ML20210R752
| ML20210R752 | |
| Person / Time | |
|---|---|
| Issue date: | 08/07/1997 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20210K626 | List: |
| References | |
| FRN-62FR42219, RULE-PR-35 PROC-970807-02, PROC-970807-2, NUDOCS 9709030248 | |
| Download: ML20210R752 (38) | |
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- i August 7,1997 WORKING DRAFT l
HIGH DOSE RATE REMOTE AFTERLOADERS 4
NOTE Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated gu! dance 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 t' -' arc key to the discussion of significant issues associated with the regulat%n a the medical use of byproduct meterial, which is an agenda item at the August 19 20 meeting of the group, it should 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 contaln different alternatives to regulation of a specific area. Hopefully, these differences will stimulate input and additional alternatives from the Working G,oup, Y
9709030248 970818-62 42219 PDR
e August 7,1997 STAFF LEVEL DRAFT DOCUMENT SECTIONA. APPLYING TO HIGH DOSE RAi'a REMOTE AFTERLOADER PART 35. MEDICAL USE OF BYPRODUCT MATERIAL I Preface .......... .............................................. 4 G e ne r al Pr ovisio ns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Section 3 5.1 Purpose end scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Section 35.600 HDR Use of a sealed source in a high dose rate remote afterloader Wnit Section 3 5.2.H D R De finitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Section 35.6 Provisions for research involving human subjects . . . . . . . . . . . . 6 Section 35.7 FDA, other Federal, and State requirements . . . . . . . . . . . . . . . . . 6 Section 35.999 Resolution of conflicting requirements during transiflon period . . 6 Specific Licensing Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Section 3 5.11 License required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Section 35.12 Application for license, amendment, or rerewal . . . . . . . . . . . . . 7 Section 35.1 B License issuance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Section 35.29 HDR Administrative requirements that apply to the provision of mobile high dose rate remote af terloader service . . . . . . . . . . . . . . . . . . . . . . . 7 Section 35.13 HDR License amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Section 35 HDR1 Authoriration for depleted uranium as shielding . . . . . . . . . . . 8 Section 35.57.HDR Authorization ior calibration and reference sources . . . . . . . 8 Section 35.14 HDR Personnel and address change notifications . . . . . . . . . . . . 9 Section 35.15 HDR Exemptions regarding Type A specific licenses of broad scope
....................................................9 Section 35.19 Specific exemptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Equipment.......................................................9 Section 35.620 HDR Possession, calibration and check of survey instruments . . 9 Section 35.630 HDR Dosimetry equ) ment . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Section 35.HDR2 Emergency equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Section 35.HDR4 Therapy related computer systems . . . . . . . . . . . . . . . . . . . 11 Radiation Saf ety Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Section 35.21 Radiation Safety Officer ............................11 Section 35.22.HDR Radiation Safety Committee . . . . . . . . . . . . . . . . . . . . . . 11 Section_35.23 Statements of authority and responsibilities . . . . . . . . . . . . . . . 12 Sectio',, 3 5.2 5 Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Section 3 5 H DR3 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Sect!on 35.31 Radiation safety program changes ..................... 14 Section 35.32 HDR Ouality management program . . . . . . . . . . . . . . . . . . . . . 14 Section 35.59 HDR Requirements for possession of sealed sources . . . . . . . . . 15 Section 35.9 2 Decay in storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Section 35.605 HDR Maintenance, repair, and disposal . . . . . . . . . . . . . . . . . 16
e STAFF LEVEL DRAFT DOCUMENT 2 August 7,1997 Section 35.610 HDR Safety instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Secuon 35.615 HDR Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Section 35.632 riDR Full calibration measurements . . . . . . . . . . . . . . . . . . . . 18 Section 35.634 HDR Daily safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Section 35.636 HDR Safety checks for high dose rate remote af terloader f acilities
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Section 35.641.HDR Radiation surveys for high dose rate remote af terloader f acilities
...................................................20 Section 35.643 HDR Modification of high dose rate remote afterloader unit or room before beginning a treatment program . . . . . . . . . . . . . . . . . . . . . . . . 20 i Section 35.404 HDR Release of patients or human research subjects treated with a high dose rate remote af terloader unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Training .......................................................21 Section 35.900 Radiat!on Safety Of ficer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Section 35.901 Training for experienced Radiation Safety Officer . . . . . . . . . . 21 Section 35.940 HDR Training for authorized user .....................22 Section 35.961.HDR Training for high dose rate remote af terloader medical physicist
...................................................22 Section 35.970 Training for experienced authorized users ...............23 Section 35.972 Recentness of training , . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Records.......................................................23 35.xx1 Records of the specific license for high dose rate remote afterloader use . 23 35.xx2 Records of receipt and. transfer of sealed sources ................ 23 35.xx3 Records of radiation survey instrument calibrations . . . . . . . . . . . . . . . 24 35.xx4 Records of dosimetry equipment calibrations . . . . . . . . . . . . . . . . . . . . 24 35.xx5 Records of Radiation Safety Committee roeetings . . . . . . . . . . . . . . . . 24 35.xx6 Records of statements of authority and responsibility . . . . . . . . . . . . . . 24 3 5.xx7 Record s of training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 35.xx8 Records of minor radiation safety program changes . . . . . . . . . . . . . . . 25 35.xx9 Records of quality management progran: ......................25 35.x10 Records of sealed source leak tests and inventories . . . . . . . . . . . . . . . 25 35.x11 Records of radiation surveys . . . . . . . . . .....................25 35.x12 Records of decay in storage disposals . . . . . . . . . . . . . . . . . . . . . . . . 26 35.x13 Records of maintenance and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 35.x14 Records of radiation monitor checks . . . . . . . . . . . . . . . . . . . . . . . . . . 26 35.x15 Records of high dose rate remote af terloader calibrations . . . . . . . . . . . 26 35.x16 Records of high dose rate remote af terloader checks . . . . . . . . . . . . . . 27 35.x17 Records of safety checks following source replacement and facility changes'............................................. 27 Section 35.5 Maintenance of records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Notifications of incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Section 35.33 Notification of incidents, reports, and records of reportable medical events..............................................27
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. STAFF LEVEL DRAFT DOCUMENT 3 August 7,1997 Viol at ion s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8
- Section 3 5.990 Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 Section 35.991 Criminal penalties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 -
Summary of Areas Discussed in AAPM Task Group Reports to Facilitate Review . . . . 30 4
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STAFF LEVEL DRAFT DOCUMENT 4 August 7,1997 '
i hafar,e The medical use or high dose rate remote afterloaders that contain a sealed source has been previously regulated under 10CFR 35.400 and license conditions. The safety procedures captured in this section have incorporated applicable 10CFR 35.400 requirements, current license conditions placed on high dose rate remote af terloader license,i, and recommendations made in Policy and Guidance Directive 86 4 with addendums. Severai AAPM documents, including two draf t documents, were also reviewed during formulation of this section. A table summarizing the proposed regulation and the applicable section of an A APM report is provided at the end of this document to facilitate review by the regulated commtinity. When comparing the proposed regulations against the applicable AAPM recommendatione, please note the additionalitems recommended by the AAPM for the given issue and when commenting, include your opinion or, whether the complete AAPM recommendation should be incorporated as regulation.
