ML20205K490

Forwards Copy of Briefing Book for Meeting of ACMUI on 990324-25.Briefing Book Has Been Submitted to PDR

ML20205K490
Person / Time
Issue date:	04/10/1999
From:	Roe M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NACMUI, NUDOCS 9904130245
Download: ML20205K490 (158)

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T April 10,1999 N,

MEMORANDUM TO:

Document Control De FROM:

Mary Louise Roe

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Rulemaking and Guidance Branco Division of Industrial and Medical Nuclear Safety, NMSS

SUBJECT:

BRIEFING BOOK FOR THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES MEETING MARCH 24-15,1999 I am submitting a copy of the briefing book for the meeting of the Advisory Committee on the Medical Uses of Isotopes on March 24-15,1999. Please place the briefing book into NUDOCS. The document is a public document. The briefing book has been submitted to the Public Document Room.

Contact:

Mary Louise Roe 415-7809 II

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r BRIEFING BOOK Advisory Committee on the Medical Uses ofIsotopes i

March 24 - 25,1999 l

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c ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES MARCH 24-25,1999 l

US NUCLEAR REGULATORY COMMISSION TWO WHITE FLINT NORTH PU:LDING AUDITORIUM AGENDA March 24,1999 8:00 a.m. - 9:00 a.m.

Ethics Briefing (clo::ed session) 9:00 a.m. - 9:15 a.m.

Opening Remarks - Dr. Donald Cool, Director, Division o" Industrial and Medical Nuclear Safety Overview and Status of the Rulemaking - Cathy Haney, Chairman. Part 35 Working Group 9:15 a.m. - 10:15 a.m.

Training and Experience Requirements - Cathy Haney

,Q 10:15 a.m. - 10:30 a.m.

BREAK 10:30 a.m. - 11:15 a.m.

Subpart A, General information - Marjorie Rothschild 11:15 a.m. - 12:00 p.m.

Subpart B, General Administrative Requirements - Diane Flack 12:00 p.m. - 1:00 p.m.

LUNCH 1:00 p.m. - 1:45 p.m.

Subpart C, Ceneral Technical Requirements - Tony Tse 1:45 p.m. - 2:15 p.m Subpart D, Unsealed Byproduct Material, Written Directive Not Required - Sam Jones 2:15 p.m. - 2:45 p.m.

Subpart E, Unsealed Byproduct Material, Written Directive Required - Sam Jones 2:45 p.m. - 3:00 p.m.

BREAK 3:00 p.m. - 4:00 p.m.

Subpart F, Manual Brachytherapy - Penny Lanzisera 4:00 p.m. - 5:00 p.m.

Subpart H, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units -

Penny Lanzisera l

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I March 25,1999 8:00 a.m. - 8:30 a.m.

Issues Associated with Prostate implant Therapy - Materials Safety Branch 8:30 a.m. - 9:00 a.m.

Subpart K, Emerging Technology - Diane Flack 9:00 a.m. - 10:00 a.m.

Subpart M: Reports - Diane hack 10:00 a.m. - 10:15 a.m.

BREAK 10:15 a.m. - 12:00 p.m.

Preparation for Commission Briefing *

• NOTE: The ACMUI Briefing of the Commission is from 2:30- 4 p.m. in the Commission's Hearing Room.

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l UNITED STATES NUCLEAR REGULATORY COMMISSION CHARTER FOR THE ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (Pursuant to Section 9 of Public Law 92-463) 1.

Advisory Committee on the Medical Uses of isotopes:

(Committee's Official Designation) 2.

Committee's objectives. scope of activities and duties are as follows:

The Committee provides advice, as requested by the Director, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, on policy and technical issues that arise in regulating the medical use of byproduct material for diagnosis and therapy. The appointed Chairman of the Committee will conduct all meetings and will prepare minutes summarizing the deliberations of each meeting. The minutes willinclude the Committee's recommendations for future actions. Subcommittees may be convened to address specific problems when it is not necessary for the full Committee to be present.

3.

Time period (duration of this Committee):

From April 4,1998, to April 4,2000 O

Official to whom this Committee reports:

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4 Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555

_A_,oency responsible for providina necessary support to this Committee:

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U.S. Nuclear Regulatory Commission 6.

The duties of the Committee are set forth in item 2 above.

7.

Estimated annual direct cost of this Committee:

a. $160,466.00 (includes travel, per diem, and compensation)

b. Total staff-year of support: 1.3 FTE 8.

Estimated number cf meetinas per year:

Three meetings per year except when ' active rulemaking is conducted, then five meetings per year.

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The Committee's termination date. if less than two years, from the date of 9.

establishment of renewal:

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April 4,2000 l

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Filina date:

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w Andrew L. Bates Advisory Committee Management Officer Office of the Secretary of the Commission l

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l 10334 Fed:ral Regist:r/Vol. 64. No. 41/ Wednesday. March 3.1999/ Notices 1

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docketed under to CFR Part 72. Docket Conduct of the Meeting STATE DEPARTMENT Og 72-1026. The exemption request and judith Stitt. M.D., will chair the (Public Notice s2990)

(v) the non-proprietary version of the CoC meeting. Dr. Stitt will conduct the applicatinn are rvailable for pubhc meeting in a mannrr that will facilitate Overseas Presence Advisory Panel nt$oom, 21 0 the orderly conduct of business. The (OPAP) Meeting; Closed Meeting l

D u t t Washington. DC 20555.

full Wins procedures apply to public The Department of State announces a Dated at RockviMe. Ntaryland. this 1Hth day er n h i

o pr vide a b ch 9.

"E 3or P el n T esd of February.1999 written 8tatement should submit a for the Nuclear Regulatory Comminion reproducible copv to Marv Louise Roe at M am at tk M mpanment E. William Brach.

(address listed previousiv'). by March f State. The panel is charged with

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• Director. Spent Fuel Pyect oriire. Offwe of 19.1999 Statements must pe'rtain to the Nuclear Marenal Safety and Safeguardt topics on the agenela for the meeting.

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on r u ed erseas in the (FR Doc. 99-5199 Filed 3-2-99: 8 45 aml Electrome submissions may be sent t s u ocooenw.ow mir1@nrc. gov.

face of new foreign policy priorities. a heightened security situation and i

2. Questions from members of the extremely limited resources. Pursuant to fneeting at t e disIt t o 8'C*

tt e A(

NUCLEAR REGULATORY o he d

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o COMMISSION Chairman.

it has been determined the meeting will be closed to the public. The agenda calls Advisory Committee on the Medical com ts wil ea la fo i r the discussion of classified and Uses of isotopes: Meeting Notice inspection. and copying, for a fee. at the sensitive mf rmation relative to NRC Public Document Room. 2120 L intelligence and operational policies of AGENCY: U.S. Nuclear Regulrory Street. NW, Lower Level Washington, aH % M hrnment ages at Commission.

DC 20003-1527, telephone (202) 634-Embassies and Consulates the ACT ON: Notice of meetirig.

3273, on or about April 19,1999.

Defhe Department regrets the shortartme Minutes of the meetit g wul be available

SUMMARY

The U.S. Nuclear Regulatory on or about May 18.1999.

notice due to the urgency of the issues Commission will convene a meeting of

4. Seating for the pubhc will be on a and coordination of multiple schedules.

the Advisory Committee on the Medical first come. first-served basis.

For more information contact Peter Uses ofIsotopes on March 24-25,1999.

This meeting will be held in Petribos. Overseas Presence Advisory

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accordance with the A.omic Energy Act Panel, Department of Siate. Washington.

( j\\ The meeting will take place at the address provided below. Topics of of 1954, as amended (primarily Section DC 20520; phone: 202-647-6477.

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discussion willinclude revisions to 161a); the Federal Advisory Committee Dated: February 25.1999.

proposed to CFR Part 35,

• Medical Use Act (5 U.S.C. App); and the of Byproduct Material"; analysis of Commission's regulations in Title 10, Ambassador William H. Itoh.

comments on the draft rule text that U.S. Code of Fedemi Begulations. Part 7.

Executive Secretary. Overseas Presence were received during the public Dated: February 25.1999 comment period; and issues associcted Andrew L. Bates, with prostate implant therapy. All Advisory Committee Managernent Officer.

sessions of the meeting will be open t (FR Doc. 99-5197 Filed 3-2-99; 8:45 ami suocmew w s on, wh2 h sb n s t as de DEPARTMENT OF TRANSPORTATION provide required Annual Ethics Training for committee members. This Omce d tM Secreary session will be closed to discuss DEPARTMENT OF STATE Reports, Forms and Recordkeeping information, the release of which would Requirements, Agencyinformation constitute a clearly unwarranted (Public Notice No: 2984]

Collection Activity Under OMB Review invaston of personal pnvacy.

AGENCY: Office of the Secretary, DOT.

DATES: The March 24,1999, meeting Advisory Committee on Historical ACTION: Notice and request Ior will be held from 9:00 a.m. to 5:00 p.m.

Diplomatic Documentation; Notice of to accommodate Annual Ethics Training Meeting comments.

for members from 8:00 to 9:00 a.m. The Reissue Public Notice Number 2971.

SUMMARY

In compliance with the March 25.1999, meeting will be held 54 FR 7938 (published February 17 Paperwork Reduction Act of 1995 (44 from 8:00 a.m. to 12:00 p.m.

1999) w th a new location s Public U.S.C. 3501 et seq.). this notice ADDRESSES:U.S. Nuclear Regulatory Notice No. 2984, announces that the Information Commission.Two White Flint North The Advisory Committee on Collection (ICR) abstracted below has Auditorium,11545 Rockville Pike, Historical Diplomatic Documentation been forwarded to the Office of Rockville, MD 20852-2738.

will meet in the State A1.nex-1.

Management and Budget (OMB) for Mrence Room L315. at 2401 E Street review and comment. The ICR describes l

FOR FURTHER INFORMATION, CONTACT:

NW, %'ashington, D.C.

the nature of the mformation collection Mary Louise Roe, U.S. Nuclear and its expected burden. The Federal O Regulatory Commission, Office of Dated: February 22,1999' Register Notice with a 60-day comment Nuclear Material Safety and Safeguards.

Willi"" Z Sl'"y>

period soliciting comments on the MS T9F31, Washington. DC 20555, Executive Secretary.

following collection ofinformation was Telephone (301) 415-7809, e-mail IFR Doc. 99-5256 Fiied 3-2-99; 8-45 ami published on December 7,1998,(63 FR mlr1@nrc. gov, an.uMo CooE ms-u 67504).

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UNITED STATES

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NUCLEAR REGULATORY COMMISSION j

2 WASHINGTON, D.C. 20655 4001 g,.....,/

4 MEMORANDUM TO:

Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:

Judith Anne Stitt, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes

SUBJECT:

CERTIFICATION OF THE MfNUTES OF THE MARCH 1-2,1998, MEETING OF THE ADVISORY COMM11 TEE ON THE MEDICAL USES OF ISOTOPES I hereby certify that, to the best of my knowledge and belief, the attached minutes for the meeting of the Advisory Committee on the Medical Uses of isotopes (ACMUI) held on i

March 1-2,1998, are an accurate record of the proceedings for that meeting.

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Judith Anfie Stitt, M.D., Chairman

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Date

Attachment:

Minutes - ACMUI mtg.

March 1-2,1998 O

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SUMMARY

MINUTES ADVISORY COMMITTEE ON THE MEDIC.$L USES OF ISOTOPES I

MARCH 1-2,1998 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on March 1-2,1998. A briefing book with background information for the issues under discussion l

was provided to the ACMUI members in advance of the meeting, and is available through the l

Public Document Room.

ACMUI members present at the meeting:

Judith Ann Stitt, M.D., Chairman Naomi Alazraki, M.D. (Appointment pending)

Daniel F. Flynn, M.D.

John Graham Andrew Kang, M.D.

William B. Nelp, M.D.

Dennis P. Swanson, M.S., B.C.N.P.

Louis K. Wagner, Ph.D.

Theresa Walkup, C.M.D.

Jeffrey F. Williamson, Ph.D.

Invited guests: Manuel Cerqueira, M.D. representing cardit.,gy perspectives; Ruth McBumey, representing State and local govemment perspectives; Robert Zoon, representing the perspective of radiation safety cor'cems from a radiation safety office of a large institution; Dolly

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Durham, representing patients' rights and care perspectives.

Also present were staff members from the Nucl ear Regulatory Commission: Carl J. Paperiello, Director, Office of Nuclear Material Safety and Safeguards (NMSS) and Cathy Haney,'

Chairman of the Part 35 Working Group, Section Leader in the Rulemaking and Guidance Branch, NMSS (Designated Federal Official for the Committee).

Ms. Cathy Haney officially opened the meeting at 8:00 a.m. with general comments on the meeting and the function of the ACMUI. Ms. Haney stated that she had reviewed the Committee members' financial and employment interests, and had not identified any conflict of interest with items to be considered during the meeting. Ms. Haney stated that any ACMUI member who becomes aware of a potential conflict of interest during the course of the meeting should so inform her or Chairman Stitt.

Carl J. Paperiello, Ph.D. welcomed the ACMUI members. Dr. Paperiello discussed the Commission's directive to revise Part 35 to incorporate a more risk informed, performance based appror 3 to the regulation of radiation for medical use. Dr. Paperiello went on to state that a number of topics had generated a lot of comments, (e.g., training and experience, precKsor events, and patient notification). Dr. Paperiello ended his remarks with his thanks to the ACMUI members for meeting on Sunday with the NRC staff.

PREVIOUS ACMUI RECOMMENDATIONS h,O Ms. Haney gave a brief cverview of staff actions regarc'ing the recommendations made by the ACMUI at the April and September 1997 aeetings.

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Or' April 1997 Staff actions on the recommendations from the April 1997 meeting were discussed with the Committee at the September meeting. Only one recommendation had not been resolved at that time. In particular, ACMbl requested that the staff re-examine the quality management inspection procedures. Ms. Haney indicated that the quality management inspection procedures would be reviewed pending completion of the Part 35 rulemaking efforts.

Sootember 1997

1. 1979 Medical Policy Statement (MPS)

The ACMUI made specific recommendations regarding how the MPS should be revised.

Ms. Haney indicated that the ACMUl's recommended changes to the MPS were presented and

. discussed at the facilitated public meetings.

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11l Quality Management Program (QMP)

. The ACMUI recommended that NRC delete the requirements for a stand alone QMP; an audit program; retention of records of recordable events; and submittal of QMPs. They recommended that NRC retain requirements for a written directive and a record of administrations and that NRC clarify rule text associated with revising written directives. Finally, they recommended O

minor modifications to the proposed attemative rule text. Ms. Haney explained that the Working Group deleted the requirement for a stand alone QMP but, maintained requirements in the strawman rule that was placed on the INTERNET on January 30,1998, (hereafter referred to as strawman rule) for written directives, records of administration, and audits.

Ill. Radiation Safety Committee (RSC)

The ACMUI recommended that RSCs be required for medical institutions, with the exception of institutions using only diagnostic low dose sealed and unsealed byproduct material. Ms. Haney indicated that the Working Group proposed deletion of the requirement for a RSC. This was i

done to give the licensees more flexibility in program management.

IV. Authorized User Training and Experience Requirements The ACMUI recommended that the rule require authorized users to be board certified or to complete a specified number of hours of training, focusing on radiation safety, and pass an examination that verifies competency in radiation safety. The ACMUI agreed that the boards would not be listed by name in the rule. The staff incorporated this approach into the strawman rule.

V. Medical Physicist Training and Experience Requirements l-L The ACMUI recommended that the training and experience requirements for a medical physicist

- be pattemed after the requirements for an authorized user, with one exception. The medical 1

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i physicist should not be required to be a physician but, should be required to have a Master's of Science degree. This approach was incorporated into the strawman rule.

VI. Reportable / Recordable Events

1.. Medical Events The ACMul recommended the current criteria for radiopharmaceutical misadministrations be rrduced from three categories to two: a) radiopharmaceuticals not requiring a written directive; and b) radiopharmaceuticals requiring a written directive. Ms. Haney explained that the requirements for reporting medical events were modified to require a dose threshold and modality specific requirements for reporting.

2. Precursor Events The ACMUl believed that the reporting of precursor events should be voluntary. Ms. Haney indicated that the Workir.g Group considered the suggestion but, believed that a reporting requirement was needed to best capture precursor events.

Vll. Patient Notification The ACMUl did not support any regulation requiring notification of physicians and pstients.

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Ms. Haney indicated that the staff planned to request guidance from the Commission in this area.

STATUS OF PART 35 Ms. Haney provided a brief description of the Part 35 Project. She indicated that two facilitated public meetings were held, one in Philadelphia, PA, and one in Chicago, IL. In addition, a workshop was conducted at the All-Agreement States meeting in October 1997. The staff also met with several professional organizations during this time period. Comments received during these meetings were discussed by the Working Group and, where appropriate, incorporated into the strawman rule. Ms. Haney indicated that the Working Group met with two ACMUI subcommittees during Februsry 1997. At these meetings, the Working Group and subcommittee members suggested revisions to the strawman rule text. Following the subcommittee meetings, the Working Group discussed the suggestions received during the subcommittee meeting and, where appropriate, redsed the strawman rule. These revisions are reflected in the February 23,1998, version of the rule that was provided to the ACMUI in the briefing book. [This version of the rule will be referred to as the " draft proposed rule" within the text of these minutes.]

Ms. Haney explained future rulemaking actions. She indicated that the proposed rule and associated guidance would be puolished in the Federal Reaister, during the summer, for a 75-day cornment period. During the comment period, the Working Group plans to hold two facilitated public meetings, one on the west coast and one in the midwest. Ms. Haney stated

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that the final rule is on schedule for submittal to the Commission in May 1999.

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if Mr. Swanson expressed his concem that guidance documents may become de facto regulation if licensees are required, by their Scenses, to comply with the documents. Various members of the ACMUI shared Mr. Swanson's concem. They offered examples, from their own experiences, of a procedure in a guidance document being imposed as a requirement. The i

procedure had been included in the ' tie-down' condition of the license. Dr. Flynn stated that regional inspectors will sometimes use the regulatory guidance as though it were the regulation.

1 Dr. Paperiello requested that the ACMUI help staff revise the guidance documents and the proposed rule to prevent this from happening in the future.

MEDICAL POLICY STATEMENT (MPS)

Ms. Haney described the purpose of the MPS. She indicated that a draft proposed MPS was ~

placed on the INTERNET on January 30,1998, and discussed at the February 1997, ACMUI subcommittee meetings. She indicated that the proposed revision would be forwarded to the Commission in May. Staff would request Commission approval to publish it in the Federal Reaister for a 75-day comment period. She indicated that the Commission Paper forwarding the MPS to the Commission would reference ACMUI recorc.mendations.

Chairman Stitt requested comments on the proposed revision to the MPS that was included in the briefing book (Attachment 1). Mr. Graham highlighted items from previous discussions on the MPS. In particular, he drew attention to the following key areas: intrusion into medical judgments affecting patients and regulation only where there is a clear risk to the patient.

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Mr. Graham reminded the AOMUI that the word, "only" was debated, at length, and finally V

agreed to, because it reinforced the idea that a risk-based threshold must be crossed prior to establishing a regulation. The ACMUI members restated their belief that the NRC's role is to provide for the radiation safety of workers, the general public, and patients.

Chairman Stitt questioned the origin of the phrase " physician's prescription" as it appeared in the proposed MPS. ".,nairman Stitt commented that a physician's prescription is different from a written directive. Ms. Haney indicated that this phrase was used in Altemative 4 for the MPS that was discussed at the facilitated public meetings. She believed that this phrase was used to express that NRC would regulate the radiation safety of patients to assure that the use of radionuclides in medicine was in accordance with the physician's directions.

The ACMUI discussed the difference between a " medical issue" and a " radiation safety issue. "

Dr. Wagner stated that the MPS should reflect the answer to the following question: 'What radiation safety aspects of the patient does the NRC wish to regulate?" He also stated that the first three modified statements, as proposed by the ACMUI in September 1997, adequately addressed his concems.

ACMUI members discussed the various levels of risk associated with the medical use of radiation as opposed to the levels of risk involved in non-radioactive medical procedures. Dr.

Paperiello discussed society's perception of the risks associated with radiation and how the NRC must respond to that perception in its regulations. He indicated that the revision of Part 35 must address this perception yet, respond to the medical community's concem regarding overly

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prescriptive regulations.

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Chairman Stitt requested that the ACMUI reach consensus in a revised MPS.

Mr. Graham moved that the committee recommend the adoption cf the following MPS:

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The NRC will continue to regulate the use of radionuclides in medicine as necessary 3 provide for the radiation safety of workers and the general public.

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The NRC will not intrude in the medical judgments affecting patients except as necessary to provide for the radiation safety of worker in the general public.

3.

NRC will regulate the radiation safety of patients only where justified by the risk to the patients and only where voluntary standards or compliance with these standards are inadequate.

4.

The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.

The motion was seconded. Dr. Wagner offered an amendment to include the second sentence from the recommendation made at the September 1997, ACMUI meeting into Statement 3

(" Assessment of the risks justifying such regulations will reference comparable risks and comparable voluntary standards and modes of regulation for other types of medical practice.").

A motion was made and seconded to discuss Dr. Wagner's amendment. Further discussion ensued among the members. Chairman Stitt called for a vote on the amendment and a vote on the motion. The vote for the amendment passed 9-0 in favor. Chairman Stitt then called the vote for the motion (reference following text). The motion passed 9-0 in favor..

[ Note, the following text differs from the motion made by Mr. Graham. In conversations between Chairman Stitt and Ms. Haney, following the ACMUI meeting, it became evident that the ACMUI did not intend to include Statement 4 because the concept ha 1 been incorporated into Statement 3. Statement 4 was deleted.)

I ACMUI Recommended MPS:

1.

The NRC will continue to regulate the use of radionuclides in medicine as necessary tc, provide for the radiation safety of workers and the general public.

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The NRC will not intrude in the medical judgements affecting patients except as necessary to provide for the radiation safety of workers in the general public.

3.

The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable voluntary standards and modes of regulation for other types of medical practice.

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TRAINING AND EXPERIENCE Ms. Haney introduced the topic of training and experience by providing the ACMUI with a brief synopsis of the training and experience criteria for authorized users, authorized nuclear pharmacists, medical physicists and radiation safety officers as it appeared in the draft proposed rule (Attachment 2). Ms. Haney indicated that, on the basis of the public input, the Working Group was proposing the following general criteria for these individuals: individuals should complete a structured educational program that consists of didactic training and practical experience; reference to speciality boards, by name, should be deleted; preceptors, when required, should cenify that individuals have achieved a level of competency sufficient to j

function independently; and individuals should demonstrate sufficient knowledge in radiation safety by passing an examination given by an organization or entity approved by the Commission or an Agreement State. She also indicated that the term " structured educational program" replaced the phrase " classroom and laboratory training," as used in the strawman rule.

Section 35.400. "Use of sources for manual brachyth'eraov." and 635.600. "Use of sealed sources in a device for thera'>eutic medical uses" Ms. Haney indicated that there were several individuals present in the audience, who had expressed a desire to formally present their views on the training and experience requirements in Part 35, to the ACMUI. The presenters were: 1) Peter Blitzer, M.D., President-elect of the g

American College of Radiation Oncology; 2) William Bloomer, M.D., Chairman of the Public V")

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Policy and Law Committee of the American College of Radiation Oncology, tenured professor of radiology at the Northwestem University Medical School, and Director of Radiation Oncology and Nuclear Medicine at Evanston Northwestem Health Care in Illinois; 3) Omar Salazar, M.D.,

Chairman of the Board of Chancellors of the American College of Radiation Oncology, Director of Radiation Therapy for the Louisiana State University Medical Center and consultant for the International Atomic Energy Agency of the United Nations; 4) James Marks, M.D., a practicing radiation oncologist from St. Louis; 5) Frank Wilson, Professor and Chairman of Radiation Oncology at the Medical College of Wisconsin; 6) Larry Holder, M.D., a practicing nuclear medicine physician and Director of Nuclear Medicine at the University of Maryland; 7) Jack Baskin, M.D., President of the American Association of Clinical Endocrinologists. Each read their statements into the record. A question and answer session between the presenters ard the ACMUI members followed the formal presentations.

The ACMUI members debated the various issues surrounding the training requirements. The discussion focused on whether it was possible, or prudent, to separate the hours required for radiation safety training from clinical training. In addition, the issue of practitioners of non-radiological specialties becoming authorized users was discussed at length. Chairman Stitt suggested that the ACMUI try to come to a consensus on those training and experience issues that were important to the ACMUI.

Dr. Williamson proposed a motion to retain, as is, the training and experience for $$ 35.400 and 35.600 (e.g., retain the 3-year clinical training experience in an accredited program as an jl attemative to board certification). It was believed that radiation safety handling experience could

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not be separated from clinical experience and that current requirements are needed to provide 6

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assurance that authorized users have adequate training and experience to handle material l

safely. Chairman Stitt, after some additional discussion, called for a vote. Mr. Graham offered an amendment to the motion to retain the requirement from the strawman rule for a written exam to verify competency The motion was seconded. Chairman Stitt called for a vote on the amendment and the motion. The amendment carried 9-0 in favor. The motion carried 9-0 in l

favc Section 35.100. "Use of unseated bvoroduct material for uptake. dilution. and excretion studies" Section 35.200. "Use of unsealed bvoroduct material for imaaina and localization studies for which a written oirective is not reauired." and Section 35.300. "Use of unsealed bvoroduct j

material for therapeutic administratioj)"

j Chairman Stitt directed the discussion to the training and experience requirements for authorized users of byproduct material used pursuant to @S 35.100,35.200 and 35.300. The members debated the issues of relative risk levels for these uses. In particular, they focused on 5 35.300, because it aJdresses the use of radionuclides for therapy. This use poses greater risk than diagnostic use of radionuclides (99 35.100 and 35.200). Dr. Alazraki commented that she thought the use of iodine-131 for therapy should require the same training and experience as materiallisted.n $35.400 and 35.600, since the radiation risks are similar. Dr. Flynn stated j

he thought that radionuclides with the potsatial for bone marrow suppression should be treated the same as those radionuclides used pursuant to @ 35.400 and 35.600.

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Mr. Graham : mposed a motion to accept the training and experience criteria for users of l

materialin @@ 35.100,35. 200 and 35. 300 as detailed in the draft proposed rule. The motion

's was seconded. The members continued their discussion of risks associated with therapeutic uses of radionuclides. Dr. Flynn emphasized the importance of proper training and experience when administering therapeutic quantities of radionuclides. Chairman Stitt commented that she did not believe that the discussions were heading in a direction where the ACMUI would reach a resolution, therefore, she called for a vote. Mr. Graham suggested that there be separate votes on training and experience requirements for each of the rule sections. Mr. Graham withdrew his original motion and put forth the following one: ".. the ACMUI is recommending the acceptance of strawman language or training for S 35.100." Dr. Nelp seconded. The motion passed 9-0 in favor.

Mr. Graham moved that: ".

the ACMUI recommend the strawman language regarding training for S 35.200." Dr. Netp seconded. The motion passed 9 - 0 in favor.

Mr. Graham moved that:

the ACMUI recorr, mend acceptance of the strawman language for training related to @ 35.300." The motion was defeated 5 opposed,4 in favor.

The subject of training and experience for authorized users of byproduct material used pursuant to @S 35.100,35.200, and 35.300 was discussed again on March 2,1998. For continuity, that l

discussion is summarized here.

Chairman Stitt asked Dr. Alazraki if she would summarize the professional societies' views on training and experience for authorized users as presented in letters to the Commission staff A)

(copies provided in Attachment 3). Dr. Alazraki summarized the comments received from three (v

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i Y[h professional societies: American College of Nuclear Physicians (ACNP)l A ierican College of

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Raduiogy (ACR), and Society of Nuclear Medicine (SNM). Key points noted by Dr. Alazraki are l

outlined below:

l ACNP L

The ACNP made the foHowing resolution: "Be it resolved that the American College of Nuclear Physicians encourages the Nuclear Regulatory Commission to maintain the six months,1,200 hour-rule for NRC licensure for use of radioactive materials in humans. And be it further resolved that the American College of Nuclear Physicians supports the rendering of such training in the future only in ACGME-accredited (Accreditation Council for Graduate Medical Education) or equivalent programs."

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The ACR made the following recommendations:

1.

Physicians certified by the American Board of Radiology (ABR) or the American Board of Nuclear Medicine (ABNM) should be licensed without additional educational or examination requ:rements.

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Physicians who are not certified by ABR or ABNM should be required to meet C

specific training and experience requirements and to pass an exam. ACR k

recommends that the exam be established and conducted by a private sector i

organization with extensive experience in such matters, (e.g., ACR, ABNM, ABR or a consortium of those groups.)

3.

Preliminary safety and isotope handling, field experience and education should be required prior to the exam.' The training and experience should be no less than 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of classroom laboratory training and 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> of supervised practical experience or a 3-month training program in nuclear medicine. This field experience should be obtained only in an ACGME-approved training program in an ACGME-l approved medicalinstitution. Entrepreneurial weekend courses should not be permitted as substitutes.

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Physicians, including those who are certified by ABNM or ABR, should be required to I

document at least 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> of nuclear medicine CME (Continuing Medical Education) credits each year.

S.NM The SNM made the following recommendations: The SNM recommends that physicians be board certified by ABNM or ABR. They believed that an equivalent educational and training component has to be described for those physicians who are not certified. The SNM suggests that competence in nuclear science be demonstrated in a performance based manner. The SNM does not believe a number of hours can be associated with this education. They agree that an exam should be used to assess competence in nuclear science.

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Dr. Alazraki went on to state that the ACMUI should consider adopting the ACR recommendations for training and experience criteria for authorized users. In a further discussion, Dr. Cerqueira stated that he strongly believes, the training and experience criteria for authorized users in these sections, as described in the draft proposed rule, should be supported. Dr. Flynn stated his disagreement in terms of the training and experience criteria for authorizad users of byproduct material used pursuant to 9 35.300. The members discussed the issue without providing any additional recommendations. Chairman Stitt concluded the discussion by saying that there will be additional opportunities for comment on the training and experience criteria during the rulemaking process.

Nuclear Pharmacist Trainino Mr. Swanson stated he had polled the nuclear pharmacy community as to what they believed was an appropriate number of hours for training and experience for an authorized nuclear pharmacist. The consensus was to maintdn the training and experience requirements in the current rule [700 hours in a structured educational program). These requirements recognized that nuclear pharmacy is a pharmacy speciality practice. Mr. Swanson moved that the training and experience criteria, for authorized nuclear pharmacists, as presented in the draft proposed rule, be accepted. The motion passed 9-0 in favor.

Medical Physicists There was little discussion in this area. Dr. Williamson moved that the training and experience criteria for a medical physicist, as presented in the draft proposed rule, be accepted. The V

motion was seconded by Dr. Nelp. The motion passed 9-0 in favor.

[There was no discussion of this topic.)

Radiation Safety Officer (RSO) Trainino Chairman Stitt called for a motion and/or a discussion regarding RSO training. Mr. Graham moved that the RSO training and experience cdteria, as presented in the draft proposed rule, be accepted. Mr. Swanson seconded the motion. Mr. Zoon informed the members that he had I

attended a Health Physics Society meeting on this issue. He stated that the Society is very concemed about the strawman rule language, and cited the proposed requirement for an exam.

The ACMUI discussed whether an authotized user should automatically qualify as a R30.

Ms. Haney explained that an authorized user would only be accepted as a RSO, if his/her j

training was commensurate with the types of uses listed on the license. Mr. Swanson requested confirmation that an individual's credentials would be examined by the NRC or Agreement State, prior to being listed on the license. Ms. Haney confirmed this. Chairman Stitt called for a vote to accept the training and experience requirements as presented in the draft proposed rule for the RSO. The motion carried 9-0 in favor.

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Nuclear Cardioloov Trainino Ms. Haney requested ACMUI's recommendation for training and experience requirements for cardiologists who wish to use intravascular brachytherapy sources. Dr. Cerqueira indicated that i

most procedures are be'ing performed with strontium-90 or iridium-192.

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He also described the current training curriculum for cardioLJ sts that plan to practice i

interventional cardiology. This program includes a 6-year training program with an additional l

year of specialized training in interventional cardiology focusing on the use of the intravascular brachytherapy sources. Dr. Cerqueira stated that this type of therapy would be done at select medical centers, using a team approach. The cardiologist would work in conjunction with a

. medical physicist and an RSO. The members discussed the r 'ropriateness of having other medical specialists on the team to support the cardiologist, in peticular, at least a medical j

physicist and a radiation oncologist. Drs. Flynn and Williamson stated that these individuals should be present for this type of therapy. Additional discussion took place regarding the relative risks involved with this therapy, The ACMUI did not offer any specific recommendations for training and experience requirements.

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NOTIFICATION FOLLOWING A MEDICAL EVENT L

Ms. Haney explained that the draft proposed rule language contains the current reporting (notification) requirements (reference current 9 35.33). Ms. Haney informed the ACMUl that the h

staff plans to request guidance from the Commission on who should be notified following a

, V, medical event. She indicated that the Working Group had identified three attematives:

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Retain current reporting requirements as listed in 6 35.33; 1.

2. Revise the current reporting requirement to require a licensee to inform only NRC and the referring physician (but not tha patient) of the medical event; and

3. Revise the current report;ng requirement,to require a licensee to inform only NRC of a medical event.

Chairman Stitt clarified that the issue under discussion should be.sh_p the licensee must inform of a medical event. The question is not whether notification takes place, since the notification is the standards of practice, but whether there is a Federal requirement for a patient or referring physician to be notified of a medical event. The discussion continued, covering various issues, such as whether or not the NRC had a ethical obligation to assure that patients have been notified of a medical event.

Chairman Stitt proposed that the ACMUI make a motion to affirm the recommendation from the September 1997 ACMUI meeting. [In September 1997, the ACMUI made the following b

recommendation: "The Committee does not support any regulation requiring notification of physicians and patients as this is redundant to existing state laws and medical ethics in existence or words.") A motion to support the previous recommendation was made and seconded. After some additional discussion, the motion was voted on and carried 8 in favor, 1 abstention.

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V REPORTABLE EVENTS Medical Events Ms. Haney reviewed the draft proposed rule language and asked for comments. The members discussed the rule language [in 35.3045), but did not offer any formal recommendations. One member suggested that staff make it clear in the rule that a medical event is an avoidable technical error, it was also suggested that NRC clarify that the 50 rem threshold, stated in the draft proposed rule, applies only in the case where an unintended dose to an organ exceeds the anticipated dose by 50 rem. Finally, it was suggested that NRC consider a separate dose threshold for wrong treatment site.

1 Sionificant Precursors Ms. Haney presented slides of the three attematives for capturing precursor events (Attachment 4). Ms. Haney explained that the objective for capturing precursor events, was to identify conditions or incidents that have implications at a facility which could affect cther licensees. She then summarized each attemative. She indicated that the first alternative was used in the draft proposed rule. She stated tnat it was patterned after the U.S. Food & Drug Administration's regulations that address reporting of medical devices. She also indicated that Alternative 2 could be used to identify hardware or software failures that could have caused a medical event at the licensee's facility, or deficiencies in equipment or procedures supplied by a

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b manufacturer or vendor, that could lead to a medical event at that facility or have outside V

implications. Alternative 3 evolved from discussion at the last ACMUI meeting, where the ACMUI stated that a reporting requirement is not needed in th3 regulations and that the NRC should rely on voluntary reporting. Ms. Haney indicated that the Working Group discussed voluntary reporting, but did not believe that all needed information would be reported.

Ms. Haney requested recommendations from the ACMUI in this area.

Most members favored Altemative 2, with modifications. Mr, Graham moved that the ACMUI recommend the adoption of Altemative 3 and the second portion of Altemative 2:

Deficiency in equipment (hardware and/or software), byproduct material, or procedure supplied by a manufacturer or vendor that, in the op:nion of the licensee, could lead to a medical event at that facility or has impi cations for facilities outside of the licensees' facility (operating prr are).

Dr. Wagner seconded the motion. The motion carried 8-0,1 abstention. Dr. Nelp abstained, commenting that he did not believe it was appropriate for the NRC to require reporting of precursor events.

RADIATION SAFETY COMMITTEE Ms. Haney indicated that the Working Group had discussed the need for an RSC at the various public meetings. The Working Group considered the public input and believes that it is not

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necessary to require a licensee to have an RSC. After reviewing the list of duties that were

()4 assigned to an RSC, it was determined that some of the duties were already addressed in 11

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10 CFR Part 20. Duties that were not addressed in other rules were incorporated into the proposed 35.24, " Authority and responsibilities for the radiation protection program."

The members discussed the merits of having an RSC; many of the members believed that large institutions would still retain an RSC in spite of the rule change. Mr. Graham stated that in his opinion, the proposed rule would not prohibit a large organization from continuing to use RSCs and would benefit the small rural hospitals where an RSC is not needed. Dr. Cerqueira stated that the proposed rule would allow smaller facilities to operate under the direction of an RSO and still allow the larger institutions to have an RSC.

Mr. Swanson moved that the ACMUl accept the wording in 9 35.24, as written, with one change

- the word " licensee" should be replaced with the phrase " licensee's management." The motion was seconded. Mr. Graham stated that the only place where this change should take place is in 6 35.24(c). The word " licensee" is appropriate for paragraphs (d), (e) and (f). The motion was carried 9-0 in favor.

STRONTIUM-90 (Sr-90) EYE APPLICATOR CAllBRATION Robert Ayres, an NRC staff member, discussed the number of misadministrations that have been taking place due to improperly calibrated Sr-90 eye applicators. Dr. Ayres reminded the ACMUI that this issue had been brought to their attention during a meeting in November 1993.

At that time, the ACMUI recommended that the NRC issue in an Information Notice (IN), alerting lV{.

the users to these problems and cautioning them about the technique used to perform calibrations. An IN was issued on March 11,1994. Subsequently, the NRC received notification of additional misadministrations involving these devices. Another IN was issued reminding the licensees that a QMP would require that a licensee ensure that the prescribed dose equals the administered dose. The NRC is still receiving reports of misadministrations from Sr-90 eye applicators which, m some cases, resulted in significant overdoses to the patients. Dr. Ayres introduced Dr. Cliis Soares from the National Institute of Standards and Technology (NIST) to discuss calibration of Sr-90 eye applicators.

Dr. Soares began his presentation with a short history of Sr-90 eye applicator calibration and reported that NIST had established a process for calibrating these devices in 1976. He indicated that this benchmark was adequate for about a decade, then a serious discrepancy between the activity that NIST was measur;ng for the eye applicator and the activity that Amersham was reporting for one of their eye applicators was noted. NIST investigated this discrepancy and then worked towards revising its calibration program. Dr. Soares stated that the University of Wisconsin is starting a calibration service and there is an effort to establish national standards as well as international comparisons.

. Dr. Soares continued his presentation with a detailed description of the calibration procedures used at NIST. Dr. Soares went on to discus the non-uniformity problems associated with these sources, which causes the calibratic,6 aifficulties. He described a proposal to cull the sources which have extreme irregularities on their surfaces. This could be done by having all sources in use calibrated by NIST or the University of Wisconsin. Dr. Soares completed his presentation p/

and retumed the floor to Dr. Ayres. Dr. Ayres informed the members that the full text of Dr.

t Soares' recommendations was in their briefing books.

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fR U) i Dr. Ayres displayed a slide containing several options to address this issue. The members of ACMUI discussed the options. Dr. Williamson made a motion that the ACMUI members recommend Option Number 3: Issue an IN recommending that all Sr-90 eye applicators be recalibrated to present standards. The motion was seconded.

After some further discussion, Dr. Swanson suggested the adoption of Option 3 and Option 5, which involved issuing an IN that dscussed the importance of decaying the sources. Further discussion resulted in Dr. Williamson amending his motion. The amendment recommended the adoption of Options 3 and 5. The motion passed with 9-0 in favor.

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QUALITY MANAGEMENT PROGRAM i

Ms. Haney stated that the Commission had directed the staff to reevaluate and revise the QMP requirements (current @ 35.32, " Quality Management Program") to focus on those requirements that are essential for patient safety, e.g., confirming patient identity, requiring written prescriptions, and verifying dose. The Working Group developed rule language which addressed these three items (reference draft proposed rule 35.40 " Written directives" and 35.41 " Procedures for administrations requiring a written directive").

Dr. Williamson suggested that the proposed S 35.40(b)(6) be changed to include the words p)

"high dose-rate" which would change $ 35.40(b)(6) to read: "6) For all hiah dose-rate gb brachytherapy." Dr. Williamson also commented that the provision to prepare a written directive, in writing, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of a given directive, was too restrictive and suggested that the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> be changed to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />. Ms. Haney acknowledged Dr. Williamson's suggestion.

The issue of what parameters should be listed in a stereotactic radiosurgery written directive

($ 35.40) was discussed. Dr. Williamson stated that the requirements in the draft proposed rule were too prescriptive. Ms. Haney stated that the Working Group will contact AAPM for input as to what should be included in the requirement for the gamma stereotactic radiosurgery written directive. Chairman Stitt agreed with this approach. She believed that there should be consistency between modalities.

Mr. Swanson commented on Footnote 1 to the proposed @ 35.40 that references " patient record." Mr. Swanson stated that he wasn't sure what constituted a " patient's record" as it could refer to a number of different things. He suggested that the words " patient's record" be deleted from wherever it currently appears in Footnote 1. Ms. Haney said she would look into the reasons that " patient's record" was included in the current rule and would determine if the words were still required.

