored in a safe in the hospital's radiation oncology " hot lab.. sourcs.h is used in the treatment of cancer. The licensee's records show that all 15 rces were

present during the last inventory on Feb mary 16, 1989. The last usage of asy.searcrfrasi -

the storage safe was to calibrate instruments on March 15~.  ;

.ity s.

ARegionIII-(Chicago)radiationspecialistwasdispatchedtothehospitalonItarch . .: ~

monitor the licensee's actions, and to assirt in the search for de lost source.. <

March 19, radiation surveys were made of all hospital corridors, the hospital tinerator, major rooms whera the source may have been used, and hospital janitariel "

ewipment. To date, the source has not been found. The licensee still plans to survey the hones of key staff members, homes of any patients, if appropriate, and a commercial landfill and truck used for hospital waste. The licensee plans to notify hospital employees of the lost source, and what precautions to take, if found.

The lost source is considered most hazardous if a person were to carry it next to his or her I

body over an extended period of time.

The State cf Wisconsin and the NRC Office of Nuclear Material Safety and Safeguards have been notified.

> Region III was first notified of this event at 3:30 p.m. (CST), March 17, 1989. This information is current as of 11 a.m. (CST), March 21, 1989.

CONTACT: W. Reichhold D. Sreniawski FTS 388-5621 FTS 388-5611 DISTRIBUTION:

WHITE FLINT NORTH 1 MMBB REGIONS FAX TO:

Chairman Zach CA ROU RI IMPO Coses. Roberts OGC ARM RII NSAC Cosmi. Carr OI OIA RIV Licensee ~

is. Rogers ED0 RV NRC Ops Ctr

t. m . Curtiss NRR NL MAIL T0: PDR(8/634-35T37 SECY NMSS ES pc5(orig.)

GPA/SLITP/PA ACRS DOT (Trans. Only)

Rev. 03/01/89

DCS No:

Date: August 26, 1988 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-I-88-90 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or pubite interest significance. The information is as initially received without verification or evaluatign, and is halfrally all that is known by uir Region !

ctatt.en this d Lv.

Facility: Licensee Emergency Classification:

IMemorial Hospitall for Cancer and Notification of Unusual Event Allied Diseases Alert New York, New York site Area Emergency (Agreement State License) General Regr9tncy

• T Not' Appl? cable

Subject:

BRACHYTHERAPY MISADMINISTRATION On August 26, 1988, Region I was notified by the New York City Department of Health that Memorial Hospital for Cancer and Allied Diseases reported a brachytherapy misadministration involving the use of radium. A patient was 4plented with 7 sources 4 in the ne(Radium ck and 3isinnot theregulated by Friday, tongue, on NRC).

August 19, for a 36 hour4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> treatment, intended dose: 3000 rads. On August 20, a resident removed the 3 sources from the tongue, but diri not remove the courees froni Lhv nn,k, although his written report indicated that he removed 7 sources. On Sunday.

August 21. licensee staff noticed 2 sources in the patient's neck. The other 2 were later found on the flocr of the patient's room. The licensee estimates that the patient rrraived 300 400 wads in e s... vf the 3,000 intanced.

The Department of Health is currently investigating the incident and updates will be provided as appropriate.

CONTACT: J. McGrath 346-5216 DISTRIBUTION:

OWFN MNBB H-$t. NL Mail: ADM:DMB

?.EiIrman Zech KE65 Kfll3 IIES DOT.Trans only Lomm. Mooerts ARM POR Comm. Carr OGC NRC Ops Ctr Comm. Rogers INPD----

SECY NMS5 NSAC----

CA NRR OGC OIA Regional Offices GPA 01 RI Resident Office PA SLITP EDO DE Licensee:

(Reactor Licensees)

Region I Form 83 '

(Rev. April 1988)

,. s /*

DCS: 03001237870810 ,

Date: August 13, 1987 ,

PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-I-87-80A

~

iis preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information has been confirmec with the licesisee by Region I personnel.

Facility: IVeterans Administration! Licensee Emergency Classification:

Medical r'nter West Haven, Conn. 06516 Notification of Unusual Event (L/N 06-01237-05) Alert Site Area Emergency General Emergency X Not Applicable

SUBJECT:

LOSS OF IRIDIUM-192 SEEDS DURING THERAPY PROCEDURE (UPDATE)

On August 11, 1987, NRC Region I received a report from the licensee that 11 tridium-192 seeds encased in a nylon ribbon, with a total activity of 11 millicuries (cci) had been lost. The seeds had been used in an therapeutic implant of a patient's lip and cheek beginning on August 7. The lip implant was removed at about 6:00 p.m. on August 10. The cheek implant was scheduled to be removed on August 13. At 6:45 a.m.

on August 11, the patient told a nurse that he had removed the cheek implant the night before and thrown it on the floor. '

The originti PN reported that a radiation survey of the facility had been performed by two inspectors from the Connecticut Department of Environmental Protection (DEP), which had been alerted by the licensee. The DEP inspectors had found slightly elevated idiation levels around the dumpster where the licensee's normal trash is collected.

On August 12, 1987, the licensee notified NRC Region I that the seeds had been found in the dumoster and recovered at approximately 1:30 p.m. that day.

Region I will review this incident during the next inspection of the West Haven YA facility to detennine the causes of this incident and to evaluate the ifcensee's corrective actions.

The .itate of Connecticut has been notified.

CONTACT: L. Friedman J. White 488-1276 488-1102 DISTRIBUTION:

H. St. MNBB Phillips E/W Willste Mail: ADM:DMB i Chainnan Zech EDO NRR NMSS DOT:Trans only C mm. Roberts PA OIA RES Comm. Bernthal OGC AE00 HRC Ops Crt Comm. Carr Com. Rogers ACRS Air Rights INPO----

SECY SP NSAC----

CA PDR Regional Offices TMI Resident Section RI Resident Office

Licensee

-

l (Reactor Licensees)

b T E '4 . . . l i- '

SSINS No.: - 6835

'IN 86-84 l

UNITED STATES L"' NUCLEAR REGULATORY COMMISSION 0FFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C. 20555 September 30, 1986 IE INFORMATION IN0TICE NO. 86-84: RUPTURE OF A NOMINAL 40-MILLICURIE 10 DINE-125 j BRACHYTHERAPY SEED CAUSING SIGNIFICANT SPREAD j OF RADI0 ACTIVE CONTAMINATION Addressees: i All NRC medical institution licensees.

Purpose:

This notice is to alert licensees of a scread of iodine-125 contamination resultina from the inadvertent cutting of the seed encapsulation during removal.

of the seed from Heyer-Schulte coaxial catheters. The seed was one of eight seeds used for brachytherapy treatment of a brain tumor. It is expected that licensees will. review this information for applicability to their facilities and consider actions, if appropriate, to preclude similar problems from occurring at'their facilities. However, suggestions contained in this information notice do 'not constitute NRC requirements; therefore, no specific action or written response is' required. ,,

Description of Circumstances: .

The seeds, which are manufactured by 3M Company, are intended to be reusable because of the initial high activity of the seeds (40 millicuries per seed).

Users of the seeds are motivated to reuse them for several patients because of the relatively high cost of the seeds. The seeds are removed from the old catheters and loaded into new catheters for implant into other patients. It was during removal of the seeds from the catheter that one of the seeds ruptured.

The rupture was believed to have been caused by cutting the catheter to free the seeds with a sharp object, such as a razor blade'or scissors. The licensee did .

not know that a seed had been ruptured. The seeds, includino the ruptured seed, were reloaded into new catheters and implanted into a patient. As a result, the patient sustained a thyroid burden of about 557 microcuries and a radiation dose to the thyroid of about 2087 rads.

Licensee personnel were not immediately aware that one or more seeds had l ruptured until they found iodine-125 contamination in a source / transport bucket stored in the brachytherapy source storage room (BSSR) on the day after the implant into a patient following reloading of the seeds into the new catheters.

" 7; .

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

. I

. IN 86-84 I

.. S:ptember 30, 1986 I

, Page 2 of 2 )

The seeds were removed from the old catheters and loaded into new catheters I in the BSSR an area not ventilated by a fume hood. Consequently, approximately l 60 bc, spital personnel, including those involved in cleanup operations, received '

thyroid uptakes of iodine-125 from 0.04 to 209 nanocuries. A proper radiation i survey meter was used, but the hich backcround radiation in the BSSR masked  !

the positive indication of contamination.

i Discussion: )

The isolated incident described is the only incident of its kind known by the NRC involving high-activity iodine-125 seeds. However, there have been several other similar incidents involving the use of low-activity seeds containing 0.1 to 1 millicuries used as permanent implants. Both types of seeds are manufactured by 3M Company.

The risk of iodine-125 seed rupture is relatively high when the seeds are used for several patients. The incident was caused because:

. the s'eeds are susceptible to damage from sharp tools such as razor blades or scissors the discolored or stained condition of the catheters after use in therapy .

makes viewing of the seeds difficult

.The consequences of the seed rupture (involving patient exposures, other personnel iodine-125 uptakes, and facility contamination) can be mitigated by performing  !

(1) adequate radiation surveys of the work area, using a radiation detection

instrument capable of detecting the low-energy photons (average of 28 kev),

(2) the proper handling of tools used to remove the seeds from the catheters, and (3) leak tests of the seeds. Also, contamination of the facilities probably can be prevented if the seed removal operation is performed in a fume hood.

Personnel uptakes of the radioactive materials and facility contamination also might be mitigated by using radiation safety procedures designed to detect seed

, leakage promptly.

No specific action or written response is required by this notice. If you have any questions regarding this information notice, please contact the Regional .

Administrator of the appropriate NRC regional office or this office.

James G. Part ow, Director M Division of Inspection Programs Office of Inspection and Enforcement Technical Contacts: J. Metzger, IE .

(301) 492-4947 H. Karagiannis, IE (301) 492-9655

~

Attachment:

List of Recently Issued IE Information Notices

August 11, 1988 1ELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE FNO-II-88-48 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public- interest significance. The information is as initially received without verifi-cation or evaluation, and is basically all that is known by the Region 11 staff on this date.

FACILITY:lProvidence Hosoitall Licensee Emergency Classification:

Mobile, Alabama Notification of Unusual Event (AnAgreementStateLicensee) Alert Site Area Emergency General Emergency X Not Applicable

~

SUBJECT:

MALFUNCTION OF A MEDICAL DEVICE Alabama,' an Agreement State, notified NRC on August 10, 1988, of an incident at Providence Hospital located in Mobile, Alabama. The incident involved high radiation levels from a.

medical device manufactured by . Nucletron Engineering BV, Holland, and distributed by Nucletron Corporation, Columbia, Maryland, under a Maryland license number MD-27-035-01.

The device (MicroSelection-HDR) is a remote afterloading device for treatment of cancer and contains a 5 curies iridium-192 source. The sealed source is a Byk Mallinckdrodt CI L BV model.-

he incident occurred during the treatment of an outpatient. The hospital reported that efter three attempts to load the sources into the patient (device malfunction), the >atient was removed from the shielded room, catheters removed and surveys were conducted o" tne patient and all materials (catheters, etc.) that were renoved from the room. . Althcugh relatively high radiation levels were measured near the device, no contamination was detected inside the treatment room. Surveys indicated that neither contamination nor radiation was present either in or on the patient or areas outside the treatment room.

'The Nucletron Corporation's RS0 responded to the incident and the representative's 200 mR dosimeter went off scale after approximately three to five minutes in the room. The hospital's panoramic survey meter read 800 millirem oer hour near the device. A subsequent entry by the RSO under Alabama Radiation Control Program guidance revealed that all source wafers were contained within the device. Additional exposure to the RSO was 60 millirem and the State calculated that the total exposure for the two entries was approximately 360 millirem.

The Alabama Radiological Health Branch responded imediately to the incident. Confirmatory surveys were performed outside the treatment room, and the hospital's survey equipment was determined to be operating properly. Regulatory oversight and guidance are being provided to the hospital and the Nucletron Corporation representative. The Alabama Radiation Control Branch has briefed the State's Health Department management on the incident.

Region 11 notified FDA of the incident at 6:00 p.m. (EDT) on August 10, 1988.

The NRC received initial notification of this event by telephone from the State at

• 30 p.m. (EDT) on August 10, 1988, and additional details were obtained at 5:30 p.m.

.EDT). The need for NRC technical assistance was discussed with the State during the initial notification and all subsequent discussions thereafter. Additionally, on August 11, 1988, the Regional Administrator contacted the Office of 'the State Health Officer, Dr. Fox, and offered Regional technical assistance. As a result of this telecon, it was determined that the only NRC technical assistance required at this time is in the

area of offering guidance on packaging and transportation of the device and liaison cith'other involved organizations.

..his information is current as of 3:00 p.m. (EDT) on August 11.

CONTACT: R. L. Woodruff - 242-5553 R. E. Trojanowski - 242-5597 DISTRIBUTION One White M' land Nat'l Flint North Bank Bldg Regions MAIL TO: DCS(OriginalIE34) chairman Zech ARM Region I DOT (TransportationOnly)

Cosa. Roberts OIA Region II Cosa. Carr AEOD Region III FAX T0: INPO Cosun. Rogers Region IV NSAC SECY Region V RRI OGC Nicholson Lane NRC OC OCA RE5 LICENSEE (Reactor Licensee)

GPA/SLITP/PA NRC HQ OPERATIONS CENTER EDO 01 H Street NRR ACR5 NMSS PDR 5520: 8/11/88 0 3:30 p.m. (EDT) TO REGIONS AND HQ ccc***************************************************************************************

6 1

s

L, .

l

... . ~

~ ' '

UNITED STATES -

NUCLEAR REGULATORY COMMISSION l 0FFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555

• July 27, 1988 i

NRC INFORMATIONINOTICE NO.88-52h FAILURE OF INTRAUTERINE TANDEM OF FLETCHER SUIT APPLICATOR BRACHYTHERAPY DEVICES DURING PATIENT TREATMENT Addressees: '

Medical licensees, purposs:

This information notice is intended to provide information on the inspection of intrauterine tandem of Fletcher Suit App 11cator brachytherapy devices for applicator weld corrosion and the proper sterilization procedures. It is ex-pected that licensees will review this information for applicability to their brachytherapy activities and distribute this notice to responsible medical staff. Suggestions contained in this information notice do not constitute new NRC requirements, and no written response is required.