Generalhovlslens Section 35.1 Purpose and scope.
This part prescribes requirements and provisions for the medical use of NRC regulated radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19,20,21, 30,40,71, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.
Section 35.600 HDR Use of a sealed source in a high dose rate remote afterloader unit.
The regulations and provisions of this subpart govern the use of high dose rate remote af terloader units,for medical uses as approved in the sealed source and device registry.
Section 35.2 HDR Definitions.
Address of use means the building or buildings that are identified on the license and where radioactive material may be received, used, or stored.
Agreement State 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 storing radioactive material.
Anthorized user means a physician who is:
(1) Board certified by at least one of the boards approved by the NRC as described in 10 CFR 35.940; (2) Identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material: or
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STAFF LEVEL DRAFT DOCUMENT 5 August 7,1997 l t
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(3) Identified as an authorized user on a permit issued by a Commission or Agreement i State specific licensee of broad scope that is authorized to permit the medical use of byproduct material.
Dedicated check source means a radioactive source that is used to assure the constant i operation of a radiation detection or measurement device over several months or years, Depleted uran /um means the source material uranium in which the isotope uranium 235 is 4 less than 0.711 weight percent of the total uranium present, which is used for shielding and i
emergency response equipment. Depleted uranium doos not include special nuclear material, High Dose Rate Remote Afterloader Medical Phys /cist means the individual identified as the high dose rate remote af terloader medical physicist on a Commission license. ;
Management means the chief executive officer or that person's delegate or delegates.
- Medicalentity means any structure of medical practice that is not defined as a medical institution.
Medica / /nst/turlon means an organization in which several medical disciplines are practiced and provides in patient care.
Medicaluse means the intentione internal or external administration of byproduct !
material of the radiation therefrom to Otedur human research subjects under the supervision of an authorized user.
1 Minor change means a change that is ude, af ter ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making :
a discretionary judgment about whether those requirements should apply in the case at hand.
Mob //e serv /ce means the transportation and medical use of byproduct material.
Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a radiation emitting source or device for a specified set of exposure conditions.
Phys /c/an 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 high dose rate remote afterloader therapy, the total dose and dose per fraction as documented in the written directive.
Radiation Safety O///cer means the individualidentified as the Radiation Safety ;
Officer on a Commission license.
Reportable medical event means the an oral and/or written report to the NRC involving:
(a) the administration of a high dose rate remote afterloader radiation dose involving the wrong individual, wrong radioisotope, or wrong treatment site or when the total administered dose differs from the prescribed dose by more than 20 percent of the total prescribed dose:
(b) a sealed source that is leaking 1c) any structural, mechanical, electrical or electronic malfunction of the high dose rate remote afterloader unit or its ancillary equipment, power supplies, and computerized treatment planning systems that may effect the dose to the patient; or (d) any report required by sections 30.50 or 21.21.
Sealed source means any radioactive material that is encased, embedded, or affixed in such a way as to prevent leakage, movement or escape of the radioactive material from the -
source apparatus and is registered in accordance with section 32.210, Wr/tten direct /ve means a written set of directions concerning patient or human f
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e STAFF LEVEL DRAFT DOCUMENT 6 August 7.1997 research subject treatment from a high dose rate remote af terloader unit to include, but not limited to, the following information: the total dose, dose per fraction, the radioisotope, and treatment site, dated and signed h/ an authorized user prior to the administration of radiation.
Section 35.8 Proviolons 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 licenses 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 activities by an " Institutional Review Board" in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
Section 35.7 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 human subjects, radioactive drugs or devices.
Section 36.V r *esolution of conflicting requirements durlag transition period.
(a)If rm direments of this part or subpart are more restrictive than the existing license condh inen the licensee shall comply with this part unless exempted by paragraph (c) of this secti ".. -
(b) Any existing license condition that is more restrictive than a requirement in this !
part or subpart remains in force until there is a license amendment or license renewal.
(c) If a license condition exempted a licensee from a requirement in this part or subpart in effect prior to ??date, it continues to exempt a licensee from the corresponding provision of this part or subpart.
(cl) if a license condition cites a provision of this part or subpart in effect prior to
??date and there are no corresponding provisions after ??date, then the license condition remains in force until there is a license amendment or renewal that modifies or removes that condition.
Specific Licensing Provialons Section 36.11 License required.
'(a) A person shall not manuf acture, produce, acquire, receive, possess, use, or transfer byproduct material or depleted uranium for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of this section.
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STAFF LEVEL DRAFT DOCUMENT 7 August 7,1997 l (b) An individual may receive, possess, use, or transfer byproduct material or depleted uranium in accordance with the regulations in this chapter under the supervision of an authorized user as provided in Section 35.25, unless prohibited by license condition.
(c) A licensee may use for medical use only sealed sources or devices manuf actured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR Part 30 and 10 CFR 32.74 or the equivalent requirements of an Agreement State.
Section 35.12 Application for license, amendment, or renewal.
(a) An application for medical use sited in a medicalinstitution may only be submitted t
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 the medical entity.
(b) An application for a license for medical use of byproduct material must be made by filing an original and one copy of NRC Form 313, " Application for Ninterials License." For ,
guidance in completing the form, refer to the instructions in the most current version of the appropriate Reguletory Guide. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.
(c) For copies of regulatory guides, application forms, or to submit an application or an amendment request, refer to Section 30.6 of this chapter.
(d) An applicant that satisfies the requirements specified in 10 CFR 33.13 may apply for a Type A specific license of broad scope.
. Section 35.18 License issuance.
The Commission shallissue a license for the medical use of byproduct material if:
(a) The applicant has filed NRC Form 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 phrt 170 of this chapter; (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; and (d) The applicant meets the requirements of part 30 of this chapter.
Section 35.29 HDR Administrative requirements that apply to the provision of mobile high dose rate remote afterloader service.
The Commission will consider an application for a license to conduct mobile high dose rate remote afterloader service if the licensee submits the following:
(a) The information described in section 35.18; (b) A letter signed by the management of each client for which services are rendered that authorizes use of byproduct material and depleted uranium at the client's address of use:
(c) Dedicated f acility description for receipt and storage of high dose rate remote afterloader units and sealed sources;
-(d) Driver training; (e) Identification of field locations;
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e STAFF LEVEL DRAFT DOCUMENT 8 August 7,1997 (f) Emergency procedures for transportation and use; and (g) Safety checks performed on device after transport and before medical use, section 35.13 HDR License amendments.