Ms. Haney asked ACMUI members to list the requirements that they believed should be included in S 35.41. Dr. Williamson indic.ated that the proposed rule should contain a requirement for verifying treatment time calculations and for verifying that programming parameters are consistent with the written prescriptions, treatment time calculations, and/or

[,sT plans of treatment.

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d Dr. Williamson stated that important elements, for providing high confidence that the prescription is implemented as written, should be listed in S 35.41, in general terms instead of making a de facto requirement in the regulatory guide. Ms. Haney responded that the Working Group had discussed this, and had determined that S 35.41 should be revised to list the minimum requirements for a program that would provide high confidence that the prescription was implemented as written.

DISCUSSION OF STAFF REQUIREMENT MEMORANDUM (SRM)

Torre Taylor, an NRC staff member, presented the contents of two Staff Requirement Memorandi issued by the Commission. The first SRM, dated June 5,1997, and addressed to Chairman Stitt, requested that the ACMUI take a focused look at the provisions of Part 35 as the NRC moves towards a more risk-informed, performance-based regulatory program. The SRM requested consideration and response to a number of specific questions. The response to the Commission is due May 1998.

Ms. Taylor discussed each question in tum and asked for a response from the members of ACMUI. The members discussed various responses and Chairman Stitt suggested that if the members sent her their comments, she would coordinate the comments and send a response, in bullet point form, to Ms. Haney. Dr. Neip made a motion to support Chairman Stitt's suggestion. Mr. Graham expressed a concern with Dr. Nelp's motion. Mr. Graham recommended that Dr. Stitt prepare a statement indicating that the Committee has been focusing their efforts on the revision of Part 35 and a written response to each question was not V)

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needed. Dr. Nelp withdrew his motion.

v Mr. Graham moved that the ACMUI respond by stating that the questions posed in the SRM had been considered by the ACMUI prior to making recommendations on the revision to Part 35 to staff. The motion carried,9-0, in favor.

The second SRM, (COMSECY-96-028), requested that all advisory committees to the NRC develop self-evaluation criteria, under which the advisory committee would be reviewed periodical!y, and a report made to the Commission. The NRC staff drafted four specific criteria.

for the ACMUI's consideration. Mr. Swanson stated that he thought the staff should decide what value ACMUI provided to the NRC and then determine if that is reflected in these four items (Attachment 5). Ms. Haney indicated that the staff believed the criteria adequately assessed the value of the ACMUI. The ACMUl then discussed the four items and offered suggestions for revising the criteria. Chairman Stitt asked the staff to incorporate the ACMUI suggestions and prepare a final draft for the ACMUI to review. Ms. Haney said that she would revise the criteria and present it to the ACMUI on March 2,1998. On the following day [Ma m. 2), seven elements for. self-evaluation were presented to the ACMUI for their review and discussion (Attachment 6).

Dr. Nelp motioned that the ACMUI approve the set of criteria. The motion was seconded by Mr.

Swanson. The motion carried,9-0 in favor.

VACANT POSITIONS ON THE ACMUI r~N Dr. Williamson announced his resignation from the ACMUI. He indicated that he planned to go

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on sabbatical to a Swedish University. In his capacity as an ACMUI member, he is considered 14

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'-)~ '1 a "special govemment employee" therefore, he cannot accept any financial compensation from foreign public universities.

Ms. Haney described the procedures for filling vacancies on the ACMUI as well as the reappointment procedures. Ms. Haney also discussed the Commission directive (SRM-SECY-97-143) to consider the appointment of an individual, to the ACMUI with the perspective of a RSO from a large institution. Ms. Haney asked the members views on appointing an RSO to the ACMUI. Ms. McBumey stated that she thought it very appropriate for an RSO to be added to the ACMUI. Mr. Graham moved that the ACMUI recommend the addition of an RSO to the j

committee. Dr. Nelp seconded the motion. The motion passed 9-0 in favor.

Dr. Wagner recommended that the process to fill a vacancy be started at least 18 months ahead of the anticipated vacancy. This should be done so the vacancy we,u!d be filled immediately. He stated this would avoid the ne'.:essity of having non-voting members sitting on the Committee.

Dr. Wagner moved that the ACMUI recommend that the Federal Reaister Notice be published in time to have replacements for the next individuals to rotate off the ACMUl. [ NOTE: Mr. Flynn and Dr. Williamson in 1998, Chairman Stitt, Dr. Nelp and Mr. Swenson in 1999.] Mr. Graham seconded the motion. The motion passes 9-0 in favor.

General Discursion on Rule Text

,q A general discussion was held on specific sections of the draft proposed rule language.

M yl Members of the ACMUI provided the Working Group with suggestions for revisions to the specific sections of the rule. In addition, the Working Group asked the ACMUI specific questions on certain rule parameters. (NOTE: The Sections were not discussed in numerical order.]

Section 35.2. " Definitions" Dr. Williamson commented that the definitions for high and low dose-rate remote afterloaders were not correct. He believed they should be defined as 20 rads per minute, not 20 rads per hour for high dose-rate remote afterloaders. Low dose should be defined as 200 centigrey per hour. Chairman Stitt suggested that Ms. Haney assign a team to work on the definitions for high and low dose-rate remote afterloader Ms. Haney asked if the member., preferred one version over another. Dr. Williamson stated that he could accept 1,200 centigrey per hour as a reasonable rule of thumb for high dose-rate and 200 centigrey per hour or less for low

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dose-rate.

1 Mr. Zoon commented that SI units should be used in the rule. Ms. Haney stated tha't the proposed rule would contain the appropriate units.

Section 35.62. " Possession. use. calibration. and check of instruments to measure dosaaes of aloha-or beta-emittina radionuclides" l

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Ms. Haney asked if the members knew of a NIST-traceable beta calibration source.

l Dr. Williamson said that there are really three separate issues when discussing calibration.

3.

What to do about sources where no primary standard exists at all?

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What to do about beta sources where no primary standard exists anywhere, either in the U.S. or anywhere?

5.

What to do about the lack of a national standard for photon-emitting sources such as palladium-1037 Dr. Williamson suggested that the rule could read: 'Where there exists an appropriate primary standard, then the user's calibration technique should be traceable to that." He also stated that for photon-emitting sources, AAPM guidance suggests that, at a minimum, a constancy check be developed to assure that the vendor's calibration does not drift from the calibration factor used by the licensee.

Section 35.67. "A,uthorization for calibration and reference sources" Ms. Haney explained that the Working Group is considering raising the possession limit for calibration sources to give the licensees more flexibility. The Group does not, however, want to put the licensee in a position where they would be required to have financial assurance.

Ms. Haney asked the ACMUI if the possession limits listed in the draft proposed rule addressed licensee needs. The members had a brief discussion of this issue but no resolution was reached.

Section 35.292. "Trainina for imaaina and localization studies"

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Ms. Haney requested the ACMUl's opinion on whether the authorized user should have experience with preparing reagent kits. Dr. Wagner commented that he did not believe it was necessary.

Section 35.400. "Use of sources for manual brachytheraov" and Section 35.600. "Use of a sealed source in a device for theraoeutic medical uses" Ms. Haney explained that the Working Group removed any references to specific radionuclides for specific modes of treatment (interstitial, intracavitary, etc.) from these sections. Ms. Haney asked if this would have an adverse impact on the industry. Dr. Wiiiismson stated that he thought this was a good change. It would eliminate probleme, of public access to new brachytherapy products as they come on the market and are approved by FDA.

Section 35.315. " Safety crecautions" Mr. Swanson asked why the rule contained a requirement that would permit individuals visiting patients or human research subjects, that are not released pursuant to S 35.75, to receive a dose of 0.5 rem (6 35.315(a)(4)). Ms. Haney stated that this section was written to address the University of Cincinnati petition that would allow visitors of inpatients to receive a dose of up to 500 millirem. The Working Group believes that this issue may be addressed by the proposed l

revision to $ 20.1301 and planned to review this section in detail after the ACMUI meeting.

Ms. Haney asked, if the requirement were to remain in 6 35.315, should a licensee be required O

to instruct the visitors in ALARA procedures, and whether the individual should be required to

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consent to the increased exposure. Drs. Wagner, Williamson, and Flynn stated their opinion 16 l

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that there should not be a requirement to instruct visitors and that they did not believe this was an informed consent issue.

Section 35.404. " Radiation surveys" Ms. Haney indicated that the Working Group had deleted the requirement ir the current S 35.404(b) which stated that "a licensee may not release from confinement for medical care a patient or a human research subject treated by temporary imp l ant until all sources have been removed." The Working Group believed that this requirement was unnecessary in light of the provisions in 69 20.1301 and 35.75. Drs. Williamson and Flynn believed that this change would

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reduce burden on licensees since this class of patients would not have to be confined in the hospital when their medical condition did not warrant hospitalization.

Section 35.406. "Brachytheraov sources inventory" Mr. Swanson directed the members' attention to S 35.406 and commented that he thought Paragraph (b) was very prescriptive and unnecessary. Ms. Haney explained that the staff thought it was important to assure that, once the brachytherapy sources were removed, the sources were returned to storage. Chairman Stitt commented that the draft proposed rule allows for flexibility but still provides for source accountability.

Section 35.415. " Safety precautions"

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Mr. Zoon suggested a change to the rule language that requires the RSO to be notified in the D

event of a patient's death, instead of specifically requiring that the RSO be notified, Mr. Zoon suggested that the rule require "that in the event of the patient's death, the licensee shall assure that appropriate precautions are taken in the aftermath of the death of a patient."

i Dr. Flynn commented that he agreed with Mr. Zoon. He stated that he believed that the authorized user should be notified in addition to the RSO. Ms. Haney agreed to review the suggestions with the Working Group.

Section 35 432. " Full calibration measurement of brachvtheraov sources" Ms. Haney discussed the addition of a requirement for calibrating manual brachytherapy sources. She asked the members how this would impact licensees and how many licensees would be affected by this change. Dr. Williamson said that there should be two requirements, one that addresses long-lived sources and a second that addresses short-lived sources. The output for each long-lived source should be determined once. Since short-lived sources are often procured in batches, he believed the output could be determined by measuring a representative sample rather than each source. He indicated that it would take approximately 30 or 40 minutes to determine the output on a batch sample. He estimated the cost to be between $1,500 and $5,000. Dr. Williamson thougFt that if Paragraph (d) is interpreted correctly the licensee could comply with AAPM standards for verifying seed output based on a representative sample.

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if Section 35.657. "Theraov-related computer systems" Ms. Haney asked Dr. Williamson how he would comply with the requirements in the proposed S 35.657. This section requires that a licensee assure that the computerized operating system and treatment planning system associated with the therapy device are operating appropriately, it also requires acceptance testing on treatment planning syste:ns. Dr. Williamson commented that the word " assure" should be replaced with " verify". Dr. Williamson stated: ". by doing some tests you can, at most, confirm the operation of a system under certain laboratory circumstances. You cannot guarantee, no matter how much quality assurance you do, that it'll function perfectly under all circumstances." Dr. Flynn indicated that it is extremely important to perform these tests since errors or malfunctions in these systems could result in hundreds of medical events prior to the discovery of a problem.

Section 35.615. " Safety crecautions for remote afterloaders teletheraov units. and aamma stereotactic radiosurcery units" Ms. Haney asked that the ACMUI focus on the requirements in the proposed @ 35.615. In particular, who should be present during remote afterloader and gamma stereotactic radiosurgery procedures. Dr. Flynn stated that the authorized user should be physically present for procedures that only take a couple of minutos. Dr. Williamson commented that it is excessively prescriptive, for low dose-rate aftenoaders, to require both the authorized user and physician to be present at initiation of treatment. Ms. Haney proposed that the rule contain

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requirements specific to each type of treatment. The following criteria were suggested by the

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ACMUl:

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For LDR, a physicist and an authorized user should be on-call.

2.

For HDR, a physicist and physician, designated by the authorized user, to remove the applicators on an emergent basis, should be physically present.

3.

For PDR, an authorized user and physicist should be present to initiate treatment, and an individual, trained to execute emergency procedures should be on-site during the whole treatment.

i Section 35.605. " Installation. maintenance. and repair" i

Ms. Haney asked the members if it was appropriate to allow the authorized medical physicists, l

or a person under the direct supervision of an authorized medical physicist, to maintain, adjust, j

or repair low dose-rate remote afterloaders. Dr. Williamson suggested that the rule should allow

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for manual manipulation of sources by individuals under the guidance of a medical physicist.

Ms. Haney suggested the language: ".. except for low dose which are going to be under the I

direction of a medical physicist." Members believed the suggested language was adequate.

Apoendix A to 10 CFR 35 "Examinina Oraanization or Entity" i

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V Mr. Swanson commented on Appendix A, specifically, items 5 and 7. He said that item 5 and the last clause of item 7, which reads: "and any sanctions imposed against examined individuals," should be deleted. Ms. Haney agreed to delete the last clause of item 7 and to revise the language iri Item 5 to read: ".. have a committee whose members could carry out their responsibilities impartially to review complaints by examined individuais."

Mr. Swanson stated that the wording in Appendix A. Section Ill, is too prescriptive. He indicated that exams can take different form and it is not appropriate to limit exams to a multiple choice format. Chairman Stitt and Dr. Wagner concurred with Mr. Swanson's assessment.

Section 35.60. " Possession. use. calibration. and check of instruments to measure the activity of choton-emittino radionuclides" and Section 35.62. " Possession. use. calibration. and check of instruments to measure dosaaes of aloha-or beta-emittina radionuclides" Mr. Swanson suggested that the Working Group contact dose calibrator manufacturers to identify the quality control tests that should be routinely performed. Dr. Wagner stated that it is important to determine what the instrument is being used to assay prior to establishing testing criteria. He indicated that there would be different criteria for each type of use.

Dr. Wagner wanted to confirm that a licensee did not have to assay unit doses and that a licensee could determine the dosage for a unit dose by mathematically decaying the activity provided by the manufacturer or preparer licensed pursuant to S 32.72. Ms. Haney confirmed m[d T

this fact. She added that, if the licensee chooses to perform a corroborating assay, the dose calibrator used must be calibrated in accordance with 9 35.60.

v General Dr. Flynn asked if draft NUREG 1556, " Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Medical Use Licenses," would address emergency response procedures associated with brachytherapy treatments. He commented that a draft NRC guidance document, he had seen in past years, contained guidance that should be incorporated into NUREG-1556. Dr. Flynn indicated that the NUREG should contain some policies and procedures detailing what steps should be taken by medical personnel to manage a medical emergency to minimize radiation exposure to the staff and other personnel. These procedures should be sufficiently detailed to provide information, on sia handling of radiation, to personnel, such as nurses and technicians. He cautioned that the information should be provided in a manner that would not result in personnel refusing to care for the patient because of undue fear of radiation. Dr. Flynn stated that, in his experience, nurses have received just enough training to scare them but not enough training for them to be able to integrate nursing care with good radiation safety practices. Ms. Haney stated that she will look for the material that Dr. Flynn described and incorporate these items into the NUREG.

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The meeting was adjoumed at 4:14pm on March 2,1998.

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ATTACHMENTS O

Draft recommendations for revision of NRC's 1979 Medical Policy Statement for regulating the medical uses of radioisotopes.

MEDICAL POLICY STATEMENT

1. The NRC will conGute to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public.

2. The NRC will not intrude into medicaljudgments affecting patients except as necessary to provide for the radiation safety of workers and the general public.

3. NRC will, where justified by the risk to the patients, regulate the radiation safety of patients to assute that the physician's prescription is correctly delivered.

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4. The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.

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ATTACHMENT 3 4

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Febmary 27,1998 I

Cathy Haney Chairperson, Part 35 Working Group Mail Stop T8FS U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 l

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? or Ms. Haney:

The American ' ollege of Radiology has followed with interest the current NRC C

re-evaluation of Part 35 CFR. We have testified in this regard at the IOM hearings and have maintained a continuous dialogue with NRC throughout this process. The ACR agrees that the revised Part 35 should be risk irformed and can be more specifically related to each modality.

Training and Experience The following comments focus on the training and experience requirements for each.

modality identified by the NRC. However, in keeping with the " risk informed" approach, we have classified the modalities into two general categories - higher-risk and lower-risk.

HIGHER-RISK MODALITIES brachytherapy sources, teletherapy, remote afterloaders

& gamma stereotactic radiosurgery -

The ACR believes that medical board certification requirements.under current i 35.940 are essential to the safe practice in the higher-risk modalities under Part 35 thct include both low-and high-dose rate brachytherapy, as well as teletherapy, remote afterloaders

)

and gamma stereotactic radiosurgery. In addition to basic training in radiation protection and source handling, safe therapeutic administration of applicator-confined radioactive i

material requires comprehensive training in the placement of applicators and sources, use l

of complex planning tools to accurately deliver treatment, and direction of developing of a safe treatment delivery program with a qualified medical physicist.

In short, the ACR firmly holds that the clinical training that is involved in a 3-year ACGME-approved training program and essential safety practices can not be separated to

['N adequately protect the safety of patients for these higher risk procedures. For a U

reasonable level of patient safety to be assured for these higher-risk modalities, the physician directing treatment.must also possess extensive clinical experience in appropriate patient selection, follow-up evaluations of the radiation's effects, AMERICAN COLLEGE OF RADIOLOGY

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(H and (most importantly) the effective management of side-effects and complications.

Moreover,in the event of a radiation emergency due to equipment failure or operational mishap, we believe that the proposed limind requirements would not adequately prepare the authorized user with the skills and knowledge necessary to limit any adverse impact.

The available data of the five years of misadministration reporting shows that such reportable events are rare and almost never lead to signifier.nt adverse consequences for the patient. The three-year supervised clinical experience requirements incorporated into radiation oncology residency programs has been the critical factor in assuring that these events are as close to zero as possible. Substantially relaxing the training and experience requirements for the higher-risk modalities by eliminating the three-year residency program will almost certainly lead to a significant rise in the number of and adverse complications resulting from misadministrations.

The higher risk procedures need to be reviewed not only for the efficacy of the procedure i

itself, but also for its acute and long term effects on normal tissue tolerance and possible carcinogenic effects on sensitive structures. Significant radiation doses may be delivered to other locations besides the vessel at risk, depending upon the source and the method chosen to deliver the radiation. Therapeutic radiation dc ses must be delivered to precise areas with precise margins. These decisions, which impact patient safety and control of

[

y the disease, require the broad training that is obtained in the three-year training program.

NJ The current requirements for these modalities ensure that authorized physicians have the appropriate skills to routinely make judgements that all safety and technical standards have been met prior to initiation of treatment. We believe that these criteria are imperative in assuring that the interests of the patient and other health care providers are well served.

LOWER-RISK MODALITIES Low-dose rate byproduct materials (diagnostic nuclear medicine)

Recent NRC regional meetings at which the revision of Part 35 has been discussed have created serious concerns among ACR members. These concerns relate to the proposed drastic reduction in training and experience requirements for the use oflow dose rate diagnostic radionuclides to 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> classroom / laboratory and only 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of supervised practical experience. The ACR convened its leaders in nuclear medicine and conducted a state-by-state poll of its representatives in nuclear medicine. In response to the advance draft proposal, we believe the following requirements offer a reasonable reduction in the training and experience for the lower-risk modalities, without detrimentall. ffecting patient safety and quality of care for these procedures:

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1. Physicians who are diplomates or in the future become diplomates of the i

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American Board of Radiology (ABR) or the American Board of Nuclear Medicine (ABNM) should be licensed to use diagnostic radionuclides without additional education or examination requirements.

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2. Physicians who are not diplomates of the ABR or ABNM should be required to meet specific training and experience requirements and to pass an examination before a license is granted. We recommend that the examination should be established and conducted by a private sector organization with extensive experience in such matters,(e'g., the ACR, ABNM or ABR or a consortium of such groups).

3. Preliminary safety and isotope handling field experience and educatior, should be required prior to the examination to qualify physicians who are not ABR or ABNM diplomates. This training and experience should be no less than 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of classroom / laboratory training and 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> of supervised practical experience, OR a three-month training program in nuclear medicine. This field experience and education should be obtained only in an ACGME-approved traiaing program in an ACGME-approved medical institution.

Entrepreneurial weekend courses should not be permitted as substitutes.

Approximately 70% of this preliminary training should be on the job experience to include the handling and control of radionuclides within a broad ranJe of radionuclide clinical applicaticns.

p

4. Any physician-including those who are diplomates of the ABNM or ABR -

y/j who wishes to continue to use diagnostic radionuclides in clinical practice should be required to document at least 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> of nuclear medicine CME v

credits each year.

The training and experience proposak given above are substantially below those currently required by the current D5.920. Thus, the reduction is consistent with the risk-informed position that the ACR ccatinues to take with respect to revision Part 35. The ACR believes that the standards pmposed are reasona' le.

o Substantially relaxing the supervised practical experience to 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> (i.e., one week) will greatly reduce the chances that a physician will experience sufficient atypical or adverse events to provide a meaningful experience. Sufficient time must be devoted to having working knowledge of what can go wrong and how it can be effectively managed.

A minimum of 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> of supervised practical experience will help ensure that the number of misadministations remains rare. Training and experience requirements lower than those proposed above will detrimentally affect the quality of nuclear medicine examinations and patient care. Inad3quate training and experience requirements for lower-risk diagnostic nuclear medicine procedures will also likely promote increased overutilization and self-referral abuses potentially leading to improper use of additional radiation exposures.

p T5 ACR believes that the requirements proposed above would be best developed, 4~')

a1 ministered and monitored by medical specialty organizations with experience in clinical applications of radiation-related technologies. The ACR's role in the implementation of regulations for the Mammography Quality Standards Act (MQSA),

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a cooperative public/ private partnership utilizing the strengths of both established accreditation / certification programs and the federal government enforcement authority, should serve as a model for such a process in nuclear medicine.

High-dose rate unsealed materials (nuclear medicine therapy)

Therapeutic nuclear medicine represents a higher risk use for patients and, therefore, the training and experience criteria to become an authorized user should be greater than those for diagnostic nuclear medicine. In addition to radiation nfety, the use of high-dose rate unsealed materials requires additional training and supervised work experience. We believe that funher classroom and laboratory training in radioisotope handling techniques for therapeutic radiopharmaceuticals is necessary to assure patient safety. For physicians not board cenified in nuclear medicine, radiology or radiation oncology, we recommend 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of combined training and experience in addition to the training and experience required for diagnostic nuclear medicine. The ohysician should document at least 10 cases involving thyroid function and treatment of hypenhyroidism or cardiac dysfunction, plus at least 10 cases involving the treatmert of thyroid carcinoma.

The ACR appreciates this opportunity to comment c n the program for revising the regulations goveming the uses of radionuclides in medicine. In addition to the training f ^'s and experience requirements, the College plans to submit funher comments on the other

,/

ponions of the proposed revisions to Part 35 in the near future. We look forward to the U

comments of the NRC and to an opponunity to continue our involvement in these imponant Pan 35 developments.

Sincerely, e6 Ja es. Potter Dir r, Federal Programs l

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SOC ETY O: N JC _ EAR M E J C N E 1850 Samuel Morse Driw Recton.\\ A. Av.L3 tin 03 a8.W 0.1 FA\\: 03 08A01; v

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February 27,1998 Cathy 4.ney Chair Medicine Section Working Group, NMSS One White Flint North Building 115555 Rockville Pike Rockville, MD 20852

Dear Ms. Haney:

On behalf of the Society ( f Nuclear Medicine, I would like to submit the following comments on Training and Experience and ask that you consider them when making revisions to Part 10 CFR

35. We are cunently working on additional comments and will be submitting them to you on a later date.

The SNM firmly believes that demonstrated competence in nuclear science should be the basis for education, training, and experience criteria in parts 35.290,292, and 390.

Authorized User Physicians direct the entire nuclear medicine program in medical licensees using unsealed by-product material. Radiation safety for the public, the workers, and the patient are all dependent on the actions of, and directions of the Authorized User Physician. However such a minimum is not sufficient for an Authorized User Physician. An Authorized User Physician demonstrating competence in nuclear science as described below ' vill be competent to

' direct the use of unsealed by-product materiat in both diagnostic and therapeutic settings.

The NRC should not define the criteria used to determine clinical competence in the diagnostic and therapeutic uses of radiopharmaceuticals, and believes that such clinical training and com'petence criteria are best defined by relevant medical specialty organizations, such as the ACGME approved training programs and the ABMS-sanctioned Certifying Boards. For example, t' e training criteria endorsed by the ACGME for nuclear medicine and nuclear a

radiology have been recognized for many years by NRC as indicators of clinical competence in the human use of radioactive materials.

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The SNM suggests that competence in nuclear science be demonstrated in a performance-based manner. The SNM does not believe that a number of hours can be associated with this education.

The SNM advocates that the NRC use the below areas as a standard for education in nuclear science and develop mechanisms that show mastery of such education. The subject matter in which competence must be demonstrated, and the mechanism for demonstration of competence is listed in 1,2,3, and 4 below.

1) Section (1) should be inserted here (in replace of the proposed 120 hour0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> md safe training)

The Training and Experience requirements identified in #1 above for an authorized user are intended to ensure that radioactive materials and radiopharmaceuticals are handled by the user in a safe and responsible manner with respe:t to issues of radiation safety.

Attainment cf or compliance with these train:ng requirements in the area of radiation safety should not be c( strued to represent adequate trainir 3 or clinical competence in the proper f

g3 diagnostic or therapeutic uses of radiopharmaceuticals.

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2) The following subject areas are critical to ensuring the safe use of radioactive material from a radiation safety perspective, regardless of the type of procedure. We believe that there should be a requirement for evidence of mastery of comprehensive nuclear and radiation sciences. This involves the understanding of the following: Radioactive decay and its calculation, radionuclide production, radionuclide detection instruments and their capabilities and calibration, radiation imaging devices and their capabilities and collimators, shielding, radiation protection and radionuclide handling and manipulation principles and techniques, internal dosimetry t

calculations, extemal dosimetry calculations, radionuclide generator operation and calculations, radiation biology, radiopharmacokinetic modeling, statistical analysis, and the application of basic nuclear and radiation sciences to all aspects of 10 CFR Part 20, radioactive waste disposal, l

and transportation requirements.

l

3) The SNM recommends that a component of the training and experience requirements contain a level of practical " hands on" training including handling, manipulation, detecting, and quantitating radioactive material in the setting of an ACGME-Accredited training program in nuclear medicine or graduate level courses in an accredited university.

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4) There are two mechanisms that the SSM suggests be used by the NRC to verify the above mentioned education in section (2). The first is through a comprehensive examination. given and graded by a third party. that clearly addresses all of these areas and can be used for verificatiorr of the education standard. In the scenario we are advancing to NRC. the second option recognizes that the certifying boards (currently. only ABNM and ABR test in FM) can potentially fulfill a dual role: (A) In the area of clinical training & competence, we aovocate that they (together with ACGME approved training programs) be acknowledged as principal standard setters. (B) In the area of radiation safety, their exams should be allowed deemed status (vis-a-vis an independent exam), provided that the exam content in the area of radiation safety meets NRC's definition of a serious testing standard. It is imponant that any examination, either through a third pany or one of the Boards, be created using the scientific thresholds listed in (2).

These above suggestions are meant to be considered as a substitute for the existing training and experience requirements in the strawman language. It is our intention to assist the NRC in developing an education standard that assures that low-risk diagnostic and therapeutic procedures are done in a safe manners by appropriate individuals. This material should be substituted for the existing lan:'uage in the training and experience sections of 10 CFR 35. 290,292. 390.

O For further infonnation on this topic please feel free to contact Mr. David Nichols, Director of

(,/

Government Relations at (703) 708-9773.

Sincerely

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H. William Strauss, MD President Society of Nuclear Medicine l

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7/0 AMERICAN COLLEGE OF NUCLEAR PHYSICIANS 4400 lenifer Street. N.W. e Suite 230

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the NRC staff on December 18,1937, to discuss the proposed revisions uo

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January 31,1998, both the ACNP House of Delegates and Board of Regents overwhelmingly passed.the following resolution:

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Nuclear Physicians supports the rendering of such training in the future

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of nuclear medicine is contingent on a cadre of practitioners well versed in both the theoretical and practical aspects o' handling (byproduct)

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and experience. We furthermore feel that the unprecedented safety u.41,*w.my uo

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record of our specialty is a consequence of meeting the historical standards of Paragraph 35.920, and as ^ result of this training and wa pw.on i experience, practitioners have the neousag expertise to practice with QUS7'"

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There are those who argue that the safety of our specialty is not the result of adhcring to the excellent standards outlined in. Paragraph 35.920, but that the risks associated with handling byproduct materialin oa'd c. '*=. e medicine are so small that the training and experience requirements can a- -

d be reduced to triviallevels. In my mind, that argument is akin to stating that commercial air transportation is so safe that airline pilot training and experience can be ~ dispensed with in large measure - an obviously specious argument.

Our College members are cognizant that the NRC is charged with ensuring safety of the public and the profession, and that clinical competence is not in its purview. However, we believe that competence and safety are inexorably intertwined. Patient and public safety cannot be served when competence is not present. The inappropriate use of a radiopharmaceutical contributes to patient (and thereby public) radiation dose in the same fashion that administration of the incorrect compound would. The American College of Nuclear Physicians end its members feel that the six months /1200 hour training and experience requirement should be extended to both diagnostic and therapeutic uses of by-product radioactive materials; the same safe handling and administration principles and practices apply to both -indeed, more vigilance is needed

/ith the higher dosages emphyed with therapy - and to mal <e A

requirements for therapy less than those for diagnosis is really not appropriate in our estimation.

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Finally, although as stated above issues of competence.are not legally a concern of the Nuclear Regulatory Commission, it must be realized that as a practical matter, a holder of an NRC license to administer byproduct radio-pharmaceuticals is generally deemed to be competent by virtue of such licensura by hospital credentiating committees, almost always composed of members unaware of the distinction between licensing for safety and certifying for competence, i

We are concerned that the proposed reduction to 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of the training and experience requirement might result in the credentialing of poorly trained individuals who cannot maintain the required safe practices; this is a scenario for a significant adverse event with all the attendant undesirable consequences.

For these reasons, we strongly urge the NRC staff and Commissioners to keep in place the six month /1200 hours training and experience requirement.

Very truly yours, f3 f

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Martin L. Nusynowitz, M.D.,FACNP President, American College of Nuclear Physicians

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PRECURSOR EVENTS ALTERNATIVE 1 - STRAWMAN Serious injury means an injury or illness that:

1.

Is life-threatening; 2.

Results in permanent impairment of a body function or permanent damage to body structure; or 3.

Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Sionificant orecursor means a condition or incident, except for a medical event, related to the use of radionuclides in medicine that caused or could cause serious injury to a patient, human research subject, worker, or the public.

ALTERNATIVE 2 - STRAWMAN Concept -

Report hardware or software failure that could have caused a medical event at the licensee's facility OP Deficiency in equipment or procedure supplied by a manufacturer or vendor that could lead to a medical event at that facility or has implications for facilities outside of the licensee's facility (operating procedure)

ALTERNATIVE 3 - STRAWMAN -

Rely on current NRC reporting requirements in 10 CFR Parts 20,21,30 (30.9 and 30.5), and 35; j

MOU with FDA: and monitor USP database.

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SUMMARY

OF ACMUI RECOMM5NDATIONS FROM MARCH 1-2,1998 MEs! TING I

1979 Medical Poliev Statement (MPS)

' By favorable vote of 9-0, the ACMUI recommended adoption of the following MPS:

1.

The NRC will continue to regulate the use of radionuclides in medicine as

- necessary to provide for the radiation safety of workers and the general public.

2.

The NRC will not intrude in the m~jical judgments affecting patients except as necessary to provide for the adiation safety of workers in the general public.

3.

The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with taese standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable voluntary l

standards and modes of regulation for other types of medical practice.

Trainina and Exoerience Reauirements D'

By a vote of 9-0 in favor, the ACMUI recommended:

1 Retention of the training and experience for $35.400, "Use of Sources for Manual Brachytherapy" and $35.600, "Use of a sealed source in a device for therapeutic medical uses" (i.e., retain the 3-year clinical training experience in an accredited program as an attemative to board certification) and a written exam to verify competency.

2.

Acceptance of the strawman language for training related to $35.100, "Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required," and $35.200, "Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required."

l 3.

Acceptance of the training and experience criteria for authorized nuclear i

pharmacists, medical physicists and radiation safety officers as presented in the draft proposed rule.

)

1 By a vote of 5 opposed,4 in favor, the ACMUI defeated a recommendation to accept the strawman language for training and experience related $35.300, "Use of unsealed byproduct material for which a written directive is required."

(

L..

v l

t.

Radiation Safety Committee

' By a vote of 9-0 in favor, the ACMUI recommended that 335.24 " Authority and Responsibilities for a Radiation Protection Program" be accepted as written in the draft (i.e., not contain a requirement for an institution to have a Radiation Safety Committee) with one mini-change: the ACMUI recommended that in paragraph 35.24(c) be revised to replace the word " licensee"

- with " licensee management."

Strontium-90 (Sr-90) Eve Applicators By a vote of 9-0 in favor, the ACMUI recommended that an Information Notice be issued that:

1.

Discusses the importance of decaying Sr-90 sources; and 2.

Recommends that all Sr-90 eye applicators be recalibrated to present standards.

SRM dated June S.1997 By a vote of 9-0 in favor, the ACMUI recommended that the ACMUI response to the SRM should indicate that the questions posed in the SRM had been considered by the ACMUI prior to making recommendations on the revision to Part 35 to staff.

SRM - COMSECY-96-028 By a vote of 9-0 h favor, the ACMUI recommended the acceptance of the set of sev' criteria to be used to perform an annual evaluation of the ACMUI. The seven items are:

1.

Does the staff and the ACMUI interact in such a manner as to satis' u:y address issues before the Committee?

2. - Do the Committee members clearly define issues for staff and provide timely, useful information to the staff when requested?

3.

Does the Committee provide critical rev'ev and oversight of issues?

4.

Does the Committee provide expertise / advice which is not available from within the agency? -

. 5.

Does the Committee meet frequently enough to address issues in a timely manner? Are any changes needed to the meeting frequency?

6.

Do Committee members bring issues from the medical community to the attention of the NRC staff? -

7.

Does the Cornmittee facilitate / foster communication between the public/ medical community and NRC7

(I o

I k'). Vacant Positions on the ACMUI By a vote of 9-0 in favor, the ACMUI recommended that:

1.

An Radiation Safety Officer position be added to the ACMUI's composition.

l 2.

Vacancies on the ACMUI be noticed in the Federal Register 18 months prior l

to the anticipated vacancy.

Patent Notification By a vote of 8-0 in favor 1 abstention, the. ACMUI recommended reaffirming the l

recommendation from the September 1997 AC6.iUI meeting: "The Committee does not support any regulation requiring notification of physicians and patients as this is redundant to existing i

state laws and medical ethics in existence or words."

Precursor Events By a vote of 8-0 in favor 1 abstention, the ACMUI recommended that staff:

1.

Continue to rely on current NRC re' porting requirements in 10 CFR Parts 20,21,30 (30.5 and 30.9) and 35; and 2.

Include the following rule language in the proposed rule: " Deficiency in equipment or procedure supplied by a manufacturer or vendor that could lead to a medical event at that facility or has implications for facilities outside the licensee's facility (operating procedure)."

V_

F 1

i UNITED STATES NUCLEAR REGULATORY COMMISSION RULES cnd REGULATIONS TITLE 10, CHAPTER 1, CODE OF FEDERAL REGULATIONS-ENERGY I f,)

\\v/

i l

l PART l

MEDICAL USE OF BYPRODUCT MATERIAL Subpart A--Generalinformation Sutmart C-General Technical Subpart F-Radiopherrneceuticals for Requirements Therapy Sec.

35.1 Purpose and scope.

35.50 Possession, use, calibration. and check 35.300 Use of unsealed byproduct material 35.2 Definitions.

of dose calibretors.

for therapeutic administration.

35.5 Maintenance of records 35.51 Calibration and check of survey 35.310 Safety instruction.

i 356 Provisions for research involving instruments.

35.315 Safety precautions.

human subjects.

35.52 Possession. use. calibration. and 35.320 Possession of survey instruments.

Subpart G-Sources for Brachytherapy 35.7 FDA. other Federal. arid State check ofinstruments to measure requirements.

dosages of alpha. or beta-cmitting

,5.6 Information collection requirements

radionuclides.

35.400 Use of sources for brachytherapy.

OMB approval.

35.53 Measurement of 6,ges of unsealed 35404 Release of patients or human 35.11 License required.

byproduct materia l

• medical use research subjects treated with 35.12 Application for licer se. amendment.

35.57 Authorization for ca'ibration and temporsry implants.

or renewal.

reference sources.

35.406 Brachytherapy sources inventory.

i 35.13 Ucense amendments.

35.59 Requirements for possession of sealed 35.410 Safety instruction.

35.14 Notifications.

sources and brachytherapy sources.

35.415 Safety precautions.

3115 Exemptions regarding Type A 35.60 Syringe shields and labels.

35.420 Possession of survey instrument.

specific licenses of broad scope.

35.61 Wal shields and labels.

gg 35.18 Ucense issuance.

35.70 Surveys for contarninauon and Subpert WSeeled, Sources for Diagnoels 35 19 Specific exemptions.

ambient radianon exposure rate.

35.500 Use of sealed sources for diagnosis.

i I'

)> 35.75 Release of individuals containing 35.520 Availability of survey instrurnent.

Subpert 8-General Administrative radiophumaceuticals or permanent Z. s.ts implants.

Subpert 8-Telethorapy u

35.20 ALARA program.

35.80 Technical requirements that apply 35.000 Use of a sealed source in a 35.21 Radiation Safety Officer.

to the provision of mobile nuclear teletherapy unit 35.22 Radiation Safety Committee.

medicine service.

35.605 Maintenance and repair restrictions.

35.23 Statements of authority and 35.90 Storage of volatiles and gases.

35.606 License amendments.

responsibilities.

35.92 Decay-ir norage, 35.610 Safety instruction.

35.25 Supervision.

35.815 Safety precautions.

35.620 Possession of survey instrument, 35.29 Administrative requirements that Subpert No m and Emm apply to the provision of mobile nuclear 35.630 Dosimetry equipment.

medicine service.

35.100 Use of unsealed byproduct rnaterial 35.632 Full cabbration measurements.

for uptake dilution,and excretion 35.634 Periodic spot-checks.

35.3t Radstion safety program changes.

studies.

35.636 Safety checks for teletherapy 35.32 Quahty management program.

35.33 Nohncations. reports. and records 05,120 Possession of survey instrument.

facilities.

35.641 distion surveys for teletherapy Supp$ies se led sources or Subpert E-Imaging and LoceRastion 35.49 devices for medical use' 35.200 Use of unsealed byproduct material 35.643 Modification of teletherapy unit or for imaging a nd localization studies.

room before beginning a treatment 35.204 Permissible molybdenum-99 Program.

concentrction.

35.645 Reports of teletherapy surveys, 35.205 Control of aerosols and gases.

checks, tests. and measurements.

35.220 Possession of survey instruments.

35.641 Five-year inspection.

{D t

i V

~.

35-1 January 31,1997

35.2 PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL Sulee'_t J-Treening'and Expertence Subpart A-Generalinformation

%_ _ m Authority: Secs. 81,161.182.183. 68 Stat.

ev 35.900 Rao n Safety Officer.

8 935,948. 953. 954. as amended 142 U.S C.

1 35.1 Purpose and scope.

35 a g for expenenced Radiation l2 2111. 2201. 2232. 2233): sec. 201. 86 Stat.

This part prescribes requirements and E

4.s e ded (42 U.SC. 58411 provisions for the medical use of 35.910 Traming for uptake. dilution. and encretion studies.

0; byproduct material and for issuance of 35.920 Trammg for imagmg and locahzation specific licenses authorizing the snedical studies.

use of this material.These requirements J5 910 Trammelor ih. r.ywuin uw of and provisions provide for the unwaled in produi.t nsaierial protection of the public health and I

35.932 Trammg for treatment of safety. The requirements and provisions yPenhyroidism'reatment of thyroid of this part are in addition to, and not in Traming for t substitution for. Others in this chapter.

35.934 The requirements and provisions of 35.940 Traming for use of brachytherapy Parts 19. 20,21. 30. 71, and 170 of this sources.

35.941 Traming for ophthalmic use of chapter apply to applicants and strontium-90.

licensees subject to this part unless 35.950 Training for use of sealed sources for specifically exempted.

diagnosis.

35.960 Tratning for teletherapy.

I 35.2 Definet.ona.

35.961 Trammg for teletherapy physicist.

35 970 Trammg for expenenced authorized

" Address of use" means the building or buildings that are identified on the users.

35.971 Physician traming in a three month g license and where byproduct material may be received used, or stored.

35.972 ecentness of traming.

15980 Tr amma kir an aut horizeti nui Irar g Mgrummt Sat ( means any kate pharma mt.

7; with which the Commission or the n981 T amma for cyrrieni ni nui leer Atomic Energy Commission has entered pharmacin!'

into an effective agreement under subsection 274bof the AtomicEnergy Act of 1954. as amended.

Subpert K-Enforcement

ALARA"(as low as reasonably as 990 violations.

achievable) means making every 35.991 Cnminal penaltin 35.999 Resolution of cos. fin ting reasonable effort to maintain exposures to radiation as far below the dose limits requirernents during traiwitiois irriod as is practical:

L-(1) Consistent with the purpose for which the licensed activity is undertaken.