Description of Circumstances:

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health received eight reports since 1983 of incidents with Fletcher Suit Ap-plicator intrauterine tandems. In each incident, the radioactive capsules were removed, but the closed end of the tandems separated from the app 11cator and remained in the patient during applicator removal. Additional radiographic and operating procedures were required to locate and remove the broken pieces.

The failure is caused by weld joint corrosion. The corrosion may be due to improper cleaning before ste-ilization.

Discussion: 1 The Fletcher Suit Applicators can be used with either byproduct material or radium brachytherapy sources. The FDA believes that all Fletcher Suit Ap-plicators should be inspected before each use, to ensure that the closed ends of the intrauterine tandem are secure. If they are not secure, the device should not be used. Cleaning the applicators with hydrocen peroxide or glutaraldehyde (Cydex) before autoclavino or cold steril' zation may cor-rode the applicators' welds. The FDA recommends that the applicators be cleaned using only mild detercent and water, and then thorouchly rinsed.

with water before sterilization. The FDA also recommends that all appli-cators of similar design be checked, and the same cleaning instructions followed, s

8807210218

IN 88-52 July 27, 1988 Page 2 of 2 No specific action or written response is required by this information notice.

If you have any questions about this matter, please contact the person 1kted below or the appropriate NRC regional office.

fh == . _ ,k-Richard E. Cunningham Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards -

Technical

Contact:

Donna-Beth Howe, NMSS (301)492-0636

Attachment:

List of Recently Issued NRC Information Notices N

e

SSINS NO.:  !

IN 82-33 UNITED STATES NUCLEAR REGULATORY COMMISSION 0FFICE OF INSPECTION AND ENFORCEMENT WASHINGTON, D.C. 20555 August 20, 1982 IE INFORMATION IN0TICE NO. 82-33l: CONTROL OF RADIATION LEVELS IN UNRESTRICTED AREAS ADJACENT TO BRACHYTHERAPY PATIENTS Addressees:

All Medical Institutions.

Purpose:

During the course of several inspections NRC inspectors have found radiation levels exceedina reculatory limits in unrestricted areas adjacent to brachy-therapy patients. This notice discusses the applicable regulatory limits and associated requirements. It is expected that recipients of this Information Notice will review the information for applicability to their facilities. No specific response to this notice is required. -

Discussion:

Radiation levels in unrestricted areas may not exceed the limits as specified in 10 CFR 20.105(b)(1) and (2) unless the licensee has been granted an exemption by demonstrating at the time of applying for a license or amendment that the requirements of paragraph 20.105(a) will be met. This exemption must be stated as a specific condition of the license.

Treatment of patients with brachytherapy sources may result in a situation where the public may be exposed.to unnecessary radiation. Insufficient distance between the restricted and unrestricted areas and a lack of shielding material in brachytherapy rooms has, in some cases, resulted in the existence of levels of radiation greater than the permissible limits specified in 10 CFR 20.105(b)(1) and (2). " Adjacent areas" may include adjacent rooms and hallways as well as areas on floors above and below the brachytherapy patient's room.

The regulations require that, unless an exemption under paragraph 20.105(a) has been granted, radiation levels may not exist in unrestricted areas so that, if an individual were continuously present in the area, it could result in that individual receiving a dose in excess of 2 millirem in any one hour or 100 millirem in any seven consecutive days. It is important to note that compliance must be established with both paragraph 20.105(b)(1) and (2). As an example, if a hospital treated a sufficient number of brachytherapy patients to maintain continuous occupancy in one room and radiation levels in adjacent unrestricted areas were greater than 0.6 millirem / hour, the facility would be in violation of paragraph 20.105(b)(2). Specifically, a situation would exist where an individual who continuously occupied the unrestricted area might receive more than 100 millirems in seven consecutive days. -

l 8204210411

^

- - --- --- m

. I

~

IN 82-33 l August 20, 1982 Page 2 of 2 In establishing compliance with paragraph 20.105(b)(1) and (2), it is necessary to conduct a survey as required by paragraphs 20.201(a) and (b). An evaluation of the radiation hazard must be made that, if appropriate, would include measure-ments of the levels of radiation. In the event that radiation levels greater

~

than permissible levels are encountered, action must be taken to reduce the level. Action might include increasing the distance between the patient and ,

the unrestricted area or the use of portable shields. After employing such methods, a survey must again be performed to assure that radiation levels in adjacent areas are below the permissible limits. Records of these surveys must  !

be maintained as required by paragraph 20.401(b).

No written response to this information notice is required. If you need additional information regarding this subject, you should contact the Regional Administrator of the appropriate regional office.

P d V a

. Cobb, Direc. tor X ision of Fuel Facilities, Materials and Safeguards, IE Technical

Contact:

C. Yaczko

, 301-492-9748

Attachment:

List of Recently Issued IE Information Notices 4

?. (

4

. Iasm naqueessoas ser possearJen of involved. the test results, and the action senses sewees one braehymerapy seween. taken.

(a) Alicenseein possession of any (f) Alicensee need not perform a uded nearce er brachytherapy source sources:

abaB follout ibe tsdiation safety and leakage (1) sourcestest on the follogo y byproduct containing LA ;;.s-:t:n ymW sy tse material with a half-life ofless than 30 menuacturer, and aball maatam tse days 1 rt-?ns for the duration of source (2) Sownes containing only byproduct use in a 'emble form convenient to users. m ri I ges:

A amdpmessionof a orless of beta or gamma. emitting (1) Test the soure for leakane befo,, mawdal or to alma wless of its Bret use unless the beensee has a *lj, ceruficate from the supplier indicating

% styah not being used.

De licensee shall. however, test each that the sowce was tested within six months before transfer to the licensee: {,fo',3ess whagebelo it has been oak

) Test the source forleakane et ew ai gen and latervale not to exceed six months or et es otherintervals approved by the r*m==laaion or an Agreement State and h)(3)Seeds ribbon. ofiridium-192 encasedin Alicenseein possession of a described in thelabela broche that accompanies the source. sealed source or brachytherapy source shall conduct a cuarterly physical (c)To estisfy theleak test inventory of au such sources in its requirements of this section, the licensee must: poemmon.no hcensee aban retain (1)Take a wipe sampleimm the each inventory record for Sve years. %e

• sealed soares or ham the surfaces of the inventory recorda must contain the model number of each source, and serial device in which the maled sourceis -

numberif one has been assigned,the mounted se sted on which radioachw identity of each source radionuchde and co2tamination misht be expected to its nominal activity, the location of each ecommulaw orwash the source 2 a source. and the signature of the smaR volume of dotargent solution and Radauon Safety OfEcer.

treat the entire volume as the sampts:

(h) Alicensee in possession of a (s) Take teletherapy and otbar device oested source or brachytherapy source eseres test samples when the source is d5 '*0F posidon; and shallmeasure the ambient dose rates quarterly in all areas where such Is)h4easure the sample so that the sources m stored.This does not apply leakane het canofdetecube GL005 hicrocunes radioecoveameanos matena o{ l to telethernov sources in teletherapy units w Md wurcesin dagnosuc on the sample.

devices.

(d) A licensee shall retain leakage test records for an years.The records must (I) A licensee shall retain a record of oostain the model number, and serial each swvey aquired in paragraph (h) of this section for two years.De record numberif esalsned,of each source must include the date of the survey, a tested, the identity of each source plan of each area that was surveyed, the redienuchde and its estimated activity. measured dose rate at several points in the measured activity of each test each area expressedin milhmm per esaple expressed in micmeuries. a description of the method used to bour, b surveyinstrument used, and the signature of the Radiation Safety maneuse nach test sample. the date of Officer, the test, and the signature of the Radiation Safety of5cer.

(e)If theleakase test reveals the presence of 0.006 microcune or more of removable contamination, h licensee aball:

(1)lassediately withdrew the sealed souros from use ano store it m sonordann with the requartments in Parts 20 and 30 of this chapter: and (2) File a report within five days of the leakass test with the appropriate NRC O!5ce usted in 130.6 of this chapter.

with a copy to Director ofInspection and Enforcement. U.S. Nuclear '

Regulatory Commiselon. Washington.

DC 206&5. describing the equipment

l t

APPENDIX H l F Model Procedure for Leak-Testing Sealed Sources (See S 35.59.)

You or your contractor may use the following model procedure to leak-test sealed sources. If you, or the contractor, follow the model procedure you may say on your application, "We will establisn ,... Implement the model procedure for leak-testing sealed sources that was published in Appendix H to Regulatory Guide 10.8, Revision 2."

You may develop your own procedure for review. If you do so, you should consider for inclusion all the features in the model and carefully review the requirements of 5 35.59. Say on your application, "We have developed a leak-test procedure for your review that is appended as ATT 10.3," and append your leak-test procedure.

jj0DELPROCEDURE

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

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

3. Prepare a separate wipe sample for each source. A cotton swab, injection prep pad, filter paper, or tissue paper is suitable. Number each wipe so you will know for which source it is to be used. Samples should be taken as follows:

a. For small sealed sources, it may be easier to wipe the entire acces-sible surface area. Pay particular attention to seams and joints.

However, do not vipe the port of beta applicators.

b. For laraer sealed sources and devices (survey meter calibrator, bone mineral analyzer source), take the wipe near the radiation port and on the activating mechanism.

c. For teletherapy machines, take the wipe with the source in the off position. Wipe the area near the shutter mechanism, taking care to touch neither field light and mirror nor crosshairs. Also wipe the primary and secondary collimators and trimmers.

d. If you are testing radium sources at the same time you are testing NRC-licensed sources, they should also be checked for radon leakace.

This can be done by submerging the source in a vial of. fine grained charcoal or cotton for a day. Then remove the source and analyze the adsorbent sample as deteribed below. A survey should be done to be sure the sources are adequately shielded during the leak-test period.

F s H-1 A _ _ _ _ _ _

g en . .

,4. The' samples.will be analyzed as follows:

a. Select an instrument that is sufficiently sensitive to detect 0.005 microcurie. For beta. sources, a proportional flow counter, liquid be scintillation counter, or thin end-window GM survey meter may appropriate. j For gamma sources, a crystal with a ratemeter or 1 scaler or a GM survey meter may be appropriate. Dose calibrators used in nuclear medicine are not sufficiently sensitive.

b.

To estimate the detection efficiency of the analyzer used to assay the wipe samples, asbay a check source that has the same isotope as

_the sealed source and whose activity is certified bv the sunolier.

If one is not available, it will be necessary to use a certified check source with a different isotope that has a similar spectrum. If calculations demonstrate that the instrument is not sufficiently sensitive to detect 0.005 microcurie, a different instrument must be used.

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

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

- Continue the same analysis procedure for all wipe samples.

f.

If the wine samole activity is 0.005 microcurie or areater. notifv the RSO. The source must be withdrawn from use to be repeired or (II discarded. Y If it is a source distributed under an NRC or Agreement State license, the NRC must be notified. (See paragraph 21.21(b) of 10 CFR Part 21 and paragraph 35.59(e)(2).of 10 CFR Part 35.)

g.

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

l x

H-2 L _ _ ___--__ _-__ _-__

e.

EXHIBIT 19 RADIATION SAFETY CHECKLIST FOR TEMPORARY IMPLANT THERAPY Patient: Room: Date:

PREPARATION a Schedule a private room in,a low traffic area.

o Mark a visitors' " safe line" on the floor.

O Brief the nursing staff on radiation safety measures.

O Supply the nursing staff with personnei radiation desimeters.

IMPLANT a Clear the room of unneeded personnel.

a Brief the patient on the clinical procedure.

O Insert the implant a Measure dose rates at bedside, 1 meter from bedside, visitors' " safe line,"

and surrounding hallways and rooms.

c. Post the room with a " Radioactive Materials" sign.

( FOLLOWOP c Make a radiation survey of the patient to assure that all sources have been removed, a Count the number of sources removed from the patient to assure that all sources have been removed.

O Remove the " Radioactive Materials sign.

4 -

EXH-35

o .

EXHIBIT 21 (Example)

SAMPLE CESIUM IMPLANT SOURCE LOG j Only the following individuals may haydle these sources:

S. Mudd,11.D. g '

Bea L'acchen, Therapy Technologist #4/ JohnAwitt.RSO/g ,

R$0 U J$u NWi$ date: / R 4 2 5 Normal storage configuration Activity at each storage point 1 A 18 1C 20 mci: -1A 18 1C 2A 2A 28 2C 10mC1: 28 2C 3A 38 3C 3A 3B .3C 15 mci: 4A 4B 4A 48 4C 5 mci: AC in storage taken out returned- -

date time no mci no mC1 no mC1 patient name mR/hr init

/ /6 ff 4 12 K4 4 122 f5 2 iSinru 9 45 3 16 L4n fidd 16 W i 25 JS ~ t: Aaw h i

its 4 -

7o /Au Adf so/M

(,

9 0 0 ~

EXH-39

.. 9 E 4 D esfew heeruseen. l (2)'fhe licensee shau provide  !

radiation safety instruction to au '

oorsonnelcarma for the patient

. undergoing implant therapy. To satisfy this ;.y.;. c.t. the instruction must  !

describe:

g as.464 nessese et pements trestos wnn (1) Size and appearance of the

1. "#8'ery impeann. .

brachytherapy sources:

(al f-Metely after removina the (2) Safe handling and shielding last temnorary imolent source from a instructions in case of a dislodged natient, the beensee shall make a .. source:

racistion survey of the patient with a (3) Procedures for patient control:

roc istion detection survey instrument to (4) Procedures for visitor control: and confirm that all sources have been (5) Procedures for notification of the removed. The licensee may not release Radiation Safety Officer if the patient from confinement for medical care a dies orhas a medicalemergency, patient treated by temporary implant (b) Alicensee shallretain for two until all sources have been removed, years a record ofindividuals receiving (b) A licensee shall retain a record of instruction required by paragraph (a) of patient surveys for two years. Each this section, a description of the record mustinclude the date of the instruction, the date ofinstruction. and survey, the name of the patient. the dose the name of the individual who gave the rate from the patient expressed as instruction.

millirem per hour and measured at one sneter from the patient, the survey I E418 88"'F P"**888"*-

lastrument used, and the initials of the (a) For each patient receiving implant individual who nude the survey. therapy.a licensee sha!!:

(1) Not quarter the patient in the same imass greehrmerapysourses room with a patient who is not r-.L;.,

""*""'Y* radiation therapy unless the licensee v (s) promptly after removing them from can demonstrate compliance with the e ne lent, a heensee shall return brecivthernov sources to the storey- muirements of I m105(b) of &is .

chapter at a distance of one meter from ersa, and count the number returned to

&e implut-ansure that a3 sources taken from the (2) post the natient's door with a storene area aave been returne_d. Radioactive Matenals" sign and note (b) A bconsee shall make a record of on the door or in the patient's chart ncbyeerapy source use which must where and how long visitors may stay in 7,*gg,I g' 3 Au its byindividuals (2)'!be number and activity of sources under patient agewith basis 13the only on a patient-by approval of t he removed from storage, the patient's name and room nuh. the Mme ud authoriaed user after consultation with date they were removed from storage, the Radiation Safety Officer:and the number and activity of the sources (4) Promptly afterimplanting the in storage after the removal, and the material, survey the done retes in initials of the individual who removed connauous restncted and unrestricted the sources from storege: amas with a radiation measumment (3) The number and activity of sources survey instrument to demonstrate retumed to storage the patient's name compliance with the requirements of

, and room number. the time and date Part 20 of this chapter. and retain for they were returned to storage, the two years a mcord of uch survey that number and activity of sources in includes the time and date of the survey, storage after the return, and the initials o plan of the area orlist of points of the individualwho retumed the surveyed, the musured dose rate et sources to storage, several points expressed in mi!!irem per (c)immediately after imolantina bour, the lastrument used to make the sources in a pauent the beensee shall survey, and the initials of the individual ma se a radiation survey of the panent who made the survey.

apt the eres of use to confirm that no (5) Provide the patient with radiation sources have been misolsced. The safety guidance that will help to keep heensee shallmake a record of each radiation dose to household members and the public as low as reasonably eury,y, (d) A licensee shall retain the records achievable before releasing the patient required in paragraphs (b) and (c) of this if the patient was administered a section for two years. Permanent implant.

