ML20210R759

Working Draft Entitled, Gamma Stereotactic Radiosurgery, as Part of NRC Program to Revise 10CFR35 & Associated Guidance Documents

ML20210R759
Person / Time
Issue date:	08/07/1997
From:	NRC
To:
Shared Package
ML20210K626	List: ML20210K620 ML20210R737 ML20210R742 ML20210R752 ML20210R759 ML20210R770 ML20210R775
References
FRN-62FR42219, RULE-PR-35 PROC-970807-03, PROC-970807-3, NUDOCS 9709030250
Download: ML20210R759 (29)

Text

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4 August 7,1997-WORKING DRAFT t

4 GAMMA STEREOTACTIC RADIOSURGERY l

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NOTE.

Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach. These draft modalities are being provided to the Part 35 Working Group at a very early stage in their development because they are key to the discussion of significant issues associated with the

< regulation of the medical use of byproduct material, which is an agenda item at the

August 19-20 meeting of the group. it shou'd be noted that at this point in their

- development that they_ have not undergone a thorough review, including a review to ensure that they reflect the Commission's direction. - in fact, in some cases, the draft documents contain different alternatives to regulation of a specific areai Hopefully, these differences will stimulate input and additional alternatives from the Working

. Group.

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Subpart X: Gamma Stereotactic Radiosurgery GeneralInformation: Gamma Stereotactic Radiosurgery

.2 Section 35.1-GSR: Purpose and scope.........

............ 2 Section 35.2-GSR: Definitions....

.3 Section 35.7-GSR: Depar1 ment of Health End Human Services (FDA), other Federal, and State requirements.................

.........5 Section 35.8-GSR: Information collection requirements OMB approval

.. 5 Section 35.GSR1: Implementation..

.. 5 Specific Licensing Provisions: Gamma Stereotactic Radiosurgery.....

.......5 Section 35.600-GSR: Use of a sealev source in a gamma stereotactic radiosurgery unit

.5 Section 35.6-GSR: Provisions for research involving human subjects...

.5 Section 35.57-GSR: Authorization for calibration and reference sources

.6 Section 35.GSR2: Authorization for depleted uranium for use as shielding..

.6 Section 35.11-GSR: License required.

... 6 Section 35.12-GSR: Application for license, amendment, or renewal

...6 Section 35.13/35.606-GSR: License amendments

.7 Section 35.18-GSR: License issuance..

.7 Section 35.19-GSR: Specific exemptions.

.8 Radiation Safety Program and Equipment: Gamma Stereotactic Radiosurgery..

.8 Section 35.21-GSR: Radiation Safety Officer

.8 Section 35.22 GSR: Radiation Safety Committee

.8 Section 35.23-GSR: Statements of authority and responsibilities

.9 Section 35.25-GSR: Supervision.....

.9 Section 35.3-GSR: Radiation safety program changes

.... 10 Section 35.32 GSR: Quality management program 10 Section 35.92-GSR: Decay-in-storage and disposal...

. 11 Section 35.605-GSR: Installation, maintenance, and repair

.. 11 Section 35.GSR 3: Therapy related computer systems......

12 Section 35.59: Requirements for possession of sealed sources and brachytherapy 12 sources Section 35.610-GSR: Safety instruction.....

.................13 Section 35.615-GSR: Safety precautions 13 Section 35.620/35.51-GSR: Possession, calibration and check of survey instruments

.14 Section 35.630-GSR: Dosimetry equipment.

15 Section 35.632-GSR: Full calibration measurements

.16 Section 35.634-GSR: Safety checks..........

17 Section 35.641-GSR: Radiation surveys for gamma stereotactic radiosurgery facilities

.. 18 Section 35.643-GSR: Modification of gamma stereotactic radiosurgery unit or room before beginning a treatment program 18

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Section 35.14/ 35.33-GSR: N otifications........................,.....,., 18 Training and Experience: Gamma Stereotactic Radiosurgery...................... 20 Section 35.900-GSR: Radiation Safety Officer......................,

.. 20 Section 35.901-GSR: Training for experienced Radiation Safety Officer......... 20 Section 35.960-GSR: Training for a gamma stereotactic radiosurgery authorized user

...........................................................21 Section 35.961 GSR: Training for gamma stereotactic radiosurgery physicist..... 22 Section 35.970-GSR: Training for experienced authorized users and physicists... 22 Section 35.972-GSR: Recentness of training......

......,,.23 Enforcement..........

....................................... 23 Section 35.990: Violations

... 23 Section 35.991: Crimin al penalties................................... 23 Records: Gamma Stereotactic Radiosurgery.....

.. 24 35.GSRred1: Records of the specific license for gamma stereotactic radiosurgery use 24 35.GSRred2: Records of receipt and transfer of sealed sources............

24 35,GSRred3: Records of radiation survey instrument calibrations........

.24 35.GSRred4: Records of dosimetry equipment calibrations.......

. 24 35.GSRred5: Records of Radiation Safety Committee meetings.

.25 35,GSRred6: Records of statements of authority and responsibility...

.25 35.GSRred7: Records of training....,

.. 25 35.GSRred8: Records of minor radiation safety program changes

.. 25 35.GSRred9: Records of quality management program.......

.. 25 35.GSRred10: Records of sealed source leak tests and inventories..

26 35.GSRred11: Records of radiation surveys...,.........

.. 26 35.GSRred12: Records of decay-in storage disposals

. 26 35.GSRred13: Records of maintenance and repair....

27 35.GSRred14: Records of radiation monitor checks....

.27 35.GSRred15: Calibration records......

.,. 27 35.GSRred16: Records of safety checks............................

27 35.GSRred17: Records of safety checks...........

27 GeneralInformation: Gamma Stereotactic Radiosuruerv Section 35.1 GSR: Purpose and scope.

This part prescribes requirements and provisions for both the medical use of byproduct material for issuance of specific licenses authorizing the medical use of this material and the use of depleted uranium for shielding material or other components at medical facilities. These requirements and provisions provide for the protection of the public health and safety. The

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this chapter. The requirements and provisions of parts 19,20,21,30,71, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.

l Section 35.2-GSR: Definitions.