A licensee shall apply for and must receive a license amendment:
(a) Before it receives or uses byproduct material for medical use permitted under this part but not permitted by the license issued pursuant to this part; (b) Before it permits anyone to work as an authorized user or authorized high dose rate remote af terloader medical physicist under the license, except an individual who is:
(1) An authorized user certified by an organization approved by the Nuclear Regulatory Commission as described in Section 35.940; (2) An authori.ted high dose rate remote af terloader medical physicist certified by an organization specified in paragraphs (a) or (b) of Section 35.961; (3) Identified as an authorized user for the medical use requested or a high dose rate remote af terloader medical physicist on a Commission or Agreement State license that authorizes the use of byproduct materialin medical use; or (4) Identified as an authorized user for the medical use requested or a high dose rate remote af terloader medical physicist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct materialin medical use.
(c) Before it changes Radiation Safety Officers; (d) Before it orders byproduct materialin excess of the amount, or radionuclide or form different than authorized on the license; (e) Before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license; (f) Before making any change in the treatment room shielding; (g) Before relocating the high dose rate remote afterloader unit or making any change in the location of the high dose rate remote afterloader unit within tbd treatment room; or (h) Before using the high dose rate remote af terloader unit in a manner that could result in increased radiation levels in areas outside the treatment room.
Section 35.HDR1 Authorization for depleted uranium as shielding.
- Any person authorized by Section 35.18 for medical use of a high dose rate remote af terloader unit may receive, possess, and use up to 999 kilograms of depleted uranium for shielding in a high dose rate remote afterloader unit and associated emergency response
- equipment.
Section 36.57 HDR Authorization for calibration and reference sources.
Any person authorized by Section 35.18 for medical use of byproduct material as a ,
sealed source in a high dose rate remote afterloader unit may receive, possess, and use the following byproduct material for check, calibration, and reference use; sealed sources manuf actured 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.
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STAFF LEVEL DRAFT DOCUMENT 9 August 7,1997 Section 35.14 HDR Personnel and address change notifications.
(a) A licensee shall provide to the Commission a copy of the board certification, the Commission or Agreement State license, or the permit issued by a licensee of broad scope, for each individual no later than 30 days af ter the date that the licensee permits the individual to work as an authorized user or an authorized high dose rate remote afterloader medical physicist pursuant to Section 35.13 (b)(1) through (h)(4).
(b) A licensee shall notify the Commission by letter no later than 30 days after:
(1) An authorized user, Radiation Safety Officer, or authorized high dose rate remote af terloader medical physicist permanently discontinues performance of duties under the license or has a name change; or (2) The licensee's malling address changes.
(c) The licensee shall mail the documents required in this section to the appropriate address identified in Section 30.0 of this chapter.
Section 35.15 HDR Exemptions regarding Type A specific licenses of broad scope.
A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
(a) The provisions of Section 35.13(b);
(b) The provisions of Sections 35.13(e), (f), (g), (h), and (l) regarding additions to or changes in the areas of use only at the addresses specified in the license; i (c) The provisions of Section 35.14(a); and (d) The provisions of Section 35.14(b)(1) for an authorized user or an authorized high dose rate remote af terloader medical physicist.,
Section 35.19 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.
Equipment Section 35.620-HDR Possession, calibration and check of survey instruments.
(a) A licensee authorized to use byproduct material as a sealed source in a high dose rate remote citerloader unit shall have in its possession a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1,000 millirem per hour.
(b) A licensee shall calibrate the survey instruments used to show compliance with this part before first use, annually, and following repair. The Ucensee shat!:
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i STAFF LEVEL DRAFT DOCUMENT 10 August 7,1997 [
(1) Calibrate all scales with readings up to 1000 millirem per hour with a radiation r source; (2) Calibrate two separated readings on each scale that must be calibrated; 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 caLulated exposure rate by not more than 20 percent, and conspicuously attach a correction ,
chart or graph to the instrument.
(c) A licensee shall check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks kd) A licensee shall retain a record of each survey instrument calibration in accordance with 35.xx3.
Section 35.630 HDR 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 NationalInstitute 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 vears 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 af ter that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past tw1nty 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 f actor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration f actor. When intercomparing dosimetry systems to be used for calibrating high dose rate remote af terloader units, the licensee shall use a sealed source with comparable radioactive emissions to the high dose rate remote afterloader source.
(b) The licensee shall have available for use a dosimetry system for spot check measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison rnust 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 sectlun.
(c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with 35.xx4, Section 35.HDR2 Emergency equipment A licensee shall have available, near each treatment room, emergency source recovery equipment to include:
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' (a) a shielded source / applicator storage container; j (b) remote handling tools; and (c)if appropriate, supplies noressary to surgically remove applicators or sources from !
a patient. j Section 35.HDR4 Therapy related computer systems The licensee shall assure that the computer treatment planning systems and computerized !
operating systems associated with the therapy device are operating appropriately. {
Badatlan Safa1YA09 tam Section 35.21 Radiation Safety Officer. {
(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing i 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 i and reguistory requirements in the daily operation of the licensee's byproduct material i program.
1 (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; (4) For medical use not at a medicalinstitution, approve or disapprove minor changes :
in radiation safety procedures pursuant to 10 CFR 35.31 that are not potentially important to safety with the advice and consent of management; and (5) Assist the Radiation Safety Committee in the performance of its duties if a Committee is required pursuant to Section 35.22. <.
Section 35.22 HDR Radiation Safety Committee.
A Radiation Safety Committee n.ust be established to oversee the medical use of NRC regulated material, the radiation therefrom, or the radiation from an NRC regulated utilization f acility, if the licensee is authorized for more than one modality described in this part.-
(a) The Committee rnust meet the following administrative requirements:
(1) Membership must consist of at least three individuals and must include an ,
authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nurs5g service, the authorized high dose rate remote afterloader medical physicist, and a representative of management who is neither an authorized uset not a i
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STAFF 4EVEL DRAFT DOCUMENT 12 August 7,1997 1
Radiation Safety Officer. Other members may be included as the licensee deems appropriate.
(2) To establish a quorum and to conduct business, et 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 licensco 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.xx5.
(b) To oversee the use of licensed material, the Committee must:
(1)(l) Review, on the basis of safety and with regard to the training and experience standards in Sections 35.900 through 35.972, and approve or disapprove any individual who is to be listed as an authorized user, the Radiation Safety Officer, or an authorized high dose rate remote afterloader medical physicist, before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to Section 35.13 (b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized high dose rate remote afterloader medical 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 Rarfistion Safety Of ficer, a summary of the occupational radiation dose recordt, of all personnel working with byproduct material; (4) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and (5) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.