(2) Taking into account the state of technology, the economics of improvements in relation to benents to the public health and safety, and other societal and socioeconomic considerations and (3)In relation to utilization of riuclear energy in the public interest.

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

9 September 29,1995 35-2

35.2 35.2 PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL (O)/

W Authorized nuclear pharrnacist means Diagnostic clinicalprocedums a pharmacist who is:

manualmeans a collection of written (1) Board certified as a nuclear procedures that describes each method pharmacist by the Board of E (and other instructions and precautions)

Pharmaceutical Specialties:

by which the licensee performs (2) Identified as an authorized nuclear f diagnostic clinical procedures: where pharmacist on a Commission or each diagnostic clinical procedure has w

Agreement State license that authorizes $ been approved by the authorized user the use of byproduct materialin the and includes the radiopharmaceutical.

practice of nuclear pharmacy; or dosage, and route of administration.

(3) Identified as an authorized nuclear pharmacist on a permitissued by a

~

, Commission or Agreement State specific g licensee of broad scope thatis E authorized to pennit the use of

" Management" means the chief E byproduct materialin the practice of M executive officer or that person's g nuclear pharmacy.

Q delegate or delegates.

Authorized user means a physician, "MedicalInstitution" means an e

dentist, or podiatrist who is:

i organization in which several medical (1) Board certified by at least one of

• disciplines are practiced.

the boards listed in Paragraph (a) of L

$$ 35.910. 35.920, 35.930. 35.940, 35.950, or 35.%0:

(2) Identified as an authorized user on a Commission or Agreement State r"*

license that authorizes the medical use i Medical use means the intentional of byproduct material: or e internal or external administration of (3) Identified as an authorized user on " byproduct material or the radiation g

a permit issued by a Commission or e therefrom to patients or human research Agreement State specific licensee of

$ subjects under the supervision of an D

broad scope that is authorized to permit

• authorized user.

the medical use of byproduct material. L u)

(

v

" Brachytherapy source" means an

" Ministerial change" means a change individual sealed source or a that is made, after ascertaining the manufacturer assembled source train 4 applicable requirements. by persons in that is not designed to be disassembled j authority in conformance with the by the u.er.

m requirements and without making a

" Dedicated check source" means a i discretionary luc'gment about whether radioactive source that is used to assure

• those requirements should apply in the l

the constant oper=" ' 4 of a radiation case at hand.

detection or me

. ment device over g severalmoe' > years.

Dent =~

means the intenticsal g

"terna'. eninistration of the radiation ex

, from byproduct material to human E beings in the practice of dentistry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

" Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia.

or the Commonwealth of Puerto Rico to practice deatistry.

4

\\

(U

)

e 35-3 September 29,1995

f..

35.2 35.2 PART 35. MEDICAL USE OF BYPRODUCT MATERIAL hMisodmirdstration means the (5) A brachytherapy radiation dose:

" Mobile nuclear medicine service" administratioa of:

(i)lnvolving the wrong individual, means the transportation and medical (1) A radiopharmaceutical dosage wrong radioisotope, or wrong treatment a use of byproduct material.

greater than 30 microcuries of either site (excluding for permanent implants.

@ " Output" means the exposure rate, sodium iodide I-125 or 1-131:

seeds that were implanted in the correct a dose rate. or a quantity related in a

" I' (i) lnvolvin8 the wrong individual or site);

5 teletherapy unit for a specified set of wrong radiopharmaceutical: or

( ) Involving a sealed source that is exposure conditions.

(ii) When both the administered leaking:

dosage differs from the prescribed (iii) When, for a temporary implant, dosage by more than 20 percent of the one or more sealed sources are not l~ Pharmacist means an individual prescribed dosage and the difference removed upon completion of the i

between the administered dosage and procedure: or 3 licensed by a State or Territory of the prescribed dosage exceeds 30

. $" dose differs from the prescribed dose by(iv) When the calculated adminis microcuries.

e or the Commonwealth of Puerto Rico to (2) A therapeutic radiopharmaceutical 7e more than 20 percent of the prescribed

$ practice pharmacy.

dosage, other than sodium iodide I-125 g dose.

y or 1-131:

(6) A diagnostic radiopharmaceutical L

(i)Involvin8 the wron8 nd vsdual-

'8

"9"*"

" 8'" "

i wrong radiopharmaceutical, or wrong than 30 microcuries of Cther sodium route of administration; or iodide 1-125 or 1-131, both:

(i) Involving the wrong individual.

(ii) When the administered dosage g differs from the presenbed dosage by wrong radiopharmaceutical, wrong

.. Physician" means a medical doctor route of administration or when the or doctor of osteopathy licensed by a y more than 20 percent of the prescribed admimstered desage differs from the State or Territo of the United States, g dosage.

prescribed dosage; and the District of C lumbia. or the (3) A gamma stereotactic radiosurgery (ii) When the dose to the m. dividual C' mmonwealth of Puerto Rico to o

radiation dose:

exceeds 5 rems effective dose prescribe drugs in the practice of (i) Involving the wrong individual or equivalent r 50 rems dose equivalent f

medicine.

t any individual organ.

" Podiatric use" means the intentional wrong treatment site: or 0 external 6dministration of the radiation j

from byproduct material to human (ii) When the calculated total administered dose differs from the total 18 beings in the practice of podiatry in presenbed dose by more than 10 percent 5 accordance with a license issued by a b

of the total presenbed dose.

3 State or Territory of the United States.

(4) A teletherapy radiation dose:

the District of Columbia, or the (i) Involving the wrong individual-Commonwealth of Puerto Rico.

wrong mode of treatment. or wrong "Podistrist" means an individual treatment site:

licensed by a State or Territory of the (ii) When the treatment consists of United States, the District of Columbia.

three or fewer fractions and the or the Commonwealth of Puerto Rico to calculated total administered dose practice podistry.

differs from the total prescribed dose by more than 10 percent of the total prescribed dose:

(iii) When the calculated weekly administered dose exceeds the reekiv prescribed dose by 30 percent or more of the weekly prescribed dose: or (iv) When the calculated total edministered dose differs from the total prescribed dose by more than 20 percent 4

of the total prescribed dose.

l t

September 29,1995 35-4

35.2 35.2 PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL Os I

)

Prescribed dosage means the quantity Recordable event means the Written directive means an order in I-of radiopharmaceutical activity as admmistration of:

writing for a specific patient or human documented; (1) A radiopharmaceutical or research subject, dated and signed by an (1)In a written directive; or "

radiation without a written directive authorized user prior to the (2) Either in the diagnostic clinical where a wntter directive is required.

administration of a radiopharmaceutical procedures manual or in any (2) A radiopharmaceutical or or radiation, except as specified in appropnate record in accordance with radiation where a written directive is paragraph (6) of this definition, the directions of the authonzed user for required without daily recordmg of each containing the following information:

g diagnostic procedures.

admimstered radiopharmaceutical (1) For any administration of g Prescribeddose means dosage or radiation dose m the quantities greater than 30 microcuries of (1) For gamma stereotactic appropnate record; either sodium iodide I-125 or 1-131: the g

radiosurgery, the total dose as (3) A radiopharmaceutical dosage dosage; e documented in the wntten directive

, greater than 30 microcunes of either (2) For a therapeutic administration of (2) For teletherapy. the total dose and :E sodium iodide 1-125 or 1-131 when both:

a radiopharmaceutical other than dose per fraction as documented in the

-o (i) The administered dosage differs sodium iodide 1-125 or 1-131: the written directive; or f from the prescribed dosage by more radiopharmaceutical, dosage and route the $ than 10 percent of the presenbed g of administration:

sourc strength nd te ti e W For gamma wreotactic sage. and g diosurgery: target coordinates, total dose. as documented in the wntten (ii) The difference between the ra directive.

admmistered dosage and presenbed 5 collimator size. plus pattern, and total dosage exceeds 15 microcunes:

$ dose:

(4) A therapeutic radiopharmaceutical (4) For teletherapy: the total dose, dosage. other than sodium iodide 1-125 dose per fraction. treatment site, and or 1-131. when the administered dcsage overall treatment period; differs from the presenbed dosage by (5) For high-dose-rate remote more than 10 percent of the prescribed afterloading brachytherapy: the 2 " Radiation Safety Officer" means the dosage:

radioisotope, treatment site, and total

$ individualidentified as the Radiation (5) A teletherapv radiatico dose when dose:or e Safety Officer on a Commission license.

the calculated weekte administered (6) For all other brachytherapy:

I dose exceeds the weekly prescribed (i) Prior to implantation: the

\\*

dose by 15 percent or m' ore of the radioisotope, number of sources, and weektv presenbed dose; or source strengths; and h.

(6) A brachytherapy radiation dose (ii) After implantation but prior to when the calculated administered dose completion of the procedure: the differs from the presenbed dose by more radioisotope, treatment site, and total than 10 percent of the prescribed dose.

source strength and exposure time (or, equivalently, the total dose).

" Sealed source" means any byproduct material that is encased in a capsule y designed to prevent leakage or escape of

g the byproduct material.

e " Teletherapy physicist" means the indmdual identified as the teletherapy physicist on a Commission license.

/U O

35.5 35.11(c)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL

$ 35.5 Mawstenance of recores.

$ 35.8 information collection 5 35.11 License required.

'*9"**"'"

8 *PP"'*'

Each record

• q' tired by this part must (a) A person shall not manufacture, be legible thmugnout the retention ji> (a) The Nuclear Regulatory produce, acquire, receive. possess, use.

~

period specified by each Comsmssion Commission has submitted the or transfer byproduct material for regulation.The record may be the ini rmation collection requirements medical use except in accordance with e

original or a reproduced copy or a e ntained in this part to the Office of f a specific license issued by the microform provided that the copy or Management and Budget (OMB) for R Commission or an Agreement State. or microform is authenticated by approval as required by the Paperwork as allowed in paragraph (b) or (c) of this authorized personnel and that the Reduction Act (44 U.S.C. 3501 et seq.).

section.

o Z microform is capable of producing a The NRC may not conduct or sponsor.

2 clear copy throughout the required and a person is not required to respond E retention period. The record may also be to. a collection ofinformation unless it G stored in electronic media with the displays a currently valid OMB control (b) An individual may receive, capability for producing legible.

number. OMB has approved the a possess, use, or transfer byproduct cccurate, and complete records during information collection requirements a materialin accordance with the the required retention period. Records contained in this part under control 8 regulations in this chapter under the such as letters, drawings, specifica tions, number 3150-0010.

E supervision of an authorized user as must include. all pertment information b) The approved information 3 provided in i 35.25 unless prohibited by such as atamps. initials, and signatures. ! co(llection requirements contamed in license condition.

The licensee shall maintain adequate 2 this part appear in SS 35.6. 35.12. 35.13.

safeguards against tamperinjr with and E 35.14. 35.20,35.21. 35.22,35.23. 35.29 loss of records.

g 35.31. 35.50,35.51,35.52. 35.53. 35.59.

35.60.'35.61.35.70.35.75.35.80.35.92.

35.204.35.205.35.310.35.315.'45.404 (c) An individual may prepare unsealed byproduct material for medical N

$ 35.6 Provisions for research invotving 35.406. 35.410. 35.415. 3 n606..s5.610.

e human subjects.

35.615.35.630.35.632.35.634.35.636. G [n s chapte und r the su ervis on of A licensee may conduct research 35 641.35.643.35.645.35.647.35.980.

$ an authorized nuclear pharmacist or inv:lving human subjects using 35.981.

authorized user as provided in 5 35.25, byproduct material provided that the (c) This part contains information unless prohibited by license condition.

research is conducted, funded, collection requirements in addition to supported.or regulated by another those approved under the control V

Federal Agency which has implemented number specified in paragraph (a) of the Federal Policy for the Protection of this section. These information Human Subjects. Otherwise. a limasee collection requirements and the control shall apply for and receive approval of numbers under which they are c specific amendment to its NRC license approved as follows:

E before conducting such research. Both (Illn S 35.12. NRC Form 313 is E types oflicensees shall, at a minimum, approved under control number 3150-E obtain informed consent from the 0120' g human sub)ects and obtain prior review and approval of the research activities (2)(Reserved]

by an " Institutional Review Board" in accordance with the meaning of these

{ (d) OMB has assigned control number terms as defined and described in the e

Federal Policy for the Protection of g 3150-0171 for the information collection Human Subjects.

E requirements contained in il 35.32 and

[ 35.33.

.a

$ 35.7 FDA. other Federal and State L

Nothing in this part relieves the licensee from complying with cpplicable FDA.other Federa! and State requirements governing radioactive drugs or devices.

9

4 t

i h

35.15(d)

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL i V l

I 35.12 Application for bleenee, i 35.t3 Ucones amendmenta.

{ 35.14 Notifications.

A licensee shall apply for and must (a) A licensee shall provide to the (a)If the application is for medical use 4 rece k (a)ive a license amendment:

Commission a copy of the board sited in a medical mstitution, only the Before it receives or uses certification, the Commission or institution's management may apply. If c by; toduct material for a clinical Agreement State license, or the permit the application is for medical use not i* procedure permitted under this Part but issued by a licensee of broad scope for sited in a medical mstitution. any person not permitted by the license issued each individual no later than 30 days i

l may apply.

pursuant to this part; after the date that the licensee permits (b) An application for a Ocense for medical use of byproduct material as the individual to work as an authorized user or an authorized nuclear cescribed in il 35.100.35.200. 35.300.

pharmacist pursuant to $ 35.13 (b)(1) 35.400, and 35.500 of this part must be made by filing an original and one copy (b) Before it permits anyone to work through (b)(4).

as an authorized user or authorized (b) A licensee shall notify the of Form NRC-313.," Application for nuclear pharmacist under the license, Commission by letter no laier than 30 Materials License. For guidance in completing the form refer to the except an individual who is:

days after:

g instructions in the most current versions (1) An authorized user certified by the (1) An authorized user, an authorized g of the appropriate Regulatory Guides. A organizations specified in paragraph (a) nuclear pharmacist,13distion Safety l

e request for a license amendment or of $ 35.910,35.920,35.930. 35.940, Officer. or teletherapy physicist renewal may be submitted as an original 35.950. or 35.960; permanently discontinues performance and one copy m letter format.

(2) An authorized nuclear pharmacist E of duties under the license or has a 7

(c) An application for a license for certified by the organization specified in G name change; or para 8jph (a) of $ 35.980:

2 (2) The licensee's mailing address medical use of byproduct material as a

g33 g entified as an authorized user or $ changes.

described in i 35.600 of this part must be $ an authorized nuclear pharmacist on a (el The licensee shall mail the made by filmg an original and one copy e Commission or Agreement State license documents required in this section to l

of Form NRC-313. For guidance m

$ that authorizes the use of byproduct the appropriate address identified in

' f "Es't current version f,r et n8 materialin medical use rin the

$ 30.6 of this chapter.

the

, ns

! ['

of the sopropriato Regulatory Guide. A practice of nuclear pharmacy.

requerifor a license amendment or respectively; or

( v' s..-

(4) Identified as an authorized user or renewal may be submitted as an original an authorieed nuclear pharmacist on a g 35.15 Exemptions regarding Type A and one copy in letter format' guides' (d) For copies of regulatory permit issued by a Commission or specific licenses of twood scope.

l application forms. or to submit an Agreement State specific licensee of A licensee possessing a Type A broad scope that is authorized to permit specific license of broad scope for d

est.

j app ti o

$,me t e the use of byproduct materialin medical medical use is exempt from the

,g 6 of t e

use or in the practice of nuclear following:

pharmacy, respectively.

(a)The provisions of $ 35.13(b);

(b) The provisions of $ 35.13(e) regarding additions to or changes in the

~

(e) An APP cant that satisfies the arcas of uso only at the addresses 3

li

requirements specified in 10 CFR 33.13 (c) Before it changes Radiation Safety specified in the license

~

e may ap ly for a Type A specific license Officers or Teletherapy Physicists; (c)The provisions of $ 35.14(a); and f bros scope ^

(d) Before it orders byproduct material (d)The provisions of $ 35.14(b)(1) for i

g in excess of the amount. or radionuclide an authorized user or an authorized a

L

$ or form different than authorized on the nuclear pharmacist.

license; and (e) Before it adds to or changes the

~a areas of use or address or addra;es of use identified in the application or on the license.

vs ee.eem.*4mee M MM

35.18 35.24b)

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL 3 35.18 Ucenseissusnce.

Subpart 8,-General Administrative i 35.21 Radiation Safety Omcor.

The Commission shallissue a license Requirements (a) A licensee shall appoint a E>for the medical use of byproduct Radiation Safety Officer responsible for

materialif

l35.20 ALARAprogrant implementing the radiation safety E

(a) Each licensee shall develop and program. The licensee. through the p'

implement a written radiation protection Radiation Safety Officer, shall ensure program that includes provisions for that radiation safety activities are being keeping doses ALARA.

performed in accordance with approved (b) To satisfy the requirement of procedures and regulatory requirements paragraph (a) of this section:

in the daily operation of the licensee's (a) The applicant has filed Form NRC-(1) At a medicalinstitution.

byproduct material program.

313 " Application for Materials License" management, the Radiation Safety (b) The Radiation Safety Officer shall:

in cecordance with the instructions in Officer, and all authorized users must (1) Investigate overexposures.

l 35.12:

participate in the program as requested accidents, spills, losses. thefts.

(b) The applicant has paid any by the Radiation Safety Committee.

unauthorized receipts. uses. transfers.

cpplicable fee as provided in part 170 of N (2) For licensees that are not medical disposals. misadministrations. and other this chapter:

$ institutions. management and all deviations from approved radiation j

(c) The Commission finds the e authorized users must participate in the safety practice and implement cpplicant equipped and committed to i program as requested by the Radiation corrective actions as necessary; obse:ve the safety standards

• Safety Officer.

(2) Establish. collect in one binder or established by the Commission in this (c) The program must include notice to file. and implement written policy and Chapter for the protection of the public workers of the program's existence and procedures for:

$ health and safety; and workers' responsibility to help keep (i) Authorizing the purchase of g

(d) The applicant meets the dose equivalents ALARA. a review of a byproduct material; g requirements of part 30 of this chapter.

summaries of the types and amounts of g (ii) Receiving and opening packages of E I 35.19 Speemcesempo ns.

byproduct material used. occupational e byproduct material:

doses, changes in radiatwn safety (iii) Storing byproduct material:

The Commission may, upon procedures and safety measures and E

(iv) Keeping an inventory record of cpplication of any interested person or continuing education and training for all byproduct material:

rpon its owninitiative, grant such personnel who work with or in the (v) Using byproduct material safely:

vicinity of byproduct material.The (vi) Taking emergency action if

)

asi eter e are u ozdy faw and willnot endanger ge or purpose of the review is to ensure that control of byproduct materialis lost:

'i licensees make a reasonable effort to (vii) performing periodic radiation property or the common defense and.

maintain indivirhal and collective surveys-t s e

so 1ee

, (vi il performing check' of survey occuPationaldo.es ALARA s

requests for exemptions from trabing mstruments and other safety equipment:

and experience requirements with the (ix) Di8 posing of byproduct material:

assistance ofits Advisory Committee on (x) Training personnel who work in or the Medical Uses ofIsotopes.

frequent areas where byproduct materialis used or stored:

(xi) Keeping a copy of all records and reports required by the Commission regulations, a copy of these regulations.

a copy of each licensing requert and license and amendments, and me written policy and procedures required by the regulations.

(3) Brief management once each year on the byproduct material program:

(4) Establish personnel exposure investigationallevels that, when i

exceeded. will initiate an investigation by the Radiation Safety Officer of the cause of the exposure:

PART 35. MEDEAL USE OF SYPRODUCT MATERIAL

~

(5) Establish' personnel exposure (2)(1) Review, on the basis of safety IasJs essesmenesetnumerseyand investigationallevels that, when and with regard to the training and roepensiemises.

exceeded, will initiate a prompt expertenex standards in Subpart J of this (a) A licensee shall provide the investigation by the Radiation Safety part, and approve or disapprove any Radiation Safety OfRcer and at a Officer of the cause of the exposure and individual whois to be listed as an medical institution the Radiation Safety a consideration of actions that might be authorized user, an authorized nuclear Committee, sufficient authority, taken to reduce the probability of pharmacist, the Radiation Safety Officer.

organizational freedom, and f

recurrence:

y; or a teletherapy physicist before management prerogative, to:

16)For medical use not at a medical u submitting a license application or (1) Identify radiation safety problems:

institution approve or disapprove minor E request for amendment or renewal: or (2) Initiate, recomment or provide changes in radiation safety procedures (ii) Review, pursuant to $ 35.13 (b)(1) corrective actions; and ll; hrough (b)(4), on the basis of the board that are not potentially important to

• t g (3) Verify implementation of sa'2ty with the advice and consent of certification, the license, or the permit 3 corrective actions.

management: and identifying an individual, and approve a (b) Alicensee shau establish and (7) For medical use at a medical or disapprove any individual prior to E state in writing the authorities, duties, institution, assist the. Radiation Safety allowing that individual to work as an ra responsibilities, and radiation safety Committee in the performance ofits authorized user or authorized nuclear activities of the Radiation Safety duties.

pharmacist:

Officer, and at a medicalinstitution the i 35.23 nadiosen sateeyt.'em m m u Radiation Safety Committee, and retain Each medical institution licensee shall establish a Radiation Safety Committee terminates e license, to oversee the use of byproduct (3) Review on the basis of safety and material.

approve with the advice and consent of Iss.as supervenien.

(a) Each Committee must meet the the Radiation Safety Officer and the (a) A licensee that permits the receipt'.

following administrative requirements:

management representative, or possession, use, or transfer of byproduct (1) Membership must consist of at disapprcve minor changes in radiation material by anindividual under the least three individuals and must include safety procedures that are aot supervision of an authonsed user as an authorized user of each type of use potentially important to safety and are allowed by l 35.11(b) of this part shall:

permitted by the license, the Radiation Permitted under i 35.31 of this Part, f Safety Officer, a representative of the

4) Review quarterly, with the M as(sistance of the Radiation Safety Fi nursing service, and a representative of L (1) instruct the supervised individual management who is neither an

- % Officer, a summary of the occupational in &e principles of re&auon safety authorised user nor a Radiation Safety E radiation dose records of a!! personnel appropriate to that individual's use of rking with byproduct material; byproduct material and in the licensee's

\\

Officer. Other members may be included ;;; w (5) Review quarterly, with the as the hcensee deems appropriate.

written quality management

/

(2)h Committee must meet at least assistance of the Radiation Safety q,,,,gy Officer, allincidents involving g (2) Require the supervised dual (3)To establish a uorum and to byproduct material with respect to g to fonow ee instrucuans of the conduct business, at est one-half of the cause and subsequent actions taken:

e. supervis authorised user. follow the u written ation safety and and 3

Comunittee's membership must be management pmoodores by prmnt,inclu&ng ee Ra&ation Safety (6) Review annually, with the se hoensee,and comply wie &e Officer and the management's assistance of the Radiation Safety regulations of this chapter and the representative.

Officer, the radiation safety program.

license con &uons with respect to se (4)N minutes of each Radiation use of byproduct material: and Safety Conucee meeting must include:

(1)The date of the meeting:

(ii) Members present:

f-(iii) Members absent:

1 (iv) hmmary of deliberations and g

pgge,g,yg,, g,,

actions sad the 8 individual e use of byproduct niatorial numerical results of all ballots; and i and the records kept to reflect this use.

(vi) ALARA program reviews described in i 35.20(c).

L (5) De Committee must promptly i

provide each member with a copy of the i

meeting minutes, and retain one copy for the duration of the license.

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

(1) Review recommendations on ways to maintain individual and collective doses ALARA:

,a5 as.e septemberto,1ess

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL

/

b (b) A licensee that permits the

[ I 35.39 Administrative requirements that i 35.31 Redetion oefety program l

preparation cf kyproduct material for

appsy to the prevteien et mobne nuclear changes.

medical use an individual under the ?, momeone servies (a) A licensee may make minor supervision o an authorized nuclear g (a)The Commission willlicense changes in radiation safety procedures l

pharmacist or physician who is an

mobile nuclear medicine service only in that are not potentially important to authorized user, as allowed by accordance with Subparts D. E and H of safety,i.e ministerial changes, that

$ 35.11(c), shall:

,this part and i 31.11 of this chapter.

were described in the application for (1)lastruct the supervised individual (b) Mobile nuclear medicine service license renewal. r amendment except in the tion of byproduct material licensees shall obtain a letter signed by for those changes in ll 35.13 and 35.606 for me use and the principles of of this part. Examples of such and rocedures for radiation safety and ;; the management of each client for which ministerial cha es include: editing of o

services are rendered that authorizes in licensee's written quality

! use of byproduct material at the client's procedures for rity or conformance I

management

, as app rists to i address of use.The mobile nuclear with local drafting policy or updating s thatindivid

's use of byp uct

,, medicine service licensee shall retain names, telephone numbers, and

@ material:

" the letter for three years after the last addresses: adoption of model radiation safe procedures published in NRC l

(2) Require the supervised individual provision of eervice.

=

f to follow the instructions given Re story Guides: replacement of I

1 pursuant to paragra h (b)(1) of this (c)If a mobile nuclear medicine

$ equi ment: reassignment of tasks among section and to comp y with the service provides services that the client 8 emp oyees: or assignment of service regulations of thle chapter and license is also authorized to provide, the client E contracts for services such as personnel conditions; and is responsible for assuring that services 7, dosimetry, radiation safety equipment (3) Require the supervising authorized M are conducted in accordance with the repair or calibration, waste disposal, nuclear pharmacist or physician who is j regulations in this chapter while the and safety surveys. A licensee is a mobile nuclear medicine service is responsible for assuring that any change an authorised user to periodically review the work of the supervised

' under the client's direction.

made is in compliance with the individualasit pertains to 13 aring

(d) A mobile naclear medicine service requirements of the regulations and the roduct material for m use and may not order byproduct material to be license.

e records kept to reflect that work.

delivered directly from the manufacturer (b) A licensee shall retain a record of or distributor to the client's address of each change until the license has been use.

renewed or terminated. The record must (c) A licensee that supervises an include the effective date of the change, individual is responsible for the acts and a copy of the old and new radiation j

omissions of the supervised individual.

safety procedures, the reason for the I

change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Saf6ty Officer, and the signatures of the affected authorized users and of management or,in a

$M [ Removed 59 FR 61767.]

medicalinstitution, the Radiation Sa'ety Committee's chairman and the management representative.

O septemtm 20,iets 35-10

___________.____________m___

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL O) tD

$ 36.33 Quamer management program.

f (2) That. prior to each admin:stration.

the review,in an auditab fonn for (a) Each applicant or hcensee under ~ the patient's or human research three years.

this part. as applicable, shall establish $ subject's identity is verified by more (c)The licensee shall evaluate and and maintain a written quality y than one method as the individual respond. within 30 days after discovery of the recorda$le event. to each management program to provide high

• naried in the written directive; confidence that byproduct material or S

recordable event bp

, (1) Assembling the relevant facts radiation from byproduct material will.[

melucing the cause:

be administered as directed by the (2) Identifying what,if any. corrective authorized user. The quality (3)That final plans of treatment and

. action is required to prevent recurrence:

management program must include related calculations for brachytherapy.

and written policies and procedures to meet I the following specific objectives:

teletherapy, and gamma stereotactic (3) Retaining a record,in an auditable radiosurgery are in eccordance with the form. for three years, of the relevant A

1)That prior to administration. a respective written diiectives:

facts and what corrective action. if any.

E wr(itten directive Cis prepared for.

(4) That each administration is in was taken.

E (i) Any teletherapy radiation dose:

g accordance with the written directive:

(d) The licensee shall retain:

(ii) Any gamma stereotactic g and (1) Each written directive: and radiosurgery radiation dose, (5) That any unintended deviation (2) A record of each administered (iii) Any brachytherapy radiation f from the written directive is identified radiation dose or radiopharmaceutical dose-g ar.d evaluated, and appropriate action is dosage where a written directive is (iv) Any ad ninistration of quantities taken.

required in paragraph (s)(1) above,in an greater than E microcuriep of either (b) The licensee shall:

auditable form. for three years after the sodium fodide I-125 or I-131: or

, date cf administration.

(1) Develop procedures for and g

(v) Any therapeutic administration of c nduct a review of the quality A (e)The licensee may make a radiopharmaceutical. other than management program including. since g modifications to the quality sodium todide I-125 or I-131:

the last review. an evaluation of:

g management program to increase the program's efficiency provided the program's effectiveness is not decreased. The licensee shall furnish the

{

3 (i) A repre.entative sample of patient modification to the appropriate NRC

and human research subject Regional Office within 30 days after the modification has been made.

$ administrations.

/,

(f)(1) Each applicant for a new license.

as applicable, shall submit to the

(

L appropriate NRC Regional Office in 1

accordance with to CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the NRC.

(2) Each existing licensee, as

- (ii) All recordable events, and appl cable, shall submit to the (iii) Allmisadmmistrations appropriate NRC Regional Office in to venfy compliance with all aspects of accordance with 10 CFR 30.6 by January the quality manager;.ent program: these 27.1992 a wntten certification that the g reviews shall be conducted at intervale quality management program has been

, no greater than 12 months:

implemente:1 along with a copy of the

'It. because of the patient s condition a delay in y (termine the effectiveness of the2) Evaluate each of these ' eviews to program.

r order to provide e wnnen remion io an emims

- de "n'*n dact "ould fop 5' dis' 'h' Pat *nt e e wNe~/e"pt bi."["i2d7a'i$e oral

$ quality management program and,if d

required. make modifications to meet i 35.33 I W ehr m rep M a,asW 6 revision is accumented immed.ately in the patient s roccid ansi a remed wnttea directive is sisned by the objectives of paragraph (a) of this W sidsadsudsustresesta.

the authonaed user within es houre of the oral section: and (a) For a misadministration:

(3) Retain eecords of each review.

including the evaluations and findings of direct e m y be or any d a n i r therapeutic procedure provided that the revision is dates and signed by en authortsed user pnor to the admemetration of the radiopharmaceutical dosase the brechytherapy dose. the samma etereotectic radiosasserv dese. the teletherapy dose, or the next teletbrary tractionaldose.

ft.because of the emersent nature of the pet ent's conation. a delay in order to provide a wntten defective.eould kortedise the potient's health. en oral ducctive wdl be acceptable. provided that the infonnation contamed am the oral directive w documented 6mmediately in the petwnt a record and A

a written directive is prepared withm 24 hou's of

/

the oral directive.

(

s

[

w.

35-11 September 29,1995

c.

35.33(a) 35.50(a)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL

,,F, (1) The.. e.see shall notify by to notify the individual without first

$ 35.4e suppliers for seeied sources or 8 telephone the NRC Operations Center 8 consulting the referring physician. If the devloes for medioet use.

no later than the next calender day after referring physician or the individual A licensee may use for medical use

$ discovery of the misadministration.

receiving the misadministration cannot only:

E be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee (a) Sealed sources or devices

[

shall notify the individual as soon as manufactured, labeled, packaged, and possible thereafter.The licensee may distri5ted in accordance with a license not delay any appropriate medical care issued pursuant to 10 CFR Part 30 and for the individual, including any to CFR 32.74 at the equivalent necessary remedial care as a result of requirements of an Agreement State; or the misadmmistration. because of any to) Teletherapy sources manufactured h(2) The licensee sha!! submit a written delay in notification.

and distributed in accordance with a license issued pursuant to 10 CFR Part report to the appropriate NRC Regional (4)If the individual was notified, the fe 30 or the equivalent requirements of an 1

Office listed in to CFR 30.6 rithin 15 licensee shall aiso furnish, within 15

i; Agreement State.

I days after discovery of the days after discovery of the E

I rniseGin3ttation. The written report misadministration, a written report to 3

must melude the licensee's name; the the individual by sending either:

prescribing physician's name: a brief description of the event; why the event (1) A copy of the report that was occurred; the effect on the individual submitted to the NRC: or who received the misadministration:

Subpart C-General Technical what improvements are needed to (iil A brief description of both the Requimments prevent recurrence: actions taken to event and the consequences as they may prevent recurrence: whether the affect the individual, provided a

$ 35.50 Possoasion, use, calibration, and licensee notified the individual (or the,., statement is included that the report check of dose ettibrators.

individual's responsibie :tlative or g submitted to the NRC can be obtained (a) A 1 censee shall possess and use a g there was notification, what information ; from the licensee.

dose calibrator to measure the activity of g guardian), and if not. why not; and if

• was provided. The report must not S (b) Each licensee shall retain a record dosages of hoton-emitting E contain the individual's namm.- an of each misadministration for 5 years, radionucli es prior to administration to E other information that could lear

,,y The record must contain the names of each patient or human research subject.

identification of the individual. To meet all individuals involved (including the the requirements of this section the Prescribing physician, allied health notification of the individual receiving Personnel. the individual who received l

I the misadministration may be made the misadministration, and that instead to that individual's responsible individod's referring physician, if relative or guardian, when appropriate.

DPphcable). the individual's social l

(3)The licensee shall notify the security nurnber or other identification I

referring physician and also notify the number f one has been assigned, a brief individual receiving the description of the misadministration, misadministration of the why it occurred, the effect on the misadministration no later than 24 individual, improvements needed to hours after its discovery. unless the Prevent recurrence, and the actions referring physician personally informs taken to prevent recurrence.

the licensee either that he will inform the individual or that, based on medical (c) Aside from the notification Judgement, telling the indivicual would requirement. nothin,in this section be harmful. The licensee is not required affects any rights or duties of licensees and physicians in relation to each other, to individuals receiving misaJn.inistrations, or to that individual's responsible relatives or guardians.

IThe COfRmerCiel telephone number of the NRC opereuens censer as (3011 sis-5100 september 2s,1995 3 5-12

35.50(b) 35.51(d)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL i

O) 1

(./

(b) A licensee sha!!:

(1) For paragraph (b)(1). the model i 35.51 caeration and check of survey (1) Check each dose calibrator for

~ and serial number of the dose cabbrator.

inetruments.

constancy with a dedicated check 9 the identity of the radionuclide (a) A licensee shall calibrate the source at the beginning of each day of 8 contained it the check source. the date survey instruments used to show use.To satisfy the requirement of this E of the checx. the activity measured, and compliance with this part before first paragraph, the check must be done on a g the initials of the individual who use, annually, and following repair. The frequently used settmg with a sealed performed the check:

licensee shall:

source of not less than 10 microcunes of (1) Calibrate all scales with readmgs radium 226 or 50 microcuries of any up to 1000 millirem per hour with a

, other photon-emitting radionuclide:

radiation source:

g (2) Test each dose cahbrator for

(?) For paragraph (b)(2) of this section.

(2) Calibrate two separated readings 8 accuracy upon installatin and at least the model and serial number of the dose on each scale that must be calibated; g annually thereafter by assaying at least calibrator. the model and serial number

two sealed sources containing different of each source used, the identity of the $and (3) Conspicuously note on the radionuclides whose activity the radionuclide contained in the source g instrument the apparent exposure rate manufacturer has determined within 5 and its activity, the date - ~ he test, the z from a dedicated check source as percent of its stated activity. whose results of the test,and th 6dentity of the

• determined at the th vis.alfuranon, activity is at least to microcuries for individual performing tha.est.

and the date of calibration.

radium 226 and 50 microcunes for any 3 (3) For paragraph (b)(3) of this section.

(b) When calibratmg a survey other photon-emittmg radionuclide. and 3 the model and serial number of the dose inurument, the licensee shall consider a at least one of which has a principal e calibrator. the calculated activities, the point as calibrated if the indicated photon energy between 100 kev and 500 $ measured activities, the date of the test.

exposure rate differs from the calculated kev:

• and the identity of the individual exposure rate by not more than 20 performing the test.

percent. and shall conspicuously attach (4) For pararaph (b)(4) of this section, a correction chart or graph to the (3) Test each dose calibrator for the model and serial numoer of the dose instrument.

linearity upon installatic a and at least calibrator, the configuration of the

. (c) A licensee shall check each survey 3 quarterly thereafter over a range from source measured, the activity measured mstrument for proper operation with the

$ the highest dosage that will be for each volume measured, the date of dedicated check source each day of use.

e administered to a patient or human the test. and the identity of the A licensee is not required to keep A research subject to 1.1 megabecquwels individual paforming the test.

-records of these checks.

['"'N

• (30 microcuries); and g-

\\

)

S E (d) A licensee shall retain a record of e each survey instrument calibration for (1) Test each dose cahbrator for

1. three yearsThe record must include

geometry dependence upon installation over the range cf volumes and volume b

configurations for which it will be used.

The licensee shall keep a record of this (1) A description of the calibration test for the duration of the use of the procedure; and dose calibrator.

(2) The date of the calibration, a g (c) A licensee shall also perform g description of the source used and the g appropriate checks and tests required g certified exposure rates-from the source, by this sectan following adjustment or and the rates indicated by the e

E repair of the dose calibrator, w instrument being calibrated the 3 (d) A licensee shall mathematically 3 correction factors deduced from the correct dosage readings for any calibration data, and the signature of the geometry or hnearity error that exceeds individual who performed the to percent if the dosage is greater than calibration.

10 microcunes and shall repair or replace the dose cahbratorif the accuracy or constancy error exceeds 10 percent.

I f (e) A licensee shall retain a record of g each check and test required by this a section forthree years unless directed

[ otherwise.The records required in a paragraphs (b)(1) through (b)(4) of this 3 section must include:

L C):

b 1

1

~. -

35 13 september 29,1996 i

35.52(a) 35.53(d)

)

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL

$ 35.52 Possession, use, calibration, and (a) Measure the activity of each (4) Date and time of the measurement; check of ins,;.;,:.nents to measure dosages dosage of a photon-emitting and of alpha or beta-emitting radionuclides.

radionuclide prior to medical use.

(5) Initials of the individual who made (a) This section does not apply to unit (b) Measure, by direct measurement or the record.

dosages of alpha or beta emitting

. by combination of measurements and radionuclides that are obtained from a $ calculations, the activity of each dosage i 35.57 Aumwtzauon tw caHbreuon and manufacturer or preparer licensed

• of an alpha-or a beta-emitting pursuant to to CFR 32.72 or equivalent E radionuclide prior to medical use.

Any person authorized by i 35.11 of Ae,reement State requirements.

E excePt for unit dosages obtained from a this Part for medic,a! use of byproduct (b) For other than unit dosages manufacturer or preparer licensed material may receive, possess. and use obtained pursuant to p graph (a) of Pursuant to 10 CFR 32.72 or equivalent the following byproduct matenal for this section, a licensee hall possess and Agreement State requirements;

~ check. calibration, and reference use:

use instrumentation to measure the 2 (al Sealed sources manufactured and radioactivity of alpha or beta-emitting h distributed by a person 1icensed

~

radionuclides. The licensee shall have w pursuant to i 32.74 of this chapter or procedures for use of ti.e

? (c) Retain a record of the

equivalent Agreement State regulations instrumentation. The licensee shall g measurements required by this section and that do not exceed 15 millicuries f

for three yearsTo satisfy this each; j@ measure, by direct measurement or by g requirement. the record must contain (b) Any byproduct materiallisted in combination of measurements and E calculations, the amount of radioactivity.a the

ii 35.100 or 35.200 with a half-life not E in dosages of alpha or beta emitting l

longer than 100 days in individual amounts not to exceed 15 millicuries; e radionuclides prior to administration to w

each patient or human research subject.

(c) Any byproduct materiallisted in

~

In addition, the licensee shall:

Ii 35.100 or 35.200 with a half-life longer (1) Perform tests before initial use, p (1) Genenc name. trade name, or than 100 days in individual amounts not periodically, ad following repair, on e abbreviation of the to exceed 200 microcuries each; and each instrument for accuracj. linearity. 8 radiopharmaceutical. Its lot number, and (d) Technetium-99m in individual and geometry dependence, as E expiration dates and the radionuclide; amounts not to exceed 50 millicuries.

cppropriate for the use of the E

instrument; and make adjustments when necessary; and (2) Check each instrument for constancy and proper operation at the (2) Patient's or human research beginning of each day of use.

subiect's name, and identification V

g number if one has been assigned;

(3) Prescribed dosage and activity of

• the dosage at the time of measurement, y or a notation that the total activity is a less than 1.1 megabecquerels (30

$ 38.63 Ideasurement of dosages of microcuries);

unseeied byproduct material for medical ues.

F a

l A licensee shall:

E E

L 9

September 29,1996 3 5-14 l

(.

i 35.59(a) 35.61(b)

PART 35. MEDICAL USE OF BYPRODUCT MATERIAL F

\\v i 35.90 maquiremente for ra=====W of

'(2) File a report within five days of the g i 35.60 Syringe eNeeds and letsels.

i eenied sources and brechytherapy sources.

leakage test with the appropnate NRC a) A licensee shall keep syringes that (a) A licensee in possession of any Office listed in i 30.6 of this chapter.

f co[ntain byproduct material to be sealed source or brachytherapy source - with a copy to Director. Office of Nuclear

• administered in a radiation shield.

shall follow the radiation safety and E Matenal Safety and Safeguards. U.S.

~n handling instructions supplied by the E Nuclear l_

manufacturer, and shall maintam the Z Regulatcry Commission. Washmgton.

instructions for the duration of source

• DC 20555. describing the equipment (b) To identify its contents. a licensee use in a legible form convenient to users.

involved. the test results. and the action shall conspicuously label each stringe (b) A licensee in possession of a taken.

or stringe radiation shield that c'ontains sealed source shall-a sv'ringe with a radiopharmaceutical.