Address of use means the building or buildings that are identified on the licensa and where byproduct material may be received, used, or stored.

Agreement Stato means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.

Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or stonng byproduct material.

Authorized user means a physician who is authorized to conduct gamma stereotactic radiosurgery with an authorized use team, provided the individualis:

(1) In compliance with the training and experience requirements of Section 35.960-GSR; and (2) Identified as an authorized user on a Commission or Agreement State license that authorizes the r iedical use of byproduct material.

Authorized-use team means, for gamma stereotactic radiosurgery use, a team of individuals consisting of a gamma stereotactic radiosurgery physicist, registered nurses, and physicians, in addition to the authorized user, with expertise in radiation therapy and other appropriate medical specialties.

Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

Depleted uranium means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

Management means the chief executive officer or that person's delegate or delegates.

Medical entity means any organizational structure of medical practice that is not defined as a medicalinstitution.

Medicat institution means an organization in which several medical disciplines are practiced and in-patient care is provided.

Medical use means the intentional extemal administration of the radiation, from NRC regulated radioactive material in a gamma stereotactic radiosurgery unit, to patients or human research subjects under the supervision of an authorized user.

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.i firste Annant i 100"h RT AFF.I FVFI WOlWING I)nrITMFNTE Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from the radioactive sources in a gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

Prescribed dose means, for gamma stereotactic radiosurgery, the dose per exposure, the total dose, and, as applicable, the dose per fraction as documented in the written directive.

Radiation Safety Officer means the individual identified as the Radiation Safety Officer on a Commission license.

Reportable MedicaI Event means any of the following situations requiring a report to the NRC Operations center:

(a) The administration of a gamma stereotactic radiosurgery radiation dose:

(1) Involving the wrong individual, or wrong treatment site; or (ii) When the total administered dose to a target volume for a single exposure differs from the total prescribed dose for the volume by more than 10 percent of the total prescribed dose.

(b) Aleaking sealed source; (c) Any structural, mechanical, electrical or electronic malfunction of the gamma stereotactic unit or its ancillary equipment, power supplies, and computerized treatment planning systems that may effect the dose to a patient, the public, or personnel. Such reporting may be pursuant to the requirements in sections 30.50 or 21.21 of this chapter, (d) Any additional report required by sections 30.50 or 21.21 of this chapter.

Sealed source means any byproduct material that is encased, embedded, or affixed in such a way as to prevent escape of the byproduct material from the source apparatus, and is registered in accordance with section 32.210.

Gamma stereotactic radiosurgery physicist means the individualidentified as the gamma stereotactic radiosurgery physicist on a Commission license.

Written directive means an order in writing for a specific patient or human research subject, which may be the specific patient treatment plan dated and signed by an authorized user prior to the administration of gamma stereotactic radiosurgery, including the following information:

target coordinates (including gamma angle), collimator size, plug pattem, total dose for the treatment, the total treatment volume, and total dose for the target volume of each exposure with radiation exposure time indicated for each target volume. The specific patient treatment plan signed and dated by the physician authorized user may suffice as the written directive, provided the information specified for a written directive is clearly specified.

Wrong Treatrnent Site means the delivery of gamma stereotactic radiosurgery to a target volume during an exposure that is (1) not within the prescribed dose target volume for the

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Section 35.7-GSR: Department of Health and Human Services (FDA), other Federal, and State requirements, Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing research involving humans, radioactive drugs or devices.

Section 35.8-GSR: Information collection requirements. OMB approval.

[Information in Section 35.8-GSR will be provided upon approval of the final rule.)

Section 35.GSR1: Implementation, (a) The applicable sections of this subpart must be used in lieu of requirements in the standards for medical use of byproduct material in effect prior to (date to be inserted) that are cited in license conditions, except as specified in paragraphs (c), (d) and (e) of this section. If tha requirements of this subpart are more restrictive than the existing license condition or unless the requirements of paragraph (d) of this section, the licensee shall comply with this subpart (b) [Section to address license conditions which are more restrictive than the regulations provided, similar to 20.1008)

(c) [Section to address license conditions exempting a licensee frorn a previous requirement, similar to 20,1008]

(d) [Section to address license conditions citing 10 CFR provisions which no longer exist in Part 35, similar to 20.1008)

Specific Licensina Provisions: Gamma Stereotactic Radiosuraerv Section 35.600 GSR: Use of a sealed source in a gamma stereotactic radiosurgery unit.

The regulations and provisions of this subpart govern the use of gamma stereotactic units for medical use that contain a sealed source of gamma radiation emitting byproduct material.

Section 35.6-GSR: Provisions for research involving human subjects.

A licensee may conduct research involving human subjects using byproduct material provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects.

Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before conducting such research. Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research

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Section 35,57-GSR: Authorization for calibration and reference sources.

Any person authorized by Section 35.11 of this part for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use:

(a) Sealed sources manufactured and distributed by a person licensed pursuant to Section 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each.

(b) Any byproduct rrsteriallisted in $$35.100 or 35.200 with a half life not longer than 100 days in individual amNnts not to exceed 15 millicuries; (c) Any byprod ct materiallisted in $$35.100 or 35.200 with a half life longer than 100 days in individual amounts not to exceed 200 microcuries each; and (d)Technitium 99m in individual amounts not to exceed 50 millicuries.

Section 35.GSR2: Authorization for depleted uranium for use as shielding, Any person authorized, pursuant to this subpart, for medical use of byproduct material in gamma stereotactic radiosurgery may receive, possess, and use up to 999 kilograms of depleted uranium as shielding or operational equipment within a gamma stereotactic radiosurgery unit, during source change operations, for source change units in use or in interim storage for use, and for associated emergency response equipment.

Section 35.11-GSR: License required.

(a) Pursuant to this subpart, a licensee may only use gamma stereotactic radiosurgery units, depleted uranium as specified in this part, and the sealed sources for such units that are manufactured and distributed for medical use in accordance witn a license issued pursuant to 10 CFR Part 30 or the equivalent requirements of an Agreement State. Authorization for any additional radioactive material or depleted uranium must be specified on an individuals license, unless used as specified in Section 35.57-GSR of this subpart (Authorization for calibration and reference sources). A person shall not manufacture, produce, acquire, receive, possess, use, or transfer radioactive material for medical use or depleted uranium, except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of this section.

