Text

Summary of 980301-02 Meeting of Advisory Committee on Medical Uses of Isotopes.Summary of ACMUI Recommendations Discussed in Meetings in Attachment 1.Attachment 2 Is More Detailed Summary of Meeting
	ML20248L189
Person / Time
Issue date:	06/04/1998
From:	Callan L; NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Diaz N, Dicus G, Shirley Ann Jackson, Mcgaffigan E, The Chairman; NRC COMMISSION (OCM)
References
	NUDOCS 9806100486
	Download: ML20248L189 (16)
	v • d • e

June 4, 1998

%-a*

MEMORANDUM TO:

Chairman Jackson

- Commissioner Dicus Commissioner Diaz Commissioner McGaffigan

. Original Signedby FROM:

L. Joseph Callan Much L. Thompson, J fo<

Executive DirectorTorUperations

SUBJECT:

SUMMARY

MINUTES OF THE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES HELD '

ON MARCH 1-2,1997 An Advisory Committee on the Medical Uses of Isotopes (ACMUI) meeting was held on March 1-2,1998. Attachment 1 is a summary of the ACMUl's recommendations discussed in the meetings. All of the ACMUI recommendations were considered by the staff in development of the proposed revision to 10 CFR Part 35 and the Medical Policy Statement. Although criteria for performing an annual self-evaluation of the ACMUl were developed, additional revisions to the guidance is being considered by me staff for discussion at the next ACMUI meeting. Attachment 2 is a more detailed summary of the meeting.

' Attachments:

p

~ 1.. Summary of Recommendations w

s

2. ACMUI Minutes, March 1-2,1998 cc:

SECY OGC

.OPA OCA CFO 4

980yd b, CIO CONTACT: Patricia Vacherion, NMSS/IMNS i

(301)415 6376

\\

Distribubon NRC File Center NMSS Dir Off r/f IMNS Central File IMAB rf LCallan CEStep

- MBridgers DO r/f D

Release to the PDR:.X., Yes No

sEE PREVIOUS CONCURRENCE A:Marmincom.wpd '

op/pssoccumwanav as, isee -

0FC IMAB*

NMSS*

IMAB*

IMNS*

NMSS*

DEDR' DQ r NARIS PVacherton EKraus JPiccone DCool MRKnapp HLhk son bl DATE' 5/15/98 52/98 5/27/98 5/28/98 8/1/98 W /98 -

/tif (,[198 h

c coven-e-cover a ENCLOSURE

. N=NO p$

Y

"'gwytse j

~POR. COMMS NRec,. _ -

M

-. CORRESPONDENCE PDR 4U

.n.n__.

____m________.__m_

f' l:,.

[. 4' l

6 l

MEMORANDUM TO:

Cnairman Jackson l

Commissioner Dicus Commissioner Diaz Commissioner McGaffigan FROM:

L. Joseph lan Executive Dire orforOperat' ns

SUBJECT:

SUMMARY

MINU OF HE MEETING OF THE ADVISORY COMMITTEE ON TH DICAL USES OF ISOTOPES HELD l

ON MARCH 1-2,1997 Attached are the summary minutes of the mee ~ g of the visory Committee on the Medical Uses of isotopes (ACMUI) held on M h 1-2,' 1998, o attached is a summary of -

the ACMUI's recommendations discussed in he minutes (Attach nt 2).

i l

Attachments:

1. ACMUI Minutes, March 1-2,1998

2. Summary of Recommendations cc:

SECY OGC OPA OCA g

CFO CIO CONTACT: Patrida Vacherlo, NMSS/IMNS (301) 415-6376 Distribution:

NRC File Center NMSS Dir r/f IMNS Central File IMAB rf LCallan CEStep MBridgers

. EDO r/f Release to the PDR: _)L es No

SEE PREVIOUS CONCURRENCE : A:Marmincom.wpd -

opfeseoorso/nmay as, isee OFC IMAB*

NMSS*

IMAB*

IMNS*

NMSS DEDR EDO NAME PVacherton EKraus

ccone ~

DCool M

HLThompson LJCallan DATE, 5/15/98 SAS/98 5/27/98 5/28/98 M / /98 5/

/98 5/

19 8 C = COVER E = COVER & ENCLOSURE N = NO COPY

' OFFICIAL RECORD COPY' i- - -

l

?