(1) Test the source for leakage before Th'e label must show the its first use unless thelicensee has a radiopharmaceutical name or its certificate from the supplier indicating (f) A licensee need not perform a that the source was tested within six leakage test on the following soraces:

abbreviation, the clinical procedure to be Performed or the Pat human researc subject,ient's or the months before transfer to the licensee:

(1) Sources containing only byproduce g s name.

and material with a half hfe ofless than 3" t:

(2) Test the source for leakage at days:

(c) A licensee shall require each individual who prepares a intervals not to exceed six months or at (2) Sources containing only byproduct w

radiopharmaceutical kit to use a s,nge other intervals approved by the material as a gas:

o Commission or an Agreement State and (3) Sources containing 100 microcunes radiation shield when prepanng e kit described in the label or brochure that r less of beta or gamma-emittmg and shall require each individual to use accompanies the source.

matenal gr 10 microcuries or less of a syringe radiation shield when alpha emitting material; administering a radiophannaceutical by (4) S urces st red and not being used.

injection unless the use of the shield is re uirements of th sect on. the hcensee The licensee shall. however, test each contraindicated for that patient or sucu s uru age many m human nsearch suW 1 Take a wipe sample from the a

E r transfer unless it has been leakage-E sealed source or from the surfaces of thetested within six months before the date device in which the sealed source is.

of use or transfer; and E

t mounted or stored on which radioactive

5) Seeds ofindium-192 encased in e

e contamination might be espected to

$ ny(lon ribbon.

I 35.s1 vial shields and labees.

accumulate or wash the source in a

[

small volume of detergent solution and E sealed source or brachytherapy source individual prepanns or handhng a vial 8 (g) A 1 censee in possession of a

(

. I* ^ "" *b" '*9 treat the entire volume as the sample; b shall conduct a quarterly physical (2)Take teletherap> and other device

• insentory of all such sources in its 4 that contains a radiopharmaceutical to source test samples when the source is posression. The licensee shall retain

$ eep the vialin a vial radiation shield.

k (b) To identify its contents. a licensee in the "off" position: and each inventory record for five years.Ths e (3) Measure the sample so that the inventory records must contain the i shall conspicuously label each vial radiation shield that contains a vial of a leakage test can detect the presence of model number of each source, and serial o radiopharmaceutical. The label must 0.005 microcuries of radioactive material number if one has been assigned, the show the radiopharmaceutical name or on the sample.

identity of each source radionuclide and its abbreviation.

(d) A heensee shall retain leakage test ts nominal activity, the location of each records for five years. The records must source, and the signature of the contain the model number. and serial Radiation Safety Officer.

numberif assigned.of each s~ource (h) A licensee in possession of a tested. the identity of each source sealed source o.stachytherapy source radionuclide and its estimated activity, shall measure the ambient dose rates the measured activity of each test quarterly in all areas where such sample expressed in microcuries. a sources are stored.This does not apply description of the method used to to teletherapy sources in teletherapy measure each test sample. the date of units or sealed sources in diagnostic the test. and the signature of the devices.

Radiation Safety Officer.

j (e)If the leakage test reveals the presence of 0.005 microcurie or more of (i) A hcensee shall retain afecord of removable contamination the licensee each survey required in paragraph (h) of j

shall:

this section for Leee years.The record 1

(1)Immediately withdraw the sealed g must include the date of tne survey, a source from use and store it in 9 plan oiesch area that was surveyed. the j

measured dose rate at several points in i

accordance with the requirements in e

Parts 20 and 30 of this chapter: and

" each area expressed in millirem per 2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />, the survey instrument used, and the signature of the Radiation Safety Officer.

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i 35-15 September 29,1996 l

35.70m) 35.75(d}

PART 35

• MEDICAL USE OF BYPRODUCT MATERIAL

$ 35.70 Surveys for contamination and effective dose equivalent to any other ambient radiation wouare rate.

Individualis likely to exceed 1 (a) A licensee shall survey with a millisievert (0.1 rem). If the dose to a r:di: tion detection survey instrument at breast-feeding infant or child could thund of each day of use all areas where radiopharmaceuticals are exceed 1 millislevert (0.1 rem) assuming there were no interruption of breast-routinely prepared for use or administered.

feeding, the instructions shall also include:

(b) A licensee shall survey with a r:diation detectiori survey mstrument at (1) Guidance on the interruption or discontinuation of breast-feeding and okarrnac u$cals o (2)Information on the consequences r:di: pharmaceutical waste is stored.

of failure to follow the guidance.

(c) A licensee shall conduct the (c) The licensee shall maintain a surveys required by paragraphs (a) and (b) cf this section so as to be able to g record of the basis for authorizing the

release of an individual, for 3 years after detect dose rates as low as 0.1 millirem e the date of release,1f the total effective per brur.

g dose equivalent is calculated by:

(d) A licensee shall establish radiation u

2 d se rate triggerlevels for the surveys (1) Using the retained activity rather

[ re: quired by paragraphs (a) and (b) of than the activity administered.

w this section. A licensee shall require that (2) Using an occupancy factor less in the individual performing the survey than 0.25 at 1 meter, immediately notify the Radiation Safety (3) Using the biological or effective Officer if a dose rate exceeds a tngger half life, or 1;v11.

(4) Considering the shielding by

(:) A licensee shall survey for tissue.

rem:vable contamination once each (d) The licensee shall maintain a week cll areas where record, for 3 years after the date of r-dirpharmaceuticals are routinely release, that instructions were provided prepared for use, administered, or to a breast-feeding woman if the stored.

radiation dose to the infant or child (f) A licensee shall conduct the from continued breast feeding could surv:ys required by paragraph (e) of this result in a total effective dose equivalent section so as to be able a detect exceeding 5 millisleverts (0.5 rem).

contamination on each wipe sample of 2000 disintegrations per minute.

(g) A licensee shall establish removable contamination trigger levels for the surveys required by paragrapn

(:) eithis section. A licensee shall

$ 35.75 Release of individuals containing require that the individual performing radiopharmaceuticals or permanent the survey immediately notify the implants.

Radi: tion Safety Officer if

> (a) The licensee may authorize the contamination exceeds the trigger level.

release from its control of any individual who has been administered g radiopharmaceuticals or permanent (h) Alicensee shall retain a record of ; implants containing radioactive material c:ch survey for three years. The record E if the total effective dose equivalent to l

must include the date of the survey, a g any other individual from exposure to plan of each area surveyed. the trigger the released individualis not likely to o level established for each area, the exceed 5 millisieverts (0.5 rem).1 s detected dose rate at several pomts in (b) The licensee shall provide the 8 each crea expressed in millirem per released individual with instructions, I

E hour f.r the removeble - m..atnation in including written instructions, on 2 each crea expressed in uisintegrations actions recommended to maintain doses per minute per 100 square centimeters, to other individuals as low as is the instrument used to make the survey reasonably achievable if the total or cnalyze the samples, and the initials Cf the individual who performed the

• Regulatory Guide a.39 " Release of Patients survey.

Administered Radioactive Materials." describes methods for calculaung doses to other individuals

~

and contains tables of activities not liLely to cause doses exceeding 5 millisieverts (0.5 rem).

Jam'ary 31,1997 35-16

35.80 M.92t bi PART 35 = MEDICAL USE OF BYPRODUCT MATERIAL O

I

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Qf f 35.80 Technical rtwa;.ts that apply (f) Retam a record of each survey to the provision of motse nuclear medicine required m paragraph fe) of this section serv 6ce o for tn's+ 3ea:, The record must include A licensee providing mobile nuclear 5 the date of the survey, a plan of each medicine service shall:

area that was surve>ed. the measured (a) Transport to each address of use w dose rate at several pomts m each area only syringes or vials containing 2 of use expressed in milbrem per hour, prepared radiopharmaceuticals or the instrument used to make the survey.

radiopharmaceuticals that are intended and the initials of the individual who for reconstitution of performed the survey.

radiopharmaceutical kits:

N (b) Bring into each address of use all l I 35.90 storage of voastines and gases.

byproduct material to be used and.

E A licensee shall store volatile before leaving, remove all unused g radiopharmaceuticals and radioactive byproduct material and all associated e gases in the shipper's radiation shield g waste; i and container. A licensee shall store a c Secure or keep under constant

• multi dose container in a fume hood 8 su(rv)eillance and immediate control all h after drawing the first dosage from it.

o>

E byproduct material when in transit or at r-si an address of use:

l p.s2 W in-stor y (d) Check survey instruments and 7,

(a) A licensee may hold byproduct dose calibrators as described in il 35.50 e matenal with a ph)sical half-hfe ofless and 35.51. and check all other e than 65 days for decay in-storage before transported equipment for proper E disposalin ordmary trash and is exempt function before medical use at each g from the requirements of 5 20.2001 of this

{cha, ster if.t.

address of use:

(e) Carry a radiation detection survey meter in each vehicle that is being used (1) Holds byproduct material for decay a minimum of ten half-lives:

to transport byproduct material, and, before leaving a client address of use, f2) Monitors byproduct material at the

[q}

survey all radiopharmaceutical areas of c ntainer surface before disposal as rdmary trash and determines that its

(%/

use with a radiation detection surs ey radioactivity cannot be distinguished Iadiopha fr m the background radiation level aceut cat nd all associated N

g with a radiation detection survey meter waste have been removed:

g set on its most sensitive scale and with e no interposed shielding:

(3) Removes or obliterates all radiation labels

and (4) Separates and monitors each J

generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level before disposal.

k (b) A bec isee shall retain a record of each dispent permitted under paragraph a) of this section for tnree t

? o) ears.The record must include the date f the disposal. the date on which the E byproduct material was placed in e storage the radionuclides disposed, the

"., survey instrument used, the background l

• dose rate. the dose rate measured at the i

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

,the disposal,

[,\\

l 35-16a.

Jamary 31, WW

[

.nen n.we is 3.517

35.100 35.220 PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL N

)%

Subpart D-Uptake, Dilution, and i 35.204 Permiss@le molybdenum-99 (c) Before receiving, using, or storing Escretion concentreteon.

a radioactive gas, the licensee shall (a) A bcensee ma) not admmister to calculate the emotant of time needed g35.100 Use of uneoaled byproduct humans a radiopharmaceuncal after a spill to reduce the concentration materlat for uptake, dilution, and excretion ; containmg more than 0.15 miuocune of

in the room low enough so ms not to studies.

i mol)bdenum-99 per milhcune of te exceed the limits prescribed by h c$ 20.1201 of this chapter. The

technetium 99m

lbl A heensee that uses mol)bdenum.

alculation must be based on the highest dilu exct'etion s di s an.v

' 99/ technetium 99m generators for activity of gas handled in a single e

unsealed byproduct Insterial Prepared preparmg a technetium.99m container, the air volume of the room.

(a bt$n radi pharmaceutical shall measure the and the measured available air exhaust g preparer h. kfr

~

rna eturer or mol)bdenum-99 cont entration n each rate' eensed pursuant to 10 CFR eluate or estract.

g 32.72 or equivalent Agreement State

$ requirements or (c) A hcensee that must measure (b) Prepared by an authorized nuclear molybdenum concentration shan retairi

=

pharmacist. a physician who is an a record of each measurement fur terce.

(d) A bcensce shall make a record of authorized user and who meets the years. The record must mclude. for each the calculations required m paragraph re uirements specified in $ 35.920, or an S elution or estraction of technetium-99m.

pj (c) of this section that includes the in ividual under the supervision of g the measured actiutt of the technetium

, assumptions. measurements and either as specified in 6 35.25.

espressed m milheuries. the measured 8 calculations made and shall retain the

- activity of the mol)bdenum espressed in E record for the duration of use of the 2 microcunes. the ratio of the measures

• area. A licensee shall also post the n

4 espressed as microcunes of calculated time and safety measures to g 35.t20 Possession of survey instrument.

molybdenum per milheune of be instituted in case of a spill at the area A heensee authonzed to use technetium, the time and date of the of use.

g bvproduct material for uptake. dilution.

measurement. and the imt.als of the m ano escretion studies shall hat e in its ndindual who made the m asurer.ent E ossession a portable radiation p

E detection surses instrument capable of (e) A licensee shall check the

~ detectmg dose rates os er the range 0.1 5 35.205 Control of aerosols and gases.

g ation of reusable collection systems n

radioactive aerosols or gases shall do so $ oper milhrt m per hour to ton milbrem per (a) A licensee that administers each month and measure the ventilation hour.

e rates available in areas of radioactive f'\\

. in a room with a system that will keep E gas use each six months.

(

3 airborne concentrations low enough no Sub art E-Imaging and Localization as not to exceed the limits prescribed by {

t H5 20.1201 and 20.1301 of this chapter.

v

$ The system must either be diree:tly f 35.220 Possession of survey 5 35.200 Use of unsealed byproduct sented to the atmosphere through an air instruments.

materlot for imaging and localization exhaust or provide for collection and A licensee suthorized to use studies.

decay or disposal of the aerosol or ga' byproduct material for imaging and A licensee may use for imaging and in a shielded container, localiza* ion studies shall have in its localization studies any unsealed 2 possession a portable radiation byproduct material pre' pared for rnedical [--

E detection survey instrument capable of 3 'se that is either:

u (b) A heensee shall administer e detecting dose rates over the range of g (a) Obtained from a manufacturer or $ radioactive gases only in rooms that are I 0.1 millirem per hour to 100 millirem per e preparer licensed pursuant to 10 CFR R at negatise pressure compared to

• hour, and a portable radiation 3 32.72 or equivalent Agreement State E surroundmg rooms-measurement survey instrument capable

• requirements; or 2

of measuring dose rates over the range 1 (b) Papared by an authorized nuclear millirem per hour to 1000 millirem per pharmacist. a physician who is an hour.

authorized user and who meets the requirements specified in $ 35.920. or an individual under the supervision of either as specified in $ 35.25.

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N

35300 35315(bE PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL Subpart F-Radiopharmaceuticals for F 35.345 satety precautioos.

(5) tither monitor materiai and items Therapy E (a) For each patient or human removed from the patient's or the

@ research subject receiving

, human research subject's room to

$ 35.300 use of unsealed byproduct g radiopharmaceutical therapy and R determine that their radioactivity cannot meterial for therapeutic administration.

e hospitalized for compliance with e be distinguished from the natural

^ $ 35.75 of this chapter. a licensee shall: E background radiation level with a l

A licensee may use for therapeutic I-g radiation detection survey instrument administration any unsealed byproduct set n its most smit,1ve scale and with mat: rid prepared for medical use that is f n interposed shielding or handle them

.th

( Obtained from a manufacturer or h

t ayf li y preparer licensed pursuant to 10 CFR 8 pr 32.72 cr equivalent Agreement State E

requirements or 5

(b) Prepared by an authorized nuclear {

> (6)(Reserved 62 FR4120.)

pharmacist.a physician who is an cuthorized user and who meets the uirements specified in 6 35.920 or an (2) Post the patient's or the human g ]n ividual under the supervision of research subject's door with a i

g

.. Radioactive Materials" sign and note (7) Surve the patient's or the human g eith:r ts specified in 6 35.25.

on the door or in the patient's or human research su ject's room and private l $

g research subject's chart where and how sanitary facility for removable b long visitors may stay in the patient's or, contamination with a radiation

$35.310 Safetyinstruction.

y the human research subject's room:

R detection survey instrument before (1) A licensee shall rovide radiation g (3) Authorize visits by individuals 6 assigning another patient or human safety instruction for all personnel o under age 18 only on a case-by-case E research subject to the room. The room caring for the patient or the human basis witl. the approval of the g must not be reassigned until removable research subject receiving authorized user after consultation with contamination is less than 200 1

radiophc maceutical therapy and the Radiation Safety Officer:

disintegrations per minute per 100 hospitalized for compliance'with square centimeters; and i

6 35.75 of this chapter. To satisfy this requirement, the instruction mu'st

~

describe the licensee's procedures for:

(4) Promptly after admim. tration of

[8) Measure the thyroid burden of s

(1) Patient or human research subject the dosage measure the dose rates in each individual who helped prepare or l

control:

contiguous restricted and unrestricted administer a dosage of lodine-131 within j

areas with a radiation measurement three days after administering the

- {

survey instrument to demonstrate E dosage, and retain for the period c mpliance with the requirements of

$ required by 5 20.2106(a)of

! E p) V sitor wrol-o l 8 (3) Contamination control:

g Part 20 of this chapter, and retain for e this chapter a record of each a three years a record of each survey that g includes the time and date of the survey, % thyroid burden measurement. its E (4) Waste control; and

• date, the name of the individual whose g a plan of the area orlist of points thyroid burden was measured and the i

l surveyed. the measured dose rate at initials of the individual who made the

{

several points expressed in millirem per t

measurements.

i hour, the instrument used to make the g (5) Notification of the Radiajon survey, and the initials of the individual

' s l g Safety Of5cer in case of the patient's or who made the survey.

e the human research subject's death or

@ Rd 1 tion Safety Officer immediately if

! % medical emergency.

(b) A licensee shall notify the L

= % petient or the human research

!,ubject dies or has a medical emergency.

l (b) A licensee shall keep for three years

' oc list of individuals receiving instruction yrequired by paragraph (a) of this section.

yo description of the instruction. the date cofinstruction, and the name of the aindividual who gave the instruction.

L 9

35.320 35.406(d)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL A

f

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$ 35.330 pa=====1an of survey g 35.404 Release of patients or human

$ 35.406 Brachytherapy sources inventory.

inemente.

research subjects treated with temporary (a) Promptly after removing them A licensee authorized to use implants.

from a patient or a human research (a)Immediately after removing the subject, a licensee shall return byproduct material for radiopharmaceutical therapy shall have last temporary implant source from a brachytherapy sources to the storage in its possession a portable radiation patient or a human research subject, the area, and count the number returned to detection survey instrument capable of licensee shall make a radiation survey of ensure that all sources taken from the detecting dose rates over the range 0.1 the patient or the human research storage area have been returned.

millirem per hour to 100 millirem per subject with a radiation detection (b) A licensee shall make a record of hour, and a portable radiation survey instrument to confirm that all brachytherapy source use which must measurement survey instrument capable sources have been removed. The incluile:

of measuring dose rates over the range 1 licensee may not release from (1) The names of the individuals millirem per hour to 1000 millarem per g confinement for medical care a patient permitted to handle the sources; hour.

or a human research subject treated by (2) The number and activity of E, temp rary imp ant until all sources l

sources removed from storage, the S, m

. utmart G-Sources for have been removed.

patient s or the human research

"""F "". apy (b) A licensee shall retain a record of subj,ect's name and room number, the 1 35.400 use of sources ter patient or human research subject time and date they were removed from brachytnarapy.

curveys for three years. Each record 3 storage, the numtier and activity of the i

o l

2 A licensee shall use the following must include the'date of the survey,the 3 sources in storage after the removal, and M sources in accordance with the name of the patient or the human a the initials of the individual who E manufacturer's radiation safety and research subject. the dose rate from the 7.; removed the sources from storage:

handling instructions

patient or the human resear,ch r.ubject (3) The number and activity of

{

(a) Cesium-137 as a sealed source in expressed as millirem per hour and sources returned to storage, the patient's needles and applicator cells for topical, measured at 1 meter from the patient or or the human researth subject's name interstitial, and intracasitary treatment the human re.earch subsc..the survey and room number, the time and date of cancer:

instrur..ent und, and the.:utials of the they were returned to storage, the (b) Cobalt.60 as a scaled source in mdividual who made the survey.

number and activity of sources in needles and applicator cells for topical.

storage after the return, and the initials interstitial, and mtracavitary treatment of the individual who returned the of cancer:

sources to storage.

A (c) Gold-198 as a sealed source in' (c) Immediately after implanting l

[

seeds for interstitial treatment of cancer:

sources in a patient or a human research

\\

(d) Iridium-192 as seeds encased in subject the licensee shall make a D.-

nylon ribbon for interstitial treatment of radiation survey of the patient or the calicer; human research subject and the area of fel Strontium-90 as a sealed source in use to confirm that no sources have 80 PPolicator for treatment of superficial been misplaced. The licensee shall eye 2nditions: and make a record of each survey.

(N iodine 125 as a sealed source in seeds for interstitial treatment of cancer.

{ (dM licensee shall retain the recor g

f"~

e required in paragrr as (b) and (c) of this

$ Ig) Pull.dn.n -luJ os a sen.ed source g section for three years.

E in seeds for interstitial treatment of g

E cancer g

L i

l l

l b

i b._.,

3 5-19 September 29,1995 i

35.410(1) 35.420 PART 35. MEDICAL USE OF BYPRODUCT MATERIAL

~

$35.410 Safetyinstruction.

$ 35.415 Safety precautons.

(b) A licensee shall notify the (1) The licensee shall provide Radiation Safety Officer immediately if E radiation safety irstr'tetion to all

> (a) For each patient or human g

E personnel caring for the patient or the research subject receiving implant

the patient or the human research subject dies or has a medical emergency.

e E human research subject undergoing therapy and not released from licensee g implant therapy. To satisfy this

$ control pursuant to S 35.75 of this part.1

' requirement, the instruction must

- a licensee shall:

describe:

E (1) Not quarter the patient or the U human research subject in the same I

toom as an individual who is not g (1) Size and appearance of the receiving radiation therapy.

g brachytherapy sources:

(2) Safe handling and shielding L

e g instructions in case of a dislodged e source:

L ins.a o e e > aot or eriatrum nt.

A licensee authorized to use I

byproduct material for implant therapy b Procedures for patient or human - (2) Post the patient's or human shall have in its possession a portable g

(ea)rch subject control:

res research subject's door with a M radiation detection survey instrument E

" Radioactive Materials" sign and note Q capable of dv.ecting dose rates over the g

on the door or in the patient's or human e range 0.1 millirem per hour to 100 L

E research subject's chart where and how b millirem per hour, and a portable 3 long visitors may stay in the patient's or

• radiation measurement survey e human tesearch subject's room; instrument capable of measuring dose F (4) Procedures for visitor control: and g (3) Authorize visits by individuals rates over the rangie 1 millirem per hour R

under age 18 only on a case-by-case to 1000 millirem per heur.

basis with the approval of the authorized user after consultation with e

g the Radiation Safety Officer; and L

(4) Pc.. jtly after implanting tF F (5) Procedures for notification of the materian. survey the dose rates in contiguous restricted and unrestrb:t :

$ Radiation Safety Officer if the patient or areas with a radiation measuremer t

= the human research subject dies or has survey instrument to demonstrate E a medicalemerEency.

g coar liance with the requirements o!

a Part 20 of this chapter, and retain fer e

L.

three years a record of each survey that

includes the time and date of the survey.

a plan of the area or list of points

~

e (b) A licensee shall retain for three surveyed the measnred dose rate at

, years a record of individuals receiving several points expressed in millirem per z instruction required by paragraph (a) of hour, the instrument used to make the e th'2 section, a description of the survey, and the initials of the individual e instruction, the date of instructi.e tnd who made the survey.

A the name of the individual who 3 the

• !nstruction.

> (5)(Removed 62 FR 4120.)

1

)

O January 31,1997 35-20

35.500 35.615(b)

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL m

(

~

Sut pert H-Seeled Sources for Subpart I-Teletherapy (2)The procedure to be followed if:

Die 9noele (i) The operator is unable to turn the 1 35.000 Use of a seeied source in a primary beam of radiation off with Use of reeled sources for telethorapy unit.

controls outside the treatment room or 1 35.900 The regulations and provisions of this any other abnormal operation occurs:

A licensee shall use the following subpart govern the use of tektherapy and (ii) The names and telephone numbers sealed sources in accordance with the units for medical use that contain a n.

manufacturer's radiation safety and sealed source of cobalt-60 or cesium-137. E of the authorized users and Radiation 8

handling instructions:

Safety Officer to be immediately

''""*"*"#P*"

(a)lodme-125. americium-241 c,e contacted if the teletherapy unit or gadolinium 153 as a sealed source in a console operates abnormally.

device for bone mineral analysis: and Only a person specifically licensed by (b) A licensee shall provide the Commission or an Agreement State nstruction in the topics identified in (b) lodine-125 as a sealed source in a to perfonn teletherap; unit mamtenance paragraph (a) of this section to all portable imaging device.

g and repair shail:

individuals who operate a teletherapy g i 35.530 AvaliabilNy of survey instrumort-(a) Install. relocate or remove a unit.

5 A licensee authorized to use teletherapy sesled source or a g byproduct material as a sealed source teletherapy unit that contains a seeled

{ (c) A licensee shall retain for three

.for diagnostic purposes shall have source:or available for use a portable radiation (b) Maintain, adjust. or repair the a years a record of individuals receiving detection survey instrument capable of source drawer. the shutter or other 7, inatruction required by paragraph (bl of detecting dose rates over the range 0.1 n, mechanism of a teletherapy unit that 2 this section, a description of the millirem per hour to 100 rnillirem per g could expose the source. reduce the E instruction, the date ofinstruction. and hour or a portable rac"ation 8 shieldmg around the socree. or result in g the name of the individual who gave the measurement surt,tf nstrument capable f increased radiation levels.

instruction.

i of measuring dose rates over the range 1 3 5 35.008 Ucones amendments, millirem per hour to 1000 millirem per hour.The instrument must have been In addition to the changes specified in calibrated in accordance with i 35.51 of i 35.13 of this part. a liceasee shall I 35.s15 safety preceuuona.

this part.

apply for and must receive a license (a) A licensee shall control access to

[m amendment before:

the teletherapy room by a door at each g

entrance.

(a) Making any change in the

' D y/.

treatment room shielding:

(b) Alicensee shall equip each (b) Making any change in the location entrance to the teletherapy room with of the teletherapy unit within the an electricat interlock system that will:

M (1) Prevent the operator'from turning treatment room:

(c) Using the teletherapy unit in a Q the primary beam of radiation on unless each treatment room entrance dooris manner that could result in increased c:' closed:

radiation levels in areas outside the teletherapy treatment room:

(2) Turn the primary beam of radiation off immediately when an entrance door (d) Relocating the teletherapy unit; or iaopened;and (e) Allowing an individual not listed (3) Prevent the primary beam of on the licensee's license to perform the rediation from being turned on following duties of the teletherapy physicist.

an interlock interruption until all

$ 35.610 Safety instruction.

treatment room entrance doers are closed and the beam on-off controlls (a) A licensee shall post instructions reset at the console.

at the teletherapy unit console. To satisfy this requirement. tl.ese instructions must inform the operator of:

(1)The procedure to be followed to g ensure that only the patient or the

human research subject is in the a": treatment room before turning the primary beam of radiation on to begin E a treatment or after a door interlock interruption; O

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U 35-21 September 29,1995

~

j

I r..

35.615(c) 35.630(c)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL (c) A hcesee shall equip each (e) A licensee shall construct or equip

- (1)The system must have been entrance to the teletherapy room with a Q; each teletherapy room to permit cahbrated by the National Institute of beam condition indicator light.

" continuous observation of the patient or Standards and Technology g

(d) A licensee shall installin each e the human reseamh subject from the or by a calibration laboratory teletherapy room a permanent radiation l; teletherapy unit console during accredited by the American Association monitor capable of continuously

• irradiation.

of Physicists m Medicine (AAPM).The l

monitoring beam status.

L cahhration musi have been performed (1) A radiation monitor must provide within the previous two years and after visible notice of a teletherapy unit any serviemg that may have affected N malfunction that results in an exposed system cahbration; or S or partially exposed source. and must be i ss.sto poosession of survey instrument.

(2) The system must have been

• bservable by an individual entenng the A licensee authorized to use calibrated within the previous four o

i teletherapy room.

byproduct materialin a teletherapy unit years: eighteen to thirty months after (2) A radiation monitor must be shall have in its possession either a that cahbration. the system must have equipped with a backup power supply portable radiation detection survey been intercompared at an separate from the power supply to the tnstrument capable of detecting dose interc mpanson meetmg with another teletherapy unit. This backup power a rate over the range 0.1 millirem per hour dosimetry systeri that was calibrated supply may be a battery system.

$ to 100 milbrem per hour or a portable withm the past twenty-four months by g radiation measurement survey S theNational Institute of Standards and t instrument capable of measunng dose p Technology or by a rates over the range 1 milhrem per hout y a cahbration laboratory accredited by (3) A radiation monitor must be to 1.000 millirem per hour.

u. the AApM.The intercomparison

~

R checked with a dedicated check source

$ meeting must be sanctioned by a 4

g for proper operation each day before the calibration laboratory or radiologic h'f,"$,"r't

{ teletherapy unit is used for treatment cif f as.sao DeWmetry equipment.

i tercompanso e patients or human research subjects.

(a! A heensee shall have a calibrated meeting must have indicated that the dosimetry system available for use. To cahbration factor of the licensee's satisfy this requirement. one of the system had not changed by more than,

followmg two conditions must be met.

percent. The licensee may not use the

~

intercomparison result to change the (4) A licensee shall mamtam a record of the check required by paragraph cabbraten factor. When intercomparing W

dosimetry systems to be used for O (d)(3) of this section for three years. The cahbrating cobalt-60 teletherapy units.,t record must include the ste of the E check. notation that the t omtor the hcensee shall use a teletherapy uni k indicates when its detect, e is and is not with a cobalt-60 source. When v

" exposed, and the initials si the intercomparing dosimetry systems to be r ca ahng cusm437 individual who performed the check.

teletherapy units. the licensee shall use "e

erapy unit with a cesium-137 (5)If a radiation monitor is sou inoperable. the licensee shall require any individual entenng the teletherapy room to use a survey mstrument or (b) The licensee shall have available audible alarm personal dosimeter to for use a dosimetry system for spot.

monitor for any malfunction of the check measurements.To satisfy this source exposure mechanism that may requirement. the system.may be result in an exposed or partially compared with a system that has been exposed source. The instrument or calibrated in accordance with paragraph dosimeter must be checked with a is) of this section. This companson must dedicated check source for proper have been performed within the operation at the beginning of each day previous year and after each servicing N of use. The licensee shall keep a record N that may have affected system 2 as described in paragraph (d)(4) of this calibration.The spot-check system may

• section.

" be the same system used to meet the k (6) A licensee shall promptly repair or requirement in paragraph (a) of this N replace the radiation monitor if it is

secten.

inop,erable.

(c) The licensee shall retain a record of each calibration. intercomparison, and comparison for the duration of the license. For each calibration.

intercomparison. or comparison. the record must inc.lude the date, the model riumbers and serial numbers of the instruments that were calibrated.

intercompared. or compared as required by paragraphs (a) and (b) of this section. e sepmmber me,ms 3s.22

l p 35.630(c) 35.634(e)

( j).

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL A

the correction factor that was Id) A licensee shall make full (2) On-off error:

I deiermined from the cahbration or cabbration measurements required by (3) The coincidence of the radiation

)

comparison or the apparent correction paragraph (a) of this section in field and the field indicated by the light j

factor that was determined from an accordance with either the procedures beam localizing device:

l intercomparison, the names of the recommended by the Scientific (4) The accuracy of all distance i

individuals who performed the Committee on Radiation Dosimetry of measunng and localitation devices used i

calibration. intercomparison. or the American Association of Physicis',

for medical use:

comparison. and evidence that the in Medicine that are described in (5) The output for one typical set of intercompanson meetmg was Physics in Medicine and Biology W1.

operating conditions measured with the sanctioned by a cahbration laboratory

16. No. 3.1971, pp. 379-396. or b' (ask

. dosametry system described in or radiologic physics center accredited Group 21 of the Radiation The.apy

I 35.630(b) of this part; and by AAPM.

,, Committee of the Americap association A (6) The difference between the Physicists in Wdicin described in Medical %,e Mat are a measurement made in paragraph (b)(5) i 36.632 Full caleewatson -

-- to-ysics Vol.10.

• of this section and the anticipated (a) A licensee authorized to use a e No. 6.1983, pp. 741471,and Vol.11. No.

3 output, expressed as a percentage of the teletherapy unit for medical use shall

, 2.1904. p. 213. (Both of these re'erences anticipated output (i.e the value j

perform full cahbration measurements

• have been approved for incorporation obtained at last full calibrat'on on each teletherapy unit:

by reference by the Director of the corrected mathematically for physical (1) Before the first medical use of the Federal Register. Copies of the decay 1 i

unit: and documents are available for inspection at (b) A licensee shall perform (2) Before medical use under the the NRC 1.ibrary.11543 Rockville Pike.

measurements required by paragraph (a) following conditions:

Rutkville. Mar) land 208U4738, Copies of of this section in accordance with (i) % henes er spot. check the dmumenin are also nn file at the office procedures established by the measurements indicate that the output of the feriered Peer. I1001. Street NW teletherapy physicist. That individual differs by more than 5 per..ent from the Room 8101. hhinuton. UC Ju40a A output obtained at the las full need not actually perform the spotcheck notice or ant thange in the n.aterial will calibration corrected mathematically for tw pubinhed in the Federal Register !

-measurements.

'***'gi7, g*r placement of the 2

(c) A licensee shall have the i; p, source or following remstallation of the (e) A licensee shall correct teletherapy physicist review the results e

~ teleoersey unit in a new location:

mathematically the outputs determined y of each spot-check within 15 days. The

/

\\

; il Following any repair of the in paragraph (b)(1) of this section for teletherapy physicist shall promptly I

4 A *eletherapy unit that includes removal of physical decay for intervals not

[ notify the licensee in writing of the

/

e the source or major repair of the exceeding one month for cobalt 60 or six

,., results of each spot-check.The licensee

" components associated with the source months for cesium-137.

shall keep a copy of each written a

v

% exposure assembly: and (f) Full calibration measurements notification for three years.

(3) At intervals not exceedmg one required by paragraph (a) of this section year.

and physical decay corrections required (d) A 1.censee authorized to use a (b)To satisfy the requirement of by paragraph (e) of this section must be teletherapy unit for medical use shall paragraph (a) of this section. full performed by the licensee's teletherapy Perform safety spot-checks of each calibration measurements must include physicist.

teletherapy facility once in each determination of:

(g) A licensee shall retain a record of calendar month that assure proper (1)The output within 23 percent for each cahbration for the duration of use Operation of:

the range of field sizes and for he of the teletherapy unit source.The (1) Electricalinterlocks at each distance or range of distances used for

= record must include the date of the teletherapy room entrance:

medical use:

$ calibration. the manufacturer's name.

(2) Electrical or mechanical stops (2) The coincidence of the radiation

• model number, and serial number for installed for the purpose oflimiting use field and the field indicated by the light

[ both the telethera9y unit and the source, of the primary beam of radiation beam localizing device:

- the model numbers and serial numbers (restriction of source housing angulation (3)The uniformity of the radiation

• of the instruments used to calibrate the 4 or elevation. carriage or stand travel field and its dependence on the teletherapy unit. tables that describe the

! and operation of the beam on off l

onentation of the useful beam:

output of the unit over the range of field

mechanism)

(4) Timer constancy and imeanty over sizes and for the range of distances used (3) Beam condition indicator lights on a

the range of use; in radiation therapy, a determination of the teletherapy unit, on the control (5) On off error; and the coincidence of the radiation field console, and in the facility; (6) The accuracy of all distance and the field indicated by the hght beam (4) Viewing systems:

usuring and localization devices in localizing device. an assessment of timer (5) Treatment room doors from inside 2 lical use.

Imeanty and constancy, the calculated and outside the treatment room; and l

i 4 4 A licensee shall use the dosimetry on-off error. the estimated accuracy of (6) Electrically assisted trastment I

sys em described in i 35.630(a) to each distance measuring or localization room dours with the teleti wapy unit measure the output for one set of device, and the signature of the electrical power turned off, exposure conditions.The remaining teletherapy physicist.

(e) A licensee shall arrange for prompt radiation measurements required in repair of any system identified in paragraph (b)(1) of this section may be Nd N *Mie**"*-

paragraph (d) of this section that is not made using a dosimetry system that (a) A licensee authorized to use operating properly. and shall not use the indicates relative dose rates.

teletherapy units for medical use shall teletherapy unit following door interlock perform output spot-checks on each malfunction until the interlock system g}

teletherapy unit once in each calendar has been repaired.

t

/i month that include determination of:

(/

(1) Timer constancy, and timer lineanty over the range of use:

a 14.9't Etamamher 90 1004

35.634(f) 35.643(b)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAL (f) A licensee shall retain a record of I as s41 P% sunreys for teletherapy (c) A licensee shall retain a record of cach spot-check required by paragraphs seemes.

the radiation measurements made (a) cnd (d) of thi, i : tion for three years.

(a) Before medical use, after each following installation of a source for the Th2 record must include the date of the installation of a teletherapy source, and duration of the license. The record must spot-check, the manufacturer's name.

efter making any change for which an include the date of the measurements, model number, and serial number for g amendment is required by I 35.806 (a)-

the reason the survey is required, the both the teletherapy unit and source, the

. (d), the licensee shall perform radiation manufacturer's name, model number minufacturer s r.ame, model number a surveys with a portable radiation and serial number of the teletherapy and serial number of the instrument

,, measurement survey instrument unit, the source, and the instmment used used to measure the output of the calibrated in accordance with I 35.51 of a

g o measure radiation levels, each dose t

t;letherapy unit, an assessment of timer this part to verifv that:

liniarity and constancy, the calculated (1) *Ihe maximum and average dose e rate measured around the teletherapy on-off error, a determination of the rates at one meter from the teletherapy 8 source while in the off position and the 3 coincidence of the radiation field and source with the source in the off position E average of all measurements, a plan of 0 the field indicated by the light beam and the collimators set for a normal E the areas surrounding the treatment E localizing device, the calculated on-off treatment field do not exceed to room that were surveyed, the measured S (rror, the determined accuracy of each millirem per hour and 2 millirem per dose rate at several points in each area "a. distance measuring on localization hour, respectively; and expressed in millirem per hour, the hice, the difference between the (2) With the teletherapy source in the calculated maximum quantity of anticipated output and the measured on position with the largest clinically radiation over a period of one week for cutput, notations indicating the available treatment field and with a each restricted and unrestricted area, operability of each entrance door scattering phantom in the primary beam and the signature of the Radiation ti:ctrical interlock. each electrical or of radiation, that:

Safety Officer.

mechanical stop, each beam condition

~

~

indicator light, the viewing system and doors, and the signature of the ndiv ual who performed the periodic

> (i) Radiation dose rates m restricted 5 35.643 Modmcation of teletherapy unit or p

areas are not likely to cause any room before tWnning a treatment occupationally exposed individual to P'*8'**-

> (a) If the survey required by $ 35.641 135.sss severy checas for tesetherapy receive a dose in excess of the limits teemes.

t specified in $ 20.1201 of this chapter; indicates that any individual member of (a) A licensee shall promptly check all ' and R the public is likely to receive a dose in systems listed in 5 35.634(d) for proper h

(ii) Radiation dose rates in controlled j excess of the limits specified in l function after each installation of a

' or unrestricted areas are not likely to e $ 20.1301 of this chapter, the licensee g teletherapy source and after making any 9 cause any individual member of the

' shall, before beginning the treatment 8

g change for which an amendment is public to receive a dose in excess of the I

prog) ram:(1 Either equip the ut.it with stops or 1

a required by I 35. sos (aHd).

limits specified in $ 20.1301 of this g (b)If the results of the checks required

chapter, add additional radiation shielding to in paragraph (a) of this section indicate ensure compliance with $ 20.1301 of g the malfunction of any system specified this chapter' in i 35.634(d), the licensee shalllock the

~

control console in the off position and

~

not use the unit except as may be (b)If the results of the surveys necessary to repair. replace, or check required in paragraph (a) of this section (2) Perform the survey required by the malfunctioning system.

indicate any radiation dose quantity per i 35.641 again: and

_~

n, unit time in excess of the respective (c) A licensee shall retain for three 9 limit specified in that paragraph, the g

(3)1nclude in the report required by years a record of the facility checks 8 licensee shall lock the controlin the off g i 35.645 the results of the initial survey, a description of the modification made 3 followinginstallation of a source.The E position and not use the unit:

e' to comply with paragraph (a)(1) of this a record must include notations indicating 3 (1) Except as may be necessary to section, and the results of the second

=

the operebility of each entrance door

interlock. each electrical or mechanical repair, replace, or test the teletherapy unit shielding or the treatment room survey.

a y stop, each beam condition indicator shielding; or light. the viewing system, and doors, and signature of the Radiation Safety (b) As an alternative to the requirements set out in paragraph (a) of

=

(2) Until the licensee has received this section, a licensee may request a a specific exemption pursuant to

~ license amendment under $ 2a1301(c)

E $ 2a1301 of this chapter E of this chapter that authorizes R

E radiation levels in unrestricted areas

{

E greaterthanthosepermittedby E $2a1301(a)of thischapter Alicensee may not begin the treatment pmgram untilthe license amendment has been issued.

m, sa

1 4

35.910(b) 35445 PART 35 e MEDICAL USE OF BYPRODL3 T MATERIAL n

i SEAa6 Reports of teletherapy surveys.

Subspert J-Training and Experience i 35.910 Trenning for uptake, dilution, and excretion studies.

cheeks. tests, and measurementa.

Requ rements Except as provided in il 35.970 and A licensee shall mail a copy of tFe records required in il 35.636. 35.641.

35.971 the licensee shall require the j

i 35m Radiscon Sawy Omcor, authorized user of a j

35.643. and the output from the Except as provided in i 35.901. the g radiopharmaceuticalin i 35.100(a) to be teletherapy source expressed as licensee shall require an individual e a physician who:

roentgens or rads per hour at one meter fulfilling the responsibilities of the t (a)is certified in:

I from the source and determined dunng (1) Nuclear medicine by the American Sdiation Safety Officer as provided in the full calibration required in i 35.632.