(b) An Individual may receive, possess, use, or transfer radioactive material and depleted uranium shielding or components associated with gamma stereotactic radiosurgery in accordance with the regulations in this chapter under the supervision of an authorized user as

- provided in Section 35.25-GSR unless prohibited by license condition.

Section 35.12 GSR: Application for license, amendment, or renewal.

(a)An application for medical use sited in a medical institution may only be submitted by the institution's management. An application for medical use not sited in a medical institution, may be submitted by any person representing the highest level of management responsible for both

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(b)An application for a license for medical use of byproduct material as a sealed source in a gamma stereotactic radiosurgery unit must be made by filing an original and one copy of NRC Form 313, ' Application for Materials License." For guidance in completing the form, refer to the -

instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.

(c)For medical use of byproduct material that is not otherwise provided for in Section C, the request must be made by:

(1) Including the request with the license application submitted in Section 35.12(b);

(2) Submitting a request for a license amendment or renewal as an original and one copy in letter format; or (3) Filing an original and one copy of NRC Form-313," Application for Materials Licenst" For guidance in completing the form, refer to the instructions in the most current versions of the appropriate Regulatory Guides.

(d) For copies of regulatory guides, application forms, or to submit an application or an amendment request, refer to Section 30.6 of this chapter.

Section 35.13/35.606-GSR: License amendments.

A licensee shall apply for and must receive a license amendment:

(a) Before it receives or uses byproduct material for a clinical procedure permitted under this pari but not permitted by the license issued pursuant to this part; (b) Before it permits anyone to work as a authorized user or physicist for gamma stereotactic radiosurgery, except an individual who is identified as a gamma stereotactic radiosurgery authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material for gamma stereotactic radiosurgery; or (c) Before it changes Radiation Safety Officers; (d) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license or as otherwise authorized in section 35.57-GSR of this subpart; (e) Before it adds to, removes radiation safety equipment specified during licensing from the area of use specified during licensing; (f) Before making any change in the treatment room shielding; (g) Before making any change in the location of the gamma stereotactic radiosurgery unit within the treatment room; (h) Before using the gamma stereotactic radiosurgery unit in a manner that could result in increased radiation levels in areas outside the designated treatment room; and (I) Before relocating the gamma stereotactic radiosurgery unit.

Section 35.18-GSR: License issuance.

The Commission shall issue a limited specific license for the medical use of byproduct material, in addition to a general license for depleted uranium shielding, if:

(a) The applicant has filed Form NRC-313 " Application for Materials License" in accordance with the instructions in Section 35.12; (b) The applicant has paid any applicable fee as provided in part 170 of this chapter;

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(c)The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; (d) The licensee has made provisions such that licensed material shall be used by or under the supervision of an authorized user physician and with an authorized use team consisting of at least a gamma stereotactic radiosurgery physicist, a physician specializing in the region of the body to be treated, and a radiation therapist; (e) The applicant meets the requirements of part 30 of this chapter.

Section 35.19-GSR: Specific exemptions.

The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. The Commission will review requests for exemptions from training and experience requirements with the assistance of its Advisory Committee on the Medical Uses of isotopes.

Radiation Safety Proaram and Ecutoment: Gamma Stereciactic Radiosurgerv Section 35.21-GSR: Radiation Safety Officer.

(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.

(b) The Radiation Safety Officer shall, at a minimum:

(1) Review personnel exposure reports and investigate overexposures, accidents, leaking sealed sources, losses, thefts, unauthorized receipts, uses, transfers, disposals, reportable medical events, and other deviations from approved radiation safety practice and implement corrective actions as necessary; (2) Establish written policy and procedures for implementing the radiation safety program; (3) Brief management as needed, but not less than once each year, on the radiation safety program; and (4) Assist the Radiation Safety Committee in the performance of its duties.

Section 35.22-GSR: Radiation Safety Committee.

Each licensee authorized for medical use of gamma sterotactic radiosurgery shall establish a Radiation Safety Committee to oversee the use of radioactive material.

(a) Each Committee must meet the following administrative requirements:

(1) Membership must consist of at least four individuals and must include an authorized user of each type of use permitted by the license (s), a gamma stereotactic radiosurgery

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physicist, the Radiation Safety Officer, a representative-of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer, Other members may be included as the licensee deems appropriate.

(2) To establish a quorum and to conduct business, at least one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's representative.

(3) The committee must meet at least quarterly.

(4) The licensee shall prepare and certify the accuracy of the minutes of each Radiation Safety Committee meeting minutes and maintain records of the Committee meetings in accordance with 35.GSRted5.

(b) To oversee the use of licensed material, the Committee must:

(1) Review, on the basis of safety and with regard to tha training and experience, and approve or disapprove any individual who is to be listed as an authorized usar, the Radiation Safety Officer, or an authorized gamma stereotactic radiosurgery physicist, before submitting a license application or request for amendment or reney/al; or (ii) Review, pursuant to Section 35.13, on the basis of the board certification, the license, or the permit identifying an individual, additional training and experience requirements, as applicable, to approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized physicist; (2) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures, provided the changes do not affect the standard of safety established in applicable NRC regulations; (3) Review at least annually, with the assistance of the Radiation Safety Officer, a summary of the occupational radiatbn dose records of all personnel working with byproduct material; (4) Review quartedy, with the assistance of the Radiation Safety Officer, allincidents involving byprodud material with respect to cause and subsequent actions taken; and (5) Review a least annually, with the assistance of the Radiation Safety Officer, the radiation safety prcgram.

Section 35.23-GSR: Statements of authority and responsibilities, (a) A licensee shall provide the Radiation Safety Officer, and the Radiation Safety Committee, sufficient authority, organizational freedom, and management prerogative, to:

(1) Identify radiation safety problems; (2) Initiate, recommend, or provide corrective actions; and (3) Verify implementation of corrective actions.