Section 35.23 Statements of authority and responsibilities.
(a) A licensee shall provide the Radiation Safety Officer, and the Radiation Safety Committee, if such a committee is required, 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 enfoty activitisa of the Radiation Safety Officer, and if required, the Radiation Safety Committee.
Section 35.25 Supervision.
(a) A licensee that permits the receipt, possession, use, or transfer of byproduct rnaterial by an individual under the supervision of an authorized user as allowed by Section
A 0
STAFF 4EVEL DRAFT DOCUMENT 13 August 7,1997 35.11(b) of this part shall:
(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 administration program; (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management program 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.
(b) A licensee th:t supervises an individualis responsible for the acts and omissions of the supervised individual.
Section 35.HDR3 Training.
(a) The licensee may not permit any individual to act as a high dose rate remote af terloader operator until the individual:
(1) Has received training in the subjects in paragraph (f) of this section; (ii) Has received copies of any instruction in the requirements described in NRC regulations contained in this part; in sections 30.7,30.9, and 30.10 of this part; in the applicable sections of 10 CFR parts 19 and 20 of this chapter, in the NRC license under which the individual will perform treatments with a high dose rate remote af terloader unit, and in the licensee's operating and emergency procedures; (iii) Has demonstrated understanding of the licensee's license and operating and emergency procedures by successful completion of a written or oral examination covering this material; (iv) Has received training in the use of the licensee's high dose rate remote af terloader unit, in the daily inspection of the unit and associated equipment, and in the use of radiation survey instruments; (v) Has demonstrated understanding of the use of the high dose rate remote af terloader unit and associated equipment, survey mstruments, and operating and emergency procedures, described in paragiaphs (ii) and (iv) of this section by successful completion of practical examination covering this material. (A practical examination is defined as " hands on" training).
(b) The licensee may not permit any individual to act as a high dose rate remote af terloader medical physicist or authorized eser untii the individual:
(l) Has received copies of the instruction described in section (a)(li);
(ii) Has received training in the use of the licensee's high dose rate remote afterloader unit and treatment planning system; (iii) Has demonstrated understanding of the use of the high dose rate remote af terloader unit, treatment planning system and associated equipment; and operating and emergency procedures, by successful completion of a practical examination covering this materiai.
(c) The licenssa shall provide annual refresher safety training, including practice of emergency response procedures, for each operator, authorized user, and high dose rate remote afterloader medical physicist at intervals not to exceed 12 months.
e o i j !
STAFF LEVEL. DRAFT DOCUMENT 14 August 7,1997 ;
(d) The licensee shall provide verbal and written radiation safety instruction to all personnel caring for the patient or the human research subject undergoing high dose rate y remote af terloader treatment. To satisfy this requirement, the instruction must describe: f (l) Size and appearance of the high dose rate remote afterloader source (s); j (ii) Safe handling and shielding instructions in case of a dislodged source; j (iii) Use of survey instruments; (iv) Procedures for patient or human research subject control; i (v) Procedures for visitor control; and '
(vi) Procedures for notification of the Radiation Safety Officer if the patient or the human research subject dies or has a medical emergency. :
(e) The licensee shall retain a record of individuals receiving instruction required by ['
, paragraphs (a), (b), (c), and (d) of this section in accordance with 35.xx7. _
- (f) The licensee shall!nclude the following subjects required in paragraph (a) of this r i anction
(l) Fundamentals of radiation safety; (ii) Radiation detection instruments' use, calibration, and limitations; l (iii) Operation of high dose rate remote af terloader units; '
i (iv) Storage, control, and disposal of licensed material; (v) Inspection and maintenance of equipment; and ,
(vi) The requirements of pertinent Federal regulations. l Section 36.31 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 3
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 v.;th 35.xx8.
Section 35.31 HDR Ouality management program. :
(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written program to provide high confidence that radiation from byproduct material l l Will be administered as directed by the authorized user. The program must meet the following :
. .- specific objectives:
(1) That, prior to administration, a written directive 1_/ is prepared for any high ,
dose rate remote afterloader radiation dose; 1_/ 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 r 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 therapeutic procedure provided 9at the revision is dated and signed by an authorized user prior to the administration of the high dose rate remote afterloader dose or the next high dose l I
.w..,- .--w-- 3 e . . , - . . , . ,,,..-m-.. .,4,- y -,.g.-,,,m_m.m-,.--%.. ,, .- s., 4.% ., sw - ,-r-y,-
, e STAFF LEVEL DRAFT DOCUMENT 15 August 7,1997 rate remote af terloader fractional dose, if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardire the patient's health, an oral directive will be t acceptable, provided that the information contained in the oral directive is documented
- _ immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
i (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; l (3) That final plans of treatment and related calculations for the radiation dose and l that each administration are in accordance with the respective written directives; and (4) That any unintended deviation from the written directive is identified and i evaluated, and appropriate action is taken.
(b) The licenses shall perform an audit of a representath 1 sample of written directives at intervals no greater than 12 months to verify the effectiveness of the program.
(3) Hetain records of each review, including the evaluations and findings of the review l
in accordance with 35.xx9.
(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 paragraph (a)(1) above, in accordance with 35.xx9.
Section 35.59 HDR Requirements for possession of sealed sources (a) A licensee in possession of any sealed source shall follow the radiation safety and handling instructions supplied by.the manuf acturer, 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 sealed source or from the surf aces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or, for small sealed sources, wash the source in a small volume of detergent solution and treat the entire volume as the sample;
-(2) Take high dose rate remote afterloader source test samples when the source is in the "off" position; 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 in accordance with 35.x10.
l
~ _ _ _ .._. , _ _ . , , . _ _. __ -._ _ . .-._.__.._._ _.._.-._ _ _ _.____ _ J
,- e i
9 f
STAFF LEVEL DRAFT DOCUMENT 16 August 7,1997 (e) If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall:
(1) Immediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this chapter; and l (2) File a report in accordance with 35.33.
i (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 microcuries or less of alpha emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage if stored for a period of greater than 10 years and before any use or transfer unless it has been leakage tested within six months before the date of use or transfer; and (5) Seeds of iridium 192 encased in nylon ribbon.
(g) A licensee in possession of a sealed source shall conduct a physicalinventory of all such sources in its possession at a six month frequency. The licensee shall retain a record of sach inventory in accordance with 35.x10.
(h) A licensee in possession of a sealed source shall perform such surveys to assure the limits of Part 20 are met in all areas where such sources are stored. This does not apply to high dose rate remote remote afterloader sources in high dose rate remote af terloader units.
(l) A licensee shall retain a record of each survey required in paragraph (h) of this section in accordance with 35.x11.