35.32 to be an individual who:

Board of Nuclear Medicine:

to the appropriate Commission Regw Office listed in i 30.6 of this chapts (a)Is certified by:

(2) Diagnostic radiology by the within thirty days following comple (1) American Board of Health Physics American Board of Radiology; or of the action that initiated the recort Comprehensive Health Physics-

2) American Board of Radiology:

requirement.

'3) American Board of Nuclear (3) Diagnc fic radiology or radiology 5 85A87 Nve year inepection.

.*dicine:

by the American Osteopathic Board of

~ Radiology:

(a) A licensee shall have each R (4) Nuclear medicine by the Royal g teletherapy unit fully inspected and e serviced during teletherapy source (4) American Board of Science in E College of Physicians and Surgeons of 8 replacement or at intervals not to Nuclear Medicine:

E Canada:or E exceed five years, whichever comes (5) Board of Pharmaceutical

$ [5) American Osteopathic Board of Nuclear Medicine in nuclear medicine:

Sp(ecialties in Nuclear Pharmacy; E first, to assure proper functioning of the

6) American Board of Medical or source exposure mechanism.

g y (ysics in radiation oncology physics:

2: Ph (b) This inspection and servicing may

7) Royal College of Physicians and only be performed by persons specifically bcensed to do so by the

Surgeons cf Canada in nuclear (b) Has had classroom and laboratory Commission or en Agreement State.

• medicine; training in basic radioisotope handling (c) A licensee shall keep a record of (8) American Osteopathic Board of techniques applicable to the use of the inspection and servicing for the Radiology: or prepared radiopharmaceuticals, and

19) Amencan Osteopathic Board of supervised cimical experience as duration of the licente. The record must Nuclear Medicine: or gagtow,.

contain the inspecur s name, the (1) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom and inspector's license number, the date of k laboratory training that includes:

1 inspection, the manufacturer's name and C-model number and serial number for (b) Has had classroom and laboratory 9 (i) Rar'istion physics and x

8 instrumentation:

both the teletherapy unit and source, a training and experience as follows:

list of components irspected, a list of (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and E (ii) Radiation protection:

i (iii) Mathematics pertainira to the use j

components serviced and the type of laboratory training that includes:

and measurement of radioactivity

service, a list of components replaced.

(i) Radiation physics and (iv) Radiation biology; and and the signature of the inspector, instrumentation:

(v) Radiophartnaceutical chemistry:

(ii) Radiation protection:

and (iii) Mathematics pertaining to the use (2) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical and measurement of radioactivity; (iv) Radiation biology; and experience under the supervision of an

, (dv) Radiopharmaceutical chemistry; authorized user and that includes:

an

)

(2) One year of full time experience as l-

@ re(i) Examining patients or human I

g a radiation safety technologist at a g medicalinstitution under the supervision of the individualidentified E case histories to determine their g

as the Radiation Safety Officer on a E suitability.for radioisotope diagnosis,

• I mitations. or contraindications:

e Commission or Agreement State beense e

that authorites the medical use of L

byproduct material: or

)

(c) Be an authonzed user identified on the licenvee's license.

(ii) Selecting the suitable E radiopharmaceuticals and calculating and measuring the dosages:

i 35. set Trainens for emper6enced nadietion see ty omeer.

g Anindividualidentified as a E

Radiation Safety Officer on a Commission or Agreement State license l

before October 1,1986 need not comply

(_

j with the training requirements of 5 35.900.

s O.

35 25 September 29,1995

35.910(b) 35.92(ife)

PART 35 e MEDICAL USE OF BYPRODUCT MATERIAc F (iii) Administering dosages to patients r (1) Exacining patients or human9i (b) Has had classroom and laboratory g

~

e or human waarch subjects and using training in basic radioisotope handling E research subp and reviewing their y syringe radiation shields:

techniques applicable to the use of 3 case histories to determine their g

prepared radiopharmaceuticals.

E suitability for radioisotope diagnosis, generators and reagent kits. supervised

$ limitations. or contraindications:

eL

-ork experi ace. *ad==pervised clinical expenence as follows:

r (iv) Collaborating with the authonzed

~

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

Rad ion physics and

$ test results: and E

S (ii) Radiation protection:

g radiopharmaceuticals and calculating and measuring the dosages:

8 (iii) Mathematics e

3 L

E *"d =a'""=at aI"ertaining to the use diac*ity:

(iv) Radiopharmaceutical chemistry

{ (v) Patient or human research subject and (v) Radiation biology: and

~

R followup:or (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work E

expenence under the supervasion of an E

authorized user that includes:

(i) Ordenng. receiving, and unpacking @ (iii) Administering dosages to patients radioactive materials safely and s or human research subjects and using performing the related radiation e syrir.ge radiation shields:

surveys:

(c) Has successfully completed a six.

(ii) Calibrating dose calibrators and month training program in nuclear diagnostic instruments and performing medicine as part of a training program checks for proper operation of survey f

that has been approved by the meters:

Accreditation Council for Graduate (iv) Co!!aborating with the authonzed Medical Education and that included g

g userin the interpretation of radioisotope classroom and laboratory training. work 2 (iii) Calculating and safel reparing g test reaults: and experience, and supervised clinical -

y patient or human research u ject

$ experience in all the topics identified in - dosages:

E g paragraph (b) of this section.

S

[

E 35.920 Trainenq tor imaging and

{ (v) Patient or human research subject I

3 4ocannenon stud 6e*

(iv) Using admiristrative controls to

~

Except as provided in i 35.970 or prevent the misadministration of 2 ollowup:or f

35.9't, the licensee shall require the byproduct matenal:

3 authorized user of a (v) Using procedures to contain spilled E radiopharmaceutical, generator, or byproduct material safely and using S

reagent kit in i 35.400(a) to be a 4 proper decontamination procedures and j physician who:

Q (vi) Eluting technetium-99m from l_

(a)Is certified in:

e generator systems, measuring and (1) Nuclear medicine by the American t testing the eluate for molybdenum-99 (c) Has successfully completed a six-Board of Nuclear Medicine:

• and alumina contamination, and month training program in nuclear processing the eluate with reagent kits medicine that has been approved by the to prepare technetium 99m labeled g Accreditation Councilic' Graduate (2) Diagnostic radiology by the radiopharmaceuticals: and g Medical Education and that included American Board of Radiology:

(3) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical classroom and laboratory training. v ork e

(3) Diagnostic radiology or radiol experience under the supervision of an t experience, and supervived clinical g by the Ame-ican Osteopathic Board f authorized user that includes:

e experience in all the topics identified in 2 Radiology;

{ paragraph (b) of this section.

E (4)Nuclearmedicine the Royal

College of Physicians an Surgeons of

• Canada:or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or

?

September 29,1995 35 26

35.930 35.940(b)

PART 35 o MEDICAL USE G BYPRODUCT MATERIAL f (1) Radiology, thera utic radiology,

$ 35.830 Training for therapeutic use of i 35.932 Tra6ning for treatment et e uneealed t>yproduct material.

1,4:.1,. ~

g orradiationoncology ythe American y

Except as provided in 5 35.970, the c Board of Radiology:

licensee shall require the authorized y

I i

E user of only iodine 131 for the treatment l

[

of hyperthyroidism to be a physician S

with special experience in thyroid

{

l f

disease who has had classroom and g Except as provided in i 35.970, the laboratory training in basic radioisotope j

• licensee shall require the authonzed handling techniques applicable to the

[ to be a physician who:

user of radiopharmaceuticals in i 35,300 use ofiodine 131 for treating (2) Radiation oncology by the

)

hyperthyroidism. and supervised clinical A'nerican Osteopathic Board of i

w expenence as follows:

Radiology:

[ (a)is certified by:

E (a) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and (3) Radiology, with specialization in laboratory training thatincludes:

radiotherapy. as a British "fenow of the (1) Radiation physics and Faculty of Radiology" or *Tellow of the instrumentahon; Royal College of Radiology": or 8I er ain'ing to the use (1)The Arnerican Board of Nuclear a e stic l

I" I ""'

Medicine; and measurement of radioactivity: and and (2)The American Board of Radiology (4) Radiation biology; and (b)Is active practice of g in radiology, therapeutic radiology, or (bj Supervised clinical experience therapeutic radiology, has had under the supervision of an authorized classroom and laboratory training in g radiation oncology:

(3) Nuclear m,edicine b the Royal user that includes the use ofiodine-131 radioisotope handling techniques a.

g College of Physicians an Surgeons of

, for diagnosis of thyroid function, and the applicable to the therapeutic use of a Canada:or g treatment of hvperthyroidism in 10 brachytherapy sources. supervised work (4)The American Osteopathic Board 8 individuals.

experience, and supervised clinical of Radiology after 1984: or h 5 35.93a Training for treatment of thyroid experience as follows:

e cerc6 noma.

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and Except as provided in i 35.970. the g laboratory training that includes:

{s licensee shall requ(re the authorized 8 ns(1) Radiation physics and e

i trumentation; user of only iodine-131 for the treatment k

of thyroid carcinoma to be a physician E (ii) Radiation protection:

(b) Has had classroom and laboratory with special experience in thyroid s (iii) Mathematics pertaining to the use training in basic radioisotope handling disease who has had classroom and and measurement of radioactivity: and techniques applicable to the use of laboratory training in basic radioisotope (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 therapeutic radiopharmaceuticals, and handling techniques applicable to the supervised clinical experier:ce as use of iodine 131 for treating thyroid exgs tvis ri ] Hon c nd' a

,er s

} tt follows:

carcinoma. and supervised clinical la re ory traim a clu s:

() hours of assroom and i) e

, receiving, and unpacking (i) Radiation physics and laboratory training that includes:

radioactive materials safely and instrumentation:

(1) Radiation physics and performing the related radiation 2fRad atn rotection:

) t ecking sarvey meters for proper i)M eae a ing to the use h and measurement o radioactivity; and (3) Mathematics pertaining to the use ope etion:

(iv) Radiation biology: and and measurement of radioactivity; and (i) Prep 3 p ting,

[4) Radiation biology; and removing sealed sources:

E (2) Supervised clinical experience (b) Supervised clinical experience (iv) Maintaining running inventories under the supervision of an authorized undti the supervision of an authorized of material on hand:

user at a medicalinstitution that user that includes the use of iodine-131 (v) Using administrative controls to includes:

for the treatment of thyroid carcinoma prevent the misadministration of (i) Use ofiodine-131 for diagnosis of in 3 individuals' byproduct material: and thyroid function and the treatment of (vi)Using emergency procedures to hyperthyroidism or cardiac dysfunction i 35.ta0 Training for use of treehytherapy control byproduct material: and

'n to individnals; and sourees.

(ii) Use of lodine 131 for treatment of Except as provided in i 35.970, the thyroid carcinoma in 3 Individuals-licensee shall require the authorized user of a brachytherapy source listed in i 35.400 for therapy to be a physician who:

(a)is certified in:

l (w) t l

l 35 27 september es,iets

35.940(b) 35.960(b)

PART 35. MEDICAL USE OF BYPRODUCT MATERIAL f (1) Radiology, thera eutic radiology.

(3)Three years of supervised c!mical I 35.s50 Trainen9 for use of sealed expenence that includes one year in a sources for dia9noans.

3 or radiation oncology y the American formal trauar g program approved by the g Except as provided in i 35.970. the g Board of Radiology:

Residency Review Committee for g licensee shall require the authorized e

Radiology of the Accreditation Council c user of a sealed source in a device listed E for Geaduate Medical Education or the i in 135.500 to be a physician. dentist. or Committee on Postdoctoral Training of podiatrist who:

L the American Osteopathic Association-(a)Is certified in:

and an additional two years of clinical

~

experience in therapeutic radiology under the supervision of an authorized r-(2) Radiation oncology by the user at a medicalinstitution that I

(1) Radiology, diagnostic radiology.

American Osteopathic Board of includes:

e thera utic radiology, or radiation Radiology (i) Examining individuals and 3 onco ogy by the American Board of (3) Rad logy, with specialization in reviewmg their case histories to e Radiology:

radiotherapy, as a British 'Tellow of the determine their suitability for 7,; (2) Nuclear medicine by the American Faculty of Radiology"or " Fellow of the brachytherapy treatment, and any

• Board of Nuclear Medicine:

Royal College of Radiology": er limitations or contraindications:

(ii) Selecting the proper brachytherapy (4) Therapeutic radiology by the sources and dose and method of Canadian Royal College of Physicians administration:

and Surgeons; or (b)15 m the active practice of

{ili) Calculatmg the dose: and therapeutic radiology and has had (iv) Post-administration followup and (3) Diagnostic radiology or radiology classroom and laboratory training irs

~

review of case histories in collaboration 2 by the American Osteopathic Board of basic radioisotope techniques applicable with the authonzed user.

8 Radiology: or to the use of a sealed source in a E

$ 25.941 Training for ophmalmic vae of teletherapy unit. supervised work otrontiumm.

g experience, and supervised clinical n

I experience as follows:

E Except as provided in i 35 970, the L.

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

E user of only strontium-90 for ophthalmic (-

(i) Radiation physics and

~

g radiotherapy to be a physician who is in l (4) Nuclear medicine by the Royal 2 instrumentation:

l the active practice of therapeutic g College of Physicians and Surgeons of 8 (ii) Radiation protection:

radiology or ophthalmology and has

Canada: or E (iii) Mathematics pertaining to the use had clas.sroom and laboratory training 2 and measurement of radioactivity: and in basic radioisotope handling (iv) Radiation biology:

w techniques applicable to the use of R

(2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work radiotherapy. and a period of supervised {

strontfum-90 for ophthalmic experience under the supervision of an authorized user at a medicalinstitution clinical trainingin ophthalmic that includes:

radiotherapy as follows:

(i) Review of the full calibration (a) 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and measurements and periodic spot checks:

laboratory training that includes:

- (b)Has had 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and (ii) Preparing treatment plans and (1) Radiation physics and laboratory training in basic radioisetope calculating treatment times:

instrumentation:

handling techniques specifically (iii) Using administrative controls to (2) Radiation protection:

applicable to the-use of the device that prevent misadministrations:

includes:

(iv) Implementing emergency (3) Mathematics pertainmg to the use and measurement of radioacuvity; and (1) Radiation physics. mathematics

}ojedures followed e event pertammg to the use and messurement P

(4) Radiation biol (b) Supervised climcal trainmg in pj of radioactivity, and instrumentation:

teletherapy unit or console; and ophthalmic radiotherapy under the 8 (2) Radiation biology:

(v) Checking and using survey meters; o'

3) Radiation protection; and and E. (4) Training in the use of the device (3) Three years of supervised clinical supervision of an authorized user at a

(

medicalinstitution that includes the use of strontium-90 for the ophthalmic 3 for the uses requested.

experience that includes one year in a formal training program approved by the treatment of five individuals that

$ 35.9s0 Tra6nin9 for telemerapy.

Residency Review Committee for includes:

i Except as provided in i 35.970, the Radiology of the Accreditation Council

)

(1) Examination of each individual to licensee shall require the authorized for Graduate Medical Education or the be treated:

user of a sealed source listed in i 35.600 Committee on Postdoctoral Training of (2) Calculation of the dose to be in a teletherapy unit to be a physician the American Osteopathic Association 1

administered:

who:

and an additional two years of clinical (3) Administration of the dose; and (a)Is certified in:

experience in therapeutic radiology i

(4) Followup and review of each individuars case history.

September 29,1995 35-28

l 35.960(b) 35.980(b) l PART 35 MEDICAL USE OF BYPRODUCT MATERIAL f^'%

i

~l noto trainine for esperienced (A) Radiation physics and under the supervision of an authonzed user at a medicalinstitution that authorised users.

instrumentation; includes:

Physicians. dentists, or podiatrists (B) Radiation protection:

2 (1) Examining individuals and identified as authorited users for the (C) Mathematacs pertaining to the, use -

g reviewing their case histories to medical. dental. or podiatric use of and measurement of radioactivity:

, determine their suitability for byproduct material on a Commission or (D) Chemistry of byproduc; material w teletherapy treatment, and any Agreement State license issued before for medicaluse: and Elimitations or contraindications:

April 1,1987 who perform only those (E) Radiation biology; and methods of use for which they were (II) Supervised experience in a (ii) Selecting the proper dose and how g it is to be administered:

,, authorized on that date need not comply nuclear pharmacy involving the 18 with the training requirements of following:

E Subpart J.

(A) Shipping, receiving, and 3

Perfo related mdiation ys; (iii) Calculating the teletherapy doses 6 as. ort phye6elen training in a three (B) sing and pe orming for G; Proper operation of dose calibrators, and collaborating with the authorized monen program.

y userin the review of patients' or human A physicina who, before July 1.1984.

survey meters, and,if appmpriate, g research subjects' progress and began a three month nuclear medicine e instruments used to measure alpha or

$ eta emitting radionuclides:

e consideration of the need to modify training program approved by the eb I originally prescribed doses as warranted Accreditation Council for Graduate (C) Calculating, assaying, and safely

• by patients' or human research subjects' Medical Education and has successfully Preparing dosages for patients or human reaction to radiation: and completed the program need not comply with he requirements of El 35.910 or jbects use avoid mistakes in the administration of

~

byproduct material:

(iv) Post-administra tion followup and (E) Using procedures to prevent or review of case histories.

minimize contamination and using Proper decontamination procedures:

~

i 36.961 Training for telethorapy physicist.

$35.972 Recentness of training.

and

- Th !

@ teletherapy phys cist to a indiv; dual The training and experience specified (2) Has obtained written certification, in this subpart must have been obtained signed by a preceptor authorized abis certified by the American Board within the 7 yean preceding the date of nuclear pharmacist, that the above g who.

E (Radiologyin:

application or the individual must have training has been satisfactorily (1) Therapeutic radiological physics; had related continuing education and completed and that the individual has 3.f o

/

V (2) Roentgen ray and gamma ray experience since the required training achieved a level of competency physica:

and experience was completed.

sufficient to independently operate a nuclear phannacy.

(3) X ray and radium physics: or (4) Radiological physics: or g

c g $ 35.900 Training for an authorized nucieer e pher.nacist.

The licensee shall require the (b)is certified by the American Board authorized nuclear pharmacist to be a of Medical Physics in radiation phannacist who:

oncology physics: or (a) Has current board certification as a nuc ar p nnadst Board of (c) Holds a master's or doctor's ical u degree in physics. biophysics.

$ck c m$p 7

'h urs in a E radiological physics, or health physics-structured educational program

• and has completed one year of full time consisting of both:

E training in therapeutic radiological (i) Didactic training in the following E physics and an additional year of full areas:

time work experience under the supervision of a teletherapy physicist at a medicalinstitution that includes the tacka listed in Ii 35.59. 35.632. 35.634, and 35.641 of this part.

+

b

!U_.

l l

l 35,981 35,9 5 l

PART 35. MEDICAL USE OF BYPRODUCT MATERIAL

$ 36.981 Tr16nhg for experlenced nuclear Subpart K-Enforcement (b) The regulations in Part 35 that are Pharmeclets.

not issued under subsections 161b,1611, A licensee may apply for and must E or 161o for the purposes of section 223 receive a license amendment identifying E are as follows: $$ 35.1,35.2,35.7. 35.8, i

an experienced nuclear pharmacist as E 35.12, 3 5.15, 35.18, 35.19, 35.57, 35.100.

I an authorized nuclear pharmacist before

• 35.600, 35.901,35.970,35.971,35.990, it allows this individual to work as an 35M0 Ylossoons.

35.991, and 35.999.

Q authorized nuclear pharmacist. A (a) The Commmme raay obtam an 2 pharmacist who has completed a "

injunction or other court order to

• structured educational program as prevent a violation of the provisions 0

speci5ed in $ 35 980(b)(1) before December 2,1994, and who as working in

) The Atomic Energy Act of1954. as amended-a nuclear pharmacy would qualify as an (2) Title 11of time Energy experient:ed nuclear pharmacist. An Reorganir.ation Act of1974. as amended experienced nuclear pharmacist need not o,

comply with the requirements on (3) A segulados or order issaed preceptor statement ($ 35.980(b)(2)) and pursuant to those Acts.

~

recentness of training ($ 35.972) to qualify (b) The Com=- sney obtain a i 35.999 Resolutlon of conf 5cting as an authorized nuclear pharmacist.

court order for abe payment of a cieil requeroments shamg m period.

penalty imposed under section 234 of the If the rules in this part conflict with Atomic Energy Act the licensee's radiation safety program (1) For violations of-as identified in its license, and if that (i) Sections 53.57,62.63.81,82.101, license was approved by the 103.104.107, or 109 of the Atomic

, Energy Act of1954. as amended; Commission before April t.1987 and has g (ii)Section 206 of the Energy g not been renewed since Aprill,1987,

,R a then the requirements in the license will g eorganization Act g apply.However,if thatlicensee (iii) Any rule, regulation, or order

, issued purseast to the sections speciDed E exercises its privilege to make minor changes in its radiation safety in paragraph (bl(11(il of this sodiose e

(iv) Any term.condit6on, orliautation procedures that are not potentially,

I of any license issued ander the asetmas important to safety under i 35.31 of this specified in paragraph (h)(1Xij of shas chapter, the portion changed must section.

comply with the requirements of this (2) For any violatien for which a Part. At the time of license renewal and license may be revoked under section thereafter, these admendments to this las of the Atomic Energy Act of1954,as Part shall apply.

amended.

l 35.901 Citrrunal penatues.

(a)bection 223 of the Atomic Energy Act of 1954, as amended. provides for crianimal sanctions for willful violados of, atterapted violation ot or conspiracy to violate any regulation issued moder sectaons 161b,1611. or teto of the Act.

For purposes of section 223. all the regulations in Part 35 are issued under one or more of sections 161b.1911.or telo, except for the sections listed in paragraph (b) of this section.

9

r 3

i

)

l

\\v l

MARCH 16,1999 REVISION OF PART 35, MEDICAL USE OF BYPRODUCT MATERIAL Attached, for the use of the NRC's Advisory Committee on the Medical Uses ofIsotopes (ACMUI), is a draft of the final revision of Pan 35 that addresses some of the comments received during the 120 day public comment period and during the three facilitated public meetings held during the public comment period. In addition, comments were considered that were received after March 1,1998, the cut-off date for input into the proposed mle. This draft of the final rule is being provided for your review in preparation for the March 24-25,1999 ACMUI meeting and the Merch 25,1999 Commission briefing.

The Pan 35 Working Group will continue to review the comments. Even though there may be additional changes we feel that it is important to provide the document at this time so that the staff has the benefit of the ACMUI's review and input.

sJ i

l L

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 i

List of Subjects 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear 3

power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protechon, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and deposal.

10 CFR Part 32 Byproduct material, Criminal penalties, l.abeling, Nuclear materials, Radiation Protection, Reporting and recordkeeping requirements.

10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.

553, the NRC is proposed to adopt the following amendments to 10 CFR parts 20,32 and 35.

i 1

l

I WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for Part 20 continues to read as follows:

AUTHORITY: Secs. 53, 63, 65, 81,103,104,161,182,186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,106 Stat. 2951,2952,2953 (42 U.S.C.

2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841,5842,5846).

2. In 6 20.1301, paragraph (a)(3) is added to read as follows:

6 20.1301 Dose limits for individual members of the oublic.

(a)

(3) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to individuals who are not ra'sased in accordance with Q 35.75 to receive a radiation dose greater than (1 mSv) 0.1 rem, but not to exceed (5 mSv) 0.5 rem, if the authorized user, as defined in 10 CFR Part 35, determines that it is appropriate.

PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

3. The authority citation for Part 32 continues to read as follows:

AUTHORITY: Secs. 81,82,161,182,183,68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111, 2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).

6 32.72 IAmendedl

4. In 6 32.72, in paragraph (b)(1), the reference to "10 CFR 35.25" is revised to read "10 CFR 35.27" and in paragraph (b)(2)(ii), the reference to "10 CFR 35.980(b) and 35.972" is revised to read "10 CFR 35.55(b) and 35.59 or 10 CFR 35.980(b) and 35.972."

6 32.74 IAmended1

5. In 9 32.74, in paragraph (a), the reference to "QQ 35.400 and 35.500' is revised to read "6$ 35.400,35.500, and 35.600* and in paragraph (a')(3), the reference to * @ 35.58, 35.400, or 35.500" is revised to read "s$ 35.400, 35.500, and 35.600."

6.10 CFR Part 35 is revised to read as follows:

PART 35-MEDICAL USE OF BYPRODUCT MArERIAL Subpart A-GeneralInformation Sec.

35.1 Purpose and scope.

35.2 Definitions.

35.5 Maintenance of records.

2

1 l

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 35.6 Provisions for research involving human subjects.

1 35.7 FDA, other Federal, and State requirements.

35.8 information collection requirements: OMB approval.

35.10 Implementation.

j 35.11 License required.

35.12 Application for license, amendment, or renewal.

35.13 - License amendments.

35.14 Notifications.

35.15 Exemptions regarding Type A specific licenses of broad scope.

35.18 License issuance.

35.19 Specific exemptions.

Subpart B-General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program.

35.26 Radiation protechon program changes.

35.27 Supervision.

35.40 Written directives.

35.41 Procedures for administrations requiring a written directive.

35.49 Suppliers for sealed sources or devi%s for tr9 dical use.

135.50 Training for Radiation Safety Officer.

35.51 Training for an authonzed medical physicist.

35.55 Training for an authonzed nuclear pharmacist.

35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized ' user, and nuclear pharmacist.

35.59 Recentness of training.

Subpart C-General Technical Requirements 35.,60. Possession, useAcalibration;-end cheele of instruments to measure the actmty of J

unseededhypsodusausedds. F.e;. e.T.;'

.,7 d; erd;1.

35.61 Calibratioaandehoekof surveyinstruments.

"I,.0^ I-::::::P., use, c "'-seL:-, er.d e.ai ef ;;.e 7 ir.er.;;;; cr.:::re d-:::,,-ee of a:pe er 35.63 Determination of dosages of unsealed byproduct material for medical use.

35.65 Authorization for calibration and reference sources.

35.67 Requirements for possession of sealed sources and brachytherapy sources.

35.69 Labelirs r. er.:;:"eg of vials and syringes.

35.70 Surveys for ambient radiation exposure rate._ _

35.75 Release of individuals containing radoedive dmgs red;.,,;.erir e.,uh;e or implants.

35.80 Provision of mobile service.

35.92 Decay-in-storage.

Subpert ENJneseled Byproduct Material - MiteTM9Ei@ bow-Bose 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

3

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 35.204 Permissible molybdenum-99 concentration.

35.290 Training for uptake, dilution, and excretion studies.

35.292 Training for imaging and localization studies.

Subpart E - Unsealed Byproduct Material -Written Directlye Required !:liih Oees 35.300 Use of unsealed byproduct material for which a written directive is required.

35.310 Safetyinstruction.

35.315 Safety precautions.

35.390 Training for use of unsealed byproduct material for,,_iki, thergpy or for use of w

On=lcd bypredsct meter:a thet requlree a written directive is" required.

35.392dTramibg foEUss of Sodiuiri iodul5 Elk 1 MwtuchTwritten directiU6Ts7r~ehridE Subpart F-Manual Brachytherapy 35.400 Use of sources for manual brachytherapy.

35.404 {.ed;eten eGurveys of pat l ente er humen research subjecte treated VAh after source implants;and. removal 35.406 Brachytherapy sources inventory.

35.410 Safetyinstruction.

35.415 Safety precautions.

35.432 Full Calibration measurernente of brachytherapy sources.

35.490 Training for use of manual brachytherapy sources.

Subpart G -Sealed Sources for Diagnosis 35.500 Use of sealed sources for diagnosis.

35.590 Training for use of sealed sources for diagnosis.

Subpart HM EmittinsiRosnote Afteriod5pr[5Mi5h=[jurd5rEIMameisa ster =*=*Badiosurgery Units gr9 pes:lc."cd:ea' Oey:ees,,

35.600,Use. of_a sealed source in a remote afterloader unit, teleitnerapy unit, Lor gamma stereotactic. radiosurgery _ unit. dev ee fer therepeutlc med;e&l sees.

35.604 P.ed:eGen eSurveys of patients and human research subjects treated with'a remote i

afterloaders iinit.

35.605 Installation, maintenance, hifyidrI5'ri and repair.

1 I

35.610 Safety procedures and instructions for remote afterloaders units, teletherapy units, and gamma stereotactic radiosurgery units.

35.615 Safety precautions for remote afterloaders bnits, teletherapy units, and gamma stereotactic radiosurgery units.

i 35.630 Dosimetry equipment.

35.632 Full calibration measurements on teletherapy units.

35.633 Full calibration measurements on remote afterloaders units.

35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

35.642 Periodic spot-checks for teletherapy units.

' 35.643 Periodic spot-checks for high dos; rate end pul ecd des; rate remote afterloaders units.

35.044 Perledic epet-checke for lcw des; rete remete efterleadere.

35.645 Periodic spot-checks for gamma stereotactic radiosurgery units. _._

35.647 Additional technical requirements for mobile remote afterloaders units.

O 4

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

)

i 35.652 Radiation surveys.

35.655 Five-year inspection for teletherapy and gamma sterectactic radiosurgery units.

l 35.657 Therapy-related computer. systems.,__._,. _

l 35 690,_Traininafo,r,use_of semote afgestoeder unita, teletherapy. units /and gamma l

storma*=e*Ae radoeurgery units. therapeutk med;cd de.icee.

Subpart 1 - Reserved Subpart J-Training and Experience Requirements i

35.900 Radiation Safety Officer.

35.910 Training for uptake, dilution, and excretion studies.

35.920 Training for imaging and localization studies.

95.930 Training for therapeutic use of unsealed byproduct material.

l 35.932 Training for treatment of hyperthyroidism.

35.934 Training for treatment of thyroid carcinoma.

35.940 Training for use of brachytherapy sources.

35.941 Training for ophthalmic use of strontium-90.

l 35.950 Training for use of sealed sources for diagnosis.

l 35.960 Training for use 'of therapeutic medical devices.

35.961 Training for an authorized medical physicist.

35.980 Training for an authorized nuclear pharmacist.

35.001 Trebbg for egerkr.cs.' r,Leker pharmec:e:e.

Subpart K-Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 35.1000 Other medical uses of byproduct material or radiation from byproduct material.

Subpart L-Records 35.2024 Records of authority and responsibilities for radiation protection programs.

35.2026 Records of radiation program safety changes.

35.2040 Records of written directives.

l 35.2045 Records of medical events.

l 35.2060 Records of instrument calibrations.

l 35.2061 Records of radiation survey instrument calibrations.

i 35.2063 Records of dosages of unsealed byproduct material for medical use.

35.2067 Records for possession of sealed sources and brachytherapy sources.

l 35.2070 Records of surveys for ambient radiation exposure rate.

35.2075 Records of the release of individualc containing M[ddgi i

redbptermeceehb orimplants.

35.2080 Records of administrative and technical requirements that apply to the provision of mobile services.

35.2092 Records of waste disposal.

35.2204 Records of molybdenum-99 concentration.

35.2310 Records of instruction and training.

35.2404 Records of radiation surveys of patients and human research subjects.

35.2406 Records of brachytherapy source inventory.

5

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 35.2432 Records of full calibrations on brachytherapy sources.

35.2605 Records of installation, maintenance, acfjustmentrand repair.

35.2630 Records of dosimetry equipment.

35.2632 Records of teletherapyhrefmote afferloader, arEigamrh5dereotactic racN6surghiy full

~~

calibrations.

30.2000 ne;erde si remete a'ter;eader 70ll ca: bsauena.

35.2005 necords of gamma eterectactic rad;oasigeri unit ful! cal;brauens.

35.2642 Records of periodic spot-checks for teletherapy units.

35.2643 Records of periodic spot-checks for remote afterloaders,_ units.

35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units.

35.2647 Records of aoditional technical requirements for mobile remote afterloaders units.

35.2652 Records of surveys of therapeutic treatment un:u.

35.2655 Records of five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

Subpart M -Reports 35.3045 Reports of medical events.

35.3047 Report of a dose to an embryo / fetus or a nursing child.

35.3067 Reports of leaking sources.

Subpart N-Enforcement 35.4001 Violations.

35.4002 Criminal penalties.

1 Appendix A to 10 Orn Part OC - Examining Organ:zetion or Entlty AUTHORITY: Secs. 81,161,182,183,68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841).

Subpart A-GeneralInformation 6 35.1 Purpose and scope.

This part prescribes requirements and provisions for the medical use of byproduct material and for issuance of specific licenses autorizing the medical use of this material.

These requirement? And provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition t), and not in substitution for, others in this chapter. The requirements and provisions Or parts 19,20,21,30,71,170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.

9 35.2 Definitions.

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

Agreement State means any State with which the Commission or the Atomic Energy 6

n WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 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 uss that has been set aside for the purpose of receiving, using, or storing byproduct material.

Authorizedmedicalphysicist means an indevidual a ph %M who -

i (1)(a) Meets the requirements in 6 35.51(a) and 35.59 or 69 35 961 and 35.59; or N[dSdr(b}fe)ialent pennit or hcensd[rebognized by NRC; oris identified as a medical p equit

~

(c)(9) is identified as a medical physicist on a permit issued by a Commission or Agreement State specific licensee of broad s : ope that is authorized to permit the use of MOVEJ2)M,alkaT W E5skssiAdaifM55Ffd M k byproduct,materi

'sieeled moisces~and brachytherapy ' sources, fun ceBbration measuromonts ($$ 35.632, 35.833, 35.635), periosse apet checks ($$ 35.842,'35.643,' 35.644,35.645), and radiation surveysjg:35.862).

Authorized nuclearpharma*cist means a pharmacist who -

(1)(a)2 Meets the requirements in 6 35.05(a) and 35.59 or $$ 35.980(a) and 35.59; or (b)(e) is identified as an authorized nuciear pharmacist on a Commission or Agreement State license or olhofequmde~ rdpermit or li6erdijecogmzed by NRC that authorizes the use of byproduct material in the practice of nuclear rGarmacy; or (c)(9) is identified as an authorized auclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use.of oyproduct materialin the practice of nucbar pharmacy; or (d)(4) is approved as an authorized nuclear pharmacist by a nuclear pharmacy _.

authorized by the Commission to approve authorized nuclear pharmacists in accordance with 9 32.72(b)(4); and,,,,,

800WE (2Wali prepares or esp,orvises indhriduals propering uneseled byproduct meterial for medical uselas provided;in 5935.11(c) and 35.27.

Authorized user meens a physician, dentist, or podiatrist who -

(1)(a) Meets the requirements in ff 35.290(a),35.292(a),35.390(a),35.490(a),

35.590(a), or 35.690(a) and f 35.59, or ff 35.910,35.920,35.930,35.932,35.934,35.940, 35.941,_35.950,35.960 and $ 35.59; or

,__A)(eLis or other equivai5. identified.as an authorized use.r on.a Commission or Agreement State lic nt permit.or floonee recognized by.NRC that authorizes the medical use of byproduct material; or (c)(9) is identified as an authorized user on a permit issued by a Commission or Agreement State specific licensea of broad scope that is authorized to permit the medical use of byproduct _rnateriahiandy_,__

MOVEJ2Ws) Directs, as apaamael in $$ 36.27 and 35.40, or otherwise; the administration ist byproduct susserlei for needical use to patients or human renseich ediae**-

__ M Askeleisters, summerse or supervlees administration or properation of _

byprosinct maassful for nues5 cal use, in accordance with $$'35.11(b) ~and (c)'and.35.27i

~

(c) Prescribes domenos or domes of byproduct meterial for-mec5 cal usefand

,Jd):Ashainisters or supervlees thel administration orpreparation.of byproduci ineseries.

Brachytherapy source means a radioactive [5at5d[5 nthidediactivatdd[M sealed 7

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

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.

Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

Diegaaetic cl,alxlpixeduree meaueline&ae e cel;xCon af wrmen precedures thet desenbee each methed (end other lnetruc0ene end procesdene) by whlch the llcenxc pedenT.e d!&gneetc cl;n ce: precedcree, where e&ch diegneeUc c; n;cJ precedsre hee bxn epproved by the esther l zed seer end lncivdea the rediephenr.ecestica, dceage, end reste of edmin!

Oen.

High dose-rate remote afterloader,.as used in this part, means a device that remotely delivers a dose rate in excess of :12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

,_,, Location o(Sssissdis~ttii61ield'd~5iiciiinisi6f 5elor 5 fedipdrarf[oiisiikidr[t' A h

purpose ofprowdog mobile _serwce in acw(dswwith.9_35.80.

Low dose-rate remote afterloader, as used in this part, means a device that remotely delivers a dose rate of less than 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

-_.. Management means,the chief,executiye officer or other.indudual having the authority.to manage', drect,;or admruster the licensee'siactwsbes, or those that persons' 2s delegate or delegates.

MirkIdiM}ishseTirT5 nth 5i~miaT536isiir5555d[

Medical event means an event that meets the criteria in 35.3045(a).

Medica / institution means an organization in which several medical disciplines are practiced.

Medical use means the intentional intemal or extemal administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the sup'ervision of an authorized user.

__ Mediodidose-rate rarn' i5Stiricidi,"as~usid liitSA'parUseans a device that]er'56U o

deliversja dose greater than 2 gray _(200 rads) - but.less than.;12_ gray.(1200 rads), per hour at Npost or surface whereithe dose is prescribed.

z Mobile service means the transportation and medical use of byproduct material by-the same ;ceaxe at temporaryjobsites.

Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.

Phys /wan 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 prescribo d7ug in the practice of medicine.

Podiatrist means an individual licensed by a State or Territory of the United States, the District,of Columbla, orpe Comrnonwealth of Pue,rto Rico to practice podiatry.____

_ __ Preospfor means a Radiabon Safety, Officer, Authonzed Medical Physicist,' Authorized Nuclear Pharmacst, or Authorized User,:as applicsbie,1who ' ettifies,in.wntingi thatithsftreining c

and expenence regurements in 6635.50(b)(2),'35.51(b)(2),'35.55(b)(2),135.290(b)(2),

35.292(b)(2),135.390(b)(3), 35.490(b)(3),135.690(b)(3) have. been met.

O 8

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 Presenbed dosage means the quantity of radiopharmaceutical activity as documented -

(1) In a written directive; or (2) Ct.es ln ^l,e d;eg..wi J,...al preceduree is.enue: er la any @pi@r:e'ejeee d in accordance with the directions of the authorized user for d;egaeet procedures performed pursient to39 35.100 and35.200.

Prescribed dose means -

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; (2) For teletherapy, the total dose and dose per fraction as documented !n the written directive; (3) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or (4) For remote afterloaders, the total dose as documented in the written directive.

Pulsed dose-rate remote afterfoeder means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose rate" range, but is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour.

Radiation Safety Officermeans the individual identified as the Radiation Safety Officer on a Commission license who -

(1) Meets the requirements in $$ 35.50 and 35.59 or $$ 35.900 and 35.59; or

2) is identified as a Radiation Safety Officer on a Commission or Agreement State

) cense'(or MedisivuiordpjusnRRliconie koognizedMNRC for simlisir types]arilM o bensodumsnesensi.

Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.

Sealed Source and Device Registry means the national registry that contains all the i

registration certificates, generated by both NRC and the Agreement States, that summarize the i

radiation safety information for the sealed sources and devices and describe the licensing and I

use conditons approved for the product.

Stereotactic radosurgery means the use of extemal radiation in conjuncbon with a stereotactic guidance device to very precisely deliver a dose to a tissue volume.

Structured educabonalprogram means an educational program designed to impart particular knowledge and practical education thagh interrelated studies and supervised training.

Temporaryjobsite means a location where mobile services are conducted other than those location (s) of use authonzed on the license.

Treatment site means the anatorWal description of the tissue intended to receive a 3

radiation dose, as described in a writter vective.

,_ftsis"c(lase seeians%sid6biciifsneedieI~aiII5dditifundirE5I66, 5106, 35.300,'35A00,JE.S00,(or35A100;

' Unit dosage means a dosage intended for medical use in a single patient or human research subject that has been obtained from a manufacturer or preparer licensed pursuant to f 32.72 of this chapter or equivalent Agreement State requirements.

Written directive means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research 9

)

i WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 subject, as specified in 6 35.40.

9 35.5 Maintenance of records.

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 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, and specifications, must (aclude all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering j

with and loss of records.

9 35.6 Provisions for research involving human subjects.

A licensee may conduct research involving human subjects using byproduct material provided !-

(a) That the research is conducted, funded, supported, or regstated 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 re"iew 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; Asech

_(b)lThs res?siritiirwolving hurEn subjects 5uthorized in paragraphia) of tl

,._ia_ll be conducted usirig byproduct material authonze'd for medical use on the bcense; and. _,

st

_ _ (c) Nothing.in this sechon reheves licensees fram_ complyng with the othe'r requirements in this_part;

$ 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 goveming radioactive drugs or devices.

9 35.8 Information collection requirements: OMB approval.

(a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requiremsats in this part under control number 3150-0010.