(b) A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and the Radiation Safety

' Committee, and retain 'he current edition of these statements as a record until the Commission terminates the license.

Section 35,25-GSR: Supervision.

(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by Section 35.11(b) of

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(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material and in the licensee's written quality management program; (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct material; and (3) Periodically review the supervised individual's use of byproduct material and the records kept to reflect this use.

Section 35.3 GSR: Radiation safety program changes.

(a) A licensee may make minor changes in radiation safety procedures that are not potentially important to safety, except for those changes in Sections 35.13 of this part. A licensee is responsible for assuring that any change made is in compliance with the requirements of the regulations and the license.

(b) A licensee shall retain a record of each change in accordance with 35.GSRred8, Section 35.32 GSR: Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a wntten program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The program must include wntten policies and procedures to meet the following specific objectives:

(1) That, prior to administration, a written directive ' is prepared for any gamma stereotactic radiosurgery radiation exposure; (2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive; (3) That final plans of treatment and related calculations for gamma stereotactic radiosurgery are in accordance with the respective written directives and that each administration is in accordance with the wntten directive; and

' If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

I nraft Anemiat 7 1997, MTAFF.I FVFI_ WnimING nOCIIMFNTE 11 (4) That any unintended deviation from th* wetten directive is identified and evaluated, and appropriate action is taken.

(b) The licensee shall:

(1) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:

(i) A representative sample of patient and human research subject administrations; and (iii) All medical event reports resulting from deviations from the written directive or inadvertent doses to personnel or members of the public, to venfy compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months; (2) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and (3) Retain records of each review, including the evaluations and findings of the review, pursuant to 35.GSRred9.

(c) The licensee shall retain:

(1) Each written directive; and (2) A record of each administered radiation dose where a written directive is required in I

paragraph (a)(1) above, in an auditable form pursuant to 35.GSRred9.

Section 35.92-GSR: Decay in storage and disposal.

(a) A licensee may hold byproduct material with a physical half-life of less than 65 days for decay in storage before disposal in ordinary trash and is exempt from the requirements of Section 20.2001 of this chapter if it:

(1) Holds byproduct material for decay a minimum of ten half lives; (2) Monitors byproduct material at the container surface before disposal as ordinary trash and detelmines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and (3) Removes or obliterates all radiation labels.

(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with 35.GSRred12.

(c) Except as otherwise described in this section, a licensee shall dispose of sealed sources and depleted uranium used as shielding or other depleted uranium components by transfer to an authorized recipient as defined in 10 CFR 30.41, and maintain a record of such transfer in accordance with 35.GSRred2.

Section 35.605-GSR: Installation, maintenance, and repair.

(a) Only a person specifically licensed by the Commission or an Agreement State to perform gamma stereotactic radiosurgery unit maintenance and repair shall:

(1) Install, replace, relocate, or remove a gamma stereotactic radiosurgery sealed source or gamma stereotactic radiosurgery unit; or (2) Maintain, adjust, or repair a gamma stereotactic radiosurgery unit and associated equipment involving work on electronic or mechanic mechanisms that could expose the l

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(b) A licensee authorized to use gamma stereotactic radiosurgery units for medical use shall perform manufacturer suggested maintenance and proper functioning checks of the unit at intervals not to exceed 12 months.

(c) A licensee shall have each gamma stereotactic radiosurgery unit fully inspected and serviced during replacement of the sources in the unit or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

(d) A licenwe shall retain a record of each repair, adjustment, or maintenance permitted under this section in accordance with 35.GSRred2 and 35 GSRred13.

Section 35.GSR 3: Therapy related computer systems.

A licensee authorized for medical use of gamma stereotactic radiosurgery shall assure that computer treatment planning system (s) and computerized operating systems associated with the therapy device are operating appropriately.

Section 35.59: Requirements for possession of sealed sources and brachytherapy sources.

(a) A licensee in possession of any sealed source shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users.

(b) A licensee in possession of a sealed source shall:

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and (2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that accompanies the source.

(c) To satisfy the leak test requirements of this section, the licensee must:

(1) Take a wipe sample from the following areas:

(i) The convex surface of a recently exposed collimating helmet; (ii) The seams of the gamma stereotactic radiosurgery unit; and (iii) The shielding door of the gamma stereotactic radiosurgery unit; and (3) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample.

(d) A licensee shall retain leakage test records pursuant to 35 GSRred10 (e)If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall:

(1) Immediately lock the gamma stereotactic radiosurgery control panel in the "off" position and take action to prevent spread of contamination; and (2) File a report pursuant to 35.14/35.33-GSR(d)

(f) A licensee need not perform a leakage test on the following sources.

(1) Sources containing only byproduct material with a half-life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 100 microcuries or less of beta or gamma emitting material or 10

e I) raft Ausnat 7_1907. ETA FF.I.FVFI. WOIH/ING linrIM4 FNTM l 'l microcuries or less of alpha emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or transfer, using the same detection limit of 0.005 microcuries; and (g) A licensee in possession of a sealed source or brachytherapy source shall conduct a physicalinventory of all such sources in its possession, once every six months. The licensee shall retain each inventory record pursuant to 35.GSRred10.

(h) A licensee in possession of a sealed source shall perform such measurements as to assure compliance witn 10 CFR Part 20 in all areas where such sources are stored.

(i) A licensee shall retain a record of each survey required in paragraph (h) of this section pursuant to 35.GSRred11.

Section 35.610-GSR: Safety instruction.

(a) A licensee shall provide adequate emergency equipment and adequate numbers of trained personnel to complete emergency procedures during unit operation.

(b) A licensee shall post instructions at the gamma stereotactic radiosurgery unit console To satisfy this requirement, these instructions must inform the operator of:

(1) The procetNe to be followed to ensure that only the patient or the human research subject is in the treatment room before initiating radiation for treatment or after a door interlock interruption; (2) The procedurc to be followed if:

(i) The operator is unable to turn the primary beams of radiation off with controls outside the treatment room or any other abnormal operation occurs, including but not limited to the following situations: electrical system failure; hydraulic system use during emergency operations and failure of the system (as applicable to the unit in operation); patient treatment table retraction failure; interlock failure; console failure; inadvertent operating mode; emergency stops and/or release failure; inoperable room monitor; and power failure.