Section 35.92 Decay in storage.
(a) A licensee may hold byproduct material with a physical half life of less than 65 i days for decay in storage before disposalin ordinary trash and is exempt from the l 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 containe.' surf ace before disposal as ordinary trash and determines 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.x12.
Section 35.805 HDR Maintenance, repair, and disposal.
(a) Only a person specifically licensed by the Commission or an Agreement State to perform high dose rate remote af terloader unit maintenance and repair shall:
(1) Install, replace, relocate, or remove a high dose rate remote afterloader sealed source; or (2) Maintain, adjust, or repair a high dose rate remote af terloader unit and associated equipment involving work on the source safe, the source driving unit, or other electronic or
t STAFF LEVEL DAAFT DOCUMENT 17 August 7,1997 ,
mechanic mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels.
(b) A licensee authorized to use high dose rate remote aftericader units for medical .
use shall perform manufacturer suggested maintenance and proper functioning checks of the source exposure mechanlom at intervals not to exceed 12 months.
(c) Except as described in Section 35.92 of this part, a licensee shall dispose of sealed sources and depleted uranium used as shielding by transfer to an authorized recipient as defined in 10 CFR 30,41.
(d) A licensee shall retain a record of each repair, adjustment, maintenance, or disposal permitted under paragraphs (a), (b), and (c) of this section in accordance with 35.x13 and 35.xx2, Section 36.610 HDR Safety Instruction.
(a) A licensee shall post instructions at the high dose rate remote af terloader unit console. To satisfy this requirement, these instructions must inform the operator of:
(1) The procedure to be followed to secure the device, the console, the console keys, and the treatment room when not in use or unattended; (2) The procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before placing the source in the irradiation posittor: to begin a treatment or af ter a door interlock interruption; (3) The procedure to be followed to prevent the dual operution of more than one radiation producing device in a treatment room; and (4) The procedure to be followed if the operator is unable to place the source in the shielded position with controls outside the treatment room or any other abnormal operation occurs. The procedure shallinclude: ;
(1) The names and telephone numbers of the authorized users, the authorized high dose rate remote afterloader medical physicist, and the Radiation Safety Officer to be immediately contacted if the high dose rate remote af terloader unit or console operates abnormally; (ii) Step by step instructions for single or multiple equipment f ailures and the individuals responsible for implementing the actions; and (iii) Process for restricting and posting the treatment area to minimize the risk of inadvertent exposure.
(b) A licensee shall provide instruction in the topics identified in paragraph (a) of this section to allindividuals who operate a high dose rate remote afterloader unit.
(c) A licensec shall retain a record of individuals receiving instruction required by paragraph (b) of this section in accordance with 35.xx7.
Section 35.615 HDR Safety precautions. -
(a) A licensee shall control access to the high dose rate remote afterloader room by a door at each entrance.
(b) A licensee shall equip each entrance to the high dose rate remote af terloader room with an electrical interlock system that will:
(1) Prevent the operator from placing the source in the irradiation position unless each treatment room entrance door is closed;
a '
STAFF LEVEL DRAFT DOCUMENT 18 August 7,1997 (2) Cause the source to return to the snielded position immediately when an entrance door is opened; and (3) Prevent the source from being placed in the irradiation position following an interlock interruption until all treatment room entrance doors are closed and the source "on-off" controlis reset at the control panel.
(c) A licensee shall equip each entrance to the high dose rate remote afterloader room with a beam condition indicator light.
(d) A licensee shallinstallin each high dose rate remote af terloader room a permanent radiation monitor capable of continuously monitoring source status.
(1) A radiation monitor must provide v!sible notice of a high dose rate remote af terloader unit malfunction that results in an exposed or partially exposed source, 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 high dose rate remote af terloader unit.
(3) A radiation monitor must be checked with a dedicated check source for proper operation each day befora the high dose rate remote af terloader unit is used for treatment of patients or human research subjects.
(4) A licensee shall maintain a record of the check required by paragraph (d)(3) of this section in accordance with 35.x14.
(5) If a radiation monitor is inoperable, the licensee shall require any individual entering the high dose rate remote af terloader room to bse a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be ..iecked with a dedicated check source for proper operation at the beginning of each day of use The licensee shall keep a record as described in paragraph (d)(4) of this section.
(6) A licensee shall promptly repair or replace the radiation monitor if it is inoperable.
(e) A licensee shall construct or equip each high dose rate remote af terloader room with continuous viewing and intercom systems to permit continuous observation of the patient or the human research subject from the unit console during irradiation.
(f) A licensee shall not conduct a treatment for which a decoupled or jammed source could not be expeditiously removed.
(g) A licensee shall require an authorized user and a high dose rate remote afterloader physicist to be present during all treatments involving the high dose rate remote af terloader unit.
Section 35.632 HDR Full calibration measurements.
-(a) A licensee authorized to use a high dose rate remote afterloader unit for medical use shall perform full calibration measurements on each high dose rate remote af terloader unit:
(1) Before the first medical use of the unit; and (2) Before medical use under the following conditions:
(i) Following replacement of the source or following reinstallation of the high dose rate remote af terloader unit in a new location; (ii) Following any repair of the high dose rate remote af terloader unit that includes
O i
~
STAFF LEVEL DRAFT DOCUMENT 19 August 7,1997 1
removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one month.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within +/ 5 percent; (2) Timer constancy and linearity over the range of use; (3) On off error; (4) Source positioning rccuracy to within + / 1 millimeter; (5) Measurement of source guide tubes and connectors; (6) Source retraction with backup battery upon power f ailure; and (7) Source homogeneity.
(c) A licensee shall use the dosimetry system described in Section 35.630(a) to measure the output.
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with the procedures recommended by the Task Group 41 of the Radiation Therapy Committee of the American Association of Phyalcists in Medicine, May 1993.
(Copies of the document are available for inspection at the NR: Library,11545 Rockville Pike, Rockville, Maryland 20852 2738. Copies of the document 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 mraterial will be published in the Federal Register.)
(e) A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one day for iridium 192, one month for cobalt 60 or six months for cesium 137.
(f) Full calibration measuren,ents required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the licensee's high dose rate remote afterloader medical physicist.
(g) A licensee shall retain a record of each calibration in accordance with 35.x15.
Section 35.634 HDR Daily safety checks.
(a) A licensee authorized to use high dose rate remote af terloader units for medical use shall perform safety checks of each high dose rate remote af terloader f acility once each day of use that assure proper operation of:
(1) Electricalinterlocks at each high dose rate remote af terloader room entrance; (2) Beam condition indicator lights on the high dose rate remote afterloader unit, on the control console, and in the facility; (3) Viewing and intercom systems; (4) Treatment room doors from inside and outside the treatment room; (5) Electrically assisted treatment room doors with the high dose rate remote afterloader unit ele ctrical power turned off; (6) Source position indicators; and (7) Applicators and connectors.