MEMORANDUM TO: Chairman Jackson' Commissioner Dicus L

Commissioner Diaz Commissioner McGaffigan

)

FROM:

- L. Joseph Callan Executive Director for Operations

SUBJECT:

SUMMARY

MINUTES OF THE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES HELD ON MARCH 1-2,1997 Attached are the summary minutes of the meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) held on March 1-2,1998. Also attached is a summary of the

- ACMUl's recommendations discussed in the minutes (Attachment 2).

I Attachments:

1. ACMUI Minutes Marcis 1-2,1998

2. Summary of Recommendations cc:

SECY OGC OPA OCA CONTACT: Patricia Vacherton, NMSS (301)415-6376

' A:Marmincom.wpd Distribution:

NRC File Center NMSS Dir Off r/f IMNS Central File IMAB rf GE6tep GPoland MBridgers EDO r/f LJCallan Release to the PDR: X Yes No OFC'

_IMAB NMSs

. IMAB /')

IMNS// [

[

NAME PVacherton EKraus e

o DATE 5/ 6 /98 5/ [f /98 5/M98 5/t}'/98 i

' OFC -

.NMSS DEDR EDO NAME CPaperiello '

HLThompson LJCallan DATE-5/

/98 5/

/98 OFFiclAL RECORD COPY:

l.

I l-sa

'L _

pccn uq$*

UNITED STATES p

g j

NUCLEAR REGULATORY COMMISSION WASHINGTON, o.C. 20555-0001 i

+

June 4, 1998 l

MEMORANDUM TO:

Chairman Jackson Commissioner Dicus Commissioner Diaz CommissionerMcGa egan FROM:

L. Joseph Callan d

Executive Director f perations

SUBJECT:

SUMMARY

MINUTES OF THE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES HELD ON MARCH 1-2,1998 An Advisory Committea on the Medical Uses of Isotopes (ACMUI) meeting was held on March 1-2,1998. Attachment 1 is a summary of the ACMUI's recommendations discussed in the meetings. All of the ACMUl recommendations were considered by the staff in development of the proposed revision to 10 CFR Part 35 and the Medical Policy Statement. Although criteria for performing an annual self-evaluation of the ACMUI were developed, additional revisions to the guidance is being considered by the staff for discussion at the next ACMUI l

}

meeting. Attachment 2 is a more detailed summary of the meeting.

Attachments:

1. Summary of Recommendations

2. ACMUI Minutes, March 1-2,1998 l

cc-SECY OGC

{

OPA OCA CFO CIO CONTACT: Patricia Vacherlon, NMSS/iMNS (301)415-6376

6 O

ATTACHMENT 1

..b

SUMMARY

OF ACMUI RECOMMENDATIONS FROM MARCH 1-2,1998 MEETING 1979 Medical Policy 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 medical judgments 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

'he risk to the patients, and only where voluritary standards or compliance with these standards are inadequ5te. 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.

Training and Exnerience Requirements By a vote of 9-0 in favor, the ACMUI recommended:

1, Retention of the training and experience.'or $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 alternative 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 j

which a written directive is not required," and 935.200, "Use of unsealed i

byproduct material for imaging and localization studies for which a written directive is not required."

3.

Acceptance of the training and experience criteria for authorized nuclear pharmacists, medical physicists and radiation safety officers as presented in i

the draft proposed ruic.

By a vote of 5 opposed,4 in favor, the ACMI." defeated a recommendation to accept the i

strawman language for training and experience related $35.300, "Use of unsealed byproduct material for which a written directive is required."

L.

. Radiation Safety Committee By a vote of 9-0 in favor, the ACMUI recommended that 935.24 " 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 Acolicators 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 recalibrates to present standards.

SRM dated June 5.1997 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-Q28 By a vote of 9-0 in favor, the ACMUI recommended the acceptance of the set of seven 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 satisfactorily 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 review and oversight of issues?

4.

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

l l

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 merr%rs bong issues from the medical community to the attention of the NRC staff?

7.

Does the Committee facilitate / foster communication between the public/ medical community and NRC7 l.

1

. i i

i Vacant Positions on thgAQMt)J By a vote of 9-0 in favor, the ACMUI recommended that:

I i

1.

An Radiation Safety Offner position be added to the ACMUI' wmposition.

{

2.

Vacancies on the ACMU) be noticed in the EndataJ HegisicI 18 months prior to the anticipated vacancy.

l Patient Notification By a vote of 8-0 in favor,1 abstention, the ACMUI recommended reaffirming the recommendation from the September 1997 ACMUi meeting: "The Committee does not support any regulation requiring notification of physicians and patients as this is redundant to existing state lews and medical ethics in existence or words."