(ii) The names and telephone numbers of the authorized user (s), Radiation Safety Officer, and other appropriate emergency contacts to be immediately contacted if the gamma stereotactic radiosurgery unit or console operates abnormally; and (3) The procedure to be followed to prevent the dual operation of more than one radiation producing device in a treatment room.

(c) A licensee shall provide instruction, with refresher training and practice drills, in the topics identified in paragraph (b) of this section to all inoividuals who operate a gamma stereotactic radiosurgery unit and are available pursuant to paragraph (a) of this section.

(d) A licensee shall retain a record of the training required in paragraph (a) of this section pursuant to 35.GSRred7.

Section 35.615-GSR: Safety precautions.

(a) A licensee shall control access to the gamma stereotactic radiosurgery treatment room by a door at each entrance.

(b) A licensee shall equip rach entrance to the treatment room with an electrical interlock system that will:

. (1) Prevent the operator from initiating the treatment cycle unless each treatment room

s

~ e Draft Anonet 7 1997. RTAFF.I TVFI. WOIR'ING HOCIM1FNTR 14 entrance door is closed; (2) Cause the sources to be shielded immediately when an entrance door is opened; and (3) Pr( > ant initiation or continuation of the treatment cycle following an interlock interruption until all treatment room entrance doors are closed and the unit on-off control system is reset at the console.

(c) A licensee shall equip each entrance to the treatment room with a beam condition indicator light.

(d) A licensee shallinstallin each treatment room a permanent radiation monitor capable of continuously monitoring source status.

(1) A radiation monitor must provide visible notice of a gamma stereotactic radiosurgery unit malfunction that results in an exposed or partially exposed sources, and must be observable by an individual entering the treatment room.

(2) A radiation monitor must be equipped with a backup power supply separate from the power supply to the gamma stereotactic radiosurgely unit.

(3) The treatment room radiation monitor must be checked to assure proper operation occurs during each use of the gamma stereotactic radiosurgery unit.

(4) A licensee shall maintain a record of the check required by paragraph (d)(3) of this section as specified in 35.GSRred14.

(5) A licensee shall promptly repair or replace the radiation monitor if it is inoperable.

(e) A licensee shall construct or equip each gamma stereotactic radiosurgery treatment room to permit continuous observation of the patient or the human research subject from the gamma stereotactic radiosurgery unit console while the patient or human research subject remains confined in the treatment room.

(f) The licensee shall provide an adequate back up power supply to sufficiently operate all applicable equipment, both incorporated within and ancillary to the gamma stereotactic radiosurgery unit, to bring the treatment to a safe end during a power outage.

(g) The licensee shall have readily accessible, and at appropriate locations, the proper equipment to assist with emergency operations, including system failures and abnormal operations identified pursuant to 35.610(b)(2)(l).

(h) The licensee shall make provisions to prevent the inadvertent release of the reserve pres:Ure from the hydraulic system reservoir, as applicable to the unit in operation.

(i) The authorized user physician and authorized gamma stereotactic radiosurgery physicist shall remain present during the gamma stereotactic radiosurgery treatment. Other members of the authorized-use team shall either be present during treatment or accessible at the licensee facility.

Section 35,620135.51-GSR: Possession, calibration and check of survey instruments, (a) A licensee authc=,ized to use byproduct materialin a gamma stereotactic radiosurgery unit shall have in its possession, in the gamma stereotactic radiosurgery treatment suite arer portable radiation detection surv0y instrument and/or a portable radiation measurement survey instrument, as appropriate to both the gamma stereotactic radiosurgery operation and designated use of the instrument (s) within the overall operation.

(b)The survey in-trument(s) shall be capable of readings over a range of use that is both appropriate during ty; Meal and abnormal / emergency gamma stereotactic radiosurgery

e 19 nrnft A omt 7.1947. RT A FF.I FVFI WORK

• LNG nort f MFNTR operations, as well as assures licensee compliance with the specific requirements in this chapter.

(c) A licensee shall calibrate the survey instruments used to show compliance with this j

part before first use, annually, and following repair. The licensee shall:

(1) Calibrate all scales with a radiation source; (2) Calibrate two separated readings on each scale; and (3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.

(4) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and conspicuously attach a correction chart or graph to the instrument.

(c)A licensee shal' check each survey instrument for proper operation with a dedicated check source each day of use. A licensee is not required to keep records of these checks.

(d) A licensee shall retain a record of each survey instrument calibration in accordance with 35.GSRred3.

Section 35.630-GSR: Dosimetry equipment.

(a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met (1) The system must have been calibrated by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the NationalInstitute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the Ucensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change tl.e calibration factor. When intercomparing dosimetry systems to be used for calibrating gamma stereotactic radiosurgery units, the licensee shall use the same type or model, as applicable, of gamma stereotactic radiosurgery unit, applicable helmet collimation, and sources of the same radioactive material as the units for which the dosimetry systems are used.

(b) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system may be compared '.."th a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.

(c) The licensee shall retain a record of each calibration, intercomphrison, and comparison in accordance with 35.GSRred4.

e I-Inrmfe Ananae *I 1007. ET A FF.I FVFI; WOul/ING I)nri!MFNTE 16 Section 35.632-GSR: Full calibration measurements.

- (a) A_ licensee authorized to use a gamma stereotactic radiosurgery unit for medical use -

shall perform full calibration measurements on each gamma stereotactic radiosurgery unit:

(1) Before the first medical use of the unit; and (2) Before medical use under the following conditions:

. (i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) Following replacement of the source or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; (iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one year.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:

(1) The measurements required in Section 35.634; 4

(2) Dose profiles that are within 11 millimeter of the 50 percent isodose line and verify mechanical isocenter with radioisocenter;

. (3) Collimator factors;and (4) Relative helmet factors.