(b) A licensee shall arrange for prompt repair of any system identified in paragraph (a) of this section that is not operating properly, and shsil not use the high dose rate remote af terloader unit following door interlock malfunction until the interlock system has been
o
- STAFF LEVEL DRAFT DDCUMENT 20 August 7,1997 l repaired.
(c) A licensee shall retain a record of each check required by paragraph (a) of this section in accordance with 35.x16.
t Section 35.636 HDR Safety iecks for high dose rate remote afterloader facilities.
(a) A licensee shall promptly check all systems listed in Section 35.634(a) for proper i
function af ter each installation cf a high dose rate remote af terloader source and after making any change for which an amendment is requirod by Section 35.13 (e) through (h).
(b) If the results of the checkr required in paragraph (a) of this section indicate the malfunction of any system specified i.i Section 35.634(a), the licensee shalllocle the unit in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(c) A licensee shall retain a record of the facility checks following installation of a source in accordance with 35.x17.
Section 35.641 HDR Radiation surveys for high dose rate remote afterloader f acilities.
(a) The licensee shall make such surveys as defined in Part 20 to assure that the maximum radiation levels at 10 centimeters from the surf ace of the main source safe with the source in the shielded position does not exceed 2 millirem per hour; and (b) Radiation levies in all areas adjacent to the treatment room, with the high dose rate remote afterloader source in the exposed position, that:
(1) Radiation doses to occupationally exposed individuals are not likely to cause personnel exposures in excess of the limits specified in Section 20.1201(a), 20.1207, and 20.1208 of this chapter; and (2) Radiation doses to individual members of the public do not exceed the limits specified in Section 20.1301(a) of this chapter.
(c)If the results of the surveys required in paragraph (a) of this section indicate any radiation levels or doses in excess of the respective limit specified in that paragraph, the licensee shalllock the unit in the off position and not use the unit:
(1) Except as may be necessary to repair, replace, or test the high dose rate remote af terloader unit shielding or the treatment room shielding; or (2) Until the licensee has received a specific exemption pursuant to Section 20.1301 of this chapter. '
(d) A licensee shall retain a record of the radiation measurements made following installation of a source in accordance with 35.x11.
' Section 35.643 HDR Modification of high dose rate remote afterloeder unit or room before beginning a treatment program.
(a) If the survey required by Section 35.641(b)(2) indicates that an individualin an .
unrestricted area may be exposed to levels of radiation greater than those permitted by Section 20.1301(a), before beginning the treatment program the licensee shall:
(1) Equip the unit or treatment room with additional radiation shielding to ensure '
compliance with Section 20.1301(a) of this chapter; and
O 21 August 7,1997 STAFF. LEVEL DRAFT DOCUMENT (2) Perform the survey required by Section 35.641 again.
(b) As an alternative to the requirements set out in paragraph (a) of this section, a licensee may request a license amendment under Section 20.1301(c) of this chapter that authorizes radiation levels in unrestricted areas greater than those permitted by Section 20.1301(a) of this chapter. A licensee may not begin the treatment program until the license amendment has been issued.
Section 35.404 HDR Release of patients or human research subjects treated with a high dose rate tornote afterloader unit, la) Immediately efter retracting the high dose rate remote af terloader source from a patient or a human research subject into its shielded position in the remote af terloading device, the licensee shall make a radiation survey of the patient or the human research subject and the remote af terloading device with a portable radiation detection survey instrument to confirm that the source has been removed from the patient and returned to the safe, shielded position. The licensee shall make a survey of the treatment area to confirm that no sources have been misplaced at the conclusion of each high dose rate remote afterloader procedure. The licensee may not release from confinement for medical care a patient or a human research subject treated with a high dose rate remote af terloader source until all sources have been removed.
(b) A licensee shall retain a record of each survey required in paragraph (a) of this section in accordance with 35.x11.
Itaining Section 35.900 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) is certified by:
(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Medical Physics in radiation oncology physica; 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:
(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radiorsis ;
(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 byproc,act
o STAFF 4EVEL DRAFT DOCUMENT 22 August 7,1997 rnrterial; or (c) De an authorized user identified on the licensee's license.
Section 35.901 Training for experienced Radiation Safety Officer.
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 35.000.
Section 35.940 HDR Training for authorized user.
Except as provided in Section 35.970, the licenseo shall require the authorized user of a high dose rate remote af terloader source for therapy to be a physician who is; (a) Board certified in a professional board applicable to therapeutic radiology and approved by the Nuclear Regulatory Commission; or (b) is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of high dose rate remote afterloader sources, 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:
(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) tfathematics 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 medical institution that includes:
(l) Oidering, receiving, and unpacking radios ctive materials safely and performing the related radiation surveys; (ii) Checking Jurvey meters for proper operation; (iii) Preparing, implanting, and removing sealed sources; (iv) Maintaining running inventories of material on hand; (v) Using administrative controls to prevent tha reportable medical event of byproduct material; and (vil Using emergency procedures to control byproduct material; 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 Osteopath!c Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medicalinstitution that includes:
(1) Examining individuals and reviewing their case histories to determine their suitability for high dose rate remote af terloader therapy treatment, and any limitations or contraindications; (ii) Selecting the proper high dose rate remote afterloader dose and method of administration; (iii) Calculating the dose; and
l STAFF. LEVEL DRAFT DOCUMENT 23 August 7,1997 i
(iv) Post administration followup and review of case hisNries in collaboration with 1 the authorized user.
Section 35.961 HDR Training for high dose rate remote afterloader medical physicist.
The licensee shall require the high dose rate afterloader medical physicist to be an individual who:
(s)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, radiological physics, or health physics, and has completed one year of full time training in therapeutic radiological physics and an additional year of full time work experience under the supervision of a high dose rate remote af terloader medical physicist at a medicalinstitution that includes the tasks listed in Sections 35.59, 35.632, 35.634, and 35.641 of this part, Section 35.970 Training for experienced authorized users.
Physicians identified as authorized users for the medical, dental, or podiatric use of byproduct material on a Commission or Agreement State license issued before April 1,1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of subpart J.
Section 35.972 Recentness of training.
The training and experience specified in this subpart must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.
Besotda 35.xx1 Records of the specific license for high dose rate remote afterloader 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.xx2 Records of receipt 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 and retain each record for 5
O O
STAFF LEVEL DRAFT DOCUMENT 24 August 7,1997 years af ter it is made.
(b) These records must include the date, radionuclide, number of becquerels (curies) or kilograms for depleted uranium, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.
35.xx3 Records of radiation survey instrument calibrations.