Etenursor Events 1

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

j 1.

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

Include the following ru!e language in the proposed rule: " Deficiency in equipment or procedure supplied by a manufacturer or vendor that could iead to a medical event at that facility or has implications for facilities outside the license 6's facility l

(operating procedure)."

4 l

l

(

i l

5 e

l l

l i

i 1

I i

l ATTACHMENT 2 4

I I

l 1

1 l

l T

I l

i l

l t

}.,'

4f 4

l '

k 6

il !

l

. )

> (n

l 1

)

o ceau j

g UNITED STATES L

_ g j

NUCLEAR REGULATORY COMMISSION s

WASHINGTON, D.C. 20555 0001 MEMORANDUM TO:

Donald A. Cool, Director J

Division of industrial and Medical Nuclear Safety, NMSS 3

l l

FROM:

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

SUBJECT:

CERTIFICATION OF THE MINUTES OF THE MARCH 1-2,1998, MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 1

l l hereby cert <fy thirt, 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 March 1-2,1998, are an accurate record of the proceedings for that meeting.

I l

Judith Anfie Stitt, M.D., Chairman I

</l2Q'af f/

Date J

Attachment:

Minutes - ACMut mtg.

March 1-2,1998 I

l i

1 1

1

'l'

.I

% h

)

1

)

- w

SUMMARY

MINUTES ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 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 was provided to the ACMUI members in advance of the meeting, and is available through the 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 cardiology perspectives; Ruth McBurney, representing State and local gavernment perspectives; Robert Zoon, representing the perspective of radiation safety concerns from a radiation safety office of a large institution; Dolly Durham, representing patients' rights and care perspectives.

Also present were staff members from the Nuclear 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 mt.eting and the function of the ACMUI. Ms. Haney stated that she had reviewed the Committee mvmbers' 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 j

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 ACMUl members. Dr. Paperiello discussed the Commission's directive to revise Part 35 to incorporate a more risk informed, performance based approach to the regulation of radiation for medical use. Dr. Paperiello went on to state that a nurnber of topics had generated a lot of comments, (e.g., training and experience, precursor e"*nts, and patient notification). Dr. Paperiello ended his remarks with his thanks to the ACMUI n; -bers for meeting on Sunday with the NRC staff.

EBEVIDUS ACMUGECOMMENDATIONS Ms. Haney geve a brief overview of staff actions regarding the recommendations made by the ACMul at the April and September 1997 meetings.

n, 1

-~

~l l

l April 1997 l

Staff actions on the recommendations from the April 1997 meeting were discussed with the i

l Committee at the September meeting. Only one recommendation had not been resolved at that time. In particular, ACMUI 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.

l 1

I September 1997 j

i

1. 1979 Medical Policy Statement (MPS)

{

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

Ms. Haney indicated that the ACMUI's recommended changes to the MPS were presented and discussed at the facilitated public meetings.

11. 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 minor modifications to the proposed alternative rule text. Ms. Haney explained that the Working l

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 recon mended that RSCs be required for medicalinstitutions, 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 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 j

complete a specified number of hours of training, focusing on radiation safety, and pass an examination that verifies competency in radia? ion 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 The ACMUI recommended that the training and experience requirements for a medical physicist be patterned after the requirements for an authorized user, with one exception. The medical 2

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 ACMUI recommended the current criteria for radiopharmaceutical misadministration be reduced from three categories to two: a) radiophannaceuticals 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 ACMUI believed that the reporting of precursor events should be voluntary. Ms. Haney indicated that the Working Group considered the suggestion but, believed that a reporting requirement was needed to best capture precursor events.

Vll. Patient Notification The ACMUI did not support any regulation requiring notification of physicians and patients.

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

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 February 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, revised 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 published in the Federal Reaister, during the summer, for a 75-day comment period. During the enmment period, the Working Group plans to hold two facilitated public meetings, one on the west coast and one in the midwest. Ms. Haney stated that the final rule is on schedule for submittal to the Commission in May 1999.

3

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

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 10LICY STATEMENT (MPS)

Ms. Haney described the purpose of the MPS. She indicated that a draft proposed MPS vias 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. Sttff viould 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 recommendations.,

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.

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

I Chairman Stitt questioned the origin of the phrase " physician's prescription" as it appeared in the proposed MPS. Chairman Stitt commented that a physician's prescription is different from a written directive. Ms. Haney indicated that this phrase was used in Alternative 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 tafety 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 w;th radiation and how the l

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 concern mgarding overly prescriptive regulations.