(c) A licensee shall use the dosimetry system described in Section 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with the (camma stereotactic radiosuroerv soecific standard (s) undqI consideration) and, as applicable, the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol.16, No. 3,1971, pp. 379-396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol.10, No. 6,1983, pp. 741771, and Vol.11, No. 2,1984, p. 213. (Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection at the NRC Library,11545 Rockville Pike, Rockville, Maryland 20852-2738. Copies of the documents are also on file at the Office of the Federal Register,800 North Capitol Street NW., suite 700,- Washington, DC. A notice of any change in the material will be published in the Federal Register,)

(e) A licensee shall correct matheme sea!!y 1 ie outputs determined in paragraph (b)(1) of this section for physical decay for intervals *.ot excmding one month for cobalt-60.

(f) Full calibration measurements requira ' of paragraph (a) of this section and physical decay corrections required by paragraph (e; of this section must be performed by the licensee's gamma stereotactic radiosurgery physicist.

(g) A licensee shall retain records of each calibration pursuant to 35.GSRred15.

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17 11 raft Ammat 7 1997+ MT AFF.I FVFI. WOlWING finriI\\tLNTR Section 35.634-GSR: - Safety checks.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall complete the following checks on the unit once in each calendar month:

(1) The radiation output within 12 percent; (2) Timer constancy, accuracy, and linearity over the range of use; (3) On-off error; (4) Trunnion centricity; (5) Helmet microswitch test; (6) Treatment table movement time; (7) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (8) The output for one typical set of operating conditions measured with the dosimetry system described in Section 35.630(b) of this part; and (9) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the gamma stereotactic radiosurgery physicist. That individual need not actually perform the spotcheck measurements.

(c) A licensee shall have the gamma stereotactic radiosurgery physicist review the results of each spot check in section (a) within 15 days. The gamma stereotactic radiosurgery physicist shall promptly notify the licensee in writing of the results of each safety-check.

(d) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform safety spot-checks of the facility for each unit once in each calendar month that assure proper operation of; (1) Treatment room doors from inside and outside the treatment room; and (2) Electrically assisted treatment room doors with the gamma stereotactic radiosurgery unit electrical power turned off.

(e) A licensee shall arrange for prompt repair of any system identified in this section that is not operating properly, lock the control console in the off position, and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system or put into place temporary procedures for the followmg circumstances:

(i) Personnel may enter the treatment room with an appropnate operable survey meter when the room radiation monitor is inoperable; and (ii) Additional adequate viewing and/or intercom systems.

(f) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall complete the following safety checks at least once on each day of use of the unit, before use:

(1) Radiation monitors; (2) Electricalinterlocks at each gamma stereotactic radiosurgery room entrance; (3) Beam condition indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; (4) Viewing and intercom systems; (g) A licensee shall retain a record of each check required in this section pursuant to 35.GSRred17.

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Section 35.641.GSR: Radiation surveys for (,amma stereotactic radiosurgery facilities.

(a) Botero md' cal use, after each installation of gamma stereotactic radiosurgery sources, and ettt' m6NnD ary change for which aa amendment is required by Section 35.606 (a) through (d), the licensed shall perform radiation surveys with a portable radiation measuremut survey instrument calibrated in accordance with Section 35.620 of this part to verify that:

(1) The maximum and average dose rates at one meter froni the gamma Sici cotactic radiosurgery co;rce component with the sources in tne shielded position and the collimators set for a normal treatment do not exceed 10 millirsm per hour and 2 millirem per hour, respectively; and (2) The licensee in compliance with 10 CFR Pan 20 requirements for personnel and the public.

(b)If the results of the surveys required in paragraph (a) of this section indicate any radiation dose quantity per unit time in excess of the requirements specified, the licenseo shall lock the controlin the off position and not use the unit:

(1) Except as may be necessary to repair, replace, or test the gamma stereotactic radiosu gery unit shielding or the treatment room shielding; r

(2) Until the licensee has roccived a specific exemption pursus,t to Section 201301 of this chapter.

(c) A licensee shall retain a record of the radiation measurements made following installation of a source for the duration of the license, pursuant to the requirements in 35.GSRred11.

Section 35.643 GSR: Modification of gamma stereotactic radiosurgery unit or room before beginning a treatment prd0 ram.

(a)Iftt rveys required in Section 35.641 indicates that an individual in an unrestricted art say be exposed tc levels of radiation greater than those permitted in 10 CFR J nning the !!eatment program the licensee shall:

Part 20. before L i

(1) Equip the unit or treatment room with additional radiation shielding to ensure compliance with 10 CFR Part 20; (2) Perform the survey required by Section 35.641 again; and (3) Include in the report required by Section 35.645, pursuant to 35.GSRred11, the results of the initial survey, a description of the modification made to comply with paragraph (a)(1) of this section, and the results of the second survey.

Section 35.14135.33-GSR: Notifications.

(a) A licensee shall provide to the Commission a copy of:

(1) The board certification; (2) The Comminsion or Agreement. State gamma stereotactic radiosurgery license stating the individual is an authorized user; and (3)The Commission or Agreement State gamma stereotactic radiosurgery license for as an authorized user, no later than 30 days after the date that the licensee permits the individual to work as an authorized user pursuant to Section G subsection (b).

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(1) An authorized user, an authorized gamma stereotactic radiosurgery physicist, or Radiation Safety Officer permanently discontinues performance of duties under the license or j

has a nome change; or (2) The licensee's mailing address changes, f

(c)The licensee shall mail the documents required in this section to the appropriate address identified in Section 30.6 of this chapter, (d) The licensee shall notify the NRC of reportable medical events (Time frame under reviaM unless otherwise specified in section 30.50.

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(d) For a leaking source, the licensee shall file a report within five days of the leak test with the appropriate NRC Office listed in Section 30,6 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, describing the equipment involved, the test results, and the action takeni 4

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'n Itaining_antlEsparlanGaLGammL51staolastis.Radinsutetty Section 36.900 GSR: Radiation Safety Officer.

Except as provided in Section 35.901, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a)la certified by:

(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; i

(3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6; American Board of Medical Physics in radiation oncology physics; L

(7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or (b) Has had classroom and laboratory training and experience as follows:

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:

(i) Radiation physics and instrumentation; (ii) Radiation prote: tion; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (c) Be an authorized user identified on the licensee's license.