(b) The approved information collection requirements contained in this part appear in

& 35.6,35.12, 35.13, 35.14,35.19, 35.24,35.26,35.27, 35.40,35.41,35.50, 35.51,35.55, 35.57,35.60,35.61,05:60,35.63,35.67,35.69,35.70,35.75,35.80,35.92,35.204,35.290, 35.292,35.310,35.315,35.390,35.292,35.392, 35.404, 35.406, 35.410,35.415, 35.432, 35.4rO, 35.590, 35.604, 35.605, 35.610, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643 35.644,35.645,35.647, 35.652, 35.655,35.690,35.900, 35.910,35.920,35.930,35.940, 35.950,35.960, 35.961, 35.980,35.2024, 35.2026,35.2040, 35.2045,35.2060,35.2061, 10

G

)

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

(

35.2063,35.2067,35.2070,35.2075,35.2080, 35.2092, 35.2204, 35.2310,35.2404,35.2406, 35.2432,35.2605,35.2630,35.2632, 35.2633,35.2635,35.2642, 35.2643, 35.2645,35.2647, 35.2652,35.2655,35.3045,35.3046,35.3047, iusd 35,3067, and Appe.dk A.

(c) This part contains information collection requirements in addition to those approved

. under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved as follows:

(1) In f 35.12, NRC Form 313, including NRC Forms 313A, and 313B which licensees may use to provide supplemental information, is approved under control number 3150-0120.

(2) [ Reserved]

$ 35.10. I,T-iM.?-4,.

(a) A licensee shall implement the provisions in this part on or before [ insert date 6 months from publication of the Final Rule), with the exception of the requirements listed in paragraph (b) of this sectm.

(b) A licensee shall implement the training requirements in $6 35.50(a),35.51(a),

35.55(a),35.290(a),35.292(a),35.390(a),35.490(a),35.590(a), and 35.690(s) on or before

[ insert date-2 years from publication of the Final Rulw].

1 (c) Prior to [ insert date-2 years from publication of the Final Rule), a licensee shall satisfy the training requirements of this part for a Radiation Safety Officer, an authorized medical physicist, an authorized nuclear pharmacist, or an authorized user by complying with either:

(1) The appropnate training requirements in subpart J; or (2) The appropriate training requirements in subpart B or subparts D-H.

j (d) If the requirements of this part are more restrictive than the existing license condition, the licensee shall comply with this part unless exempted by paragraph (f) of this section.

(e) Any existing license condition that is MIaiadsid5 morenestnettve-then a requirement in this part remains in effect until there is a license amendment or license renewal.

(f) If a license condita exempted a licensee from a provision of Part 35 on [ insert date-

)

-6 months from publication of the Final Rule], it will continue to exempt a licensee from the corresponding provision in this part.

(g) If a license condition cites provisions in Part'35 that will be deleted on [ insert date-6 months from publication of the Final Rule), then the license condition remains in effect until i

there is a license amendment or license renewal that modifies or removes this condition.

f 35.11 License required.

(a) A person may not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) or (c) of this section.

(b) An indsvidual may receive, possess, use, or transfer byproduct material in accordance with the regu8ations in this chapter under the supervision of an authonzcd user as provided in f 35.27, unless prohibited by license condition.

(c) An individual may prepare unsealed byproduct material for medical use in accordance with the rsgulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in f 35.27, unless prohibited by license condition.

11

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

$ 35.12 Application for license, amendment, or renewal.._. __

(a) An application must be signed by the apphcant's.orlicensee'.s management of-the feetitty.

(b) An application for a license for medical use Of byproduct material as described in

@$ 35.100,35.200,35.300,35.400, and 35.500, and for medica: use of remete efterlcader3 in

$ 35.600, must be made by-(i) Filing an original and one copy of NRC Form 313, " Application for Material License;"

and (ii[Sutimdlii@irMediireRediMIdifffiubi6iflI,15'dpbl5i:Eis. _..._

(c) A request for a license amendment or renewal must be.made by -- may be esbinitted as (i)[ SUM 5Aan original aFI o ie copy in letter format.

(ii);Submthng Nocedun5Muiisd b{sutiparth aSMM.

(c) Ocept fer med;ca uee, f remste afterlcadere, a separete llcenee app l:couen mget be f led fer each medica: use of byreduct materia l as dcecribed in s 30.000 of th;e part by f::;ng an eiig na: and one copy of N"l0 Jerm 010. A request for a l; cense amendment er renewa:

may be submltted b an er:glna: and one cepijnjetter format.

(d) An application for a licenso,or amendment for medical use of byproduct material as described in b 35.1000 of this part must be made by filing an original and one copy of NRC Form 313.

(1) In addition to the information required in NRC Form 313, the application must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in Subparts A through C of this part, as well as any specific information necst sary for -

(i) Radiation safety precautions and instructions; (ii) Training and experience of proposed users; (iii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (iv) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

(2) The applicant or licensee shall also provide any other information requested by the Commission in its review of the application.

(e) An applicant that satisfies the requirements specified in 33.13 may apply for a l

Type A specific license of t, road scopo.

$ 35.13 License amendments.

A licensee shall apply for and must receiva a license amendment -

)

(a) Before it receives or uses byproduct material for a type of use that is permitted under this part, but that is not authorized on.he licensee's current license issued pursuant to this part; (b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except an individual who is -

)

(1) An authorized user who meets the requirements in of 35.290(a),35.292(a),

35.390(a),35.490(a),35.590(a), or 35.690(a) and 35.59, or Q 35.910,35.920,35.930, 35.932,35.934,35.940,35.941,35.950,35.960 and @ 35.59; (2) An authorized nuclear pharmacist who meets the requirements in @ 35.55(a) and 12

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

$ 35.59; or $$ 35.980 and 35.59; (3) An authorized medical physicist who meets the requirements in 6 35.51(a) and f 35.59; or $$ 35.961 and 35.59; (4) Identified as an authorized user, an authorized nuclear pharmacist,.or..auth_orized medical physicist on a. Commission or Agreement State license or other equivalent permit or iicinse recognizid t@ ##IC that authorizes the use of byproduct material in medi::al use or in the practice of nuclear pharmacy, respectively; or (5) identified as an authorized user, an authorized nuclear pharmacist, or authorized 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 material in medimi use or in the practice of nuclear pharmacy, respectively.

(c) Before it changes Radiation Safety Officers, except as.pmwided in f.35.24(c);

(d) Before it orders byproduct material in excess of the amount, or radionuclide or form that is different than the radionuclide or form authorized on the license; (e) Before it adds to or changes the areas identified in the application or on the license, except for areas where byproduct material is used in accordance with $$ 35.100 and 35.200; and (f) Before it changes the address (es) of use identified in the application or on the license.

$ 35.14 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 after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, pursuant to $ 35.13 (b)(1) through (b)(5).

(b) A licensee shall notify the Commission by letter no later than 30 days after:

(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change; (2) The licensee's mailing address changes; (3) The licensee's name changes, but the name change does rn.. :mstitute a transfer of control of the license as descnbed in f 30.34(b) of this chapter, cr (4) The licensee has added to or changed the areas where byproduct material is used in accordance with $$ 35.100 and 35.200.

(c) The licensee shall mail the documents required in this section to the appropriate address identified in f 30.6 of this chapter.

$ 35.15 Exemptions regarding Type A specific licenses of broaci scope.

A licensee possessing a Type A specific license of broad scope for medical use is exempt from -

__ ; 60 %NcTfENI((vesi5friiWriodEWah aniendrriniEUWlE555e for medicetuses of bspeduct manei,.as describod in f a5.to00:

dbMe) The provisions of f 35.13(b);

(c)(b)-The provisions of f 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license; 13

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

'd)(c) The provisions of $ 35.14(a);

(

(e}{d) The provisions of s 35.14(b)(1) for an authorized user, an authorized nuclear pharma.cist, or an authorized medical physicist; and (f)(e) The, provisions. of,6.35.49(a); and-(g)$The provisions of.$ 35.600.

i 9 35.18 License issuance.

(a) The Commission shall issue a license for the medical use of byproduct material if -

(1) The applicant has filed Form NRC-313 ' Application for Materials License" in accordance with the instructions in 6 35.12; (2) The applicant has paid a.iy applicable fee as provided in Part 170 of this chapter; (3) 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 (4) The applicant meets the requirements of Part 30 of this chapter.

(b) The Commission shall issue a license for mobile services if the applicant:

(1) Meets the requirements in paragraph (a) of this section; and (2) Assures that individuals or human research subjects to whom radioactive drugs red;ephermecentice:e or radiation from implants will be administered may be released following treatment in accordance with 9 35.75.

9 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.

Subpart B-General Administrative Requirements 6 35.24 Authority and responsibilities for the radiation protection program.

(a) in addition to the radiation protection program requirements of 6 20.1101 of this chapter, a licensee's management must approve in writing -

(1) requests for license application, renewal, or amendments before sub,mittal to the Commission; (2) Any individua! before allowing that individual to work as an authord user, authorized nuclear pharmacist, authorized medical physicist; and (3) Radiation protection program changes that do not require a license amendment and are permitted under 35.26; (b) A ::cen;;; wlth mLlt p;e mode lltles er mLFJpie usare ehe!! &lac dev;lep, implement, and rna raein wr;; ten adm n;etrene procedures for interdepartmente:/;nterd;eciplinary coord; net;pa of the llcen;;;'s.ed:et;en pre ect;en pregram.

(b)(c) A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being 14 L

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 performed in accordance with licensee-approved procedures and regulatory requirements. in h C;;i[b0h tosidyTdess inaciiyearMhcensee;mer permit 5idutiikiiodiinian

%, c4 2.e ;.ar._x,'e sedth,p;datr, pigierr,

()

~

iriiiiidusi Massear%be arareamare[sofety officer to furiicbon as'a temporary radiation sofei _

4 idfloor and to perfonn ihe 6aaranam of a radialen safety officer, as prended in paragraph (f) of t

Weis soctdprovided MScenses takes [the' actions required in paragraphs'(b)l(d), (f)l ond (g) ofMsection.

(d) A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation. Safety Officer.

(e) MoonAisthiitliiiE5iiGiidiii362TiiiiiiidliiiEiiiftdioiiN liiissTliisir65uidt iiuesdehooler&dipartsE,4Fijnef_H shall amanNhh ~a Radiation Safety Committee to;oversie thie' ass;aNigpsoductniidesiol.

mecseesdnee meetinoinihausi5iisiidiser of'esch tWiiEiF6mTp"siiiEinted bitfisii6shiis, tasaadation Sofety;OEloor, si seposeentothe id.thiinunang sermoefand aispresenletive of manegonient who is'nother assautedmod assor;norin Radiation Safety _ Officer,'andimoy include

~

' ther snembers as die _80enese deems. appropriate.

o (f)(e) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to -

(1) Identify radiation safety problems; (2) Initiate, recommend, or provide corrnctive actions; (3) Stop unsafe operations; and, (4) Verify implementation of corrective actions.

(g)(f) A licensee shall retain a record of actions taken porsuant to paragraphs (a), (b),

(c), and (d) of this section in accordance with 6 35.2024.

l 35.26 Radiation pic f=, program changes.

(a) A licensee may revise its radiation protection program without Commission approval if -

(1) The revisions doeIs not require an amendment under f 35.13; (2) The revisions is_iriiWjohh the segulations aid'thh Bodrisi de r,cA redwe sed; Or, e.A;,;

(3) The revisions iisis have been reviewed and approved by the Radiation Safety Officer and licensee management; and (4) The affected individuals are instructed on the revised program before the changes are implement.ed.

(b) A licensee shall retain a record of each change in accordance with 6 35.2026.

$ 35.27 Supervision.

(a) A hcensee that permits the receipt, possessin, use, or transfer of byproduct material by an indiwdual under the supervision of an authorized Jser or as allowed by 6 35.11(b) of this part shall-(1) instruct the supervised indivirtual in the licensee's written radiation protection procedures, written directive procedures, regulations of this ' hapter, and license conditions with respect to the use of byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising 15

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, regulations of this chapter; and license conditions with respect to the medical use of byproduct material.

(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 35.11(c), shall -

(1) instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's use of byproduct material; and (2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, the written radiation protection procedures established by the licensee and the regulations of this chapter, and license conditions.

(c) A !:cen;;c ehall eet b;;eh, ; rep;ernent, end ni&intair. & pel;cy for ell esper.ieed indi.idsale te reciscot clerificat;en, as n;;ded, fre.T. -

(l) ne auther; zed seer, before :nldedng er cen^enging eny precedure thet requiree &

ad;;en directic, f the esper.iesd indMdva hae any queetien ebest whet ehesld be done er

,m,v,. _ m..,2 m 2___.

.muvmuuomuuo,onu-(;l} The &cthesized seer er astherized nucl ear pharnisc:et &best the inetruct,ene end requirerr.en;e prev;ded to the evper.ieed individual ln &ccordence with peregrep.e (s) &nd W cf thie seeden.

(c)(d) A licensee that permits supervised activities under paragraph (a) and (b) of this section is responsible for the acts and omissions of the supervised ndividual.

9 35.40 Written directives.

(a) A written directive must be prepared, datedi and signed by an authorized user prior to administration of I-131 sodium iodide greater than.1.11.Megabequerels (MBq) (30 microcuries (pCi) ), any therapeutic dosage of unsealed. byproduct material a rad;cpharnwcendcej, or any therapeutic dose,of radiation.frorn byproduct mate. rial. [.... -

_._. J1) If, because of the emergent nature of the patient's condsbon, a delay inl order to provxle a written directive would jeopardize the patient's health, an oral directive will be

~

a=*ahaa, provided that the information contained in 'the oral directive is documented _,.

immediatelyin wnting in_the. patient's record and_a written directive.is_ prepared.within.48_ hours of the oral directive. __

_._.,J2) f A wntien revision ^to an existing written directive may be made provided that the revision isitated and signed by an authorized user prior to the administration of the 1

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16

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 ilois, theIolotheiady dose, or 16iIM'fial50ional3ose.

(S)(8f, *===a of the initient's condition,4a deleiin order toiirihidiMrittih revisiin~to "sliiiling usttten directive would isopardize the pellent's heellh, an oral revision to'an existag a

wrliten drecthelwB helmermp8mMa, provided that.the ' oral revision is documentsd immediatelyin the patient'sl record andia revised willeen directive'isfeigned by the authonzed user within 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />sof tiis dral'sevlsion.

(b) The written directive must contain the patient or human research subject's name and the following:

(1) For any administration of quantities greater than 1.11 MBq (30 pCi) of sodium iodide I-131: and the dosage; (2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide 1-131: the radiopharmaceutical, dosage, and route of administration; (3) For gamma stereotactic, radiosurgery: target coordinates (including gamma angle),

collimator size, plug pattem, and the total dose for the treatment, and-the-totaHreatment volume; (4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site, and everell :ree:a.en; perled; (5) For remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or (6) Forallotherbrachytherapy:

(1) Prior to implantation: treatment site, the radionuclide, ii_d aer,,L.i of eeusce; er.d i

eseiee.;..r.p er dose; and (ii) After irnplan,tation but prior to completion of the procedure: the radioisotope, treatment site, number of ar-rma, and total source strength and exposure time (or, equivalently, the total dose).

(c) The licensee shall retain the written directive in accordance with f 35.2040.

$ 35.41 Procedures for administrations requiring a written directive.

(a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(1) The patient's or human research subject's identity is verified before each administration; and (2) Each administration is in accordance with the written directive.

address I) The procedures required by, paragraph (a) of this section must, at a mini (b

(1) Verifying the identity of the patient or human research subject; wntten directive and treatment (2) Verifying that the specific details of the administration are in accordance with the written-directive 1md treatment plan 15pp05did,liisdMiirillio5[dssi5ivi;

.(3) Checking both manual and computer-generated dose calculations; and (4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical devices authorized by 9 35.600.

i 6 35.49 Suppliers,for, sealed sources or devices for rnedical use.

For needcol use, a A licensee may Uni use for ined;e : use en:, --

(a) Sealed sources or devices initiaty manufactured, labeled, packaged, and distributed 17 l

i

]

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 in accordance with a lice'nse issued pursuant to 10 CFR Part 30 and 32.74 of this chapter or the equivalent requirements of an Agreement State; or (b) Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to 10 CFR Part 30 or the equivalent requirements of an Agreement State.

9 35.50 Training for Radiation Safety Officer Except as provided in 9 35.57, the licensee shall require an individual fulfilling the j

responsibilities of the Radiation Safety Officer (RSO) as provided in 35.24 to be an individual Who -

(a) is cemfied by a speciality board whose certification process includes all of_th.e.

requirements in paragraph (b) of this section and whose certification has been recognized approved by the Commission or; j

(b)(1) Has completed a structured educational program consisting of both:

1 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic training in the following areas-(A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Radiation biology; and j

(E) Radiation dosimetry; and 1

(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the RSO on a Commission or Agreement State license that authorizes similar type (s) of use(s) of byproduct material involving the following; (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and instruments used to measure radionuclides; (C) Securing and controlling byproduct material; (D) Using administrative controls to avoid mistakes in the administration of byproduct material; (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and (F) Disposing of byproduct rnaterial; and __ _,_ _

(2) Has obtained written certdication, sogned byja preceptor RSO, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this se,ction.hagbcp.

ea;@facteijly comp leted and that the ;nd;.idsa: has achieved a level of radiatonisafety knowledge compe:cacy sufficient to independently function as an RSO for medical uses of byproduct material; pr and (0) rellcMag cempl eden of the requiremente in paregraph (b) of thie esction, has demone:mted asific;ent kncdcdge n red:aden safety commenevra:e Wth the see regsce:ed by paee:ng an eaminaten g'rien by an organizaden er entity appicved by the Oemmiselen in eccerdence 4th AppendN A of this part, er (c) is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has RSO responsibilities.

9 35.51 Training for authorized medical physicist.

I8 4

1

e

\\

p WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 The licensee shall require the authorized medical physicist to be an individual who -

(a) is certified by a speciality board whose certification process includes all of the training aryd e,xpe.rience requirements in paragraph (b) of this section and whose certification has been secognized.ervisced by the Commission; or (b)(1) Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, or health physics, or an equivalent training program approved by the NRC, and has completed one year of full-time training in therapeutic radiological physics and an addebonal year of full-time practical experience under the supervision of a medical physicist at a medical institution that includes the tasks listed in 66 35.67,35.632. 35.633,35.635,35.642, 35.643,35.644,35.645 and 35.652, as applicable; and (2) Has_obtained written _ certification, signed.by,a preceptor authorized medical physicist, that theJnsSwidualhas:sselefecksty completed the requirements in paragraph (b)(1) in this section haa; L;;a -1iMen j eT.p%;;d and that-theMndividual has achieved a level of competency sufficient to independently function as an authorized medical physicist. t1md-(3) id:e bg ee.nyb;ba of Le rege:ie.T. eat; b preg. yh (b)(1) cf L;e ew;en, hee d..T w;. ;ed w"Zbi.;;;.c;.bdve b reds;ba

%;i w.T..T.enn.e:e l1 Le eee req.e;2d by p; :c.; en eat.be:ba steen by en eiv a;w;ba er e.JJi appicved by Le O T.robeba b a;w.d a J. 1 Appendh A ef 1% pen.

$ 35.55 Training for an authorized nuclear pharmacist.

The licensee shall require the authorized nuclear pharmacist to be a pharmacist who -

(a) is certified as a nuclear pharmacist by a speciality board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been bedoinlImed ppic;;d by the Commission, or (b)(1) Has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program consisting of both:

(1) Didactic training in the following areas -

(A) Radiation physics andinstrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and (ii) Supervised practical experience in a nuclear pharmacy involving -

(A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides; (C) Calculating, assaying, and safely preparing dosages for patients or human research i

subjects:

(D) Using administrative controls to avoid medical events in the administration of j

byproduct material; and (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

-(2) Has obtained written, certification, signed by a preceptor authorized nuclear pharmacist, that thejndividual has.anmedar*wgy completed the requirements in paragraph (b)(1) hsee he;a e : f.,0.. i ee.T.pttd and that4he-individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy. t-end (3) re:L bg eTpb;ba of Le rege:re.T.enbla pregieph (b)(1) of 1:e ew;;w, hee 19

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 demonsLated sufficlent knces'cdge in red:auen e&fety commensurate viith the use reques'ed by peee:ng en exam:naden glven by en organizeuen er enuty approved by the Ocmmise en ln accordance v.ith AppendL A e' th e par'.

9 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist.

(a) An individual identified as a Radia*jon Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license before [ insert date-6 months from publication of the Final Rule) need not comply with the training requirements of @ 35.50, and 35.51 and 35.55, respectively.

(b) Physicians, dentists, or podiatrists identified as authorized users for the medical, dental, or podiatric use of byproduct material on a Commission or Agreement State license issued before [ insert date-6 months from publication of the Final Rule] who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts D 6-H.

9 35.59 Recentness of training.

The training and experience specified in subparts B, D, E, F, G, H, and J 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.

O Subpart C-General Technical Requirements 6 35.60 Sossession, use, idd calibration, and check of instruments to measure the actl4 u,'ieter. cmltt:5;g gedjersucl:dc; unsealed byproduct'materiahi.

(a) i-or drect measurements. performed in_ accordance with;9 35.63 ether then unit _

desegegaji. cense.e shall possess and use instrumentation to measure the activity of imsealed byproduct; materials phe'en+m;tui.g 5edienscudes prior to administration to each patient or human res. e, arch su.b.. ject _.

__m-

,_.jb) A heensee shsil calibrate the instrumentation _re_quir,edlm paragraph (a) of this section in accordance.with~nanonallyf,ecogniized standcris or the manufacturer's.instruchons.:

,m 5, _.

._ _____ m

__.m._, m ____ _, m.__

gW) 55 E IIVU5 5www WpWG EB 5Gbf W3 4 5U5 5&pl3v5 5 LV 5 5 5UugW5 9 Li sU uvk5 v 5LJ %#3 %#Vgu gU @ V5. VI I%#5v5 B'

.w

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e._ _ e. m._ _.. _ u A _ _ _ _ _ a _ t _ in x.. _ i _ _ -

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U6 5 55LLB5 Og 5 9%dTv1 IbfVff%#UG, 53 F%a5W%531 Ig W5 iib %5%r%PhagD99 f h 95 5955 hav v Up%y, 54 5 IffUE 5 595 Ibg E4 5%5 I I Gust 542355 F.8 5 bbU5 5 piGc6dO4eS Ici picy6i epeiaNvn of $56 5sieIiunieitiauvn. Ai n in n inUiii, a NGei ccc eIidN -

(1) Perform teste, before :n:Ca ue; and 'e: ev ng repa;r, en each lOstrument for

&ccurecy, l:neadri, end geemetry dependence; (2) reiform en accuracy tes' ennua"y,

' (0) Peiferm a Snea;ity 'est annua::y ever the renge of inedlce: Use; and (4) Oheck each lnetisment for cerls'ency and proper opereden et 2,e beg;nning of e&ch day of use.

(c) Accurecy tests must b peiformed velth source (s) v&h a principel pheten energy of t,etiseen 100 &nd 500 ke','i.hese ect?.ity !3 treceable 's the Nauen&l l net.tute of Otenderds-and 94 l

20

i WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 Techne legy (NlO',) er by a espp :.. who hae compaied the eevice te e essice that v.as

-om m o my,,o.

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w, n.mm.-. 2 _ o.._o a _ _ _ i. _ _.t.um.um m...y m o m,

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o ieye i ei iey ac6 Ihe neiidmen'mi un i Ihe acCUiacy ei ceneiency' esiei enc 66de '^ peic6isi.

v (c)(e) A licensee shall retain a record of each instrument calibrabon check and ce; required by this section in accordance with 35.2060.

6 35.61 Calib.ation andeheck of survey instruments.

(a) A licensee shall calibrate the survey instruments used to show compliance with this part and._10 CFR Part 20 before first use, annually, and following repair that will effect the calbration. A licensee shall-(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source; (2) Calibrate two separated readings on each scale or decade that will be used to show compliance with this part; and (3) Conspicuously note on the instrument the date of calibration.

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A licensee shall not use 6 survey instruments m. u. st be iemoved ficamse if the..

difference between the indicated exposure rate d"'eie fiem and the calculated exposure rate is by more than 20 percent.

(c)(d) A licensee shall retain a record of each survey instrument calibration in j

accordance with 6 35.2061.

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. C 21 i

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 eccordence v.ith & 00.2000.

6 35.63 Determination of dosages of unsealed byproduct material for medical use.

(a) A licensee shall determine and record the activity of each dosage prior to medical use.

_(b) For a unit dosage of en elpha, beta, or pheten-emitt;ng"uis5aiditsyhiodiict matenal i&dienscl;de, this determination must be made either by direct measurement of radioactivity or by a decay correction, based on the measurement made by a manufacturer or preparer licensed pursuant to G 32.72 of this chapter or equivalent Agreement State requirements.

_..-(c) Fore-dosagekof fasealed bypfo'ddi[mseTihl otherlthdUIEAEcivir631n paragraph (b) of this section & alpha, beta, er pheten-em;;0ng red:enuel;de rep &ied by the l;ceneee, this determination must be made by direct measurement of radioactivity or by combination of measurements and calculations.

(d) A licensee shall not use a dosage if the dosage _ differs from the prescribed dosage by more than 20 percent,'unless otherwise; directed by.the,authonzed user.[ NOTE to WG:

Should we increase the percentage for $$ 35.100 and 35.200 dosages?)

(e) A licensee shall re*ain a record of the dosage determination required by this section in accordance with 35.2063.

9 35.65 Authorization for calibration and reference sources.

Any person authorized by 6 35.11 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 f i32.72 and 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 1.11-kGBq (30 mci) each; (b) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.555 GMBq (15 mci);

(c) Any byprodu.ct _ material with a half-life longer than 120 days in individual amounts not to exceed the. smaller of c7.4 MBq ( 200 pCi) each and act to exceed or 1000 times the quantities in Appendix B of Part 30 of this chapter v,hichever le mere l:mlung; and (d) Technetium-99m in amoun*s as needed.

$ 35.67 Renuirements for poss6 >n of sealed sources and brachytherapy sources.

(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.,-and-ehall ma:nta:n the instimctione for the dur& Gen of sesics see ;n

.y,-.

.m... c~nvenient to cocre.

(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 6 months before transfer to the licensee; and

'(2) Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Commission or an Agreement State in the Sealed Source and Device Registry.

(c) To satisfy the leak test requirements of this section, the licensee shall measure the sample so that the leakage test can detect the presence of 185 Bq (0.005 pCi) of radioactive material on the sample.

22

)

\\

J

v WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (d) A licensee shall retain leakage test records in accordance wkh 6 35.2067.

(e) If the leakage test reveals the presence of 185 Bq (0.005 pCI) or more of. removable contamination, the licensee shall-(1) immediately withdraw the sealed source from use and store, dispose, or udse it to be repaired in accordance with the requirements in parts 20 and 30 of this chapter; and (2) File a report within 5 days of the leakage test in accordance with 6 35.3067.

(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 th& s 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 3.7 MBq (100 pCi) or less of beta or gamma-emitting material or 0.37 MBq (10 pCI) or less of alpha-emitting material; (4) Sources stored fa bx 2.en a 10 yxi pubd 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 6 months before the date of use or transfer; and (5) Seeds of iridium-192 encased in nylon nbbon.

(g) A licensee in possession of sealed sources or brachytherepy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with 9 35.2067.

$ 35.69 Labeling endshielding of vlais and syringes.

g yyy ga ggygyg N 'rus: Each eydr6eistualdieddidad shield shst'asso be labeled indoos em label dA

~

d ensisydnee:er del issioibse whosi shisened.

(a) A = axe c :: ca:4, :a.,,z.T a;, and.T.e:r.t:. r: La pra;4.ree a -

(1)!

,, :::A eyda e, eyda e C.i:d, u.ie: J.i:d :he; u,a:e:ne e v

v red?:,2eric-eas:e; te ;d.;;;i

.edb,,he.Ti.eceu;;a: reine, a lC :,:,re.t;.en, and te 0

en re Ce; 2.e a,a en; are a,nak.ewri ;da.;;;;.d ee e.a; :a:n, edbee:Le.T.et.-Ll, and d

(2) Ohb:d;as V:': and 6 ayee a,r.".:c.:n, red;.,2.7.ai.ee.u;Leb.

(b) A ;Z.an; #ell ber.;; ;..d:M ':, a,carna ieL

1. 0.e biidal'e a::ined de:be, in 0.e preceiree requ red by pere,re,,h (e) ef 0.;e eee;;.a.

5 35.70 Surveys for ambient radiation exposure rate.

(a) Except as provided in paragraph (b) of this section, a licensee shall survey _with_a radiation detecbon survey instrument at the end of sach day of use all areas where pusaarem Mags fadiopharmecoutseels requiring a written directive were prepared for use or administered.

l (b) A licensee does not need to perform the surveys requ,i[ed,by paragraph (a)_of this j

sechon in an area (s) where patients or human research subjects are cordined when Wesy can not be released pursuant to 6 35.75.

(c) A licensee shall retain a record of each survey in accordance with 6 35.2070.

$ 35.75 Rolesse of individuals containing sesNoacNuo ensgs ;: ":p ;.c.:::f::': or i

implants.

(a) A licensee _may authorize the release from its control of ar'y individual,who.has been administered =,ana,e= dmgs radiopharmaceutseets or implants containing byproduct tednesettvelmaterialif the total effective dose equivalent to any other individual from exposure to

\\

23

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 the released individual is not likely to exceed 5 mSv (0.5 rem).2 (b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include -

(1) Guidance on the interruption or discontinuation of breast-feeding; and (2) Information on the potential consequences, if any, of failure to follow the guidance.

(c) A licensee shall maintain a record of the basis for authorizing the release of an individual, in accordance with 6 35.2075(a).

(d) The licensee shall maintain a record of instructions provided to breast-feeding women in accordance with 35.2075(b)je).

9 35.80 Provision of mobile service.

(a) A licensee providing. mobile service shall-(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address of use and clearly delineates the authority and responsibility of each entity; (2) Check instruments ss dese.1,ed :n GG 05.00 and 05.02 for preper funcuen before medical use at each locanog eddress of use or on each day of use, whichever is more frequent; (3) Check survey instruments for proper operation with a dedicated check source before use at each location eddress_ of use; (4) Before leaving a location cl;ent's addiees af use, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter, and i

(b) A mobile nuclear medicine sewice may not have byproduct material delivered from the manufacturer or the distributor to the client's address of use, unless the client has a license allowing possession of the byprodJd m aterial. Byproduct Radioac0ve material delivered to the client's address of use must be received and handled in conformance with the client's license.

(c) A licensee providing mobile nuclear services shall retain the letter required in paragraph (a)(1) and the record of each susey required in paragraph (a)(4) of this section in accordance with 6 35.2080.

f 35.92 Decay-in-storage.

(a) A licensee may hold byproduct mat _eria1 with a physical half-life of less than 120 days for decay-in-storage before disposal.without regard to its radioactmty in sid;nerf tresh if it (1) Monitors byproduct material at the surface before disposal es cid;narf trash ar.d determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

'(2) Removes or obliterates all radiation labels, except for material that is handled as 2 Regulatory Guide 8.39. " Release of Patients Administered Radioactive Materials." describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem (5 mSv).

24 l

j

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 ticidedicIAl'waiste'.

(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with 9 35.2092.

Subpart D-Unsealed Byproduct Material - how-Bose WrEieEUlddEiilEHeipiireiii

~

9 35.100 Use of unasaled byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

A licensee may use for uptake, dilution, or excretion studies any unsealed byproduct material, except in quantities that require a written directive pursuant to $ 35.40, prepared for medical use that is either-(a) Obtained from a manufacturer or preparer licensed pursuant to 6 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 6 35.292, or an individual under the supervision _of either.as specified in f.35 27;for _

(c) Obtained (som an 960 or Agreernent State licensee for use in research in iifoliianos"withla Parnaarde Dms Research.G- =. 'i ;--c;;d protocol or an Irwestigational New Drud @D) protocollanwWad W FDA;:or

~

PaaaEic(hK M if Mc.t.fapplicationMan investigational New Drug (IND) proto W byFDA.

l 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

A licensee may use for imaging and localization studies any unsealed byproduct material, except in quantities that require a written directive pursuant to 9 35.40, prepared for medical use that is either-(a) Obtained from a manufacturer or preparer licensed pursuant to $ 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified,in 6 35.292, or an individual under the supervism of either as specified in f 35.27: or

~

liioGann$0tdainefinien inINRC 'or AdrMirn;eriiftaioli565ieeTf6fti E

aetidosaRadioecoveDasRosemahoi "-M

---4protocoloran Irwestigasonal New Dmg1HO) protocol annead W FDA; or,_ in__e wHh a' RarGaarn

_J4 Peopmed tw1he.liconome for,use in resemah in' accord c

veLDmg R,esearch Caramatee approved application' or"an investigabonal New Drug (lle) protocial

""I

=4 by FDA.

d

$ 35.204 Permissible molybdenum-99 concentration.

___(a)_ A, licensee may not administer to humans a radiopharmaceutical containing rnore than.0.15 idlobecquerel of molybdenum-99 por megabecquerel of technebum_99m (0.1.5 nuevoeurie of molybderann-99'per mitcurie d teMnetium-99m:3.Z lO g (0.5 pOl} ef 25

i WORKING GROUP DRAFT DOCUMENT MARCH 16,19W l

molybdenum-00 per m lll curie of technetium-00m.

(b) A licensee that uses molybdenum-99/ technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this i

section.

(c) A licensee that must measure His molybdenum %9 concentration shall retain a record of each measurement in accordance with o 35.2204.

6 35.290 Training for uptake, dilution, and excretion studies.

Except as provided in @9,35.57, the licensee shall require the an authorized user of a radiophany.acestco: unsealed byproduct materialfor the uscs hsted described in 6 35.100 to be a physician who -

(a) is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b)(c) of this section and whose certification has been approved recognized by the. Commission;

,. b) is quakfied as an authorized user under.$935.292 or 35.390 or an equivalent

(

A,greement Stateyemarement; of- _,. _., _.__ _. _

,_(c)(1)~Has =Wully completed 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training in basic radionuclide handling techniques appbcable to the' medical use of unsealed byproduct material foriuptake, dilution,

~

~

~

and excretion studies as an estabhshed ~ component of 'a training program that has been recognized by.the NRC.and approved by'estherethelAccreditation Councd for Graduate Medichi

~

{

Educationsth5 Committee bn Po~stdoctoralTramingLof the'American Osteopathic ~ Association, or an 6tistructured $ducationalfprogram,(that.has been. recognized by NRC[that

~

includesw-(b)(1) l:es comp sted e structured educ Cone provem in bes:c rediensc ;de hendl ng techniques app;;ceb;e tc the use of djegneedc redisphermecevuce:e, cone sung of both -

(i) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of d;decuc classroom and laboratory traming in the following areas -

(A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and (E) Radiation biology; and

.. (ii) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />,of supervised practical experie.nce under the, supervision of an authorized user..who meets the requirements in f 35.290,135.292,;or;$ 35.390, or an_ equivalent Agree nent State requirement,' involving -

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (B) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (C) Calculating, measuring, and safely preparing patient or human research subject dosages;,

-(D)'Using administrative controls to prevent a medical event involving the use of byproduct material; (E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;and (F) Administering dosages to patients or human research subjects; and 26

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

,.,,J2) pas,obta,ined. written certification, signed by a preceptor authorized user, No*SEots the: requirements in 96 35.290,35292,;or 35.390 or egiavaient Agreement state reawrements, that the indindual has natidar*wty completed ttie requirements in paragraph (b)(+) (c)(1).of this section.and has:have b;;.7 e.'He!-cter;ly corr.pb;;d and met the bdt.idge: hee achieved a level of; radiation sedety iW S-y ceinp;;;;;.cy su"bkn te jf.desead.a l(feac;ba sufficient to fundian independently as an authorized user 3 or raedical uses described in f.35.100.; of-a f

d6gaW.:% redbph..Taecee:be; for the see; %:ed la f O';.100, and (0) re'b ing ce.epbiba sf to requlsen.eate b peregiaph (b)(1) of L!e eect;en, hee dorava.H.:.d eu"L en ;,nei.iedge b redi ; a eefeti ceraT.eaeuse:e l1 ee use requei,:;d by pee.bg en e_,Tbe:ba gisea by en e. gen;at;en er e..:.;f eppieved by the Oeina.;e.ba la

_____m___

.____2,_

. _, m m p%#%#%#3 %5HE GW ras B 3 EME#% F"% v5 H H9 fM3 b.

5 35.292 Training for imaging and localization studies.

Except as provided in f 35.57, the licensee,shall require-the an, authorized user of pegge. 2.redbpheiraecestk.% and genere eie unusaled byproduct material for the uses hated described in f 35.200 to be a physician who -

(a) is certified by a medical specialty board whose certification process includes all of the requirements in paragraph-(b)(c) of this section and whose certification has been oppieved recognized by the Commission;

~

_, _ J) is ddaWied"as"an aUth8iiiiil Usedr$iN.5IfoIaI5duiMe5 A EM5rd State I

requ._ir.emen,Has_r l t d 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and.experi,e_nce in_ basic

_ tt(o me.__,

,, m c) 5555c(lide handing todiniqUes arP r aMa to the~medcel uselof unsealed byproducir'n f ll

.mannama u ycomp e e li for imaging 'and tanannainn studies as a _ component #a training prograrn that has'been. _

recognized by tie NRC and approved by ellhor tho' Accreditation Council for Grmrinata Medical r thnasind or the Committeelon Pnairerw*wal Trainng of nAmencan'Ostareashic Amancant wt, E

' ran^equWalent structured annasinnal program that haslbeen recogn: zed ty NRC[#iat o

includes

,n l

,m

___.mm_

_ m.__2

_1

__2

._.2_

m _ 2., _

gWfg 4 ) B B69 %#%#5 5 Ef3.EUU R U H W%rEMI W W W%#U H%#5591 f3 g 5H355 53 5 bru.f%# 4MWr%75EU%r1 M 3 3W3 FWWI.

IecIsirengwee e[-[E ---I're Ie be Wee eI d shave C ied5[ibeiineces %s5 eird hes r.ie viU,

. - _ _m _m DV3 '**" T M,3.WH & -

y,.,,m

,m y,,,i g.

,,,,,n,,g,.

m.

(i) (1) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of thdacte classroom and laboratory, training in the following areas -

(A)(1) Radiation physics and instrumentation;

)

(O)(11), Radiation protection; (6)(R) Mathematics pertaining to the use and measurement of radioactivity; (3) liv) Chemistry of byproduct material for medical u',e; and (E)(v) Radiation biology; and fii)(2)A0 hourspf supervised practical _. experience under the supervision of.an

)

authorized _ user, who~ meals the requirements.in j 35.292,19,35.390,;or:an equwaient j

Agreement State requirement, involving -

(A)(l)iOrdering, receiving, and unpacking radioactive materials safely and performing the reisted, radiation surveys; (B)-(ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (G)illi) Calculating, measuring, and safely preparing patient or human research subject dosages; 27

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (B) W))Using administrative controls to prevent a medical event invoMng the use of byproduct material; (E) (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

.fF)(vi) Eluting technet sm ^^g.frern generator systems appropriate for preparation.of radioactwe. drugs forimaging.and ' 2L'h studies, measuring and testing the eluate for F

radiochemical puntymolybdensm-00, and processing the eluat_e with reagent kits to prepare technet;gm ^0m labeled rad:epharmaceuticale radioactwe. drugs; and (G) (vii) _ Administering _ dosages,to patients or human research subjects;_.

(3).580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> of supervised expenence in a cimical environment under the direction of Erifut'horized User physscian who meets ths requirements in f.35.292,i.35.390 or an equwalent Agreement Statefequirement; and

_ _f0} (4);Has obtained, written certification, signed by a preceptor autho_rized, user, who

. meets' the requirements in 6135.292, tor f 35.390,'or an equivalent Agreement State pequirementsMhat the:indwidual has" satisfactorily ceivg,ieted the require _m,ents in paragraph (b)fff(c)(1) to (3) of thi.s.section and has achieved a level of radiation safety knowledge sufficient to function independently have bcca eat.efectori!y comp eted and that the lndMdual hae achleVed aJEdef eempe:eneV 30fficleM to. lndependent;y function as an authorized user for medical uses desenbed in.ff 35.100 and 35.200. of d agnestic radiopharmeceuticale and gcaeratorslarme uaca ll5:sdla 5 35.^o0; and (0) re!;ev.ing comp let;en of the reqv remente in paragreph (b)(i) of th e ecctien, hae demenet.ated esffic;ent knew.iedge in rad:at en eofeti commenesrate v.ith the Lee requested by paee ng arrsaminet;en given by an organiza;;en er ent;ti eppicved by the Osmmies!en in 8cceidance vith Appends A GI thl5 pad.

I Subpart E-Unsealed Byproduct Material -lllgh Ceu Written DirecUvieRequired 9 35.300 Use of unsealed byproduct material for which a written directive is required.

A licensee may use any unsealed byproduct material prepared for medical use and for j

which a written directive is required that is either -

l (a) Obtained from a manufacturer or preparer licensed pursuant to 9 32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 6 35.292, or an individual under the i

supervislor of either as specified in.6.35_.27; or

_(c) Obtained from an NRC or Agreement State bcensee for use in research in j

accordance with an investigational New Drug (IND) (nah accepted by FDA; or

. (d)LPrepared by the hcensee for use in accordance with an investigational New Drug (IND) protocol accepted by_FDA:

$ 35.310 Safety instruction.