(b) Alicensee shallnotify the

> Radiation Safety Officer immediately if

! the patient dies or has a medica!

l emergency. .

,o .

. APPENDIX Q

- .}~ Model Procedure for Radiation Safety During Implant Therapy  ;

(See SS 35.75, 35.404, and 35.406.)

You may use the following procedure to reduce worker ard public dose during implant therapy. If you will. follow the model procedure, you may say on your application, "We will establish and implement the model procedure for radiation safety during implant therapy that was published in Appendix Q to Regulatory Guide 10.8, Revision 2."

If you prefer, you may develop your own procedure for review. If you do so, you should consider for inclusion all the features in the model procedure and carefully review the requirements of SS 19.12, 20.105, 35.75, 35.404, and 35.406. Say on your application, "We have developed a procedure for radiation safety during implant therapy for your review that is appended as ATT 10.15,"

and append your procedure.

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

MODEL PROCEDURE

1. The patient's *oom will be as far away from the nursing station and heavy traffic hallways as is consistent with good medical care. It will be a private room unless the dose at one meter from the implant meets the re- '

quirements in paragraph 20.105(b) of 10 CFR Part 20.

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

3. Brief the nurses on radiation safety precautions. Use the sample form, "Hursing Instructions for Patients Treated With Temporary Implant Sources,"

Exhibit 20, or your own nursing instruction form as an outline. Allow time for questions and answers during the briefing.

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

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

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

7. Following the implant, measure the exposure rate in mR/hr at bedside, at 1 meter from bedside, at the visitors' " safe line," and in the surrounding hallways and rooms (the last rates must conform to requirements in para-graph 20.105(b)). Record this and any other necessary information on the nursing instruction form or the nurses' dosimeter signout form. Post the room with a " Radioactive Materials" sign.

f4 8. Do not release any patient who has received a temporary implant from the

) hospital until both a radiation survey of the patient and a count of f

Q-1

implant sources, trains, or ribbons confirms that all sources have been removed from the patient and are accounted for. Perform this check imme-diately after the removal of the sources. Keep a record confirming the ~

j source count and radiation survey on the implant source running inventory form. . For low-activity seeds (less than 1 millicurie), use an individual seed to check the survey meter to be sure it will easily detect a seed that has not been removed or has been lost.

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

You may want to use the sample forms in Exhibit 19, " Radiation Safety Checklist for Temporary Implant Therapy," Exhibit 20 " Nursing Instructions for Patients Treated with Temporary Implant Sources," and Exhibit 21, " Sample Cesium Implant Source Log."

l l

Q-2

o .

4 EXHIBIT 20 (Example)  !

Nursing Instructions for Patients Treated With Teniporary Implant Sources Patient Name: //o //MfS//>>O Patient Number: #250/0/

Attending: [ // fat /4d ///Mor.e:65f4 Pager:3 8 8 Patient Room: 36/5 Dose: Jto mci of 1-/ffas 78 individual soure , was loaded on 1-M.

Sources will be removed at approximately d- on 1-p-d.

Radiation Exposure Rates Unrestricted areas: door- / / mR/hr; re g -8 3 mR/hr; rm M d.dmR/hr Patient supine in bed o d -

Date Time Bedside 3 ft from bed Door //:r. t/Ad 6 8 mR/hr /d mR/h /./ mR/hr 7./mR/hr 1-g-g g: __

Relea'se certification: Patient may not be' released from the hospital until the following certification is signed and dated by the RSO or the attending physician.

I have removed and counted Mdindividualscarcesfromthispatient. A low-range GM survey of the patient failed to in icate ining sources in the patient.

Signature:. 4 NIM Date 8 ff_

l9 Instructions V itor Restrictions:

No visitors under 18 or pregnant.

minutes each day maximum for each visitor.

itors must stay behind line on floce at all tirts.

Nursing Restrictions:

o Patient is restricted to room.

e' Patient is restricted to bed.

Patient must not move.

e# N s/ o nurses who are minutes eachpregnant day per may nurserender in the care.

room.

e PaJientCare: Leave at nursing af Wear your radiation monitor when caring for patient.

station at the end of your shift. You may use the same monitor on your next Do not share. Call RSO for additional monitors if needed.

s' shift.If a source appears dislodged, call the attending physician and the RSO immediately.

o Omit bed bath, o No perineal care. Pad may be changed as necessary.

/ Save surgical dressings for disposal by attending physician or RSO.

/ See special oral hygiene care instructions.

o o

ou have a question, call:

case ofMM emergency h [, or if Woi t : Home: - Pager:

WoiI: Home: -

Pager:

lain Nas/C f

EXH-37

d ..

.

• s.

. )

)

Radium / Cesium Iridium Iodine Therapy Dosimeter Assignment Log Patient Room Dose mR/hr at following locations and times bedside 1 meter 2 meter hallway am om  :

Am Da ..

am Da  :

~

1

1. Identification mR

. .Name . .

. Soc. Sec. No. . .

. .Name . .

. Soc. Sec. No. . .

. .Name . .

. . Soc. Sec. No. . .

. .Name . .

. . Soc. Sec. No. . .

. .Name . .

. . Soc. Sec. No. . .

. .Name . .

. . Soc. Sec. No. . .

, . .Name . .

. . Soc. Sec. No. . .

. .Name . .

. . Soc. Sec. No. . .

9

y, . . . . . . .=. ~ , . . . . . . . . . .

-l - .

3

'/

. i Se 2 .

.o -

. p ,

Inv.en:ory contro_ or 192Ir

~

. therapy sources NORMAN L. McELROY, JAME5 A. DEYE, ARNOLD HER5KOVIC "A'n[inv'ehory-control system for "21r-seeded nylon M *s i' brachytherapy ribbons is described. After addressing

%er.pr- , t

• C

• Inventory-control problems peculiar to the seeded rib. .-

bons,the auth' ors present the forms that were developed

" 3 k -

to' document the receipt, use, and transfer of the Q- "[

,, g lic.nsed m,aterial. ,

j, ,

J C E.. ~\

D. etailed protocols for the use of "21r seeds in the treat-ment of certain malignancies have been ' described

'elsewhere.' Utilization of multiple sources at medium esPf' 8

, k.k snirgy (370 kev radiation)in and around the tumor i'tself allows l .C &

the therspi,stjo delivery very high concentrated doses of radia- .l. ..

• ti:n io the tumor while limiting radiation of surrounding struc- --

..,@. 4 turss, in the example s':rwn in Figure 1,4000 rads were deliv. f . f. ,

• al '*

grad in three days to a large tumor in the tongue, whereas the q dos 2 to the surrounding structures. including salivary glands, g muessa of the rest of the mouth; and spinal cord, was very 3 I ,, , p'

~

.. u modest. Interstitial implants of this nature have frequently.

• be:n used to treat breast tumors, head and neck tumors. lymph ' d.

7 n: des, gynecological tumors, rectal tpmors, and urethral tu-mors in a similar manner. . ,' .A 8 =, .

Basically, needles are used to thread nylon catheters through the tumor volume under general anesthesia. Fo!!owing r ecov. M" a cry,the catheters are afterloaded with r.ylon ribbons that have a n:mina) diameter of 1 mm and that contain 0.3- to 0.5-mg i Figure 1. T ypical loading ior iongue cancer (one ribbon is highlight ed).

radium-equivalent seeds of iridiu m at 1-cm intervals. A needle, cathiter, and seeded ribbon are shown in Figure 2. Each new ribbon may contain four to fourteen seeds of a specified Several inventory. control problems surface in complying activity, and a shipment may contain as many as 50 ribbons, with regulations and recommended guidelines.2 The half- I which are frequently cut into shorter lengths for use. Following life is 74 days, and each seed is nominally 0.5 mg radium usa, the ribbons are returned to the supplier in a well within equivalent on receipt. Different activity, e.g., 0.5-mg seeds versus 0.4-mg seeds. is visibly distinguishable only by tinting of tha shipment pig.

' the nylon ribbon. The <ccch are tiny: 0.5 mm in diameter by 3 wt980 by Aarrmgron Pubhratuim. #nr All senhrs sewrms Rerwi=Lr.

mm. A shipment t uufd puustily a osit.iiri 100 weds at 0.5 mg.100 sion in whole or part wirhour written permenion n irrx ely prolulured.

ma j

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,eed.

a. /.

,.... .iu . u.u.n..

.m w t

. . - . . , ,. u . 4b e-

~; J Figure 3. Form 1. used to record receipt. change of contents. an i ,

return.

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• 6

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t i ca un i.us ' ess i tLe R UD 6 l_sa n 50 29 140 10 - -.--t--

s.N Figure 4. Form 2. for recording use.

• t APPLIED RADIOLOGY, November December 11 102 A _ _ _ . _ _ _

o .,

e se:ds at 0.4 mg, and 100 snds at 0.3 mg. Finally,tha configura- u,,,,_ ,.,,,,,,,,,,,,,,,,,,g.,,,,,,,,,,,, ,, ,

"- * * ** * ""a ' ~

• a " " *-* *" ' . =a = m a s

, tion cf the seeds changes with each use, f.e., the number of seeds pu ribbon and/or the number of ribbons containing _,_,,,,,_,,,,,,,_,,,,,,,[,ris 4 ~ai** a ab,1f .21

--a,,,,;~ . ~.a- a . ~ a on] or more seeds. p-.- r a,n, ,,,,.n

a. . ..uw.M in addition to these physical problems, the bventory system g "j-- g must address four management problems.The first, verification 20 ._._M

1. -- ..s.s. .

cf th2 packing slip, includes checkir.3 the number of ribbons, -- """ '"'" "*"'

number of seeds contained in each ritbon, and ribbon color.

See:nd, more than one patient may be treated at the same _ . ~ _ . . . . . . . . #..'l#.D*M.9.N.... .

• .*r*".',.*' .s. a_.g._zy tim a from a single shipment. Third, a set of seeds may be used "1l"  !*d ca /f/s ..

for treating several. patients before being returned to the to _A jyt

1. • M* * *U supplier for disposal. Fourth,the number of seeds assigned to a

",li C';,

. u,,

pig can increase if the remaining unused ribbons from an *

- fp ,.yg. 7,f.fa,4 caril;r pig pre transferred into.it so that the earlier pig can be """""""""""" ~ " '~ *-

returned to the supplier fol' disposal. *

, ,,,,,,,, ,, u";";*;,,; ;Q;;0::; j Th2 purpose of an inventory 5ystem is o record the several

• i locations of the inventoried material *and the activity at each ~ , .

~ ~ '. " ~ ~ .~ ~ ' ' -

I: cation; with this in mind,the following inventory iormat was i - - , , , , , , ,

-.--- -- =aa '- a' **a

,d;v; loped. -

• *-~*

• ........................Z.- . ... .

. System "";,"' ;=,,;' a;;;

, , , , ,_" * ' " ' ' " " " ~ ~ " " " * ~

On receipt,three separate forms contained in a ring bmder C * '

• cra assigned to the pig: receipt, change of contents,and return

/ -- -

(Farm 1); use (Form 2); and return calculation sheet (Form 3).

/ __._ "i!$ O ===

Th2 manufacturer's packing slip and cc-'ification of activity are ' ' ' '

also filed here. N """

Thabacking slip includes a listing of pig contents and a **

-E[T- N.f

• * * " * * *~~ ' W*'#"""

calibration of milligram radium equivalence on the day of """*"'"'""*'"# "" N'" ~ "'

shipment. This information is recorded at the top of Form 1 (Figure 3). A nose count of ribbons and seeds per ribbon is ""*"* " # ~ D ** f M perff rmed by the radiation safety technologist; verification of . Figure s. Form 3, used to calculate actwity in pig returned to suppher.

activity is the responsibility of the therapy physicist.

Use of materials is recorded on Form 2 (Figure 4). In this cxample, on receipt there were 120 seeds contained in 10 tions on the form and a fifth section for tallying. Each section is ribb:ns (12 seec's per ribbon). The patient was then loaded used for. calculating the total activity 'I a set of seeds with the with 72 seeds co'ntained in 12 ribbons (six 12-seed ribbons were sarie mariufacturer's shipping date etSD) calibration. For a j halv:d leaving 48 seeds in four ribbons unused). The third particular set of seeds,the number of ribbons with, for exam-cntry indicates that all 72 seeds were recovered, from the ple, six seeds per ribbon is counted while the pig is loaded for patigt and placed in the well. (The results of the radiation return. lf seeds of a different MSD calibration are being re-

• survey o'f'the patient and room are recorded elsewhere.) The turnedin the same pig,the second section of the form is used.

fyutth entry shows a transfer in of 40 seeds contamed in four After a nose count is run while the pig is packed, the total

, ribb:ns for possible future use.The fifth entry shows the total activity, total number of ribbons, and total number of seeds number of seeds and ribbons returned to the supplier for can be calculated and logged at the bottom of the form.The disposal. Note that the transferm, dicated by the fourth entry is final packaging information is recorded at the bottom section also recorded at the center of Form 1 (Figure 3). of Form 1(FiEure 3).The total numbers of ribbons, seeds,and in addition to a total nose count, the idealinventory system activity en date of packaging are recorded. Measurements shiuld indicate,in case of a loss,its configuration,e.g.. the loss needed for compliance with transportation regulations are cf a six seed ribbon versus the loss of two three-seed ribbons - also noted here.