(d) in addition to the requirements in paragraphs (a), (b), and (c), the individual identified as the Radiation Safety Officer on a gamma stereotactic radiosurgery license must have knowledge of gamma stereotactic radiosurgery unit operation, appropriate response to abnormal and emergency operations, and procedures for compliance with regulatory requirements associated with gamma stereotactic radiosurgery operations Such knowledge shall be obtained before the licensee receives sources for the gamma stereotactic radiosurgery -

unit.

Section 3ti 901-GSR: Training for experienced Radiation Safety Officer.

(a) An individualidentified as a Radiation Safety Officer on a Commission or Agreement State license before October 1,1986 need not comply with the training requirements of Section (35.900).

(b) An individualidentified as a Radiation Safety Officer on a Commission or Agreement State license before (date to be entered) need not comply with the training requirements of Section 35.900(c).

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nrmff Anumf 1149% MTAFF.I.rVrl_ WOHkiNC linrINrNTM Section 35,960 GSR: Training for a garnma stereotactic radiosurgery authorized user.

Except as provided in Section 35.970, the licensee shall require the authorized user of sealed sources listed in Section 35.600 in a csmma stereotactic radiosurgery unit to be a physician who:

(a) is certified in:

(1) Radiology, thiapcotic ndiology, or radiation oncology by the American Board of Radiology; (2) Radiation on dogy by the American Osteopathic Board of Radiology; (3) Radiology, with specialization in radiotherapy, as a Dritish " Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b)is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of sealed sources in a gamma stereotactic radiosurgery unit, supervised work experience, and supervised clinical experience as follows:

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an authorized user at a medicalinstitution that includes:

(i) Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent inappropriate deviations from the wntten directive, resulting in a medical event report; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a gamma stereotactic radiosurgery unit or console; and (v) Checking and using survey meters; and (3) Three years of supervised clinical experience that includes one year in a formal training program approved 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 and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical Institution that includes:

(i) Examining individuals and reviewing their case histories to determlne their suitability for gamma stereotactic radiosurgery treatment, and any limitations or contraindications; (ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally presenbed doses as warranted by patients' or human research subjects' reaction to radiation; and (iv) Post administration follow up and review of case histories.

(c) After training specific to gamma stereotactic radiosurgery, the proposed authorized user physician for gamma stereotactic radiosurgery must obtain a preceptor statement from an

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established gamma stereotactic radiosurgery physician which certifies that the proposed i

authorized user has adequate knowledge of the gamma stereotactic radiosurgery unit to be operated at the proposed licensed facility such that the proposed authorized user has adequately demonstrated and can successfully conduct the following areas:

(i) Gamma stereotactic radiosurgery treatments; (ii) Typical and emergency operations involving the gamma stereotactic radiosurgery; l

and (iii) Supervision and completion (J all of the gamma stereotactic radiosurgery operations i

and procedures to comply with the associated regulatory requirements specified in this chapter, as well as any additional commitments to NRC made by the licensee regarding gamma stereotactic radiosurgery unit operation.

Section 35,961 GSR: Training for gamma stereotactic radlosurgery physicist.

The licensee shall require the gamma stereotactic radiosurgery physicist to be an individual who:

(a)is certified by the American Board of Radiology in:

(1) Therapeutic radiological physics; (2) Roentgen ray and gamma ray physics; (3) X ray and radium physics; or (4) Radiological physics; or (b) is certified by the American Board of Medical Physics in radiation oncology physics; or (c) Holds a master's or doctor's degree in physics, biophysics, radiologlJ.al physics, or health physics, and has completed one year of full time training in therapeutic radiological 4

physics and an additional year of full time work experience under the supervision of a teletherapy physicist at a medical institution that includes the tasks listed in Sections 35,59, 35 632,35.034, and 35.641 of this part.

(d) After training specific to a gamma stereotactic radiosurgery physicist position, the proposed authorized gamma stereotactic radiosurgery physicists must obtain a preceptor statement from another established gamma stereotactic radiosurgery physicist which certifies that the proposed authorized physicist has adequate kwwledge of the gamma stereotactic radiosurgery unit to be operated at the licensed facility such that the proposed authorized physicist has adequately demonstrated and can successfully conduct the responsibilities of a gamma stereotactic radiosurgery physicist in each of the following areas:

(i) Gamma stereotactic radiosurgery treatments; (ii) Typical and emergency operations involving the gamma stereotactic radiosurgery; ano (iii) Completion of all of the gamma stereotactic radiosurgery operations and procedures to comply with the associated regulatory requirements specified in this chapter, as well as any additional commitments to NRC made by the licensee regarding gamma stereotactic radiosurgery unit operation.

Section 36,970-GSR: Training for experienced authorized users and physicists.

(a) Physicians identified as authorized users for the medical use of byproduct material on a Commission or Agreement State license issued before April 1,1987 who perform only

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(b) An individualidentified as a gamma stereotactic radiosurgery authorized user on a Commission or Agreement State license before _ (date to be entered) need not comply with the training requirements of Section 35.960(c).

(c)An individual identified as an authorized gamma stereotactic radiosurgery physicist on a Commission or Agreement State license before _ (date to be entered) need not comply with the training reouirements of Section 35.961(d).

4 Section 36.972-GSR: Recentness of training.

The trainirig and experience specified in this subpart must have been obtained within the 7 years preceding the date of application or the ind.odual must have had related continuing education and experience since the required training and experience was completed.

Enforcement Section 36.990: Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of-(1) The Atomic Energy Act of 1954, as amended; (2) Title ll of the Energy Reorganization Act of 1974, as amendad; or (3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of-(i) Sections 53,57,02,63,81,82,101,103,104,107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act, (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(l) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(1) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

Section 36.991: Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b,1611, or 161o of the Act. For purposes of section 223, all the regulations in part 35 are issued under one or more of sections 161b,1611, or 161o, except for the sections listed in paragraph (b) of this section.

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(b) The regulations in part 35 that are not issued under subsections 161b,1611, or 161o for the purposes of section 223 are as follows: Sections 35.1,35.2,35.7,35.8,35.12,35.15, 35.18, 35.19, 35.57, 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and 35.999.