In addition to the requirements of 619.12 of this chapter, (a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that have received 28

/"

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 radiopharmaceutical therapy and cannot be released in accordance with $ 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and -

include -

(1) Patient or human research subject control; (2) Visitorcontrol, including-(i) Routine visitation to hospitalized individuals in accordance with 6 20.1301(a)(1); and (ii) Visitation authonzed in accordance with G 20.1301(a)(3);

(3) Contamination control; (4) Waste control; and (5) Notification of the authentedeoer1uwHhe Radiation Safety Officer, or his or her designee, sind #EauthostastTus' &if the patient or the human research subject dies or has a e

medical emergency.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with 6 35.2310.

$ 35.315 Safety precautions.

(a) For each patient or human research subject that cannot be released in accordance with 6 35 75, a licensee,shall - ____

(1) Quarter the paleont 'or the. human research subject either in --

(i) A private room with a pdvate sanitarv factity; or, fil Aveom;wWiaguluste nenhavincWIy, ulkanother indwidual who also hdrecewed

_tissapyMe!I!$alsocarinattie_W pursuard to $ 35.75; Pnmdes 2

p..:a;u a, 0,a g,:.

=, = -;,,

(2) Visibly post the patients or the human research subjects room with a " Radioactive Materials" sign and note on the door or in the patienfs or human research subjects chart where and how long visitors may stay in the patients or the human research subject's room; and (3) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactrvey cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle such material and items as radioactive waste.

(b) A licensee shall notrfy[the-outhenred-user 4md the Radiation Safety Officer, or his or her designee, and See whadmad user.as soon as possible,1f the patient or human research subject has a medical emergency and, immediately, if the patient dies.

$ 35.390 Training for use of uneoaled bypr,oduct meterial for O. a;Ge ::: el j

a::if 5,p;;f " - :^ " / O.;;.:;i.; puedeh"a written directive:Isireiguhid.

Except as pro Ei fadiopharmaceutieel =,vided.irt6,35J7, the., licensee shall require the r authorized u a physician who -

(a) is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been w..-

secognised by the Commission l

,,,._{hlHaskMNM; oryiEUE6fjiETn3EFraidi EUESiinntiisi decimiques anparaNa to metScal.uos of unseeded byproduct matodel where a ' written diredwe is inquired,fas_an componentW a trainirig program that has been recognized by th's NRC and 29'

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 hpprched5 eitheithe 56hieditalicFCNiicilio'Maduaje Medical'Educatidrior tim Committ'ee r

on PcmidevivialTraining of the Amencan Ostecipathic Association, or an equivalent structured ehnhonal program.that has been recogruzed byLNRC, that includes (b)(t) j lae cernp c;;d a etivctvied educatena progrern in bee:c rad:ensclide hand l;ng techn:qves app" cob:e is the use ef. Uneca:cd byp[ educt inaterial cone:ehng of both -

(i) (1); 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of d;dect;c classreein andlaboratory training in the following areas -

(A) (i)_ Radiation physics and instrumentation; (O)(ii)iRadiation protection; (O)(iii), Mathematics pertaining to the use and, measurement of radioactivity; (iv) Ct=geistiy of byproduct matenal for medical use; and (O)(v) Radiation biology; and.

P (PN40 hours of supervised practical experience unde.r the_supervisior) of.an. _ _

authe jser at afnedical in Genjnvelylng who meets the requirements in.35.390 or an e/

at Agreement State requirement,'involwng -

(A)(i) Ordering, receiving, and unpacking radioactive materials safely and performing

]

tc telated radiation surveys; (B) (ii) Calibrating dose calibrators as apprepr: ate, and diagnostic instninentation, and performing. checks for proper operation of survey meters; (6)(iii) Calculating, measuring, and safely preparing patient or human research subject dosages; ___

l (O) (iv)LUsing administrative controls to prevent a medical event involving the use of I

byproduct material; (E)(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; ^

(vi) F Admunstering dosages t$idiisiAE6um' n researc6 ' uNissts; a

s

, _(vii);Elutmo a generator, measunng and testmg the' eluate for radiochemica' l h6rit, and.

~

processmg the ' eluate with reagent kits to prepare labeled radioactive drugs; and (2) llas had ewrience, ebte:ned sader the d;iect supervie en ei en authorized caer, invehing at l east five casee fer each piecedure v,ith rad:ation eafety hazarde a:rnllar to that vee fer which the indivldual lejeque; Sag authesized seer etatse; (3) 580 hours0.00671 days <br />0.161 hours <br />9.589947e-4 weeks <br />2.2069e-4 months <br /> of.s6pervised expenehce'in a cimical envindi65ntiiAkithe'diIechod5f firiiuihonzed user physician who meets the requirements in f 35.390 or equivalent.Agreemed

~

State requirements, includen a mmanum of 3~ cases in each_ of the following'categones for whichthe indindual is requestmg authonzed user status.--L._.___

(i); Oral administration of less than or. equal to 33 millicuries of sodium iodide;l-131;-

(ii). Oral adm;nistration of greateithan 33 millicuries of sodium iodide.l-131 ; __ _

8

, _ iii) Parenteral administration"of any beta. emitter or a photen-emitting radionuclide with a

(

s P oton energy less than.150 kev; and/ ort _ __

h (iv) Parenteral. administration;of any,otherradionuclide.

_...(s)(4)lias obtained. written certification, signed by,a preceptor authorized user, who meets the requirements.in_6.35.390 or an equivalent Agreement. State: requirement, that the individual has requgernente in paragraphe (b)(1) and (2) of thie secten have been satisfactorily 1

I m.-

m~,..w-,

.--v cm - - n m

,,..._em...

'Extierience with at least 3 cases in Category (ii) also satisfies._the)equirement in Category (i).

30

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

.., _, -._ c

-.. _. - _ -. -. ~ ~.. _ _.. ~

completed thofeguirements.in paragraphs l(b)(1), (2)(,and.(3) of this.section and th. the indmdual has achieved a level of rarnahan safety knowiedge em,,r :e.,;, eufficient to function e

-y r,

_ _ _. _ _. _., _ _ u _.. _ _ for

)

independentlyj.._ _,

as an authon. zed user m_,

._ _ _ _, _, t. _ _ _

.~ m m

.....W.W.,

.,. 5W..,_

medcel uses p ; '^^M lb:ed in 6 35.300.rtmd

___,_c~a_

_x

,u,,,

_ _,,,,, _s a. _ _ _ _..

g'"vf 3 %#ff%#77 us pg W%,I I fyrw u%#3 I %#5 U 59 5U%jnsIIWIIUWBEb6 31 3 P3 Mgl uyB 5 (Uf(f M BUG GWVtrV4 4,

.f M3 End gK f %#3.. _ _

, _ _ _ _.._,_,.. _..-_ x,__,_

__,._c

_ an a -

EUM9 %591B5%#1BWM W4W%5 W3 IEW3 54 UTE 5%rvu svidp II 5 3 u%svgistrVI I tyv.srW sy %r%#13 g3 5 rul 394s3 utU TV s u I MUU %3N

___..__i_,t..___._

_e__

t..

e__

em. _____.._, u.. a _

3 U%ghsww.wid My,_ _ _ _ _ Eg us 5 W#tus I BUI e4ispVE 5 gu vWg i My El3 %,5g ul554.4istyv35 %#5 W5 EHE7 pyyy gr yUgs Uf M IU

,, _ _. _ _ _ _. _ _ _ __,____.-... nyym.m,,,.,.,, a n _

,_a

,____,w,

%.,m.....,_,.....-WW.-.WU

.....r....

-n,.-,

m.---m

,y--nc-,,mm.= -

.~.,.,mn,,m:v.,.~.n,-.,

.m.m.-.,-,

jfl35.302 Tiraining dor.use si sodum iodde I-131; for which a usfuengibeceveAsequhad.

.n,,.a--~.----.

-._ _ Exo.pt as suavided pg 35.57, the liconeselshed_ requite an authorized user of, sodium iodde 4-13.1;for medical use, to be a phveican -

,,. ~

cor.dl

-n-n.

nn.-.-

-(a)!ls.-

the requM%,ed ty a medical speciality board whoes certificatio_n process inclu paragrapfi fc) of this sectionLand_whose_ certification has been recognized by.the.Com. mission;'.or m __

(b.)?Is..quauned as an authonaed u_ser u_nder $ 35.3_90; or (c)(Has,ancriaaahe. r completed training in basic radionuclide handing techn. iques n.

arvaraMa to medcal use of sodium iodide 1-131 for procedures requirng a written drective as anM_etabgehedeom~po. m. nen appsowedtsyaltserh ac,t sf a traming prognun that has been recogneed by ths P.y

.._ SIC _lend,.

can,mmean CouncBMararah naaranal 1:rt raaman or the Committee I

.Tminingh h OnesapathiC' %'"^' Wwan W h ar**=engal propam~secognized b..y NFIC, that i. ncludes E

. ~, _ - -

(1)110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br />.cifdameroom an_d taboratory training, inLahe foNowing areas.Q

6) faa,mamanphveies'and instrumentation;

01) Radiation pmesolion;

.._..m.,_.-mm m

t (5HAsshomadics pertaining to the use~ and measurement of rarenare ity;

~

v

}

ps)~Chemisery af byproduct masonal for medical use;

)

Dv)faanemaan biology:and:

- - - ~.

.._ 05 supondeed practical expedencei that may be obtained concumm, tly with the supondeed expedance in paragraph (b)(3) of this:sedion, under,the 'supondaion of 'an authodaad tisoiioho meses;the requirements in:$l35.390 or.$;35.392lor/aKequivalent

~

Agpeanimet State seguinwaest, inwolving 9_..,_ive materials:sa, fely and perfom 0[Osdodng.secelsing!,and unpaddng sadoact rei nod d.nonaunmes:,

ddiagnaalic_ instrumentation..andperfonning,,_c_ hecks n.-. _ -,,,.

l SI)Caltaneing dose caltwasorsan forososieroperaha t e

.._ _05)_Calcdating, m n or.surveyme sss;n.n,.- lent or. human research &lect

,.- _ _. n easuring,-and safelyproposing pel m

dosages;

__ ov) using administrasve contrais to prevent ac medical event irwolving the.use of &__i byproductmotorisi:

~.v-

_~

nn jv) Using psocedures to contain splBed byproduct matenal safely and usmgproper BifosiItamin. nelon paiueduies;"_and_

!(vt) Administesing dosages to panents orhuman r_esearch subjects; and_ _,

~

(3) Has had experience, obtained under the~ direct supervision of an authorized user, 31

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 whoheeis th5 r$quirements in'f 35390'or'@55.392 or an eduEal5hi gr~5emeniStdte

~

2

~

requirement, invoMng at least.3 cases in each of the following categones for.which the indmdual is' ram== hog authonzed user, status l-,.. _ _

~

(i); Oral administration of less or equal to 33 millicuries of sodium iodide'1331;4 (ii) Oral admmistration of greater than 33' millicuries of sodium iodKie 1-131f

,.,,,(4)l Has obtained written cintifidiidicia,'sx3ned by a deceptor authorized usei,% rnie~ts the requirements of in fj35.390 or 6 35.392 or equevalent Agreement State requirements, that.

the indudual has satisfactorily completed the requirements in paragraphs (b)(1), (2), and.(3) of this section'and has~ achieved a level'of radiation safety knowledge sufficient to function independently'aslan authonzed user for medical'uses of. unsealed byproduct material usin'g

~

sodium iodide 1-131)

Subpart F-Manual Brachytherapy 9 35.400 Use of sources for manual brachytherapy.

A licensee shall use only brachytherapy sources for therapeutic medical uses!

(a) Aas approved in the Sealed Source and Device Registry; or

,(b) In ressaich ifhbith an effective inveistigatiorrJ Device'Eicemption]lDE) aidemikW accepted by,the FDA.

1 6 35.404 Radiatiem5eurveys of pat l ente er hu.T,an re;;;;;h subject; tr;;ted v.;t;, EEAr source implants and removal.

(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a rad lat en survey of the patient or the hvinen research subject pad the_

.odIoooni oioo of Loo tg ceq@m Q&t gs sources have been mlepl&ced. to locate and account for all sources that.have.not been. implanted.

(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a radiation survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

(c) A licensee shall retain a record of pat ent er hurnen rese&rch asbject ibisurveys in accordance with 6 35.2404.

9 35.406 Brachytherapy sources inventory.

i (a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(b) Promptly after removing sources from a patient or a human research subject, a licensee shall retum brachytherapy sources to a secure storage area.

(c) A licensee shall maintain a record of the brachytherapy source accountability in accordance with Q 35.2406.

. Expen,ym, h at least 3, case. 7, Category (ii) also, satisfies the r,equirement m fy

_m y. ms m

.m. -

. -. m7 ence_ wit sm Category (i).

32

T _-

1

)

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 1

1 5 35.410 Safetyinstruction.

In addition to the requirements of $ 19.12 of this chapter, (a) The licensee shall provide radiation safetv instruction, initially and act least annually, to personnel caring for patients or human research subjects that are undergoing im,n!=d therapy and cannot be released in accordance with ! 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the -

(1) Size and appearance of the brachytherapy sources; (2) Safe handling and shielding instructions; (3) Patient or human research subject control; (4) Visitor control, including both:

(l) Routine visitation of hospitalized individuals in accordance with 6 20.1301(a)(1); and (ii) Visitation authorized in accordance with $ 20.1301(a)(3); and (5) Notification of the authenreduseren& Radiation Safety. Officer, or his or her designee,55d shaul6br6ies[uisir if the patient or the human research subject dies or has a i

medical emergency.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with 9 35.2310.

$ 35.415 Safety precautions.,

EEks(eloisednM]uillij a,..!;aed pure a; to 9 35.75 ef th;e pait, a licensee shall-a) For each patient or human research subject _that.is receiving brachytherapy and can (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation-bishiytherapy; and (2) Visibly post the patient's or human research subject's room with a " Radioactive l

Materials" sign and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(b) A licensee _shall t3 ave.available, near each treatment room, emergency response equipmenthrespond to.asource-(1[inadvertendipe*wd5*dNWpaS5t;R__6__the;soume applicators.;

(apnadversendyjodged.within me patient fotowing vernoval f

........,~,...,~._,,

q u;p m e n; m ue;;r~_l.de, e; g. m a b:e --

m

,.2_.

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1.,

~-.s.,....._,~...,

(2) A 2.ilded ec~re./eppl;ee:er e;.re e een;ehr, v

(^,) F.eir.ete her.d;;a tee le, and -

)

v (4) Oupp be i.e.x.rj te e.rgM:lj ieT.we ep,,lM; ie er ee.,e.e fi T. e pe;;;a; ei human inn.id, subjee; tra.;ed la;e.T.e:ti eT. ;.bd eeuseee.

(c) A licensee shall notify the euthented-user-and the Radiation Safety Officer, or his 5 iiiiir designee, iiid:asFMisser as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies.

,_,.m

.m-

$ 35.432 camw=manori==anys,_osan===ese-

• reehrm==pr.o==e=

4 (e) A ;;;;r.x; e.e.a:ad to see trahy=repy secrees fer medh: use r.el: pe,1e,m fv;l w. ;b. ;;.r. meabiemen;e en biefcythag,y eeu,eee b.fere the 7;..; medh: uee of N ee.se er ^.e.salep,,llafes er.f gu. ;;.a.

(b) A lLr.x; may use ee::b,e;;.a meeeuremente pie.ided by 2.e eeuree men. fee:ura 33

1 WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 thet are made in accordance #th the requirements of th:e section.

(c) To eat:afy the requirements of persgraphs (&} &nd (b) of th:5 secdon, full ce!!bretien meaegrements must inclUde determinetien of -

(1) The eviput er scu.iti within +/- 5 percent, end (2) Ocurce pee!!!ening accurecy within eppl;ceters.

(d) A Scenxc shell Use the deel metry ayatem desci; bed in G 05.000(s) 10 measure the output er acti ity of the brachytherepy eevice.

(a) A llcenxc shall make full cellbr&Sen measurements required by peregraph (a)of th!e sectica in accordance a:th pub ehed protece's by natjenal!y raccgin! zed bed cs.~

_.ji) Prior tb the fiist'medicil'use of a brachytherapy source ori or'afterJidsert t6e eifective dat'e of thisirulella licensee shall-d}1) Dete6mindtlio 5w. output or a500it Mnia dosime~tisistem Siaimedisith requirementsof @35.630(a);_,

(2) Determine source positioning accuracy lwithin app'Jeators; and (3) Use published protewis accepted bV nationally recognized bodies to meet the fen 5mbnts of paragrai:tsl(a)(1) and (a)(2)~offtbis section.1 i.

[

(b) A bcensee mEy use measurements provided by'the source manufacturer that are

~

~

~

~

~

nIdijehaccuidance with'parayapli(a)of this'sechon.

(fc) A licensee shall mathematically correct the outputs or activities determined in paragraph (ca) of this section for physical decay at intervals consistent with 1 percent physical i

decay.

(gif) A licensee shall retain a record of each calibration in accordance with 35.2432.

9 35.490 Training for use of manual brachytherapy sources.

Except as provided in 35.57, the licensee shall require the authorized user of a manual brachytherapy source for the uses listed in 6 35.400 to be a physician who -

(a) Is certified by a medical specialty board whose certification process includes.all of the requirements in paragraph (b) of this section and whose certification has been recognized eyy d by the Commission; or (b)(1) Has completed a stmetured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources consisting of both -

(i) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic traming in the following areas; (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaming to the use and measurement of radioactivity; and (D) Radiation biology; and (ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised practical experience, under the supervision of an authorized user at a medical institution, involving -

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (B) Checking survey meters for proper operation; (C) Preparing, implanting, and removing sealed sources; (D) Maintaining running inventories of material on hand; (E) Using admmistrative controls to prevent a medical event involving the use of 34

WORIGNG GROUP DRAFT DOCUMENT MARCH 16,1909 byproduct material; (F) Using emergency procedures to control byproduct material; and___ _

(2) Three years of supervised clinical experienceinf=diarian oncologyjas pait ofthat d-v= is- = a fprmal training pmgram approved by the Residency Review Committee

=

forRadissioniOmselojgy ".J;e:v, ef the Accreditation Council for Graduate Medical Education or the Committee on Postdcctoral Training of the American Osteopathic Association or it__.t un,-

3 is..

meu.

mya a-o-yyav -vyu.a m m,-.u..o - uvu-a-u p,m sm m.- mo raa.um, usa $a Ja,.upa vs.$v.a er s.as.uiIavana&d u v.

f MininaisiinicEnlEie ienceinsnindisp==imph(isx1)(iikthi(=*w an,d,_

,~.,. :(3) Has o,btained written certifica.t, ion,_ signed,by,a precepto. r authorized user, who. meets the =ri=a n -==*= ins 35A90 er equivalent h~are-ncument State requirements, that the individual has

- n n -; n

~

'iinimEnrenn$i:heihiesd[ ale requirements in paragraphs (b)(1) and (2) of this section 1. L ~u n

J.f i aily wmyk,J and Ja.a J., iud;.;Ju.J has achieved a level of competency sufficient to independently function as an authorized user of manual brachytherapy sources for the uses h#irstedin i 35.400; and; su, -,.

s r.t

, st r i. x _. 3 im

_r..

g v/ a vuv-aug waaayawuvaa us as., amguuvaan.u asa y a.ga.yan gujg 3j.asu ge.j va uma

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u uomvuma==.uaan.a mauv-a-su-a s..u u v o m y w - ----. m - u u u. u a msm...m by --- ; -a sa muu.deu es..u vy ou vas-.- vu va oumy oyyav..,J by J., Ceuuu-seu m

-,ws.:

-ida Ayy.,m'Ja A v' Ju. y-E.

Subpart G--Sealed Sesiss for Diagnosis 5 35.500 Use of sealed sources for diari.

A. licensee shall use only sealed sources for diagnostic medical uses as approved in the Scaled Source and Device Registry.

I 35.590 Training for use of sealed sources for diagnosis.

Except as provided in 6 35.57, the licensee shall require the authorized user of a diagnostic sealed source for the use in a device listed in 6 35.500 to be a physician, dentist, or podiatrist who -

(a) Is certified by a speciality board whose certification process includes _all of,the requirements in paragraph (b) of this section and whose certification has beenincognized appsved by the Commission; or (b) Has had 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device that includes -

-(l) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Radiation biology; and (5) Training in the use of the device for the uses requested.

35

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 I

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c-%,,.-

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Subpart H-p.erepet e ".";d:ee: Cey;eee Photon Emitting Remote Aftertoader Units, Teletherapy Units, Land Gamma Star-d=* Radiosurgery Units n.-

f 35.600 Use of a sealed source in a d,.;;ee fpithereppt!; ; red:ee: see; remote afterloader unit,1olotherapy unit, or_ gamma ster =*w* radiosurgery unit _

_ _.-_. A licensee shall use sealed, sources and,iridev;;ee phot 6n ' mitting remotejafterloader e

taiits,: teletherapy. units, orl gamma stereotactic units for;therapyeutic for medical uses:

(a) Aas approved in the Sealed Source and Device Registryt or (b) in ressaittiin adde,4is,oe with an effshive inveshgatiorial.IE0iciExemidosi (IDEi) iiirTpica_ tion accepted by the FDA.

1 9 35.604 Hadiation-e5urveys of patients and human research subjects treated with h remote afterloaders unit.

(a) Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader isnit devree with a portable radiation detection survey instrument to confirm that the source (s) has been removed from the patient or human research subject and returned to the safe shielded position.

~

(b) A licensee shall retain a record of pedent er humen reecerch esbject the surveys in accordance with 35.2404.

$ 35.605 Installation, mainter;ance, a" djustlid, and repair.

(a) Only a person specifically licensed by.the Commission or.an Agreernent State shall install, maintain, adjust, or repair a devree remote afterloader unit, teletherapy unit,.or gamma stereotacbc radsosurgery. unit that involves work on the source (s) shielding, the source (s) driving unit, or other electronic or mechanical component that could expose the source (s),

reduce the shielding around the source (s), or compromise the radiation safety of the device unit or the source (s).

(b) Except for low doss-rate remote afterloader Eltd;v;cee, only a person specifically licensed by the Commission or an Agreement State shall install, replace,_ relocate, or rernove a sealed source or source contained in a remote afterloader_ unit teletherapy unit, or_ gamma ster =W un:tdev;ce, (c) For a low dose-rate remote afterloader unitdevree, only a person specifically licensed.by,the Commission or an Agr_eement State,or an authorized rnedical physicist shall install, replace,' relocate,'or remove a sealed source (s) contained in the_ unit.: pe.ierm the functiene l:sted in peregreph (b) ei thie :-ect;en.

(d) A licensee shall retain a record of the installation, maintenance, adjustment and repair done on theregsdc med:ce! dev cee' remote afterloader units,leietherapy units, and gamma stereotache mdiosurgery ur,its in accordance with 35.2605.

535.610 Safety procedures and instructions for remote afterloaderTunits, teletherapy units, and gamma stereotactic radiosurgery units.

(a) Alicensee shalldev;;ep,irrvo....., o..

me;ntein wr;t'en precedures for -

36

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (1) Securingi the deviceUsit, the console, the console keys, and the treatment room when not in use or unattended; (2) Mp; fer bw d%ekreg.etegsMdere, eaeork; 2,e; eQia q;;L goryg i

henen 7:::.r1 QRb, Permit caly3ndviduals approved bysthe.aulhosizedl user,.Redelion Safety [Olnosr,Maulhonned modcal physicist to be present in the treatment room before

^

initiateg dudng treatment with the source (s), eat.e e.....Ld%.;ed, er e%er e deer L;e.-l.3

..; err.,,; n; (3) Preventing dual operation of more than one radiation producing device in a treatment room if applicable; and (4) Devoltip, implement,IricInielssiiriVsEl'e'rIpiricieddies'IWrResponding to an abnormal situation when the operator is unable tc place the source (s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. This procedure must include -

(i) instructKms for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; (ii) TholpProcess for restncting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and (iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the device ' unit or console operates abnormally.

-(b) A copy of the procedures required by 9 35.610(a)(4) must be physically located at the unit console.

(c) A licensee shall post instructions at the device EiiilI[ console to inform the operator of (1) The location of the procedures required by 9 35.610(a)Sj; and (2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the de;te er e.a.e6 unit or console operates abnormally.

~ (d) A licensee shall provide instruction and p.ee:Le... 6, initially and at least annually I6~eRinduisiiulsiuldepsiintstheMiltladippr6pqI'assitheint9vidders5sIsi5didMl ins,

(1) Tthe procedures identified in. paragraph (a)(4) of this sechoniand (2) Fthe operating procedures for_tholunt te ell bd /.dd te spe. ;. ;;.e de;

, ee ep;-r.piL;. is 2 LC/Me :::7.ed dd:-a. A lL.. :::.;e:: en re 1e; ep...;ere rec::;.

..:..# ; tie:.....,L 2 epe..; a e: 1,e.i.l:and piee.dere. trperidt.pe;-d.e.L.andfull calibrationetand___ E e,n_suus, that operators, authonzed_rnedical physicists, (e) Aeoensee.she users participate in drills of the emergency procedures,inflisNylanId atleast annuely.

(FHe) A licensee shall retain a record of induduals receiving instruchon required by paragraph (d) of this sechon, in accordance with 6 35.2310.

9 35.615 Safety precautions for remote afterloader "n5ts, teletherapy units, and gamma a

storsatactic radiosurgery units.

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

(b) A licensee shall equip each entrance to the treatment room with an electrical irterlock system that will-(1) Prevent the operator from initiating the treatment cycle unless each treatment room 37

l i

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 entrance door is closed; (2) Cause the sources to be shle!ded immediately when an entrance door is opened; and (3) Prevent the primary beam of radiation from being tumed on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console.

(c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have retumed to ambient levels.

(d) Except for low-dose remote afterloader Iinits, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

I (e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled orjammed source.

(f) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee shall-(1) For low dose-rate End $UlrixfSosi-iatiremote afterloader unitdevrees, require -

__(i) Akauthonzed medical physicist and aAn authorized, user or h physician, under tiie supervision of an authorized user,.who _has been trained in the operation and emergency

~

response for the unit en esthodzed med;cel phye:ciet to be physically present during the e

initiation of ali patient treatments invoMng the unit device; and

-._,.- (ii) An authoriz,e.d medical physicist _and an authorized user or an individual phy3;cien, under the supervision of an authonzed user, who has been dcsi;inated by the authedzed user end vihe is a radiatien encelcgy phys'clan trained to remove the source appbcator(s) in the event of an emergency reopenee fer involving the, unit devree, to be immediately available during continuation of all patient treatments involving the. unit devree.

(2) For high dose-rate remote afterloader ursdev cea, require -

1 (i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments invoMng the un!!devlce; and

__ (ii)_An aut_horized medical _ physicist and an authorized user or a physician,[ unde [ths supervision.of_ an authorized user, who has been deo gnajed by,thq suthedzed user end ohe l5

& redia;;en encelegy ph e:c en thet hee bcen trained in the operation snd emergency response i

for the 'unitdevice, to be physically present during continuation of all patient treatments involving the urutdevree.

(0) Ier pgl sed desc-rate remete aftedeader devlces, requirc --

(l) An authorized seer er end en evtherized med;co physic 31 to be phys:cs!!y prcecat during the inl :at!en of all paden; treatmerds inveMag the des:ce, &nd (ii) An evtherized ined;cei phy3;me and an euthedzed seer er e physicien, vihe has b;;n d;;;;noted by Le ouZedzed u;;i and ehe lo a sod lotlen encelegy phyo;;;&n Lo; boo 1

bcen treined in emergency re3penee for the dev ce, te be mmediately ava!leble dvdng

{

cendnuat;en of all pat;ent treetinente inveMag the devlce.

i (3)(4) For gamma stereotactic radiosurgery units, require an authorized user r nd an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(4) Notify the Radiation Safety Officer, offiis oitiiridesigriee[ard ariaUttbriied user as i

38

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 Mony TEMYMM@MEMecalMW immodately,Vesepatient. des.

(g) A%e licensee shall have available, near each treatment room, emergency response equipment,,asapplicablesto:sespond to a souses i (1) Inaduestently semeisung in ese unshielded position; and (2) Inadussteneydodged umhin saipselent togasing compleSisi6f ENaisE5tl n.e e.T.ergeraf ;e.yer Sp;r.u.; ir..e; ;r.c.de, ea -g-;;== -

(1) A d;.-M ;e a::':: lr. pt:4, i.e earee(e) ir, i.e eE;:d+d ;--;;; er.;

i

@) A.M::f+d ;-:--ia/=?:-:zi e;aese eerO:..,

l

?).7e.. e;; l.u.d;;..; ; die, d

(4) Oui-g":: re:::::ri;; eigh;t se.T.we -g-g"-e;ae er ;ca.e. ii.,T. a pe;;;..; ei i

t.;..T r. seen.d. wyes;;;n;;d ;..;e.T :t ef, en:ed esasee.

i 5 35.630 Dosimstry equipment.

(a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this j

requirement, one of the following two conditions must be met.,__

(1) The system must have been calibrated.using a system.or source traceable to the National institute of Standards and Technology (leST) and published protocols ppraed acompted.by nationally recognized bodes; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and aftar any servicing that may have affected system calibration; or f

(2) The system must have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system must have been intercompar ed with another dosimetry system that was calibrated within the past 24 months by the NIST Natim T ; Wy or by a calibration laboratory accredited by the AAF M. The results of the intercomparison must have indicated that the calibration factor 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 factor. When intercomparing dosimetry systems tc$be used for calibrating sealed sources for therapeutic unitdevices, the licensee shall use a comparable dence unit with beam attenuators or collimators, as applicable, and sources of the same radionuc:5 as the source used at the licensee's facility.

(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 must have been performed within the previous year and after each servicing that may have affected system calibration. The epot-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, intercomparison, and comparison in accordance with 6 35.2630.

$ 35.632 Full calibration measurements on :::_^3.eie y units.

r (a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit -

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

39

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (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 teletherapy unit in a new location; (iii) Following any repair of the teletherapy 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 1 year.

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

(1) The output within +/-3 percent for the range of field sizes and for the distance or range of distances used for medical use; (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (4) Timer constancy and linearity over the range of use; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices in medical use.

(c) A licensee shall use the dosimetry system described in 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 shMI make full calibration measurements, required by paragraph (a) of this section in accordance with published protocols appreved accepted by nationally recognized bodies.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) i of this section for physical decay for intervals not exceeding 1 month for cobalt-60,6 months for cesium-137, or at intervals corisistent with 1 percent decay for all other nuclides.

(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.

(g) A licensee shall retain a record of each calibration in accordance with 35.2632.

6 35.633 Full calibration measurements on remote afterloader EEEs.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit -

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

(i) Whenever spet<heek me&eusemente ;ndhie thet the estput differe by mere then 5 pereen; frem the evtput ebteined et the laet fv!! e&libretion cerrected methemet;ea::y for sod;;o;fie;decai, i

(ii) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

]

(iii) Following any repair of the unit that includes removal of the source or major repair

]

of the components associated with the source exposure assembly; and 3

9I i

40

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (3) At intervals not exceeding 120 deve iqUster for high dose-rate and pulsed dose-rate remote afterloader Units with' sources "whose halHile asoceds 75 days; and _

(4) At intervals not exceeding 1 year for low dose-rate remote afterloader. units.

(b) To satisfy the requirernent of paragraph (a) of this section, full calibration measurements must include,' as._ applicable; determination of:

(1) The output within +/- 5 percent; (2) Source positioning accuracy to within +/- 1 millimeter; (3) Source retraction with backup battery upon power failure; and (4) The ope.L;;;ti of :he e:st.ia::i;n;;;;d ;ree;.aea; resa deae eit te h;;h-dee.

.ek, rene;e e';e.h.d.s ua;; eb;iMl,~.;;; tened eff.

(e) in add.;;en ;; me seqe.seinen. fu fell s::bre:Me fu e:: rane:e a;;e;iceder a;;. a p.rega.ph (b) ef 1l. am;M, e lbr.x; ehell.

(1) ra h gh des ; ;; and pe:xd dwe.e:. rane:e e';er eeder.;, a::bre:e -

(!)4) Ciridthlaf tThe source gende transfer tubes; A;;a; rJeb ae; e-eeedlas se questa.

(A (95) Timer accuracy and linearity over,the typical range of use; and (06) Length of the connectenrepplicators; and (ii7 Ana "y,1. fTunction of the source transfer tubes, ge:d.e and eena.e:we "sIgipiid$1Ei) anstransfor'W~ interfaces.

^

(ec, inp*hri to1hofreguirements for fad calNisiidis for$ low dose-rate remote

~

afterloader ' nitsM paragraphjb):of,this.sootionfa iloonees shall perform an autoradiograph of u

the source (s) to verify inventory and source (s) arrangemen; and e ape; ched of te ebee.;;

n.es ea~recy at intervals not exceeding one quarter.

(d) A licensee shall use the dosimetry system described in 6 35.630(a) to measure the output.

(e) A licensee shall make full calibration measurements required by paragraph (a) of

. this section in accordance with published protocols appised amaf adby nationally recognized d

bodies. fifor Cdosi-rale rirnato MWiliiioideEInsEWh is6ivEe[d tithe' source _ manufacturer that'are..made in accordance with '

(efeithis section'.

(g)(f) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.

(h)(g) Full calibration measurements required by paragraph (a) of this section and physical decay correchons required by paragraph (fg) of this section must be performed by the authonzed medical phys' mist.

9(h) A licensee shall retaln a record of each calibration in accordance with 6 35.26329.

$ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authonzed to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit -

-(1) Before the first medmal use of the unit; (2) Before medical use under the following 0Erditions -

(1) 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; 41

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and (iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and (3) At intervals not exceeding 1 year.

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

(1) The output within +/-3 percent; (2) Relative helmet factors; (3) Isocenter coincidence; (4) Timer accuracy and linearity over the range of use; (5) On-off error,and,

(6) Trunnion centricity;__ _.,

_ _(7) Treatment table retrachon mechanism, usmg backup battery power or hydraulic backups with the unit off;_ _

(8) THelmet microswitchs; _ _ _.

(9)' Emergency tumng cercuits;and.

(10); Stereotactic frames and localizing devices _(trunnions).

(c) A licensee shall use the dosimetry system described in 6 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 published protocols &ppicved accepted by nationally recognized bodies.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.

(g) A licensee shall retain a record of each calibration in accordance with 6 35.26325.

9 35.642 Periodic spot-checks for teletherapy units.

(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of -

(1) Timer constancy, and timer linearity over the range of use; (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization devices used for medical use; (5) The output for one typical set of operating conditions measured with the dosimetry system described in Q 35.630(b) and 42

~- _ - _ -

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (6) 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 authorized medical physicist. That individual need not actually perform the spot check measurements.

(c) A licensee shall have the authorized medical physicist review the results of each

. spot-check within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the results of each spot-check.

(d) A licensee authorized to use a teletherapy unit for. medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of -

(1) Electncal interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

(3) Source exposure indicator lights on the telethe.rapy unit, on the control console, and in the facility; (4) Viewing and intercom systems; (5) Treatment room doors from inside and outside the treatment room; and

~(6) Electrically assisted treatment room doors with the teletherapy unit electricai power tumed off.

(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall 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.

(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d),in accordance with $ 35.2642

$ 35.643 Periodic apot-checks for h;iiih f:::. ^ er.d 7::f f::: 7 ^ remote afterloader units.

(a) A licensee authorized to use h;gh dex ce:. er pp:sd dae,..

Siemote afterloader Esilts for medical use shall perform spot-checks of each remoteM"faicEty andlon each unit:

(j) A; r.; bes;na;a; d each - A d ues,

~

.,.j$e) At the,beginning of each day of use id~a"iilndohior;p35id DIGENE samote abastander unit;iillait tisiassisisiii s[tiddiis5fli Mmoti~alied5 midis 56 and

~

g$Euledifianch (3) After each source installation.

(b) The licensee shall have the authorized medical physicist *

(1) E::^sLh written procedures for performing the spot-checks required in paragraph (a) of this sectki., and (2) ";V..

0a ree.2; d eed epe:-;t k ieq.;ied by p res.,,h (e)(1) d 2;e es%n 7.:;.1"; d y; d Oe Ceek. Oe e.W.e.:ied T.edk l phy;:.;.; r.xd.e; eeto "i pefe.in to spoMheelemeeswoments.

(e) Te

. y.a r.q.

.e.caa:. d p.;.rcy. ph; (e)( ) d.;; euta, ep=-chuk; rr.ue:,

i 43

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (1) edfy escree positenlng &ccurecy;

,m m___e__

2__e_._

e--

,s,m. _ _ a umU...,U vu,yo. m..L..L.U w e o. U u, _. _. _ _

2_ _ _ _m _ ; 1_

r,s u

oyo.... m

..-Uu o. s ~.

v w,, o..u

~

(0) Oelcvl&te the d;fference between the meessiement mede in peregreph (c)(2) of this secuen end the ent;cips:cd output, expressed se & percen'ege of the enucipeted output (i.e.,

the v&lue eb;&lned et lest fu" ceUbr&Sen m&them&Scelly ceriected foi phys;ce decey).

(c)(d) To satisfy the requirements of paragraphs (a)(^) &nd (s)(0) of this section, spot-checks must, at a minimum, assure proper operation of,--

(1) Electricalinterlocks at each remote afterloader unit room entrance; (2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

,_ _,_.,,3) Viewing and intercom systems in each high_ dose _ rat.e.an.d pulsed dose-rate remote l

(

aftedoader facility; (4) Emergency response equipment; (5) Radiation monitors used to indicate the source position; (6) Timer accuracycenetency; and (7), Clock.(date and time) in the unit's, computeriand (8) Decayed source (s) actMty in the unit's computer.

(e) ln add Sen to the requiremen'5 fer opet check 5 in peregr&ph (d), & ::cen c; sh&"

enwre over&l pieper spereden of the Unit by conducGng & e:muisted cyclc of treetmen; &5 pe.1

v..L,U orv. m..Umme.

____._L__.._

u (f) A l:censce eh&ll errenge for premp; rep &ir of any eyetem identf cd ln peregreph (c) of this sectier, ths' ;5 net operetag.

(d)(g) If the results of the checks required in paragraph (cd) of this section indicate the malfunction of any system, a licensee shall 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. _

(e)(h) A licensee shall retain a record of each check required by paragraphs (c) and-(d) of this section in accordance with 6 35.2643.

n__

,~.-.m.._

.y

_<__.._,__._..._.,~,.. _ __ _ _.

_m..U.._

.m.,mm....... -

...U...U (e) A ncer.xi, euthorized 'o use lew desc rete reinste efterlceders ter med;ce: use sh&"

perform ope' _checke en cach unl: prier to e&ch pet;ent treetment end aber e&ch eevice

.L

.,__,a___

El 4G4ussu43%#3 5 o IEL H IVlWWU V3 %#p 5__

Vp6 963%#4 5 %#5 '

(1) C;ectrice ;nteriecke &; c&ch reme'e eftedceder seem entience; (2) Oevice expoegre lnd:eeter Ughie en the remete efterioeder unit, en the contre; cense e, and in the fec;U;y;

,m, m.....,3.....______.._.___..U. ~ u. o,..eu..,

(4) Emergency response equipment; m__._.,______..__

..__2

._m.__._

.L _ _ _.. _ _ _ _ _ _...

ghFf 5 39%AsELBh#3 5 5 5 3%#1384%#4 G ba@wb6 LV 343%dIVut9 ba lU G%/bli kU p@lks%,8 5, (d) Eisei cGiset&Ocy^; &nd

.,m m.__,

,a_.

.1__,

.L_

.._m_____..._.

gi f b#I%Fban (%#uLD El 5%d u8 4 IUf 54 5 u IU WB 55L G %e%#5 IIyLA 696.

(b) !n edd Neis Is Ihe e eQU$i6mente Ici spei checN5 6 p&i&Qieph (6), & Ecenc^c 5h&N enesie cvei&" preper oper& Gen of the unit by cendscung & 3lms:eted cyc;e of tre&; ment 25 per!

_,.L_

_L__i_

%/4 LI 5% GWLNiIUbh e

,_\\

"PL _

f?______

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B4IU%dibG5 f3If.IW5..

(Uf 5 4 3G 53WU4 saw he G8 4985 4 IQ W he na 59 ubsta l'e#4 44.Uhd 6 --

O i

I

1 l

1 O

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 V

s,.

....... m... r --

.... ro......m.,.....y m m... m.. v..

... r.

3.

r..

j (a) of 1:e esc 0 n, and (2) T'.r.ia;. Le reesite ei eech epe;-check reqv; red by peregreph (e) of mie esct;en

.;1;n 15 doye of Le check. The euCei:ad.T.ed al phyo:c o; r,ad ne; edu;lly pedeira Le eps;4hecksneaeuseinente.

(d) lf the reeuite of the checke regs; red in peragraph (e) of Zle secten :nd; ate the

.Ta#unct;en ef any ey;;;.T., a l; cones ehallled the cen;.u: cen e:e ln the off pee: Gen &nd ne; uee the unF. exe.p; as.T.ay be necease.i to sepa!i, sepl ace, er check Ze.Ta%und;enlng s,e:c,T,.

(e) A ;; cense ehall re: :n a reevid of each check required by paragreph (a) of m;e sect;en ln acceidence wlth s 05.2045.

9 35.645 Periodic spot-checks for gamma stereo'.actic radiosurgery units.

(a) A licensee authorized,to,use a garnrna stereotactic rad'osurgery. units for medical use shall perform spot-checks of each gamma stemotactic radio 6urgery facility and on each unit -

(1) Monthlyd (2) At the beginning of each day of use-; and (3) After each source installation.