Each licensee shall maintain records of the calibrations of its radiation survey instruments that are required under 35,620 and retain each record for 5 years after it is made.
The record must include:
(1) A description of the calibration procedure; and (2) The date of the calibration, a description of the source used and the certified exposure ratea from the source, and the rates indicated by the instrument being calibrated, the correction lactors deduced from the calibration data, and the signature of the individual who performed the calibration.
35.xx4 Records of dosimetry equipment ct.librations.
Each licensee shall maintain records of the calibrations, intercomparisons, and comparisons of its dosimetry equipment that are required under 35.030 and retain each record for the duration of the license. For each calibration, intercomparison, or comparison, the record muet 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 f actor that was determined from the calibration or comparison or the apparent correction f actor 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.xx5 Records of Radiation Safety Committee meetings.
Each licensee shall maintain records of each Radiation Safety Committee meeting that is required under 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:
(iii) Summary of deliberations and discussions 35.xx6 Records of statements of authority and responsibility.
Each licensee shall maintain records of the statements 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.xx7 Records of training.
o STAFF LEVEL DRAFT DOCUMENT 25 August 7,1997 Each licensee shall maintain records of training that are required under 35 HDR3 and 35.610 and retain each record for five years af ter it is made. The record must include names of :
the personnel receiving instruction, a description of the instruction, the date of instruction, the name of the individual who gave the instruction, written and practical examinations, and refresher safety and emergency training.
35.xx8 Records of minor radiation safety program changes.
Each licensee shall maintain records of minor changes made 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.xx9 Records of quality management program.
(a) Each licensee shall maintain records of the medical administration procedure reviews 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 af ter 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 f acts and what corrective action, if any, was taken, in an auditable form for 5 years after it is made.
(c) Each licensee shall maintain written 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.x10 Records of saaled source leak tests and inventories.
(a) Each licensee shall maintain records of leak test results for sealed sources and retain each record for 5 years af ter 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, and the date of 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 af ter 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, and the location of each source.
35.x11 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 4
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STAFF LEVEL DMAFT DOCUMENT 26 August 7,1997 survey, a plan of each area that was surveyed, the measured dosi tate at several points in each area expressed in millirem per hour, and the survey instrument used, r
(b) Each licensee shall maintain a record of the radiation measurements made following installation of a source that are required by 35.641 and 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 manuf acturer's name, model number and serial number of the high dose rate remote afterloader unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the high dose rate remote af terloader 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 millirem per hour, and the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area.
(c) Each licensee shall maintain a record of each patient and high dose rate remote afterloader unit survey required undar 35.404 and retain each record for 5 years after it is made. Each record must include the date of the survey, the name of the patient or the human research subject, the dose rate from the patient or the human research subject and the remote af terloading device expressed as millirem per hour and measured at 1 meter from the patient or the human research subject and at 10 centimeters from the surface of the unit safe, the survey instrument used, and the initials of the individual who made the survey.
35.x12 Records of decay in storage disposals.
Each licensee shall maintain a record of each disposal permitted under 35.92 and retain each record for 6 years af ter 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, 3e dose rate measured at the surf ace of each waste container, and the name of the individual who performed the disposal.
35.x12ecords of maintenance and repair.
Each licensee shall maintain a record of each maintenance, adjustment, or repair of the high dose rate remote af terloader or source that are required or allowed under 35.605 and retain each record for the duration of the use of the high dose rate remote afterloader unit.
The record must include the date of the maintenance, adjustment or repair, the manuf acturer's name, model number and serial number, a description of and the results of the maintenance, adjustment or repair, and the signature of the individual performing the maintenance, adjustment, or repair.
35.x14 Records of radiation monitor checks.
Each licensee shall maintain records of the radiation monitor checks that are required under 35.615(d) and retain each record for 5 years after it is made. The record must include the date of the check, a notation that the monitor indicates when its detector is and is not exposed, and the initials of the individual who performed the check, 35.x1tiRecords of high dose rate remote afterloader calibrations.
. . ~
STAFF LEVEL DRAFT DOCUMENT 27 August 7,1997 Each licensee shall maintain records of calibration measurements of high dose rate remote afterloader units that are required under 35.637 and retain each record for the duration of use of each high dose rate remote af terloader unit source. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for both the high dose rate remote afterloader unit and the source, the model numbers and serial numbers of the instruments used to calibrate the high dose rate remote afterloader unit, an assessment of timer I;nearity and constancy, the calculated on off error, and the signature of the high dose rate remote afterloader medical physicist.
35.x10 Records of high dose rate remote afterloader checks.
Each licensee shall maintain records of each check required by 35.634 6,d retain each recor t for 5 years af ter it is made. The record must include the date of the check, the manuf acturer's name, model number, and serial number for both the high dose rate remote af terloader unit and source, an assessment of timer linearity and constancy, the calculated on off error, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electricalinterlock, each beam condition indicator light, the viewing systern and doors, and the signature of the individual who performed the periodic check.
35.x17 Records of safety checks following source replacement and facility changes.
Each licensee shall maintain records of facility safety checks required under 35.636 and retain each record for 5 years following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each beam condition indicator light, the viewing system, and doors.
Section 35.5 Maintenance of records.
Each record required by this part must be legible throughout the retention porlod 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 period. The record may also be stored in electronic media with the capability for producing ledi ble, 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.
Natifications of incidents Section 35.33 Notification of incidents, reports, and records of reportable medical events.
(e) for a rapertablc racica avena
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STAFF LEVEL DRAFT DOCUMENT 28 August 7,1997 1
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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 20505, describing the equipment involved, the test results, and the action taken.
Violations Section 35.990 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 11 of the Energy Reorganization Act of 1974, as amended; 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
. STAFF LEVEL DRAFT DOCUMENT - 29 August 7,1997 under section 234 of the Atomic Energy Act:
(1) For violations of-(I) Sections 53, 57, 62, 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 >ch 'ns specified in paragraph (b)(1)(l) of this section.
(2) For any violation for which a license may be revoked under section abd of the Atomic Energy .Act of 1954, as emended.
Section J5.991 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 N3, all the regulations in part 35 are issued under one or more of sections 161b,161i, cr 161o, except for the sections liste6 in paragraph (b) of thic section.
(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: Sec,lons 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.