Besords: Gamma Stereotactic Radiosurgery Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention i

period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

35.GSRredi: Records of the specific license for gamma stereotactic radiosurgery use.

Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the Commission, or until the Commission terminates the license.

35.GSRred2: Records of recolpt and transfer of sealed sources.

(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and devices and depleted uranium used as shielding or other components associated with the gamma stereotactic radiosurgery unit and retain each record for 5 years after it is made (b) These records must include the date, radionuclide, number of Becquerel (curies) or kilograms for depleted uranium, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

35.GSRred3: Records of radiation survey instrument calibrations.

Each licensee shall retain a record of each survey instrument calibration, that is required pursuant to 35.620, for 5 years after it is made. The record must melude:

(1) A description of the calibration procedure; and (2) The date of the calibration, a description of.he source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.

35.GSRred4: Records of dosimetry equipment calibrations.

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Each licensee shall maintain records of the calibrations, intercomparisons, and comparisons of its dosimetry equipment that are required under 35.630 and retain each record for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.

35.GSRred5: Records of Radiation Safety Committee meetings.

Each licensee shall maintain records of ecch Radiation Safety Committee meeting that is required pursuant to 35.22 and retain each record for the duration of the license. For each Radiation Safety Committee meeting, the records must include:

(1) The date of the meeting; (ii) Members present and absent; and (iii) Summary of deliberations and discussions.

35,GSRred6: Records of statements of authority and responsibility.

Each licensee shall maintain records of the statenients of authority and responsibility that are required under 35.23 and retain the current edition of these statements as a record until the Commission terminates the license.

35.GSRred7: Records of training.

A licensee shall retain for five years a record of individuals receiving instruction required in section 35.610(c), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

35.GSRred8: Records of minor radiation safety program changes.

Each licensee shall maintain records of minor changes mkde in the radiation safety program as allowed by 35.31 and retain each record until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical

-institution, the Radiation Safety Committee's chairman and the management representative.

35.GSRred9: Records of quality management program.

(c)Each licensee shall maintain records of the medical administration procedure reviews

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. that are required under 35.32(b) and retain records of each review, including the evaluations and findings of the review, in an auditable form for 5 years after it is made.

(b) Each licensee shall maintain records of recordable event reviews that are required under 35.32(c) and retain records of each review, including the relevant facts and what corrective action, if any, was taken, in an auditable form for 5 years after it is made.

(c) Each licensee shall maintain wntten directives that are required under 35.32(a) and retain a record of each administered radiation dose, in an auditable form, for 5 years after the date of administration.

35,G8Rred10: Records of sealed source leak tests and inventories.

4 (a) Each licensee shall maintain recordo of leak test results for sealed sources, as required in 35.59 GSR, and retain each record for 5 years after its is made. The records must contain the model number, and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in units of radioactivity as defined in 10 CFR Part 20, a description of the method used to measure each test sample, the date of the test, and the signature of the individual conducting the test.

(b) Each licensee shall maintain records of the inventory of sealed sources that are required under 35.59 and retain each record for five years after it is made. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the individual conducting the test.

35,GSRred11: Records of radiation surveys.

- (a) Each licensee shall maintain a record of each survey that is required by 35.59(h) and retain each record for 5 years after it is made. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem per hour, and the survey instrument used.

(b) Each licensee shall maintain a record of the radiation measurements made following installation of a sources that are required by 35.641, and as may be modified according to 35.643(a)(3). The licensee shall retain the record for the duration of the license. The record must include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial numbers of the unit, sources, and the instrument used to measure radiation levels, each dose rate measurea around the unit while in the off position, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in units appropriate to 10 CFR Part 20 requirements, and the calculated maximum quantity of radiation over a peind of one week for each restricted and unrestricted area.

35.GSRred12: Records of decay in storage disposals, Each licensee shall mentain a record of each disposal permitted under section 35.92

- and retain each record for 5 years after it is made. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides

- disposed, the survey instrument used, the background dose rate, the dose rate measured at

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the surface of each waste container, and the name of the individual who performed the

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36.GSRred13: Records of maintenance and repair.

Each licensee shall maintain a record of each maintenance, adjustment, or repair of the gamma stereotactic radiosurgery unit or sources that are required or allowed under 35.605 and retain each record for the duration of use for the gamma stereotactic radiosurgery unit. The p

record must include the date of the maintenance, adjustment or repair, the manufacturer's name, model numbers and serial numbers for both the un!t and the sources, a description of and the results of components addressed during the maintenance, adjustment, inspection, or repair, and the signature of the individual performing the maintenance, adjustment, inspection, or repair.

36.GSRred14: Records of radiation monitor checks.

A licensee shall maintain a record of the check required by paragraph (d)(3) of this section for five years. The record must include the date of the check, notation that the monitor indicates when its detector is and is not exposed, and the signature of the individual who performed the check.

36.GSRred16: Calibration records.

Pursuant to Section 35.632 GSR, a licensee shall retain a record of each calibration for the duration of use of the gamma stereotactic radiosurgery unit sources. The record must include the date of the calibration, the manufacturer's name, model numbers, and serial numbers for both the gamma stereotactic unit and the sources, the model numbers and serial numbers of the instruments used to calibrate the unit, tables that describe the output of the unit over the range of use, the results of the remaining calibration tests required in section 35.632, 4

and the signature of the gamma stereotactic radiosurgery physicist. Facility related records of

. calibrations completed pursuant to 35.632, is referenced to Section 35.634 paragraphs (a)(7),

(d), and (f), shall also be signed by the Radiation Safety Officer.

36.GSRred16: Records of safety checks.

Each licenses shall maintain records of each check required by 35.634 and retain each record for 5 years after it is made. The record must include the date of the check, the manufacturer's name, model number, and serial number for both the gamma stereotactic radiosurgery unit and sources, an assessment of timer linearity and constancy, the calculated on off error, the difference between the anticipated output and the measured output, notations f

indicating the operability of each entrance door electrical interlock, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic check.

36,GSRred17: Records of safety checks.

A licensee shall retain a record of each check required in Section 35.634 for five years, m

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