This was considered but not implemented because an inordo nat) amount of time would have been spent tracking down rnistakes on paper that did not repre--nt a true loss of licensed References mat', rial and would require a seed recount with its concomit ant 1. Syed, A.M., Nisar, and Feder, B.H., Technique of After. Loading personnel exposure. Furthermore, handling during implant Interstitial lmplants," Radiol. Clin., Vol. 46,1977, p. 458

• end handling during remoyal are the two most probable 2. Title 10, Code of Federa! Regulations, Par: 30.51

3. Titte 10, Code of Federal Regulations, Part 35.14 periods of loss; although the inventory does not list the 4. Brodsky, A., Principles and Practices for Keeping Occupational number of seeds contained in each individuaf ribbon,if one or Radiation Esposure at MedicalInststutions as low as 'tessonably more ribbons *were missing after implant or removal, such Achievable, Nuclear Regulatory Commission. NUREG-0267 E

]

ini rmation could be reconstructed from the implant radio.

graph at that time. Norman t. McElroy is currently affiliated with Radioisotope R esearch Fcrm 2 is used until the seeds in a pig are nolonger clin.ically at the veterans Adm,nistration Medical Center, washington, D.C.

us;ful owing to the length of the cut ribbons or the decayed lames A. Dere is currently affiliated with the Department oI Radiation  ;

oncology ,, f airfa, sospital, r,Ils Church va Arnold Herskovic rs j activity of the seeds. At this time, Form 3 (Figure 5)is used to aIIdiased wirh the Department of Radiology at he Ceorge Washingron calculate the activity in the pig prior to it5 packa gin g ior return t intverury urdic al renver, w.nhenston. O c 43 the manu8pcturer for disposal. There are four identical sec-

--~_~ _m- - m _ m_ _m 103

_ n - _ - , - - - _ _ __ _

~

a cecign:d to pig, cnd monitor pig prior to RETURN. M.S.D. ic MANUFACTU ER'S

, SHIPPING GCIE.

For Pig rscaivsd on - -

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Initial Contents Certified by Supplier ribbon ' number of

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color ribbons ribbon " seeds

• mgRaeq " mgRaeq cm - dd - yy R E

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• " seeds

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color ribbons ribbon C

H Came from A Went to. Pig on - , by - N G

ribbon number of

• seeds per total M.S.D. total M.S.D. E color ribbons ribbon " seeds

• mgRaeq " mgRaeq mm - dd - yy S Came from Went to Pig on - - by

• w *****************************************c Exposure Rates from Packaged Pig ribbons containing a total of seeds were packaged for shipment on ____y- - . On that date, the activity of 192Ir was mC1.

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For Pig r ccivid on

. seeds per x number of , total ribbon ribbons seeds Color M.S.D. - -

Humber of days since calibration:

+ + + =

M.S.D. decay mgRaeq factor mgRaeq X

• X seeds per number of total

• M.S.D.

ribbon ribbons " seeds Color - -

Number of days since calibration:

+ + + =

M.S.D. decay mgRaeq factor mgRaeq X X

• seeds per number of total ribbon

• ribbons " seeds Color M.S.D. - -

Number of days since calibration:

+ + + =

M.S.D. decay mgRaeq factor mgRaeq X

• X seeds per x number of , total ribbon ribbons seeds Color M.S.D. - -

Number of days since calibration:

+ + + =

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• X mgRaeq Total Total x 1.62 mci /mgRaeq f Ribbons Seeds Total activity in the pig on -

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-7y IAEA IAEA {

^ ~-

Training Course {

M: Safety and Regulation of Sealed Sources '

Ri of Radioactive Materials 10 April-12 May1989 Lecture 42. 6.10 Inspection of Teletherapy Programs l

- by Jenny Johansen ~'

Senior Enforcement Specialist Office of Enforcement U.S. Nuclear Regulatory Commision g Washington, D.C. 20555 26 Apd11989 l(. =

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REINSPECTION PREPARATION READ DOCUMENTS ASSOCIATED WITH LICENSE READ REGULATIONS ASSOCIATED WITH LICENSE PREPARE INSPECTION FIELD NOTES FROM DOCUMENT INFORMATION OBTAIN PROPER SURVEY INSTRUMENTS / CALIBRATION

. TRAVEL ORDERS /MCNEY/ MAPS / TRANSPORTATION

.~

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TYPICAL INSPECTION WALKTHROUGH (CESERVE THE TECHNICAL OPERATIONS)*

DISCUSSIONS WITH EMPLOYEES (TRAINING)*

INDEPENDENT MEASUREMENTS

• RECORDS REVIEW (EVALUATIONS, EXPOSURES, CALIBRATIONS)*

MEETING WITH MANAGEMENT (IMPORTANT-DISCUSS RESULTS)*

• THE OBJECT IS TO PERFORM THE INSPECTION WITHOUT DISRUPTING PATIENT TREATMENT.

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j SPECIFIC TOPICS CCVEPED IN TELETHERAPY INSPECTION ORGANIZATION INSPECTION HISTORY SCOPE OF PROGRAM TRAINING

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s RADIOLOGICAL PROTECTION PROCEDURES-MATERIALS, FACILITIES, AND INSTRUMENTS RECEIPT GF MATERIAL ,

PERSONNEL PROTECTION-EXTERNAL l

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_ . _ _ _ _ _ _ __ __-_____________-_-__---___-__Q

SURVEYS NOTIFICATIONS AND REPORTS BULLETINS AND INFORMATION NOTICES TELETHERAPY CALIBRATION L

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__ . _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ . . _ _ _ _ _ _ ___________,.____._____-__.______.__________________._m_____m.__ - _-_. ___

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2 PROTOCOL f

OUTPUT VERIFICATION-(0PTIONAL)

~*

OTHER TESTS l

-ITEMS OF NONCOMPLIANCE 9

__.____.__.__m__________ _ _ . _ _ _ _ . _ _ _ _ _ ____ _ _ _._ _ .___.. _ _ . __m_

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SUGGESTED METHOD OF INSPECTION i i

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LOCATE TELETHERAPY DEPARTMENT IDENTIFY YOURSELF ASK FOR THE RSO >

4 44

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q ASK WHEN YOU CAN USE THE ROCM TO DO YOUR SURVEYS AND TALK WITH TECHNICIAN REVIEW RECORDS WITH RSO, DOCUMENT DATES IF NONCOMPLIANCE FOUND

'N

PERFORM SURVEYS AND TESTING WITH HELP OF TECHNICICAN OR RSO PREPARE LIST OF VIOLATIONS, IF ANY

e 4

O DISCUSS VIOLATIONS WITH MANAGEMENT AND CONSEQUENCES OF ENFORCEMENT l

h ____.________.1.__...__._._____

p- ,

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s IV. CRITERIA TO INSPECT AGAINST 35.605 MAINTENANCE AND REPAIR RESTRICTIONS

.ONLY SPECIFICALLY LICENSED PERSON MAY INSTALL, RELOCATE REMOVE SOURCE OR UNIT, OR MAINTAIN, ADJUST OR i REPAIR SOURCE DRAWER, SHUTTER, OR l

OTHER MECHANISM OF UNIT THAT COULD EXPOSE SOURCE, REDUCE SHIELDING, OR INCREASE RAD LEVELS l

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35.6b6 AMENDMENT CHANGE ROOM SHIELDING UNIT LOCATION IN ROOM USE WHICH INCR RAD LEVELS RELOCATE TELE UNIT NEW TELETHERAPY PHYSICIST l'

e

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L -

35.610 SAFETY. INSTRUCTION POST AT CONSOLE PROCEDURES .

- ONLY PATIENT IN ROOM BEFORE BEAM ON OR AFTER DOOR INTERLOCK INTERRUPTION

- SHUT OFF BEAN WHEN OUTSIDE CONTROLS-FAIL OR OTHER ABNORMAL OCCURRENCE

- NAMES & TELEPHONE NUMBERS RSO 8 USER PROVIDE TO ALL TELETHERAPY UNIT USERS RETAIN RECORD OF WHO GOT TRAINING 3 YEARS I

~

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35.615 SAFETY-PRECAUTIONS l CONTROL ACCESS EACH D00R INTERLOCK EACH-DOOR

- NO BEAM UNLESS DOOR CLOSED

- BEAM OFF IMMEDIATELY D0OR OPENED

- NO BEAM ON UNTIL D0OR CLOSED AND CONTROL RESET AT CONSOLE BEAM ON LIGHT-1 e

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-s RADIATION MONITOR IN ROOM CONTINU0USLY FOR BEAM OBSERVED BY PERSON ENTERING / PROVIDE NOTICE VISIBLY OF EXPOSED SOURCE BACKUP DAILY WITH DEDICATED CHECK SOURCE KEEP RECORD OF CHECK 3 YEARS IF MONITOR INOPERABLE USE SURVEY METER CHECK SOURCE / RECORD PROMPTLY REPAIR / REPLACE IF INOPERABLE CONTINUOUS OBSERVATION OF PATIENT FROM CONSOLE 1

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4 35.620 POSSESSION OF SURVEY INSTRUMENT DETECTION DOSE RATE 0.1-100' MILLIREM /HR-OR MEASURING DOSE RATE 1-1000 MILLIREM /HR 9

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s 35.630 DOSIMETRY EQUIPMENT CALIBRATED DOSIMETRY SYSTEM AVAILABLE CALIBRATED BY NBS OR AAPM APPROVED LAB WITHIN LAST 2 YEARS AND AFTER SERVICE OR CALIBRATED WITHIN PREVIOUS 4 YRS AND INTERCOMPARED 18-30 MOS AFTER THAT CALIBRATION WITH A SYSTEM CALIBRATED WITHIN PAST 24 MOS BY NBS OR AAPM LAB--CALIBRATION FACTOR WITHIN 2%

SAME SOURCE CO-60 OR CS-137 SYSTEM FOR SPOT CHECKS COMPARED TO AAPM OR NBS CALIBRATED WITH LAST YR RECORD OF CALIBRATION /INTERCOMPARISON/

COMPARISON FOR DURATION OF LICENSE--

DATE/ MOD N0/SER N0/ CORRECTION FACTOR /NAME PERSON PERFORMED CALIBRATION / OKAYED BY AAPM 1

_ -___ _ _ a

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35.632 FULL CALIBRATION MEASUREMENT BEFORE FIRST MEDICAL USE BEFORE MEDICAL USE WHEN SPOT CHECK OFF BY 5% OF LAST FULL AFTER SOURCE REPLACEMENT OR REINSTALLATION AFTER REPAIR INVOLVING SOURCE OR COMPONENTS ASSOCIATED WITH SOURCE EXPOSURE ASSEMBLY YEARLY MEASUREMENT MUST INCLUDE:

OUTPUT WITHIN +/-3% FOR RANGE OF FIELD SIZES DISTANCES MEDICALLY USED COINCIDENCE RAD / LIGHT FIELD UNIFORMITY OF RAD FIELD TIMER CONSTANCY AND LINEARITY OVER RANGE OF USE ON-OFF ERROR ACCURACY DISTANCE MEASURING AND LOCALIZATION I DEVICES 1

h ,

9 DOSIMETRY SYSTEM PER 35.630 USED FOR ONE SET OF EXPOSURE CONDITIONS OTHERWISE DOSE SYSTEM THAT INDICATES RELATIVE DOSE RATES CALIBRATION PROCEDURES IN ACCORDANCE WITH SCRAD OR TG 21 OUTPUT DECAYED AT INTERVALS OF 1 M0 CO-60 OR 6 M0 CS-137 PERFORMED BY TELETHERAPY PHYSICIST NAMED ON LICENSE RETAIN RECORDS OF DURATION OF USE OF l TELETHERAPY UNIT SOURCE 4 CERTAIN SPECIFICS OF RECORD I

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s 35.634 PERIODIC SPOT-CHECKS ONCE PER CALENDAR MONTH ON EACH THERAPY UNIT MUST INCLUDE TIMER CONSTANCY /LINEARITY ON-OFF ERROR CONGRUENCY LIGHT / RAD FIELD ACCURACY DISTANCES / LOCAL DEVICES OUTPUT ONE SET OF CONDITIONS

% DIFFERENCE BETWEEN ANNUAL OUTPUT CORRECTED FOR DECAY AND THE SPOTCHECK PERFORMED IN ACCORDANCE WITH PROCEDURES OF PHYSICIST IF NOT PERFORMED BY PHYSICIST REVIEWED BY PHYSICIST WITHIN 15 DAYS WHO NOTIFIES LICENSEE IN WRITING OF RESULTS LICENSEE KEEPS COPY OF WRITTEN NOTIFICATION FOR 3 YRS

~

SS

s 35.634 (CONT)

MONTHLY SPOT-CHECKS FOR OPERATIONS ROOM INTERLOCKS ELECTRICAL MECHANICAL STOPS BEAM INDICATOR LIGHTS VIEWING SYSTEMS TREATMENT ROOM D0 ORS INSIDE/0UTSIDE PROMPT REPAIR OF NON OPERATING SYSTEM---

CANNOT USE TELETHERAPY-UNIT WITH DOOR WITHOUT PROPER OPERATION OF DOOR INTERLOCK.

RECORD OF SPOT-CHECKS FOR 3 YEARS SPECIFICS OF RECORDS l

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s 35.636 SAFETY CHECKS FOR TELETHERAPY FACILITIES.