1 e
a
o STAFF LEVEL DRAFT DOCUMENT 30 August 7,1997 Summary of Areas Discussed in AAPM Task Group Reports to Facilitate Review REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35,2: Section V,B: Section 2.3:
Prescribed Dose Range of Doses Several
& Written Additional Directive Requirements 35.2: Section IV.D.5:
Reportable NRC Misadmini-Medical Event stration definition meaningless 35.620(a): Type Appendix C: Section 4.5.6:
of Survey Scale not Scale 0.1 to instrument Specified 1000 mR/hr 35.620(b):
Cahbration of Survey Instrument 35.630: Section V.A 3 Table Vil & IV:
Dosimetry Frequency: Frequency:
Equipment initial ADCL Initial and with 2 year annual inter-linearity comparison with ADCL every two years 35,HDR2: Section V.C Section 5.1 Emergency Equipment 35.HDR3(a): Section 3.3 Training of includes (a)
Operators (iv) & (v) 35.HDR3(b): Section 3.3 Training of includes Physicists and (b)(ii)
Authorized Users
l STAFF LEVEL DRAFT DOCUMENT 31 August 7,1997 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.HDR3(c): Section 4.5.6 Refresher includes Training emergency refresher 35.HDR3(d): Section V.G Caretaker Training 35.59(b): Section VI.D Table 11 & lll Sealed Source includes (c)(1) &
Leak Test (c)(3) 35.59(g): Table 11 & Ill Quarterly Inventory 35.59(h): Table VI: survey Quarteny of device Survey of quarterly Sealed Source Storage Area 35.605:
Maintenance anci Repair 35.610(a)(1): Section IV.B Section 4.5.7 Security 35.610(a)(2):
Ensure Only Patient in Treatment Room 35.610(a)(3): Section IV.B &
Prevent Dual Section VI.B Operation of Radiation Producing Devices ,
35.610(a)(4): Section V.C Section 5.2 Emergency Procedures
e STAFF LEVEL DRAFT DOCUMENT 32 August 7,1997 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.610(b): Section 3.3 Operator Instruction 35.615 (a): Section Ill.C Control Access to HDR Room 35.615 (b): Section Ill.C Door Interlock 35.615(c): Section Ill.C Beam Condition Indicator Light 35.615(d): Section Ill.C (In Appendix C (Area Permanent room instead of Monitor)
Radiation permanent)
Monitor 35.615(d)(2): Section Ill.C Backup Power Supply for Monitor 35.615(d)(3): Section VI.B Table V Appendix, Daily Check of Section 1 Monitor 35.615(d)(5):
Ur.e of Survey Instrument if Monitor Inoperable 35.615(d)(6):
Prompt Repair
/ Replacement of Monitor if inoperable 35.615(e): Section lil,C Viewing and Intercom Systen
l .o I
STAFF LEVEL DRAFT DOCUMENT 33 August 7,1997 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.615(f):
Decoupled or Jammed Source 35.615(g): Section 4,5.6 Authorized User (physicist &
and Physicist individual Presence qualified to remove applicators) 35.632(a): Section V.C Section Vll.B Table VI Frequency of Soure exchange Monthly or Quarterly or Full or quarterly quarterly source exchange Calibration 35.632(b)(1): Section V.C Table V: spot- Appendix, Output Within Frequency: check daily Section 1:
, + /- 5 % source exchange Table VI- spot check or quarterly and Frequency: daily within + / 3% source exchange and quarterly Section ll.A.4:
+/3%
35.632(b)(2): Section V.C Section Vll.B Table V: spot- Appendix, Timer Constanc) Frequency: check daily Section 1:
& Linearity source exchange Table VI- spot-check or quarterly Frequency: daily source exchange and quarterly Section ll.A.3:
+ /- 2% for accuracy 35.632(b)(3): Section V.C Section VI.A Table Vil-On-off Error Frequency: Section Vll.B Frequency:
sourc.* exchange annually or quarterly i
l
(
STAFF LEVEL DRAFT DOCUMENT 34 August 7,1997 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.632(b)(4): Section V.C Section VI.C Table V. Appendix, Source Frequency: Section Vll.B Frequency: daily Section 1 Positioning weekly Table Vl- Frequency:
Accuracy Within Frequency: daily
+ / 1 millimeter source exhange and quarterly Cection ll.A.2:
+ / 2 mm 35.632(b)(5): Section V.C Section VI.C Table VI Appendix, Source Guide Frequency: Section Vil,B Frequency: Section 1 Tubes & source exchange quarterly and Frequency:
Connectors or quarterly source exchange daily 35.632(b)(6): Section VI.A Table VI. Appendix, Source Retract Section Vll.B Frequency: Section 1 with Battery quarterly and Frequency:
Backup source exchange daily Table Vil-Frequency:
annually 35.632(b)(7): e . : tion V. A.2 Tables I, ll, Source Frequency; and ill Homogeneity Initially Frequency:
Initially 35.632(c):
Use of Dosimetry System Described in 35.630(a) .
35.632(d): Section Vill.D Section 111.B.2 Full Calibration as Described in TG#41 35.632(e): Table V Appendix, Corrections for Frequency: daily Section 1 Physical Decay Frequency:
daily
STAFF LEVEL DRAFT DOCUMENT 35 August 7,1997 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.632(f): Section VI.B.2 Full Calibration Measurements and Decay Corrections Performed by Physicist 35.634(a)(1): Section V.C Section VI.B Table V Appendix, Daily Interlock Section 1 Check 35.634(a)(2): Section V.C Section VI.B Table V Appendix, Daily Beam Section 1 Condition Indicator Light Checks 35.634(a)(3): Section V.C Section VI.B Table V Appendix, Daily Viewing & Section 1 Intercom Systerr Check 35.634(a)(4): Section V.C Tchle V Daily HDR Treatment Room Door Checks 35.634(a)(5):
Daily Door Checks with HD i Electrical Power Off 35.634(a)(6):- Section VI.C Table V Appendix, Daily Checks of Section 1 Source Position Indicators
, o.
STAFF LEVEL DRAFT DOCUMENT 36 August 7,1997 -
REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.634(a)(7): Section V.A 4 Section VI.C Table VI- Appendix,
., Daily Checks of Frequency:
Frequency: Section 1 Applicators & Initially quarterly and Connectors soure exchange Tables 11 & lil-applicator dimensions initially and annually 35.634(b):
Prompt Repair 5
of System not Operating Properly 35.634(o):
Restriction of
. Use if Door Interlock Malfunctioning 35.636: Safety Table VI after Checks after source Source replacement Replacement or Table Vil after Facility Change f acility change 35.641: Table VI Radiation Frequency:
Surveys of quarterly and at Facility source exchange for device and at source exchange for .
facility 35.404: Section 4.5.7 Patiant Release includes Surveys patient and
, room but not device
STAFF LEVEL DRAFT DOCUMENT 37 August 7,1957 REGULATION AAPM TG#40 AAPM TG#41 AAPM TG#56 AAPM TG#59 35.940: Section 3.2 Training for Authorized User 35.961: Appendix A Section 3.2 Training for includes (a)(1)
Medical and (b) ,
Pnysicist Note: severalitems recommended by AAPM reports are not included la the regulations. Also TG#56 and TG#59 are draft documents.
.