(b) The licensee shall have the authorized medical physicist -

(1) Establish written procedures for performing the spot-checks required in paragraph (a) of this section; and (2) Review the results of each spot-check required by paragraph (a)(1) of this section within 15 days of the check. The authorized medical physicist need not actually perform the spot-check measurements.

(c) To satisfy the requirements of paragraph (a)(1) of this section, spot-checks must, at a minimum -

(1) Assure proper operation of-i (i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; (ii) Helmet microswitchs; (iii) Emergency timing circuits;

('.) : ineigency off bst;er.e, and r

(iv) Stereotactic frames and localizing devices (trunnions).

(2) Determine-(i) The output for one typical set of operating conditions measured with the dosimetry system described in s 35.630(b);

(ii) The difference between the measurement made in pr.:ngraph (c)(2)(i) 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);

(iii) Source output against computer calculation;

- (iv) Timer accuracy and linearity over the range of use; (v) On-off error;and (vi) Trunnion centricity.

(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must assure proper operation of -

b

\\

45

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (1) Electricalinterlocks at each gamma stereotactic radiosurgery room entrance; (2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit. on the control console, and in the facility; (3) Viewing and intercom systems; (4) Timer termination; (5) Radiation monitors used to indicate room exposures; and (6) Emergency off buttor.ellydmL::c cL;cff rnechan;ern (if epp;;ceble).

(e) A licensee shall arrange for prompt repair of any system identified in paragraph (c) of this section that is not operating properly.

(f) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensoe shall 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.

(g) A licensee shall retain a record of each check required by paragraphs (c) and (d) of this section in accordance with 35.2645.

9 35.647 Additional technical requirements for mobile remote afterloader units.

(a) A licensee providing mobile remote afterloader service shall-(1) Check survey instruments before medica l use at each address of use or on each day of use, which ever is more frequent; and (2) Account for all sources before departure from a client's address of use.

(b) In addition to the periodic spot-checks required by 9 35.643, a licensee authorized _

t to use mobile afterloaders for medical use shall perform checks on each remote afterloader; unit before each address of use. At a minimum, checks must be made to verify the operation of -

(1) Electricalinterlocks on treatment area access points; (2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (3) Viewing and intercom systems; (4) Applicatorscsource transfer tubss, arx3 transfer)tMapplicat6r_.inierfacesland connecter 5:

(5) Radiation monitors used to indicate room exposures; (6) Source positioning (accuracy); and j

(7) Radiation monitors used to indicate whether the source has retumed to a safe shielded position.

(c) In addition to the requirements for checks in paragraph (b), a licensee shall ensure ovemil proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

(J) A ;;cer.;;; eh&ll &rrenge for piernpt repaj;pf eny eyetern l der,t:yedjqperepeph 'b) of th e section that is ne; eperat;nsi pieperlv. If the results of the checks ' equired,in paragraph r

(b)lof this secten irxhcate tfie rnalfunction of any systerri, ja licensee'shall lock the control ~

console in the off position and not 'use the unit except as may be necessary to repair,4eplace, or check the malfuricnorirg system.

(e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with 35.2647.

9 35.652 Radiation surveys.

46

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999

.~(a) Ir! addition to the survey requirement in f 20.1501 of this chapter, a licensee l Ilooneed pursuant to this adpart, shall make such surveys as defined in the Sealed Source and Device Registry to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source (s) in the shielded position does not exceed the levels stated in the Registry.

(b) The licensee shall make the survey required by paragraph (a) of this section at installation of a new source and following repairs to the source (s) shielding, the source (s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source (s), or compromise the radiation safety of the device unit or the source (s).

(c) A licensee shall retain a record of the radiation surveys required by paragraph (a) of this section in accordance with 6 35.2652.

5 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper funcboning of the source exposure mechanism.

(b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.

(c) A licensee shall keep a record of the inspection and servicing in accordance with 6 35.2655.

$ 35.657 Tt,es.,.y n' ^- 2 computer systems.

The licensee shalk (e) Ve.-;ty re; te eup.;erled epe..;...g eye:eT. and tea;...er,; phan;ag ;y;te.T.

- ::.e! :ei ji We ter vy de.iee ere spere:...g apprepik:e y, er.d (tr) Pperform acceptance,testir,g on the treatment planning system in accordance with published protocols approved manar*we by nationally recognized bodies.% At a trununurn, the acceptanceiesling nestinclude/as verthalion'of:

j w*=ut s====ar= =ran om=*a*4 **.oun= ar=vst "_

M: dose, does sline, and smalment time c*a datinns..ati+f

points; n---a(yx.i.coonicwmangertnmim ntp.mmers

(c)accurac of source (s)W2s 5.35.800, Training fo,r use.of,

'miimatiaitiiilisinfd nessmanapyanna,amesammme essosarserymans.

Except as provided in 6 35.57, the licensee shall require the authorized user of a sealed source for a use listed in 6 35.600 to be a physician who -

(a) is certified by a specialty board whose certification process includes.all of _the_

requirements in paragraph (b) of this section and whose certification has been: recognized wreJed by the Commission; or; (b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical imit device consisting of both -

(i) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic training in the following areas -

47

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; and (D) Radiation biology; and (ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised practical experience, under the supervision of an authorized user at a medical institution, invoMng -

(A) Review of the full calibration measurements and periodic spot checks; (B) Preparing treatment plans and calculating treatment doses and times; (C) Using administrative controls to prevent a medical event involving the use of byproduct rnaterial; (D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device unit or console; (E) Checking and using survey meters; and (F) Selecting the proper dose and how it is to be administered; and (2) Three years of supervised clinical experience in radiation oncology as part of that inclvdee one.ficarja a formal training program approved by the Residency Review Committee for Radiation Oncology Gedieiegy of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association er equivalent piegrari, appreved by the NCO. end en edd; Gen &l twe isere of c;;nica! experienc9 cader the esper.ie:en of an &ctheiized usetThis e.xperience may be.obtained concurrently with the. supervised pracbcal experience requwed by. paragraph (b)(1)(ii) of.this sechon; and _ _

-,-.(3),Has,obtained written certification, signed by a preceptor authorized.userwho rneets the requirements in 6 '35!690 or' equivalent Agreement State. requirements, that the individual has satisfactorily completed the requirements in paragraphsf(b)(1)'and (2) of this sechon above training has been eadefecter;ly ccmpleted and thet the indiv;dva; has achieved a level of competency sufficient to independently function as an authorized user of the therapeutic i

medical device unit;for which the individual is requesting authorized user statustand-(4)."e!! ewing cernplenen of the regs.remente in peregreph (b)(1) and (2) ei th e escuca, has dernenetrated evific ent lmceiedge in red;&Sen eafety commeneurate with the see requested by peseing an eam:netica given by en erganizaden er enG;y eppicved by the Osmmles en ln accerdance with Appendix A ef thle pert.

i Subpart J-Training and Experhnce Requirements

{

$ 35.900 Radiation Safety Officer.

Except as provided in 6 35.57, the licensee si. P sire an individual fulfilling the responsibilities of the Radiation Safety Officer as provL.

6 35.24 to be an individual who -

(a) is certified by the -

(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 Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; 9i 48

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (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 protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmacauticalchemistry;and (2) One year of fuil time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified 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.

5 35.910 Training for uptake, dilution, and excretion studies.

Except as provided in 6 35.57, the licensee shall require the authorized user of a radiopharmaceutical in f 35.100(a) to be a physician who -

(a) is certified in -

(1) Nuclear medicine by the American Board of Nuclear Medicine;

'(2) Diagnostic radiology by the American Board of Radiology;

^

(3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or (b) Has had classroom and laboratory. training in basic radioisotope handling techniques applicable to the use of prepared rmeaareve drugs fadiopharmaceuticals, and supervised clinical experience as follows -

(1) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-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; (iv) Radiation biology; and (v) Radiopharmaceuticalchemistry;and (2) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical experience under the supervision of an authorized user and that includes -

(i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope _ diagnosis, limitations, or contraindications; (ii) Selecting the suitable rarenareivedrugs,e2,p.er-,eeeAle and calculating and measuring the dosages; (iii) Administering dosages to patients or human research subjects and using syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient or human research subject follow up; or_

(c) Has successfully completed 6 months of training e 0,7.a ;;. ;re;r.;r g i,igie,T. In 49 m

m

l I

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section.

9 35.920 Training for imaging and localization studies.

Except as provided in 6 35.57, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in @ 35.200(a) to be a physician who -

(a) is certified in -

(1) Nuclear medicine by the American Board of Nuclear Medicine; (2) Diagnostic radiology by the American Board of Radiology; (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (5) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or (b) Has had classroom and laboratory, training in basic radioisotope handling techniques applicable to the use of prepared radioactive drugs red;epharinacesticale, generators, and reagent kits, 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; (iv) Radiopharmaceuticalchemistry;and (v) Radiation biology; and (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 that includes --

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for pioper operation of survey meters; (iii) Calculating and safely preparing patient or human research subject desages; (iv) Using administrative controls to prevent the medical event of byproduct material; (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (vi) Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radioactive drugs r&diopherm&ceuticeis; and (3) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience under the supervision of an authorized user that includes -

(i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotop0. diagnosis, limitations, or contraindications; (ii) Selecting the suitable radioactive drugs red;cphermaceuticeis and calculating and measuring the dosages; (iii) Administering dosages to patients or human research subjects and using syringe radiation sh!alds; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and 50 j

j

I WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (v) Patient or human research subject _ follow up;.or L

(c) Has successfully, completed 6 months of.trasung e 0-inear. ;re a:ag i;regrera in nuclear medicine as.part of a trainingpsogram that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, l

work experience, and supervised cliriical experience in all the topics identified in paragraph (b)

I of this section.

$ 35.930 Training for therapeutic use of unsealed byproduct material.

Except as provided in 9 35.57, the licensee shall require the authorized user of l

_4._._,

l radoscilve drugs fadiopharmacetteels in $ 35.300 to be a physician who -

(a) is certified by-l (1) The American Board of Nuclear Medicine; l

(2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; (3) The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or (4) The American Osteopathic Board of Radiology after 1984; or applicable to the use of therapeutic M,laboratorypaining in basic radioisotope handl (b) Has had clseerooin and drugs N, and supervised clinical experience as follows -

(1) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratoty training that includes -

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactmty; and (iv) Radiation biology; and (2) Supervised clinical experience under the supervision of an authorized user at a medicalirstitution that includes-(i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and (ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.

)

$ 35.932 Training for treatment of hyperthyroidism.

Except as provrjed in f 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has hLd classroom and laboratory training in basic radioisotops handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows-(a) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training that includes -

(1) Radiation physics and instrumentation; (2) Radiation protection, j

(3) Mathematics pertaining to the use and measurement of radioactmty; and (4) Radiation hiology; and

-(b) Supervaed clinical experience under the supervision of an authorized user that

{

includes the use of iodine-131 for diagnoss of thyroid function, and the treatment of hyperthyroidsm in 10 individuals.

$ 35.934 Training for treatment of thyroid carcinoma.

51 1

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 Except as provided in 6 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows -

(a) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training that includes -

(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; and (b) Supervised clinical experience under the supervision of an authonzed user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals.

$ 35.940 Training for use of brachytherapy sources.

Except as provided in 6 35.57, the licensee shall require the authorized user of a brachytherapy source listed in 6 35.400 for therapy to be a physician who -

(a) is certified in -

l (1) Radiology, therapeutic radiology, or radiation oncology by the American Board of

(

Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with specialization in radiotherapy, as a British " 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; l

(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 brachytherapy 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 (i) Radiation physics and instrumentation; l

(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 cupervised work experience under the supervision of an authorized user at a medical institution that includes -

' (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; J

(ii) Checking survey 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 a medical event involving byproduct material; and

-(vi) Using emergency procedures to control byproduct material; and

, 3),Three, years of supervised clinical experience that includes one year in a formal

(

radiation oncology 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 52 1

J

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 clinical experience in therapeutic radiology under the supervision of an authorized user at a medicalinstitution that includes -

(i) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications; (ii) Selecting the proper brachytherapy sources and dose and method of administration; (iii) Calculating the dose; and (iv) Post-administration follow up and review of case histories in collaboration with the authorized user.

$ 35.941 Training for ophthalmic use of strontium-90.

Except as provided in 6 35.57, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows -

(a) 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training that includes -

(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation b: ology; (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes -

(1) Examination of each individual to be treated; i

(2) Calculation of the dose to be administered; j

(3) Administration of the dose; and

)

(4) Follow up and review of each individual's case history.

$ 35.950 Training for use of sealed sources for diagnosis.

Except as provided in 6 35.57, the licensee shall require the authorized user of a sealed source in a device listed in 6 35.500 to be a physician, dentist, or podiatrist who -

(a) is certified in -

(1) Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (2) Nuclear medicine by the American Board of Nuclear Medicine; (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or (4) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (b) Has had 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes -

(1) Radiation physics, mathematics pertaining to the use and measurement of radioactmty, and instrunsentation; (2) Radiation bitdogy; (3) Radiation ptotection; and (4) Training in the use of the device for the uses requested.

1 53

i WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 6 35.960 Training for use of therapeutic medical devices.

Except as provided in 9 35.57, the licensee shall require the authorized user of a sealed source listed in Q 35.600 to be a physician who -

(a) is certified in-(1) Radiology, therapeutic radiology, or radiation oncology by the Ar.ierican Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with specialization in radiotherapy, as a British " 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 a sealed source in a j

therapeutic medical device, 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 medical institution 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 medical events; i

(iv) Implementing emergency procedures to be followed in the event of the abnoimal operation of the medical device or console; and I

(v) Checking and using survey meters; and (3)_Thre_e, years of supervised clinical experience that includes one year in a formal radiation. oncology training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Corr.mittee on Postdoctoral Training of the American Osteopathic Association and an ad6tional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medicalinstitution that includes -

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

j

$ 35.961 Training nor authorized medical physicist.

The licensee shall require the authorized medical physicist to be an individual who -

O s4

i l! rm WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (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 l

(4) Radiologicalphysics;or (b) is certified by the American Board of Medical Physics la radiation oncology physics; l

or l

(c) Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed 1 year of full time training in therapeutic radioicgical physics l

and an additional year of full time work experience under the supervision of a medical physicist at a medical institution that includes the tasks listed in f5 35.E7, 35.632, 35.633, 35.634, 35.635,35.642,35.643,35.644,35.645 and 35.652.

r l

9 35.980 Training for an authorized nuclear phannacist.

l The licensee shall require the authorized nuclear pharmacist to be a pnarmacist who - -

(a) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or (b)(1) Has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program consisting of both -

l (i) Didactic training in the following areas:

l (A) Radiation physics and instrumentation; (B) Radiation protection; O

(C) Mathematics pertaining to the use and measurement of radioactivity; (D) Chemistry of byproduct material for medical use; and j

(E) Radiation biology; and l

(ii) Supervised experience in a nuclear pharmacy invoMng the following -

(A) Shipping, receMng, and performing related radiation surveys; (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides; (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (D) Using administrative controls to avoid mistakes in the administration of byproduct material; (E) Using procedures to prevent or minimize contamination and using proper decontamination procedures; and j

(2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.

I35.001Tra:naii b r saper;e nc ed a uc:: r p herr.,ac ete.

A ::cenecc may app ly for and must recetic a ll cense amendinent ldenGl,ing an exper;enced nscl ear pharmac;et as an auther: zed nucl car pharmec;et before it all ewe th;e lndhidsal 10 werk as an autherized nucl ear phermaciet. A pharmeciet who has cernplcted e etructured edsc Gena l program as spec f;ed in s 00.000(b)(1) before December 2,1004, end who l3 werk:ng ln a asc:cer pharrr.acy wesld quaffy as en experienced nuc' ear pharmac et. An experienced nec; ear pharmecie...-..m w..v,y.ith the requiremente ter e precepter 55

l l

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 sieternent (G 05.000(b)(2)) &nd recentness of treining (s 05.00) to que:Fy ea en euthorl zed nucleer phenT.ecist:

Subpart K-Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 9 35.1000 Other medical uses of byproduct material or radiation from byproduct material.

A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if -

(a) The applicant or licensee has submitted the information required by 9 35.12(d); and (b) The applicant or licensee has received written approval from the Commission in a license and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.

l 1

O l

l 56

O WORKING GROUP DRAFT DOCUhENT MARCH 16,1999 Subpart L-Records 3 35.2024 Records of authority and responsibilities for radiation protection programs.

(a) A licensee shall retain a record of actions taken by the licensee's management in accordance with 6 35.24(a) for 5 years. The record must include a summary of the actions taken and a signature of licensee manage /nent.

(b) The licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer as required by 35.24(d). The record must include the signature of the radiation safety officer and licensee management.

$ 35.2026 Records of radiation protection program safety changes.

A licensee shall retain a record of each radiation protection program change made in accosdance with 35.26(a) for 5 years. The record must include a copy of the old and new J

procedures; the effective date of the change; and the signature of the red;at;en eafety eff;cer an&the licensee management that reviewed and approved the change.

1 6 35.2040 Records of written directives.

A licensee shall retain a copy of each written directive as required by 35.40 for 3 years.

$ 35.2045 Records of medical events.

A licensee shall retain a record of medical events reported pursuant to $6 35.3045 and b

35.3046 for 3 years. The record must contain the licensee's name, names of all the individuals

\\

involved, the affected or potentially affected individual's social security nu'mber or other identification number if one has been assigned, a brief description of the medical event, why it occurred, the effect on the individual, and the actions taken to prevent recurrence.

$ 35.2060 Records of instrument calibrations.

A licensee shall maintain a record of instrument calibrations required by 99 35.601md SS-61Ffor 3 years. The records must include--

(a) Ier cenotency, Le modo l and eede: number of Ze netrument, te l dent,ti of the i

rad;ensc;;de contained in the check essice, the eate of me check, end be acti.iti meassied, and me name of the :ndtildsa 2.0 performed es cher,k; (b) rer accsiecy, the model and serial numier of the instrument, me medel and seda number of each essice seed, me ;dentdi of me rad ensc ;de centalned in the eevice and its activity, the date of the calibration test, en&the results of the ' alibration test, and the name of c

the individual who performed the calibrabon test. -

(c) For l:ncedti, to medel and eer:al nLmber of me lnetrument, Le calculated actrelt;es, the meessied ecit. ee, and me date of the test, and me name of the ;ndividva! #,e pedermed the test, &nd (d) rer geometdc dependence, me mode: and seda' number cf Le instinment, me cent;6 set;en of me eevice measui d the ecit.iti measured for each ve:sme meaeused, and me date of the test, end be name of the ndte dval #,e pedermed tria teet.

$ 35.2061 Records of radiation survey instrument calibrations.

A licensee shall maintain a r6 cord of radiation survey instrument calibrations required by

\\

57

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 9 35.61 for 3 years. The record must include -

(a) A deecilpden of the caubiaSen precedure; and. _. _

(b) the date of the calibration, the results of the calibrationj a descdpuen of the esame Leed and the ceitf;ed egeogre ratee from the sevice, and the retee lndicated by the :netrument being canbieted, the correcden factere deduced frem the ca';breuen data, and the name of the individual who performed the calibration.

6 35.2063 Records of dosages of unsealed byproduct material for medical use.

(a) A licensee shall maintain a record of dosage determinations required by 35.63 for 3 years.

(b) Te seefy th;e reqs,rement, The record must contain the -

(1) Red;enacl;de, genedc nems, trede neme, er ebbre.iatien of the radiepharinacestcal, and lte let number; (2) patient's or human research subject's name, or identification number if one has been assigned; (0)- the prescribed dosage; and activity of the determined dosage at the Sme of dctccm:naupa, or a notation that the total activity is less than 1.1 MBq (30 pCi);

(4) the date and time of the dosage determination; and (5) the name of the individual who determined the dosage.

6 35.2067 Records of possession of sealed sources and brachyttarapy sources.

(a) A licensee shall retain records of leak tests required by 9 35.67(b) for 3 years. The records must contain the model number, and serial number if one has been assigned, of. each source tested, the identity of each source radionuclide and its estimated activity, the results of the test, meessied ecuvity of each teet eamp;e, a descdpuen of the mothed secd to meaevie each teet eample, the date of the test, and the name of the individual who performed the test.

(b) A licensee shall retain records of the semi-annual physicalinventory of sealed sources and brachytherapy sources. required by 9 35.67(g) for 3 years. 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 name of the individual who performed the inventory.

9 35.2070 Records of surveys for ambient radiation exposure rate.

A licensee shall retain a record of each survey require,d by 6.35.70 for 3 years. The record must include the date of the survey, the results.cf the survey, a plan of each area eurveyed, the tdgger :cve,l estabnehed for each area, the detected deee rate at ecveral pelnte in each area egreesed ln mC;;.em per hour er the reinovable contamineSen in eech area egreeeed in d;eintegrauer,e per ininste per 100 equare centime;cre, the instrument used to make the survey er analyze the eamp'ee, and the name of the individual who performed the survey.

9 35.2075 Records of the release of individuals containing radioacEwe dSgs radiepitermaceutieels or implants.

(s) A tcenecc ehell retain records of the rc'caec of icdiv;dveis centeining pharmaceuncele er imp larste in accordence ith G 00.70 for 0 care siter the date of re' ease.

5 (a)(b) A licensee shall retain a record of the basis for authorizing the release of an 58

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 inilvidualM3 yGrialleiWE datiMeloise, in eew;d aee el0, s 05.2075(e) 2.e: ds.r:.ee

~

te bn:; fer eur,e,%..r, h re:ne; ef l ads ld e if the total effective dose equivalent is calculated by -

(1) Using the retained activity rather than the activity administered; (2) Using an occupancy factor less than 0.25 at 1 meter; (3) Using the biological or effective half-life; or (4) Considering the shielding by tissue.

(b)(c)-A licensee shall retain a record,2foithr5jiahs aWtiditate[ofrelease, that the instructions required by 6 35.75(b) were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equ! valent exceeding 5 mSv (0.5 rem).

5 35.2080 Records of administrative and technical requirements that apply to the 1

provision of mobile services.

(a) A licensee shil retain a copy of the. letter (s) that permits the use of byproduct material at a client's address of use,5as required byin-seeerdance-with 6 35.80(a)(1),-Weis

e;;er raue; e'nf d;::r.n;; ia auterlti and see,,ene:b;l;;i et ad, e...;.i and raue; be..,; :aed i

for 3 years after the last provision of service.

(b) A licensee shall retain the record of each survey required _by 6 35.80(a)(4), for 3 years. The record must include the date of the survey, the results of the survey, a g,;en of ;;3.

er.e h;;;r earseyed, h rm xar.ddas.e:eete;scre:f,e;,,;.;n a #,ereeefuee e4rnsd in.T.;;;....T. i,er,Wr, the instrument used to make the survey, and the name of the individual who performed the survey.

$ 35.2002 Records of waste disposal.

A licensee shall maintain records of the disposal of licensed materialsias,requwed by:

made1rtseeerdance with 9 35.92, for 3 years. The record must include the date of the disposal, re redR. ;;;d.e d;wsd, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

$ 35.2204 Records of molybdenum-99 concentrations.

A licensee shall maintain a record of the molybdenum-99 concentration tests required by $ 35.204(b) for 3 years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (microcuries of molybdenum per millicurie of technetium),

the time and date of the measurement, and the name of the individual who made the measurement.

l 35.2310 Records of instruction and training.

. A licensee shall maintain a record of instructions and training required by ff 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date i

of the instruction or training, the name(s) of the attendee (s), and the name(s) of the individual (s) who provided the instruction.

$ 35.2404 Records of radiation surveys of patients and human research subjects.

59 l

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 A licensee shall maintain a record of the r& diction surveys of petients and hurnan re;;;rch esbjects raquired by $$ 35.404 and 35.604 for 3 years. Each record must include the dats, locenen, and results of the survey, en idendfier for the patent er the hvinen rescarch subject, the survey instrument used, and the name of the individual who made the survey.

9 35.2400 Records of brachytherapy source inventory.

(a) A licensee shall maintain a record of brachytherapy source accountability required by 35.406 for 3 years.

(b) For temporary implants, the record must include -

(1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and (2) The number and activity of sources retumed to storage, the time and date they were returned to storage, and the name of the individual who retumed them from storage.

(c) For permanent implants, the record must include -

(1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage; (2) The number and activity of sources retumed to storage, the date they were retumed to storage, and the name of the individual who retumed them to storage; and (3) The number and activity of sources permanently implanted in the patient or human research subject.

9 35.2432 Records of fedi calibrations on brachytherapy sources.

A licensee shall maintain a record of the full calibrations on brachytherapy sources required by @ 35.432 0or 3 years after the last use of the source. The record must include the date of the calibration; the manufacturer's name, model number, and serial number for-the source and instruments used to calibrate the source; the source output or.actMty; source positioning accuracy within applicators; and the signature of the authorized medical physicist.

6 35.2605 Records of installation, maintenance, $chusitd5mt, and repair.

A licenses shall retain a reco.rd of the Installation, maintenan.ce, adiustment,2and repair of jhe,rapeste gdica' dewcas remote afterloader units, teletherapy units,' and gamma stereotactic units as required by 6 35.605 for 3 years. For each installation, maintenance, adlustment and repair, the record must include the date, description of the service, and name(s) of the individual (s) who performed the work.

6 35.2630 Records of dosimetry equipment.

(a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 35.630 for the duration of the license.

(b) For each calibration, intercomparison, or comparison, the record must include -

(1) The date;

'(2) The model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of 35.630; (3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and (4) The names of the individuals who performed the calibration, intercomparison, or

l WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 comparison.

, n, n.

n.

6_35.2632 Records of teletherapy, remote anortoadoriand gamma stereotactic radiosurpary. full calibrations.

_,(a),. _, lice.n. se,e,sh.all main,tain a record of the teletherapy, remote aftedoader, and _

A gamma stereotactic radiosurgery full calibrations required by 96 35.632?35.633, and 35.635 for 3 years.

(b) The record must include -

(1) The date of the calibration;

-.- -(2) The manufacturer.'s name, model num.be.r, and serial number for the teletherapy, remote afterloader..and gamma stereotactic radmourgery unit, source, and instruments used to calibrate the ;;l2_.o.ro,,y~ unit; (3)iThe;resullsjand an assessment of the_ full czJiin iisi. Tat,:ee :tfat de.~5Le tle ectpst

_,m_

._m

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$ 35.2642 Records of periodic spot-checks for teletherapy units.

61

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by 35.642 for 3 years.

(b) The record must include --

tb The dde of the spot-check;.

(2) The manufacturer's name, model number, and serial number for the teletherapy unit, source and instrument used to measure the output of the teletherapy unit; (3) An assessment of timer linearity and constancy; (4) The calculated on-off error; (5) A determination of the coincidence of the radiation field and the fiald indicated by the light beam localizing device; (6) The determined accuracy of each distance measuring and localization device; (7) The difference between the anticipatcd output and the measured output; (8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and (9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

9 35.2643 Records of periodic spot-checks for remote afterloader units.

(a) A licensee shall retain a record of each spot-check for remote afterloader un'its required by GS 35.643 and 35.644 for 3 years.

(b) The record must include [asIappbcabiel-(1) The date of the spot-check;

}

(2) The manufacturer's name, model number, and serial number for the remote afterloader unit-and sourcs, and ln3;rument seed to meaegre the egtput ef the remete oneilo&d6i the meaegred setput; (4) Notations indicating the operability of each entrance door elec+rical interlock, source retract;en mechan em, radiation monitors, source exposure indicator lights, viewing and.,

intercom _ systems, app llcetere and connectors-and clock and decayed. source _ activity in the unit's computer eesrce pes l tion lng accuracy; and (4)(5) The name of the individual who performed the periodic spot-check and the signatcre of the autherized medica l phye:c st vihe re.ievied the record of the apet-check.

6 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units.

l (a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by 6 35.645 for 3 years.

.o) The record must include -

(1) The date of the spot-check; l

(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the outp# of the unit; (3) Anassessmentof timerknearity;andaccuracy; (4)Tlie calculated on-off error; E65triR (5)'Aldetermination'of; trunnion

~~

(96) The difference between the anticipated output and the measured source output-end 62 4

(

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 pINM"M source output against computer calculations; (48) Notatio7s indicating the operability of radiation monitors, helmet microswitchs, emergency timing c rouits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination systems, hyd..u::c cates.;3 trasernent tobie retraction mechanismiand stereotactic frames and localizing devices (trunnions); and (59) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the mt-check.

5,35.2847 Records of additional technical requirements for mobile remote afterloader units.

(a) A licensee shall retain a record of each check for mobile remote afterloader iinits required by $ 35.647 for 3 years.

(b) The record must include -

(1) The date of the check; (2) 3e manufacturers name, model number, and serial number of the remote aftarloader unit; (3) Necations accounting for all sources before the licensee departs from a facility; (4) Notations indicating the operability of each entrance door electrical interlock, radial,cn monitors,, source, exposurejndicator lights, viewing and intercom system, applicators and connectors soume transfer _ tubes, and source po.itioning accuracy; and (5) The signature of the individual who performed the check.

$ 35.2652 Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with 9 35.652 for the duration of use of the unit.

(b) The record must include -

(1) The date of the measurements;

-(2) The manufacturers name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; (3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and j

(4) The signatu're of the individual who performed the test.

j

$ 35.2655 FM of 5-year inspection for telethorapy and gamma stereotactic surgery (a) A licensee shall maintain a record of the 5-year inspecticos for teletherapy and gamma stereotactic radiosurgery units required by 6 35.655 for the duration of use of the unit.

(b) The record must contain -

(1) The inspectors radioactive materials license number; (2) The date of inspection;

'(3) The reanu'acturers name and model number and serial number of both the trestment unit and source; (4) A list of components inspected and sennced, and the type of seMee; and (5) The signature of the inspector.

~

.O 63 i

i WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 Subpart M-Reports 9 35.3045 Reports of medical events.

(a) A licensee shall report any administration, except for administrations resulting from a derwet intervention by;of-a patient or human research subject that could not have been reasonably prevented by the llcean, that results in elther -

(1) A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent,0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivaient to the skin; and "either (i) The total dose or dosage delivered differs from the prescribed dose or dosage by 20 percent or more; or (ii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

(2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent,0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following -

(1) An administration of a wrong pharmaceutical; (ii) An administration of a radiopharmaceutical by the wrong route of administration; (iii) An administration of a dose or dosage to the wrong individual or human research subject;

)

(iv) An administration of a dose or dosage delivered by the wrong treatment mode; or (v) A leaking sealed source.

(3) A dose to the skin or an organ or tissue other than the treatment site that exzeds by 0.5 Sv (50 rem) to an organ or tissue and 20 percent of the dose expected from.the_ _ _

administration defined in.the_ written directive (excludirdfor permanent implants,' seed <t that were implanted in' the correct site but migrated outside the treatment site). _ _.__

(4)fA ~ dose due to intervenbon of a medical procedure by a patient or human research subtect that results in an unintended permanent funcbonal damage to an organ:or_a physiological system, as detennined by a physician..

5 (b) The licensee shall notify by telephone the NRC Operations Center no later than the next calendar day aiter discovery of the medical event.

(c) The licensee shall sutsmit_a written report to the appropriate NRC Regional Office listed in 6 30.6 of this chapter within 30.45 days after discovery of the medical event.

(1) The written report must include -

i (1) The licensee's name; (ii) The name of the prescribing physician; (iii) A brief description of the event; f

(iv) Why the event occurred; (v) The effect on the individual (s) who received the administration; (vi) What improvements are needed to prevent recurrence; (vii) Actions taken to prevent recurrence;

.(viii) Whether the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not; and 1

(ix, if there was notification, what information was provided.

i 5 The commercial telephone number of the NRC Operations Center is (301) 951-0550.

I y

[

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (2) The report may not contain the individual's name or any other information that could lead to identification of the individual.

(d) The licensee shall notify the referring physician and also notify the individual affected by the medical avent no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgement, telling the indmdual would be harmful. The licensee is not required to notify the indmdual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the indudual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this section, the notification of the individual receiving the medical event may be made instead to that individual's responsible relative or guardian, sien yri@r; ;;.

(e) If the individual was notified pursuant to paragraph (d) of this section, the licensee shadi also fumish, within 30,46 days after discovery of the medical event, a written report to the.

Individual by sending either-(1) A copy of the report that was submitted to the NRC; or (2) A brief description of both the event and the consequences as they may affect the indivic'ual.

(f) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that indudual's responaible relatives or guardians.

b

$ 34.3047 Report of a does to an embryo fetus or a nursing child.

(a) A licensee shall report any dose to an embryo /fetas that is greater than 50 mSv (5

_rem 5091msm) absorbed dose that is a result of an administration of byproduct material or radiation from opproduct material to a pregnant individual unless the dosa to the embryo / fetus was specifically approved, in advance, by the authorized user.

(b) A licensee shall report any dose to a nursing child 2.a; h,,e;;;; 2, a 5 ra^e (500

,T,ie,T,) L; e%e;;t;; i_e ga;ba; that is a result of an administration of byproduct material to a breast feeding individual that -

((IsdresseiGuri jie m8E/5Niidiailiffeii1IiEdIiiEMoir

- a$ nes hes unineandenennenent funemones damageMan oiseRrii iiiiiisWiessions syneenLasjeseenmined by a shy *s=

(c) The licensee shall notify by telephone the NRC Operations Center within 5 days after discovery of a dose to the embryo / fetus or nursing child that requires a report in paragraphs (c) or (b)in this section.

(d) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 6 30.6 no later than 30 45 days after discovery of a dose to the embryo / fetus or nursing child that requires a report in paragraphs (a) or (b) in his section.

,(1) The written report must include -

(1) The licensee's name;

. (ii) The name of the prescribing physician; i

(iii) A brief descispuon of the event;

. (iv) Why the event occurred; (v) The effect on the embryo / fetus or the nursing child; O

65

WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (vi) What improvements are needed to prevent recurrence; and (vii) Actions taken to prevent recurrence.

(2) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(e) The licensee shall notify the referring physician and also notify the pregnant individual or mother, hereafter referred to as t..a mother, within 5 days of discovery of an event that would require reporting under paragraph (a) or (b) of this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgement, telling the mother would be harmful.

(f) To meet the requirements of this section, the notification of the mother may be made instead to the mother's or child's responsible relative or guardian, when appropriate.

(g) The licensee is not required to natify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 5 days, the licensee shall make the appropriate notifications as soo 1 as possible thereafter. The licensee may not delay any appropriate medical care for the embryo / fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification.

(h) If notification was made pursuant to paragraphs (e) and (f) of this section, the licensee shall also fumish, within 30;45 days after discovery of the event, a written report to the mother or responsible relative or guardian, by sending either -

(1) A copy of the report that was submitted to the NRC; or (2) A brief description of both the event and the consequences as they may affect the embryo / fetus or nursing child.

$ 35.3067 Reports of leaking sources.

A licensee shall file a report within 5 days if a leakage test required by Q 35.67 reveals the presence of 185 Bq ( 0.005 pCi) or more of removable contamination. The report must be filed with the appropriate NRC Regional Office listed in & 30.6 of this chapter, with a copy to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the thit; measured &ctNiti of each test samp e agreseed ln m crocu;iee; &

~

descr;pGen of the methed uecd te meaegre each teet 5&mple; the date of the test; and the action taken.

Subpart N-Enforcement 9 35.4001 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 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 under Section 234 of the Atomic Energy Act:

O 66 l

I l

l WORKING GROUP DRAFT DOCUMENT MARCH 16,1999 (1) For violations of-(l) 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 sections specified in paragraph (b)(1)(l) 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.

$ 35.4002 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 10 CFR Part 35 are issued under one or more of sections 161b,1611, or 1610, except for the sections listed in paragraph (b) of this section.

(b) The regulations in 10 CFR Part 35 that are not issued under subsections 161b,1611, or 161o for the purposes of Section 223 are as follows: ff 35.1,35.2,35.7,35.8,35.12. 35.15, I

35.18, 35.19, 35.65, 35.100, 35.200, 35.300, 35.600, 35.4001, and 35.4002.

O 67

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l Dated at Rockville, Maryland, this day of

,1999.

For the Nuclear Regulatory Commission.

Annette L. Vietti-Cook, Secretary of the Commission.

(k 69

)

l l

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FOL. LOW-UP ASSIGNMENT SHEET No Sort Spectfled g

GUERY> "! NOB" S Assigned To & Assigned Date >= 04/30/98 & Assigned Date <= 04/30/98 &

"ST. JOSEPH HOSPITAL" S Plant Nar.

ASSIGNED / REFERRED TO: IMOB ASSIGNMENT DATE: 04/30/98 LICENSER / VENDOR:

ST. JOSEPH HOSPITAL EN NO:

0 EVENT DATE:

04/30/98 NR NO EVENT TYPE:

NMS PN BO SPECIALTY CODE:

0 ACCESSION NO:

0 OTNER REPORT:

IMNS-7047 EVENT / CONDITION DESCRIPTION Idaho hospital accepted two, !*125 seeds from patient that received prostate laplants at Northwest Hospital in Seattle, W4. Patient was instructed to strain urine and return any seeds excreted to a responsible facility.

SPECIPIC FOLLOW-UP ASSIGNMENT

\\\\,/

CLOSEOUT TEXT SAFETY $10NIFICANCE: E01 CAM IDATE FOR OP EVENTS BRIEFING 7 NO ENERIC FOLLOW-UP RECCBDEWED: No ENERIC SAFFTY ISEE: NO STATUS D E DATE: 09/30/98 OTNER INP0MATION: Concern is whether patients collecting and handling seeds is a good idee. We are aware that same licensees instruct their pottents to strain their urine. We may need to establish guidance on instructions patients should be given on how to handle seeds if they are excreted. GAP tasked RGB with asking ACNUI edwther they believe NRC guidance is needed. (Combine with Nichael Reese 7.wstion on yee of uttr See INNS-

3) era 33M/ PrJ-3-Hf-w.

AcceP),

HAW W, Thans-7047 was closel n tolD O 8 b

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g r % g & V4# /%4 /W1 mee jcgg/gyttgGtgdeutal k &M M&AA%&M FIAL SCREENING DATE: 05/01/98 ya aE1L SCREENING DATE:

05/05/98 3

CLOSBOUT DATE ETS 30 Page:1 06/16/98

1 u

From:

P azee, Terry" <tef03039 hub.doh.wa. gov >

To:

WCD1.WCP1 (JWH3), ARD1. ARP1 (MLM1), WND1.WNP9 (PHL)

Dates ~

4'30/98 6:43pm Subjects

. Excretion of I-125 Prostate seeds This is an uptlate of the information provided to us by NRC regarding a prostate patient treated in Seattle and sent home to Idaho.

It was incorrectly communicated to us by NRC that St. Joseph Hospital in Lewiston, Idaho had refused to accept from the patient the seeds passed in the urine. 'According to Doug Hidorn, the physicist at St. Joseph, "it was better for us to hold the seeds than to leave them with the patient",

and the hospital is currently in possession of the seeds. They did NOT refuse to accept the seeds as stated in the NRC communication. Hidorn called NRC simply to forestall any concern an NRC inspector might have if the seeds were " discovered" during an inspection.

.The seeds were implanted at NW Tumor Institute, which is a satellite facility of Swedish Medical Center (Seattle) co-located at Northwest Hospital in north Seattle. According to Juri Eenmaa, Ph.D., physicist for Swedish, these facilities are leaders in developing the use of I-125 seeds for prostate implants. The Seattle area is considered to be a teaching center for this procedure. The standard protocol includes several pages of written instructions for the patient which has a short section on " radiation safety".

The patient is given the written s

instructions to take home (mostly dealing with drugs) and supplemented with verbal instructions. The basic instruction is as stated in the previous communications: the patient is expected to strain the urine and U

return any seeds to the hospital. The written instruction specifies that straining of the urine should occur for the first couple of days; it is believed that the verbal instructions may encourage straining for a longer period of: time. The reason for this is to assure the patient is receiving the correct dose to the prostate. Ordinarily the patient is brought back to the hospital the day after being implanted to assess the

._ number and position of seeds for dosimetry purposes. Experience has shown that in about:lt of implant cases, seeds are passed in the urine in

.the first 24 *>urs or not at all.

Seeds are typically 0.1 to 0.2 mci of I-125 and an average implant will contain 60 to 80 seeds. A couple of extra seeds are usually implanted to accommodate the possibility of seeds that may be passed in the urine at some future point. 'The patient is usually given a small-lead foil container and instructed to use tweezers to place the seeds in the

container a1.d to return them to the implant facility or to a responsible person or facility if they have already left the area.

'In the case reported to us, the patient passed two seeds on about the fourth day post implantation and dutifully followed instructions and turned the seeds into the local hospital which acted responsibly in accepting them. From the treatment standpoint, a loss of a few seeds does not appreciably alter the dose to the prostate, however, knowledge-of this (principally'through straining the urine) is important in case the seed losses start to add up.

From a disposal standpoint accidentally flushing the seeds down the toilet is acceptable, however, once

" collected" by the patient, _the instruction to turn them over to a N

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hospital or other responsible person is much preferred to. leaving them

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lying around the patient's house.

The physicist at Swedish stated that this procedure is relatively new (in

'the last six months implants have been down at a pace of about 30 to 40 l

cases per facility)- and it is likely that " late passing" seeds may turn up at additional facilities for patients that do not live near the treatment facility.

This message from: Terry Frazee Quick ways to reach me:

Voice = 360-236-3221 FAX = 360-236-2255 l

Also, visit our Home Page at

--> http://www.doh.wa. gov /ehp/rp k

l p'~s s.

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