PROMPTLY CHECK TELETHERAPY OPERATIONS SYSTEMS (35.634D)

AFTER EACH INSTALLATION OF SOURCE OR ANY CHANGE FOR WHICH AMENDMENT IS REQUIRED BY 35.606 IF CHECK INDICATES MALFUNCTION LOCK UP IN OFF OR MAY REPAIR REPLACE OR CHECK THE MALFUNCTIONING SYSTEM RETAIN FACILITY CHECK RECORDS FOR 3 YRS WITH SPECIFICS

-~

m

-_.---_._______.._-___..______________m..__,.__________ _______ _ _

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35.d41 '

RADIATION SURVEYS FOR TELETHERAPY

. FACILITIES l BEFORE MEDICAL USE - AFTER SOURCE INSTALLATION AND ANY CHANGES PER 35.606(A-D) D0 WITH RAD MEASURE SURVEY INSTRUMENT CALIBRATED PER 35.51 VERIFY MAX AND AVE RAD DOSE RATES AT IM FROM SOURCE IN HEAD IN OFF POSITION AND COLLIMATORS SET FOR NORMAL TREATMENT FIELD DOES NOT EXCEED 10 AND 2 MREM RESPECTIVELY WITH LARGEST FIELD AND PHANTOM IN PRIMARY BEAM THAT DOSES DON'T EXCEED 20.101 AND 20.105(B)

IF LEVELS IN EXCESS OF LIMITS LOCK UP IN OFF OR REPAIR OR REPLACE OF TEST UNIT AND ROOM SHIELDING OR GET EXEMPTION RETAIN SURVEY RECORD WITH SPECIFICS s

i _ _ ___ _ _ - -

. t l -

s 35.643 '

MODIFICATION OF TELETHERAPY UNIT OR

. ROOM BEFORE TREAT-IF SURVEY INDICATES RAD LEVELS 20.105(B)

MUST:

PUT STOPS ON UNIT OR ADD SHIELDING--

RESURVEY-MAKE REPORT OF MODIFICATIONS OR AMEND LICENSE PER 20.105(A) AWAIT NRC APPROVAL OF AMEND a

l

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35.645 REPORTS OF TELETHERAPY SURVEYS, CHECKS, TESTS, a MEASUREMENTS

. MAIL TO NRC REPORTS REQUIRED BY 36.636, 641, a 643 AND OUTPUT OF SOURCE IN R/HR OR RAD /HR AT 1 M DETERMINED AT FULL CALIBRATION PER 35.632

--___--_D

T 4

35.647 FIVE YEAR INSPECTION

~

EACH TELETHERAPY UNIT MUST BE FULLY INSPECTED AND SERVICED EVERY 5 YRS OR AT SOURCE REPLACEMENT WHICHEVER IS FIRST TO ASSURE PROPER FUNCTION OR EXPOSURE MECHANISM CAN ONLY BE DONE BY PERSON (S)

SPECIFICALLY LICENSED RETAIN RECORD OF FOR DURATION OF LICENSE WITH SPECIFICS I

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IAEA O IAEA

, Training Course l .- l Safety and Regulation of Sealed Sources of Radioactive Materials 1

10 April-12 May1989 Lecture 42.8.1'

~

Irradiators-Types, Facilty Design & Construction Parameter by

.V-George Dietz Isomedix 7g 11 A llo Drive 6

g Whippany, ewJersey 07981 j  ! , _

3 May 1989 ,

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__m__.____m__-_______________-.__.______.________.__.____.m_ _ _ _ _ _ . _ _ _ _ _ . _ , _ _ _ _ _ _ _ , _ _ _ _ ___

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IAEA MUC!.1AR NWER C0lRSE C'

Lecturer's Vita lecture No. 92,8-(

MAME: (.k. e o ^<re k . )Iebt ~

Yice h e e i c d + -[~ J r a w s_ d ic PRESENT POSITION:

AFFILIATION:

ADDRESS: // , App //e 'ber' p ki,l 9 % V ~)/L

, y D790) fnX 2 a / -#.P 7 -/ V 74, AREA CODE: u (- PHONE: 987-V 7 oo .F.T-S:

e4 R q~ s;.lle fe e sale s a e p A n .:

SCOPE OF PRESENT DLTTIES:

eo/>o.(f-Go f9euteSist , u)d'c k ejeca.h s y /a y e g c a {e

' "o S E b r* 5 in 7t{e (d 5 4 l&& ,n a

/nclus&a { t la / 9 7z See-d rc e 'bav}s, Ouc _o f oArq}xa.l' h u le+.s MOST RELEVANT PAST EXPERIENCE: lr fr e]

W yr-s wif$ Now Sc Eu e+ff S uer$Co,- c4 clas pi u ,

1 5en.da% Pesq.~ . A c(~ e; Weoinnr E d<L ks

% a f, u e hk to

'th<pa ca.h*m eoy m .

5 ype,~Ly k EDUCATIONAL BACKGROUND: ~

y;Wecffete, / 9 C 2. - .8.S l/ C A fe'// h y b a-i u i Asafcc & L iw e.,

G a. L J > f 7 & h o le p y , '

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TYPES,. FACILITY DESIGN AND CONSTRUCTION ,

ELECTURE 42.8.1 GEORGE R. DIETZ ISOMEDIX INC.

I. Self-contained, Dry Source Storage

• Cobalt-60 .

Cs-137

• Uses

Design

• Construction-

• Transportation

• Examples II. Panoramic, Dry Source Storage

.

• Cobalt-60 Cs-137

• Uses

• Design

~* Construction

.

• Transportation

• Examples III. Self-contained, Wet Storage

• Cobalt-60 Cs-137

• Uses

• Design

• Construction

• Transportation

• Examples IV. Panoramic, Wet Source Storage

• Source

• Types

- Tote

- Carrier

- Pallet

- Fully automatic

• Typical facility layout

• Shielding

• Occupied Area Radiation Level Specifications Points of Access / Egress

- Personnel

- Product

~

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i

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iI IV. . Panoramic, Wet Source Storage (continued)

Control Devices, Alarms and Signals

. ' ' Safety Systems andLInterlocks Radiation Detectors and Measuring Instruments Fire Control y

. Ventilation System  !

Contamination Control

. Preoperational Testing Quality Control, Maintenance Licensing Requirements

- Facility

- Personnel -

- Radiation Safety Program

' ' Preoperational Regulatory Inspections

- Soil analysis Source Storage Pool

- Irradiator Shield Footings

- Pool Liner

- Safety System

- Mechanism Operation

- Facility Survey e

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• 1 RADIATION SAFETY PROGRAM FOR IRRADIATORS LECTURE 42.8.2 I

This lecture will be limf.ted to the discussion of large scale industrial irradiators cf the panoramic, wet source storage type.

I. OPERATING PROCEDURES

- Cell entry

- Source raising

- Source receipt and handling

- Shipping cask surveys

- Irradiator operational logs and reports l

II. EMERGENCY PROCEDURES

- Maze monitor alarm

- Source moving alarm

- Water treatment system alarm

- Fire alarm

- Outside of irradiator

- Inside of irradiator .

- Non-radiation accident

- Personnel Overexposure III. PERSONNEL MONITORING

- Film Badge

- Pocket Dosimeter

- Chromosomal damage

! IV. LEAK TESTING

- Basic purpose and requirements

- Source wipe test

- Facility wipe tests

- Water treatment monitor

- Absolute filters V. WASTE MANAGEMENT

- Source disposal

- Effluent from water treatment system regeneration

- Refuse from accident cleanup VI. PERSONNEL TRAINING AND QUALIFICATIONS

- Office personnel

- Freight Handlers

- Facility Operators

- On-site Radiation Protection Officer

- Maintenance Personnel VII. SAFETY EXPERIENCE

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

p

.VIII. EXAMPLES OF SAFETY RELATED INCIDENTS AND THEIR SOLUTIONS

- Static dosimetry experiments

-_ Damaged totes

-.Open carrier. door.

- Inoperable source hoist solenoid

--Frayed source hoist cable

- Operating irradiator during major modification

~

- Leaking cs-1376 source-

. Leaking co-60 source

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1 l Key for figure 2 with reference to the pertinent part of this standard. l I. Water Cooler 10.4

2. Radiation Room Ventilation System 8.21.2

3. Radiation Room Monitor Probe 8.4

4. Safety Delay Timer Alarms 8.7

                                                               ,            5.            Emergency Stop Device 8.9      -

6. Heat and Smoke Sensors 8.20.2

7. Water Level Control-Normal 10.2.1 8.

Water Level Control-Abnormal (Low) 10.2.2

            ,                                                             9.              Source Hoist 8.13                                                                  .

10. ' Source Down' Switch 8.13

11. Roof Plug Interlock Switch (s) 8.15

12. Pool Guard 8.19

13. Radiation Room Shield-Concrete 9.2

14. ' ' Source Up' Switch 8.14.1

15. Source Storage Pool 9.1

16. Safety Delay Timer Keyswitch 8.7

17. Exhaust Air intake 8.21.2

18. Personnel and Product Entry / Exit Maze 8.6 & 8.11

19. Radiation Warning Light 8.14.1

                                                                    -20. ' Source Moving' Light 8.14.1

21. Product Entry / Exit Barrier Doors 8.11

22. Product Entry / Exit Maze 8.11

23. Product Exit Monitor 8.12

24. Source Hoist Power Disconnect 8.22

25. Check Source Location 8.3

26. Personnel Access DoorWith Interlocks 8.6

27. Radiation Room Monitor with Alarms 8.4

28. Seismic Detector 8.25.3

29. Master Key Attached to Portable Survey Meter 8.2 & 8.3

30. Control Console 11.1

31. Water Conditioner 10.3

__ ,_mm_m2. _ _ _ _--"A------'-"-----""--" " - - ~ - - - - - _ _ _ _ _ _ _ _ _ . _ _ - - - - --- - - - - - - - - - - - - - - - -

l - INDEX j- NRC-313 ~ kev Iten Pg - PART 1 - IRRADIATOR DESCRIPTION 1.1 Introduction 1-1 Item 6 1.2 Use 1-1 1.3 General Facility operation 1-2 Item 5 1.4 Licensed Material 1-4 Item 9 PART 2 - RADIATION DETECTION INSTRUMENTS 2.1 Portable and Fixed Monitors 2-1 Description, Rato/F 2-2 Description, Eberline E-130G 2-5 Fixed Radiation Monitors 2-7 Description, Model L118 Appendix C Description, Model D/L 2, No. L119 Appendix C 2.2 Calibration of instruments 2-8 2.2.1 RAT 0/F and Eberline 2-8 2.2.2 Model L118 2-8 2.2.3 Model L119 2-8 Itom 10 PART 3 - PERSONNEL MONITORING 3.1 Film Badges and Pocket Dosimeters 3-1 3.2 Procedural Restrictions 3-1 3.3 Suppliers 3-2 Item 9 PART 4 - FACILITIES AND EQUIPMENT 4.1 Site Location and Description 4-1 4.1.1 General Information 4-1 4.1.2 Plant Site 4-2 4.1.3 Map of Area 4-4 i 4.1.4 Selsele History of Puerto Rico 4-5 l 9

1 n IM0EX NRC-313 Key item pg 4.2 Building Layout Appendix B l 4.3 Mechanism Operation 4-6 4.3.1 Description 4-6 4.3.2 Source Movement Procedure 4-7

            '             4.3.3 Spread of Radioactivity Due to Foreseeable Accidents                         4-9 4.3.4 Radiation Levels due to Foreseeable Accidents                            4-10 4.4 Shiciding and Calculations                               4-11 4.4.1   Radiation Room Shielding                         4-11 4.4.2 Shielding Calculations                             4-12 4.4.3 Radiation Survey                                   4-20 4.5 Pool and Water Treatment System                          4-22 4.5.1   Details of Pool Construction                     4-22 4.5.2 Pool Waterproofing Specifications                                   4-24 4.5.3 Water Treatment Plant                                         !

Specifications 4-27 -l 4.6 Ventilation System 4-29 4.6.1 Design Basis 4-29 4.6.2 Noxious Gas Production and Control 4-30 4.6.3 Control by Ventilation and Lowering of Source 4-30 4.7 Safety Devices - Summary 4-31 4.7.1 Machine Key 4-31 4.7.2 Maze Door Lock 4-31 4.7.3 Source Holst Valve 4-32 4.7.4 Emergency Stop Cable and 4-32 Button 4.7.5 Fixed Radiation Monitors 4-32

INDEX

• NRC-313 i Key item l

pg 4.7.6 Start-up 71mer 4-33 4.7.7 Source Moving Alarm Radiation Warning Light 4-33 l

4. 7. 8 Source Rad Guide Cables 4-33 1 4.7.9- Pool Water Level 4-33 4.7.10 In-cell Temperature Sensor 4-33 4.7.11 Security System 4-34 4.7.12 Roof Plug Interlock 4-34 4.7.13 Fire Protection in Radiation 4-35 Cell 4.7.14 in-Cell Smcke Detector 4-35 4.7.15 in-Cell Startup Alarm 4 4.7.16 Power Failure 4-35 4.7.17 Hand-Held Monitors 4-35 I

Item 11 . PART 5 - WASTE 0~SPOSAL 5-1 Item 10 PART 6 - RADIATION PROTECTION PROGRAM 6.1 Introduction 6-1 i 6.2 Organization 6-2 6.2.1 Operations 6-2 6.2.2 Radiation Protection 6-2 6.2.3 Maintenance of' Safe Working Conditions 6-3 6.2.4 Contamination Detection Procedures 6-3 6.2.5 organization Chart 6-5

                                                         .s                                                       t i

1NDEX

           -NRC-313                                                                                                                                   4
 .             Key                                                                            item        __                     g item 10           PART 7 - OPERATIONAL. AND SAFETY CHECKS -

7.1 Irradiation Entry 71 7.2 Safety & Maintenance Related Checks 7-3 7.2.1 Weekly Safety / Maintenance Check 7-4 ,

                                                                                                                                                   .J 7.2.2 Monthly Safety / Maintenance Check                               7-6 7.2.3 Quarterly Safety Check                                     7-8 Item 10           PART 8 - OPERATING PROCEDURES 8.1               Normal Operation                                                8-1 8.1.1 Normal Startup                                             8-1 1

8.1.2 Normal Shutdown 8-4 8.1.3 Emergency Shutdowa 8-4 8.1.4 Automatic Fault Shutdown 8-5 8.2 Procedure for other Operations 8-7 { 8.2.2 Checkout Procedure After Initial Cobalt-60 installation 8-7 8.2.3 Receipt of Radioactive Material in Casks 8-8 i 8.2.4 Placing task in Pool and Uni : ding Source Basket 8-9 8.2.5 Sealed Source Leak Test 8-11 Procedures 8.3 Emergency Procedures 8.3.1 General 8-16 8.3.2 Radiation Alarm 8-16 { 8.3.3 Radiation Overexposure 8-18 l 8.3.4 Emergency Procedures for Malfunctions 8-20 8.3.5 Notification of incidents 8-22

                                                         .8.3.6 Decontamination Procedures                                        8-23              j

                                                                                                           ~

1NOEX NRC-313 .i Key item Pg item 8 PART S - OPERATOR DESIGNATION AND TRAINING 9.1 General' 9-1 9.2 Contents of Training Program 9-2 9.3 - Examination ior Operator Qualification 9-4 9.4 Answers to Examination for Operator

• Qualification 9-9 9.5 Personnef Training PoIicy 9-12 9.6 Radiation Protection Officer Responsibilities 9-15 Item 7
• PART 10 - TRAINING AND EXPERIENCE IN RADI ATION SAFETY 10.1 Operational Plan 10-1 10.2 Training and Experience Resumos 10 .-

APPENDIXES A DRAWING B110701 002 G

                                                                           .                    Carrier Type Irradiator B

GENERAL LAYOUT OF BUILDING. C DESCRIPTIONS OF FIXED MONITORS s

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

c 1

                                                                                                            }

8-1

                                                                                                             )
     ..                                                                                                      j PART 8       -

OPERATING PROCEDURES 8.1 NORMAL OPERATION l 8.1.1 Normal Start-up Normal start-up is defined as the commencement of operations not dictated by faulty or abnormal conditions. To start the machine, the operator should proceed as follows: In the Equipment Room Turn on the main power supply to the control power transformer. At the Control Consolo

1. Using the MACHINE key, turn the POWER keyswitch to the

                                          " RESET" position and release. The RESET / POWER TRIP Indicator will briefly illuminate.

NOTE: The radiation alarm may signal for a short period until the irradiation room monitor capacitors have fully charged.

2. Check the FAULT INDICATORS:

a) Source Pass / Overdose Timers b) Source nack/ Maze Monitor c) Low Air / Safety Stop d) High Temp / Exhaust Fan e) Safety Timer /'ntern conv f) Load-Unload /Delonizer Monitor if any of these indicators are illuminated, a fault exists and must be rectified befora proceeding (refer to

                                          " AUTOMATIC FAULT SHUT-DOWN").         ,

3. Check that the irradiation room monitor, located at tte maze door, is functioning as indicated by the flashing of the lamp and that the indicated radiation level is norma!.

If the radiation level is not normal, or !f an alarm condition is indicated, leave the facility immediately (refer to " CONTAMINATION DETECTION PROCEDURES" in this manual).

                                               .                                     ~

l e

8-2 - i 4

4. Check that the digits on the MASTER CONTROL are set to their correct positions. If the setting is incorrect, alter the time cycle accordingly.

5. Set the OVERDOSE CONTROL to a duration approximately 20%

longer than that set on the MASTER'CohTROL. Use the TIMER key for this purpose.

6. Check that carriers are available on the inlet conveyor and that the outlet conveyor is clear.

7. Proceed as outlined in Figure 3.1 " ENTRY PROCEDURE".

NOTE: The maza door can not be opened if, a) the monitor has not been tested, or b) the radiation alarm is signaling, or c) the source is not in the fully down position. IMPORTANT When entering the maze: If a noticeable increase in the audio output of the portable monitor is evident, leave and close the maze door, and notify the Radiation Protection Officer immediately. The Radiation Protection Officer will check the radiation levels with the survey meter and will notify Atomic Energy of Canada Limited - Commercial Products of unusual conditions or incidents and/or take appropriate safety actions. Do not enter the irradiation room. l

       .                                                 ~

l

C 9(.)

    ,0 , , , , A P - E , ,0 - ,,0 ,, ,0 . - , - A ,0 A , . .             _ , -

IMPORTANT 1

        ~

DO NOT ENTER THE IRRA[lATION CILL

                                                                                   ~

WITIGJT AN AljTHORIZED JPERATOR EMERGENCY CONDITIONS if RADIAT10N MONITOR ALARM SIGXALS [ LOUD CLAION OR SOURCE MOYEMEXT BELL SOUXD; TAKE THE ICLLOWIMG ACTION (A) PERSONNEL IN MAZE OR 1RRADIAT:ON CELL Putt SAFETY CABLE ON WALL AND LEAYE FAclLITY WME CLOSE MAZE 0002 BEHIND TOU. (B) PERSONNEL IN.THE CONTROL AREA PUSH THE RE3 EMERSEXCT STOP Bt TT0X OX THE CONTROL COXS FOR EMERGENCY SERVICE, CONTACT ATOMit ENERCT OF CANADA l!NITED. COMMERCIAL PRO CABLE.XEMOTA TELEPH0XI:[613] 592 2790 TELEI 053 4152 COBALT 60.lRRADIATOR

                                                                                                                                   ~

8-3 In'the Irradiation Room

                                                                            ~

1. Ensure that the pneumatic cylinders are in their normal start-up positions as indicated by green lights in the console display.

2. Ensure that the maze conveyor is in the start-up position.

3. Under norral conditions, there should be no personnel in the irradiation room. However, a check mus.t be made to ensure that the room has been vacated.' .

NOTE: The operator must lead all visitors when they are entering the cell and follow behind when they are leaving. 4. Actuate the SAFETY TIMER keyswitch using the MA0 HINE key. This will start the 90 second safety timer. An audible device will operate while the timer is running.

5. Leave the room (at a normal walking pace) making certain to engago the source hoist air interlock and to close the maze door on the way out. Closing the maze door will illuminate the MACHINE READY indicator on the control console provided the safety timer is still running.

NOTE: If the safety timer runs out before the machine is started, the start-up procedure will have to be repeated. Starting the Irradiator

1. Check that all green indicators are illuminated and that all red FAULT INDICATORS are extinguished. If either condition does not exist, the fault must be rectified before proceeding.

2. Turn the MACHlHE keyswitch to the " Start" position and release. The key will return to the "On" position and the MACHINE.ON Indicator will illuminate.

                                               ~
                                                                                            ~

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                              'The source will begin to rise as indicated by the ringing of the source travel. alarm and the extinguishing of the SOURCE         ,

DOWN indicator..When the source is in the fully up position,- L the red SOURCE UP indicator will illuminate and the source i travel alarm will sto machine will begin.. p ringing. Automatic operation'of the

3. Make a complete entry in the Losf Book. Entries should include.

the date, time of start-up, cycle time, box number, and other information required on log sheet. 8.1.2 Normal Shut-Down Normal shut-down is defined as tim termination of operations not dictated by faulty or abnormal conditions. To shut-down the machine, the operator must:

1. Turn the MACHINE keyswitch to the "Off" position when the'.

machine has reach >d the end of a cycle. The MASTER CONTROL timer will reach zero and the source will begin to lower (the SOURCE UP indicator will extinguish) and the source travel alarm will signal.

2. When'the source is in the fully down position (after the green SOURCE DOWN light illuminates and the source travel alarm stops ringing), remove the MACHINE key from the MACHINE keyswitch. The POWER keyswitch should be kept "On"

                       '            at all times in order to keep the irradiation room monitor operating.             -

8.1.3 Emergency Shut-Down a) Press the emergency STOP button on the control console, or b) Turn "Off" the MAINTENANCE keyswitch (if being used), or c) Turn "Off" the POWER keyswitch. d) PulI the emergency PULL cable.

b5 , 8.1.4 Automatic Fault Shut-Down During operation, a riumber of fault conditions or abnormal occurrences may cause the irradiator to automatically shut-down. In this event, the cause will be indicated by the illumination of one or more of the FAULT INDICATORS on the control console. 1MPORTANT in the event of either a " Source Rack" or a " Monitor" shut-down, the operator must notify the Radiation Protection Officer (RPO) immediately. - in the case of a " Monitor" shut-down, the Radiation Protection Officer (RPO) will check the radiation levels with a survey meter and will notify Atomic Energy of Canada Limited-Commercial Products of unusual conditions or incidents. For either shut-down, the resumption of normal operations is subject to the Radiation Protection Officer's (RPO) approval. The indicator (s) will remain illuminated until the fault is rectified and the POWER keyswitch is turned to the " Reset" position and released. If the irradiation room must be entered in order to rectify the fault, make certain that the " ENTRY PROCEDURE", Figure 3.1 is adhered to. To correct tha problem:

1. Rectify the fault.

2. " Reset" the POWER keyswltch.

3. Turn the MACHINE keyswitch to the " Start" position and release.

The machine will resume normal operation.

l 1 8-6 "JT V C a [i.4 11 I u)t i 200P i nllD

                                                                                                        ~

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8-7

8.2 -

PROCEDURE FOR OTHER GPERATIONS 1 8.2.1 Check Out Procedure Prior To Cobalt-60 installation As each facility component is installed it is checked for correct operation before proceeding with the next stage of assembly. These cc w ent. checks include:

1. A full operation check out of the source rack (unloaded).

Lielt switch settings are adjusted to provide smooth operation and the rack is cycled at least 20 times.

2. The ventilation fan is checked for satisfactory operation and filters are installod.

3. Standby compressor operation. (If installed)

4. Water level float switch and water filtration unit.

E. The complete c.onveying system (using dummy product boxes) for smooth operation.

6. Interlock procedure and safety switches. The start-up procedures are simulated and machine functions are checked for satisfactory operation. All safety interlocks, emergency stops and alarms, are actuated to check for ccrrect operation.

7. The monitor is checked using the test source.

8.2.2 Check Out Procedure After initial Cobalt-60 Installation

1. The operating area is monitored with an appropriate survey meter during and after source replenishment. The source penclis and associated components are wipe tested "in situ."

2. The first time that the radiation source is raised from the pool the following items must be checked:

a) The correct interlock procedure is carried out and Luthorized persons only are in attendance during the test. b) The source is raised with the " Source" keyswitch (without conveyor operation). The survey meter is checked for radiation readings. c) A complete radiation survey of the building is conducted with the source in the raised position.

3. The source rack is then lowered. The monitor is rechecked using the test source.

4. Final test of complete machine.

__ _ _ _ _ _ _ _ , ._. -. - - - - - - - - - - - - " - - - - - - - - ^ - ' - - - - - ^ - - - - - ^ ~ - ~ ^ - - ' ' -

8-8 i 8.2.3 Receipt of Radioactive Material in Casks Cask unloading will require the physical presence of the RPO to supervise operations. Pocket dosimeters and film badges will be worn by participating personnel.

1. Survey the exterior of the cask while on the vehicle with a survey meter (RAT 0/F or equivalent generic survey instrument). Radiation level should not exceed 10 millirad at one meter from the cask's surface. If this rate is exceeded, the shipper wIII be notifled to determine possible causea and courses of action.

2. Smear the cask surface and truck bed in five or more locat'lons. Count with RAT 0/F or equivalent survey instrument.

3. If smears read more than 0.1 mrem source shipper will be notified to determine courses of action including rejection of shipment. Truck driver will be held until the prot; tem is resolved.

4. If removable contamination limits (Item 3) and radiation levels (item 2) are acceptable, unlash the cask, An overhead crane or mobile crane will be used as appropriate.

5. Move cask into designated area. If reading at cask surface is less than 2 millirad per hour, cask may be placed in unrestricted storage. Place radioactive sign on cask. If surface dose rste is between 2 and 10 millirad per hour a rope barrier will be established at the 2 millirad distance and a radioactive sign will be hung from it. -

6. If source loading / unloading is to be accomplished by a qualified AECl. team of at least two persons, the physical presence of the on-site RPO is not mandatory requirement.

8-9 8.2.4 Placing The Cask in the Pool trradiator and Unloading Source Basket This operation will require the physical presence of the RPO to supervise operations. RPO will use RAT 0/F meter or equivalent to continually monitor radiation levels at pool surface.

1. Lower underwater light into pool or use high intensity dry Iamp on suriace.

2. Remove any conveying equipment on the irradiator floor directly beneath the stepped roof plug to permit easy access by the cask into the source storage pool.

3. Remove any obstructions from where cask will be placed in bottom of pool.

4. Utilizing a mobile crane, remove the roof plug from the irradiator roof.

5. Utilizing the mobile crane, lift the cask above the roof level, position it over the opening in the irradiator roof and from the roof of the building direct the crane operator as the cask is being lowered.

6. Cask is lowered to approximately floor level of the irradiation room.

7. From inside of the irradiator remove bolts securing the cask lid while cask is still suspended from the mobile l crane. ~

r

8. Lower cask to bottom of pool

9. Using long handled tools, disengage the crane hooks from the cask and secure them in the lifting lugs on the cask lid.

10. Advise crane operator to raise cask tid and set it to one side of the cask on the pool floor. Using long handled underwater tools, disengage crane hooks from cask lid.

11. Raise crane cables out of working area.

12. Using lon5 handled tools, remove the basket holding the irradiation sources from the shipping cask. CAUTION: DO NOT RAISE THE HANDLING TOOL AB0VE THE PolNT WHERE THE RED LINE A7 THE 8' MARK IS LEVEL WITH THE SURFACE OF THE WATER.

                                                                               ~

_.A__ __ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___

3 - 8-10 13. Place the sources (in their basket) on'the floor of the pool,.well away from the shipping cask. 14. Advise crane operator.to lower _ crane..Using long handled , tools, hook the crane to the lid.

15. Replace lid on cask.

                                                             %. Using !ong handled tools, disengage crane hooks from lid and secure them in the lifting lugs on the source cask.

17. Guide the crane operator in removing the shipping cask from the pool, and through the roof. Monitor cask as it is raised. -

18. Advise crane operator to place 0; 'f shipping cask on

                                                                   . parking lot.

19. Replace stepped plug on top of irradiator, if this function is to be performed by a qualified two-man AECL team, the physical presence of the RPO is not mandatory. .

                                                                 ~

m A _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ _ _ _ _ _m_____m_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

                                                                                                                                                          .a 8-11
               '8.2.5                Sealed Source Leak Test Procedures

• General: In the absence of a certificate from a transfer, or indication-that a test for leakage and/or contamination has been made.within six months prior to a transfer to Abbott, each source will be leak tested upon arrival at Abbott.

                                   -After source receipt, leak tests will be performed on the source plaque at intervals not exceeding six months.

Specific Information Name and' Address of Individual Performing Leak Test Site Radiation Protection Officer A. Rosado, or designee, to take smears; Abbott Hospitals inc; Macco Industrial Park; State Road 690 Km 1.7; Vega Alta, Puerto Rico 00762. Paul Ward or designee to perform monitoring tests at Abbott Laboratories, Abbott Park, IL 60064 or alternatively:

                                  .G. Dietz or designee to perform monitoring tests at Isomedix inc., 11 Apollo Drive, Whippany, New Jersey 07981.

Type of Test Wipe. Leak Test Experience of Individuals Abbott Eighteen years experience doing similiar procedures. Isomedix Fourteen years experience doing identical procedure for up to 11 Isomedix facilities. Radiation Detection Instruments Used CANBERRA Series 20 multichannel analyzer with sodium lodid-well detector (or equivalent). i RAT 0/F (or equivalent) Baird-Atomic Spectrometer, Model 530, with deep well counter (or equivalent), or single pulse height analyzer (EberIine or Ludlum)

                                                                                                                    .~
                                    - - . _                O -

   =..                   ,

8-12

~

GENERAL DESCRIPTION OF PROCEDURE (Note: The following procedure is currently being followed under isomedix License 29-15364-01 in New Jersey.) Wipe testing of the source'in the pool is conducted as follows: '

1. Attach a styrofoam, gauze or equivalent pad to the end of an underwater tool.

2. Rub the pad along the source, and on the accessible ends of the sources in a source modula.-

3. Remove the pad from the pool.and check for radiat. ion with a RAT 0/F or equivalent meter. Meter.should read below inr/hr. If-not, call RPO.

4. If reading'in (3) is below lar/hr, remove pad _from tool, and allow to dry.

5. Repeat for several source modules

6. Send pads to Corporate Radiation Protection Officer, Abbott Park or Isomedix, Whippany, New Jersey for counting

7. Shipment of pads to be performed in accordance with the applicable regulations of U.S. Department of Transportation..

PROCEDURE F_0R COUNTING SMEARS AND DETERMINING CONTAMINATION LEVELS Swipes are counted using at least a 5 cm x 5 cm Mal Well Detector. Results are compared to counts from a NBS tracable standard cobalt-60 source. Removable NBS tracable activity, in microcuries, is calculated as follows:

1. Take background count (BC).

2. Count Leak Test Swab (LTS).

3. Then LTS-8C = Test Swab Count.

4. Then:

Test Swab Count Detection System Efficiency

5. Removable contamination should be less than 1 x 10-8 microcuries.

L -- - - - - - - - - _ - - - - - - - - - - __ _ --___ _ _ _

                      ,,                                                                                                              O
           ~        '

8-13 -3

 .           .. ' 8.3          Emergency Procedures                                                                                 ~~

8.3.1 General ' Although plant facilities and equipment are designed to minimize radiation hazards and to facilitate their control, the possibility of an unforeseen accident cannot be overlooked.. Radiation monitoring systems, through their meters ar.d alarm features, provide warning and measurement of- i abnormal conditions to employees and the Radiation Protection Officer. Warning of a condition requiring emergency action might also come.from an operator-in his observation of such a-condition. However, in virtually every conceivable instance, the radiation monitoring system would respond to the condition also. - 8.3.2 Radiation Alarm if any unexplained audible alarm sounds, immediately lower source to bottom of pool. Call Radiation Protection Officer.- RP0 will monitor surrounding area with a meter and attempt to determine the cause of the alarm. If the alarm sounds and the cause can be immediately ascertained'and controlled by the operator, he can first control the cause and then reset the alarm system. He will then notify the RPO or his designee of the situation and. circumstances surrounding the incident. If the alarm sounds and the cause cannot be immediately ascertained and controlled, personnel will proceed to their designated area. The RP0 or his designes, determines the

                         . appropriate action based or. a review of the monitoring system, ratemeters, and other available information. Appropriate action by a designee would be to evacuate the area while calling for further assistance.

Emergency actions selected are based on limiting radiation exposures to employees with regular restricted area access authorization to 2.5 rem and other employees to .25 rem during the course of the emergency and its aftermath. Actions that are considered include: relocation of sources, crection of temporary barriers or shielding, area or building evacuation.

                                                                       ..s S

ft._ _ __ __ . _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ __. _

 '?      .

8-14 i ( 8.3.3 Radiation overexposure (;

                      . Copies of this procedure will be conspicuously posted near the irradiator entrance door, in the office area, or in any other conspicuous Iocetion determined by the Fzeiiity Manager.

The procedure was developed after consultation with the personnel, doctors and hospital listed. The procedure is on the following page. m. O b l L A V

y u w g'h li ;f 1 E .8-15 * '

                                                                                      . Radiation Overexposure fl. Extreme Overexposure - Victim Unconscious A. If a person is. unconscious from an overexposure, immediately call the ambulance and-tell the driver to take
                                                      ,him to the Bayamon Regional Hospital. Call the Bayamon Hospital, explain the problem, and request that Dr. Manuel Martinez be notified, and that he be requested to come to the hospital.'Dr. Martinez can be reached at 787-5151.                     . . . .

B._ Escort the victim to the hospital either in the ambulance or in your own car. C. Following the above, immediately call one of the following:

                                                      .Mr. Paul ~ Ward                     - 312-937-5276 - 312-336-3079 Mr. George Dietz - 201-876-9588 - 201-887-4700 Mr. John Masefieid - 201-234-2396 - 201-887-4700
                                                      .Mr. Jonathan Young - 201-895-2137 - 201-887-4700 D.

The person notified above in ites C will contact the NRC, Region II (404-331-4503), and explain the circumstance:

                                                          ;with a view toward obtaining the services of either Dr.

Jiell Ward or Dr. Thoma, both experts in overexposure, and both available to NRC on a consulting basis. The NRC Emergency number af ter duty hours in our area: 301-951-0550. II. Moderate or Suspected overexposure - Victim Conscious

• A. Immediately call on of the following:

Mr. Paul Ward, Dietz, Masefield or J. Young (same as in item I (c) above); if none of the above can be reached on the first try, call the Bayamon Regional Hospital and take the victim there, and proceed as in 1 (A). B. Take the actions directed from your contact of the above mentioned people. Actions may include the following:

1. Taking ,the victim to the hospital (Bayamon Regional) in your own car. ,

2. Calling for the ambulance.

3. Notifying Bayamon Regional Hospital, and telling them to expect the victim, and to alert emergency.

C. If for some reason the above personnel cannot be reached lamediately and other action is taken, be sure to continue to try to contact either Mr. Ward, Dietz, Masefield or Young untiI at ieast,one has been notified.

8-16

     ,                             - 8.3.4 Emergency Procedures for Malfunctions in Automated irradiator

For.any malfunction.in the interior of the irradiator, personnel safety is maintained as long as personnel do not enter the chamber. In the event of product or carrier blockage.

of the source and the sourc ,cannot be returned to its normal storage position,.the following corrective procadures can be conducted depending on the situation and source location, under the direction of the RPO. However, before other action-is undertaken, the on-site RPo will take the following action:'

1. Notify P. Ward and G. Dietz, J. Masefield or J. Young..

2. Notify AECL.

The following action may be authorized, but most likely will not be allowed until AECL representatives arrive on-site:

1. If source will not lower, raise source to the fully exposed position.

2. Attempt to lower source again in :he normal manner.

3. If it is determined that a product is blocking the source from returning to.Its storage position, enter the Irradiator roof and slacken the source rack guide cable tensioners located at the top of the irradiator roof which in turn will-permit the source rack to float within the constraints of the slackened cables.

5. Return to the control console and attempt to lower the source in the normal manner.

6. If this cannot be done,'a less desirable procedure can also be followed. This involves drilling one or more access holes through the roof, and the use of closed circuit TV and special tools to return the source to the storage

, position. This procedure, undertaken previously by AECL on other facilities, is to be performed only by AECL personnel. s e_

8-17 ' '

    ' 8.3.5 Notification of incidents The P.adiation Facility Manager or his authorized representative shall famediately notify:                                                                                                   -

a. The

• Corporate RPO.

b. NRC Region 11 c, Atomic Energy of Canada Limited, Ottawa, Ontario, Canada by telephone or telegraph, of any incident involving any source of radiation possessed by him and which may have or ,

threatens to cause a radiation hazard, in the event of an incident which endangers or threatens to endanger Plant Personnel or the Pubile, the licensing authority may take any steps necessary to remove the danger. Any further action to decontaminate the plant and return it to operating condition will be taken by AECL. If for any reason AECL personnel cannot reach the plant in a reasonabie-tir.e,.further action may be taken by the Iicensee at the specific request of AECL. . O e

                                                 -                             -                                                                             ~       -

g 7 .-, __ ,

                                                                                                                                                                       .]

8-18 s 8.3.8 Decontamination Procedures l in the event of any Indication of contamination by any of the { monitors or from routine wipe tests, the licensee will immediately closeedown the facility, restrict entrance, and quarantine all products in the suspected area, and will notify Atomic Energy of Canada Limited by phone. The licensee will j4 lamediately advise the pertinent licensing authority that an incident is suspected and will effect the safety control measures as 1isted below: -l

1. No lunediate attempt shall be made to clean up the contamination. ,

2.'_Allwindowsshallbeclosed; fans, water.fiktrationplant; and air conditioners shall be shut off, and everyone shall leave the facility.

3. All doors shall be closed and locked. .

4. All personnel who may have been contaminated shall be

                                                                                                                                      ~

thoroughly tested for contamination and immediate steps taken to remove any radioactive contamination.

5. Entrance to the .facliity (or contaminated area) shall be prohibited except to authorized. personnel requiring access in the performance of their special ' duties.

6. tinder no circumstances shall any unauthorized or untrained persons attempt to examine or clean up any " spilled" radioactive material.

Fans or ventilating apparatus shall not be used in an attempt to disperse the radioactive material or its decay products. Such a maneuver will only disseminate the radioactive contamination throughout the area. Atomic Energy of Canada Limited will dispatch quallfled personnel to the site to assess the situation and confirm or deny the presence of contamination, and will report their findings to the pertinent licensing authority. Atomic Energy of Canada Limited, or their Agent, have available, and will provide if necessary, emergency equipment as listed later in this manual. If it is confirmed that contamination has been detected, Atomic Energy of Canada Limited will dispatch 3 Senior Radiation Protaction Officer together wIth qualified personneI to institute corrective action. x e

                                     , _ _ . _ _   _ - - - - - - - - . - - - -   --- - - - ' - - - - - - - - - - - - - - - ' ^ - - ^ ' " " ' ' ^ " ^ ^ ^        ^^'^

8-19 ' 8.3.7 Emergency Equipment l Atomic,'.nergy of Canada Limited, or their Agent, have equiprant listed hereunder:avallatle and will provide if necessa;

1. Personnel protective clothing, including plastic suits, special footwear, plastic hoods, gloves, etc.

2. Respiratory equipment, including, demand air packs (MSA),

canister type respirators, and supplied air respirators.

3. Decontamination supplies, including polyethylene deeting, disposal bags and containers.

4. Approved radiation monitoring devices'and personr.el exposure dostmeters for all personnel involved.

5. instruments of adequate sensitivity for the measurement of low level beta-gamma contamination.

6. Area radiation monitors with alarm.

7. General safety protective helmets, gloves, shoes, etc. equipment, such as safety l

                                                   =
                                                                           ,___,__a---

r, .

'          3.
                                                                                                                              ,-2   j
                 -Protection

a. Time from External Radiation '3

b. Distance

c. Shielding materials -]

    -             d. Define curies and half value layers,                                                                            i dose rate curves in the irradiator.

Radiation Physics 4 .-

5. The nucleus-isotopes-radioactive decay 3 Internal Radiation Problems

                   - a.                                                                                                     2

b. How radioactive material enters the body. 2 Effacts on the body.

6. ' Contamination 4

a. Hazards associated with contamination

b. Prevention of spread.

c. Decontamination procedures

7. Instruments and Dosimetry

a. Geiger counters 7

b. lonization chambers

c. Scintillation counter

d. Film badges

e. Pocket Electroscopes

f. Practical instrument use

8. Irradiator-Safety System and Procedures

a. Source interlock systems- 10

b. Operating procedures-routine irradiation

c. Operating procedures for irradiator operations

9. Instruction in Survey Techniques "

2 instrument Survey Techniques Wipe Test Methods 10. General Discussion and Summary 2

11. Written Test 2

TOTAL 40 hrs The NRC publication, "Living with Radiation" is used as a basis for this training, together with the facility operating manual, s r

i

                                                                                                     , ,e 9-3 Page 1 of 5                               -

9.3 Examination for Operator Qualification

1. Name the three common types of radioactive decay emissions.

2. Of the three emissions from Question 1 above, cobalt-60 emits the highly penetrating.

3. Cobalt-60 emits energy which (circle correct answer (s):)

(a) Can make other materials radioactive. (b) Can damage living tissues. (c) Can penetrate only the human skin. (d) is identical to X rays, except for the mechanism by which they are " born".

4. Regulatory agencies allow limits of exposure for licensed, badged personnel working in radiation areas. The acceptable yearly level, if radiation history is unknown, is:

(a) 12 ram. (b) 5 rem. (c) 25 rem. (d) 500 rom.

5. True or False (circle)

It is far more detrimental to the body to receive a 3 ran dose over a two-hour period as opposed to over a three-year period.

6. The normally accepted dose of whole body radiation, over a short period, at which about 50% of the population would die, <

is rom. Below rom, there are no physical detectable effects.

7. A 30-year old worker joins tho' staff as an authorized worker around radiation. In his past work, he has received a total whole body exposure of 2 rom. Under the " banking" concept, how many rems should remain to his credit?

8. Can this worker use up all of his " credit" within the next three years" Yes No 4

Sr Define the term " rad".

l -). . I 3-4 l Page 2 of 5 l

10. High personnel exposures could cause genetic effects. What are genetic effects? I t

11. What are the three best means'of protection from external exposure?

12. The dose rate at one foot from a source is 160,000 rads per hour. What is the dose rate at 4 feet? .

13. How often should you zero your pocket dosimeter?

14. When are the pocket dosimeter and D Im badge worn?

15. You are on duty at night and the source automatically drops during the cycle. However, the access door to the irradiator will not open because the alert radiation light is ilt. Perhaps the light has malfunctioned. Your correct course of action is to: (a) Unscrew the light and enter the cell normally. (b) Walt until the next shift arrives. (c) CalI the Radiation Protection Officer. (d) Try to bypass the alarm and enter the chamber very carefully with a hand-held meter.

16. It is necessary to enter the irradiation; chamber. You make a test check of the hand-held monitor, and find that you get no reading response. What action do you take?

17. A group of important looking visitors arrives unexpectedly at night and would ilke to go into the irradiation chamber to see the mechanism. The Radiation Protection Officer is temporarily absent and is expected to return in three hours. What do you do? s e O

                                    . . . _ _ _ . _ _ _ _. _ . _ _ . _ _ _ . _ . _ _ _ _ . _m_ __.._____ _ _ _ _ _ _ _ . _ _ _ _ . -

         , ._._,_--.__-______c,____._,,__,-_-__-                          - _ _ . . . , _ _ , - , _ - - - - _ _ _ - - - , _ _ , _ _ , _ _ . , . _ _ _ _ - _ _ _ _ . , _ _ _ _ _ _ - _ _ - _ - . _ _ _ . _ . - - _ , _ . , _ . - - . . _ . _ _ - - _ _ _ . _ _ - - - , _ - . _ - . .                             _ . _ - _ _ _ _ _ _ _ . _   - - . _ _ - . - ,
       -h i
                                                                                                                                                                                                                                                                                                                                          .               .?-

9-5 Page 3 of 5- '- 18. While.you are working'In the control room, you hear strange scraping sounds coming from the irradiation chamber. What is your first action?

19. Irradiation'causes a= toxic gas to be formed inside the irradiation chamber. What is-it called?

If you enter the'irradiator and the odor is vwy noticeable, what'is'your actlon? 20. In your is any type firstof.action? actual or suspected radiation emergency, what-r 21. If a source were to leak or rupture, airborne or waterborne contamination could occur. Name at least two procedures which could'give early warning of trouble. 22.

e. .in an actual personnel overexposure, where you are quite sure

                                                           .a person has received an overdose, who are the three persons
                                                         . .or agencies to contact immediately?

23. An overexposed person will show physical signs which might give a clue to the doe he received. Match the following doses and symptoms: 25 rem Nausea, fati 100 rem Unconscious,gue shock 1000 ram No detectable effect

24. Can cobalt-60 Irradiation of a person make him radioactive for a short time? -

25. The irradiator is a production unit which is expected to operate on a continuous basis. Its primary function is to process. Only one consideration is more important. What is it? s _ -- _ -___-____- __ ________a

E ,

   .o                               -

1 9-6

                                                                                                                     ^

Page 4 of 5 L> l For questions 26-30: an electrical storm hits and power is knocked i out. Under these conditions, \ \ l j

26. True False The irndiator will continue to p~rocess until the  !

air supply'is exhausted.

27. True False The emergency generator will kick in immediately, allowing the cycle to continue.

28. True False If the source descends, you should enter the cell to make sure there is no damage.

29. If you answered False to 28, state why?

30. What is your action when power is restored?

31. .lf you pull the emergency cable in the irradiator, what will happen?

32. What happens when you activate the key activated timer in the cell?

33. Approximately how long do you have after activating the delay timer, to complete lockup and raise the source?

34. What happens if the alIowed time is exceeded?

35. If the allowed time is exceeded, what is your action?

36. What is the purpose of the chain across the personnel entry door?

37. When would it be safe to step over the chain and enter the irradiator, without disconnecting it?

38. When is power to the personnel door lock turned on?

39. Does the " source moving" alarm sound when the source is moving up, or down, or both? (circle answer) 40; You are in the control room, and the source begins to descend.

Name 5 possibilities or reasons it might be lowering.

41. Is your film badge or pocket dosimeter more reliable as an Indicator of small radiation doses to which you might be exposed? (circle one)

O

      . _ _ , _ _ _ _ _ _ _ _ _ _ _   m--_   -              -

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                                                                                          . 9-7                                ',!

t J Page 5 of 5 426 During a source. loading, the surface of a shipping cask might-read as high as 30 mrem /hr. ) 3 True or False?

43. If you touch open wires in the irradiator, will you receive a bad shock? Why?.

44.. Where is the shut-off valve to the in-cell sprinkler system?

45. True/ False: The pool water is normally contaminated with cobalt-60?

46. All of our sources are doubly encapsulated. What does this mean?

For questions 47 - 49 You are in the control room and the source begins to descend.

                         -47.      You see the " low air" light on. What'Is your action?

48. You see " smoke alarm" lIght on. What ;is your action?

49. You see " low water" light on. What is your action?

1. 50. When are we authorized to operate the unit with no operator present in the building?

a. Weekends only

b. When doing non-flammable items

c. When no product is in chamber

d. None of the above .

l

                                                                                   ~

ls L P.y ..

     .                                                                                   9-8 Page 1 of 3

,E ~ V . 9.4 Answers to Sample Examination for Operator Qualification 1.- Alpha, Beta, Gamma

2. . Gamma

3. b. and d.

4.. b. , 5. True

6. 500 and 25 respectively -

7 58 B. . No - 9 The absorption of 100 ergs per g am of energy.

10. Effects on future generations (such as mutations) which may be.

caused during or after conception, until birth.

41. Times distance and shielding

12. 10,000 rad /hr.

2

13. Whenever the reading exceeds 15 area at the beginning of the work tour.

14. At all times when and on duty.

15. c.

16. Any of the following:

a. Call Radiation Protection Officer.

Do nothing until he advises.

b. Take the spare meter.

c. Replace batteries in the first meter; made sure it responds; then proceed.

17. Politely refuse entry of the visitors past the office / reception area.

18. Lower the source.

              '19.      Ozone. Leave the cell for 2-3 minutes, then re-enter.

20. Call the Radiation Protection Officer.

                                                                   ~.
                                                                                 --__    _ _ _ _ _ _ _ _ _ _       0

e 6

                                                                                      '9-9
                 ~

Page 2 of 3 Answers to sample examination for Operator qualification - continued

21. Source wipe test.

Monitoring of water treatment system. Smearing walls, floor, vent, in cell.

22. a. Hospital or emergency squad

b. Radiation Protection Officer ,

c Nuclear Regulatory Commission 23, 25 rem No detectable effect . 100 rem Nausea, fatigue 1000 rem Unconscious, shock

24. No -

25. Safety

26. False * ~~

27. False

28. False

29. No power to door lock. Cannot enter.

30. Enter cell normally, restart irradiator.

31. Unit will shut down, source descends to bottom, warning light appears on console.

32. 90 seconds to complete lockup, lights flash, bell sounds.

33. 90 seconds.

34. Timer times out. Sequence has to be started over.

35. Return into cell, begin sequence again. #

36. Shuts off air to cylinders that raise sources.

I i l i l __:__. - n

 *'                                                                                                                                               i I                                                                                                                   9-10 Pag] 3 cf 3
 - , 7 ,, .
      . . ,3 Answers to sample examination for operator qualification - continued               1 L

{ l

37. Never i

l' 38.

             . .                                                   After radiation. the in-cell monitor is *osted and shows no abnormal

39. Both .

40. End of cycle, carrier movement not completed in prescribed 1 i time, low air, no power, smoke alarm, high temperature alarm, emergency stop activated. ~

41. Film badge

                                                         ' 42. True I

43. No. 2 4 volt system . . .

44. As appropriate

45. False i 46.

Cobalt is totally enclosed in a stainless steel cylinder, ' which in turn is again encased in a second sealed stainters steel cylinder.

47. . Check air com maintenance. pressor and its circuit breakers. Reset or call 1 48.

Enter cell normally to assess situation. Call appropriate'- personnel. 49. Enter cell normally to assess situation. Call appropriate personnel.

50. D.

                                                                                                                                ~

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           \                                                                                             .

- _ _ - - . _ - - _ _ _ - - _ . - _ _ - _ _ .E

G. ' 9-11 Page 1 of 2

      .; y .

9.5 Perscnnel Training Policy RADIATION FACILITY POLICIES AND PROCEDURES ' Distribution: Radiation Facility Mana3er

Subject:

Personnel Tralning Policy Effective Date: March 15, 1988 Approved By: This policy covers the general training requirements applicable to warehouse personnel, operators, supervisors and production control managers, and Radiation Facility managers. The program shall consist of both formal training requirements and on-the job training administered and the by personnel deemed quallfled by the Division office Plant Manager. A. Basic Training, All Personnel

1. Scope of activities of in

2. Description of radiation operations.

3. Operational policies and procedures.

4. Need for general cleanliness and care in the handling and processing of medical devices and drugs.

5. General requirements of regulatory bodies, including the Nuclear Regulatory Commission and the Food and Drug Administration.

6. General guidelines. requirements of FDA Good Manufacturing Practice

7. NRC license requirements as they relate to the use and operation of cobalt-60 irradiators.

1

8. 0ther items which may be designated from time to time.

B. Operators, Facility Managers Supervisors, Production Control Managers, Radiation in additiontraining additional to (A) above, this category of personnel will receive as follows:

1. Formal training course for qualification as Irradiator Operator (course ac defined in NRC license).

2. General procedures for inspection and acceptance and/or rejection limited to: of good housekeeping conditions, including, but not i

1 l l r i _ _ _ _ _ _ _ _ _ _ . _ _ - - - - - - - - - -- - - - - - - - - - - - - - - ~ ^'

9-12 a Page 2 of 2 . , .

           '8.        Operators,-Supervisors, Production Control Managers, Radiation Faciiity Managers - continued                                                

a. Warehouse cleanliness.

b. Mechanisu appearance / cleanliness.

                         -c. Inspection of outgoing trailers for cleanliness, holes in body, dirt, strange odors, or other odd factors which might be sensitive to the shipment of finished medical devices.

d. General-insect and rodent control on premises.

3. Irradiator operation and maintenance.

4. Processing procedures.

5. Dosimetry procedures and training. ~

6._ Shipping /recelving procedures. - 1 C. Supervisors, Production Control Managers, Radiation Facility Managers This category of personnel shall, in addition to (A) and (B) above, receive additional. training as follows:

1. Personnel-administration.

2. Production control, including factors related to scheduling, processing and administrative requirements related to processing.

3. Full indoctrination and training of all Abbott policies and procedures as they relate to processing.

4. Other subjects as determined by the Radiation Facility Manager or Corporate Staff.

D. Radiation Facility Managers In addition to alI of the above, the Radlation Facility Manager shall receive additional training as determined appropriate by a Corporate Staff, including administration, budgeting, personnel l and quality control. The Radiation Facility Manager is also specifically. charged with adherence to GMP procedures, and is responsible for quality control of his facility. Among other QC responsibilities the Radiation Facility Manger, in terms of his Quality Assurance Program, will assure himself that he is capable of:

1. Identifying quality assurance problems.

2. Solving quality assurance problems.

3. Verifying implementation of solutions.

4. Determining that procedures are performed correctly.

This basic policy may be amended or added to from time to time p either formally or informally as additional training requirements become obvious. Refresher training, elther on a formal or informal basis, should be conducted semiannually or earlier as the need arises. U a

4 o 5 9-13 1 4 Page 1 of 1 { 9.6 Radiation Protection Officer Responsibilities  ! RADIATION FACILITY POLICIES AND PROCEDURES Distribution: Radiation Facility Manager

Subject:

Radiation Protection Officer Responsibilities Effective Date: March 15,1988 Approved by: This policy covers the responsibilities of the site Radiation Protection (- Officer (RPO). The responsibility and authority'of the,RPO includes:

a. Maintain on-sita Nuclear Regulatory Commission (NRC) license conditions.

b. React in an emergency to safeguard worker and public health and safety.

c. Correct minor machine malfunctions,

d. Prompt notification to Divisicn or Corporate RSO of any unusual situation which may be or threatens to be an unusual or potentially hazardous situation.

                                                         ~                                                                                                                                                     t

e. Allow no corrective action to be taken for major malfunctions or i potentially hazardous situations without guidance and approval of the Division or Corporate WSO.

l

f. The site Radiation Protection Officer has complete site authority for aili situations which threaten worker or public health and safety. He is reportable only to the Division or Corporate RPO 'in these '

situations. Radiation safety considerations will take precedence over operational issues if there is a conflict.

                                                                                        -                                                                                              _.  -________.t_.___

l

                                                                                                  .          oq*

9-1 8 PART 9 - OPERATOR DESIGNATION AND TRAINING s 9.1 General it is proposed that . be authorized to appoint qualified personnel as operators. Such an appointment would be authorized when the trainee has:

a. Completed the required formal training,

b. Passed the written test with a minimum score of 80%.

           .c. Completed a minimum of 90 days of on-the-job training.

d. Been recommended for operator status by the Radiation Facility Manager to the Corporate RPO, wherein the trainee's qualifications are reviewed.

e. Been approved by the + tot Corporate RPO.

The contents of the training program, together with the written test (and answers) follow. Test questions may be chanced from time to time. The . policy for training of all personnel (including but not limited to Jrradiator operations) is shown beginning on Page 9-12. 9.2 Contents of Radiation Training Program Hours

          " 1. The Hazards of Radiation                                      2 Unavoidable low level exposure Hazard evaluation l

2. The Effects of External Radiation 3

a. Effacts on the body,

b. Units of measurement.

c. Levels of injury.

d. Long term exposures.

e. The banking concept.

I l l l s e _____._,__________._--_-J

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IAEA JIAEA - Training Course Safety and Regulation of Sealed Sources _ of. Radioactive Materials 10 April-12 May1989

         ., ,                                                                                                                                        _ Lecture 42.8.4 Inspection of Irradiators
                                                                            ~

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                                                                                                                                                    .                            -                     -_.,x 9-*                                                                       ,

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4 INSPECTION DF POOL-TYPE IRRADIATORS I. GENERAL

                 - 171 Pool-type irradiators currently in operation in the world (in 40 counties) 39 in the U.S. (15 licensed by the U.S.N.R.C.,                                                                                24 licensed by agreement States)

B in the State of Tenas (3 more under construction) 3 in City of El Paso, Tx plus 3 more under

                       ~ construction for a total licensed activity of 48 Million     Curies of Co-60 (Avg.                                                     6 mci                              Co-60/irradiator) 4 within 80 miles of my office in Dallas / Fort Worth area (2 of those within 10 miles)
                     @ 6 mci Co-60 potential field of 8 million Rem /hr at 1 meter
 .                                2 million Rem /hr at 2 meters 550 Rem /sec. at 2 meters one second at two meters and an individual                                                                       will have 50-50 chance to survive II. INITIAL INSPECTION A. PRE-LOADING       INSPECTION  -

in conjunction with licensing group of the Agency only opportunity to see the actual movement of the f source rack in response to safety breaches (FIG.3) l 1 check operation of every single safety feature l required by the License (see Routine Inspection, Guarterly Maintenance cheeks) source hoist and guide cables (FIG.4) check movement of totes or product carriers for clearance of source rack. loading of product into carriers (some designs call for automated systems inside the vault, including switching of shelf level) B. SOURCE LOADING (see Part IV - Inspection During Resourcing) delivery of radioactive material proper unloading contamination checks material handling C. POST-LOADING overall survey of the vault for hot spots survey and inspection by licensed service coupany (See part IV) s e}}