4 L

l

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

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

1.

The NRC wi!! continue to regulate the use of radionuclides in medicino as necessary to l

provide for the radiation safety of workers and the general public.

l 2.

The NRC will not intrude in the medical judgrnents affecting patients except as necessary to I

provide for the radiation safety of worker in the general pub!ic.

3.

NRC will regulate the radiatbn safety of patients only where justified by the risk ta the patients and only where voluntary standards or compliance with these standards are l

inadequate.

l 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. 'Nagner offered an amendment to include the second sentence from the recommendation made at the September 1997, ACMUl meeting into Statement 3

(" Assessment of the risks justifying such regulations will reference compar&ble risks and comparable volulitary standards and modes of regulation for other types of rnedical 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 amendrnent 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 had been incorporated into Statement 3. Statement 4 was celeted.)

6CMUI Recommended 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 medical judgements effecting 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 cuch regulations will reference comparable risks and comparable voluntary standards and modes of regulation for other types of medical practice.

5

1 I

I TRA!NLNG AND EXPERIENCE 1

Ms. Haney introduced the topic of training and emerience by providing the ACMUI with a brief synopsis of the training and experience criteria for authorized users, authorized nuclear I

pharmacists, medica physicists and radiation safety officers as it appeared in the draft proposed l

rule (Attachment 2). Ms. Haney indicated that, on the basis of the public input, the Working Group was proposing the followin9 general criteria for these individuals: individush! should I

complete a structured educational program'that consists of didactic training and practical experience; reference to speciality beards, by name, should be deleted; preceptors, when required, should certify that individads have achieved a levai c) competency sufficient to function independently; and individuals should demonstrate suG:wnt knowledge in radiation safety by passing an examination given by an organizMion or entity approved by the Cornmission or an Agreemen> State. She also indicated that the term " structured educational program" replaced the phrase "c'assroom and labWory training," as used in the simwman rule.

Se: tion 35.400. "Use of sources for manual brachytheraov." and R35.600. "Use of sealed i

sources in a device for therapeutic medica! uses" Ms. Haxy 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 Put 35, to the ACMUI. Re presenters were: 1) Peter Blitzer, M.D., President-elect of tne American College of Radiation Oncology; 2) William Bloomer, M.D., Chairman of the Pub!ic f

Policy and Law Committee of the American Couege of Radia90n Oncology, tenured professor of radiology at the Northwestern Undersity Medical School, and Director of Radiation Oncology and Nuclear Medicine at Evanston Northwestern Health Care in Illinois; 3) Omar Salazar, M.D.,

Chairman of the Board of Chance!! ors 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 j

radiation oncologist frem St. Louis; 5) Frank Wilson, Professor and Chairman et Radiation I

Oncology at the Medical Couego of Wsexsin; 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 and the ACMUI members followed the formal presentations.

The ACMUI members debated the various issues surrounding tho traininc 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 ACMUl try to come to a consensus on those training and experience issues that were important to the ACMUI.

Dr. Williamson prooosed 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 alternative to board certification). It was believed that radiation safety handling experience could not be separated from clinical experience and that current requirements are needed to provide i

i i

assurance that authorized users have adequate training and experience to handle material safeiy. Chairman Stitt, after some additional discussion, es!!ed for a vote. Mr. Graham offered j

an amenoment 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 favor.

Section 35.100. "Use of unsealed bypro.d_u_qijpaterial for uptake. dilution. and excretiolsludies" Sec$pp_MJ00. "Use of unsealed bvoroduct material for ima_gino and localization studies for which a wr,uen diactive is not reovired." and Section 35.300. "Use of unsealed bvoroduct j

material f ar therapeutic administration"

{

Chairman Stitt directed ine discussion to the training and experience requirements for authorited users of byproduct material used pursuant to @S 35.1C43,35.200 and 35.300. The members debated the issues of relative risk levels for these uses. In particular, they focused on 6 35.300, because it addresses the use of radionuclides for therapy. This use poses greater risk than diagnostic we of radionuclides (SS 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 material listed in $535.400 and 35.600, since the radiation risks are similar. Dr. Flynn stated he thought that radionuclides with the potential for bone marrow suppression shouH be treated the came as those radionuclides used pursuant to $$ 3L400 and 35.600.

Mr. Graham proposed a motion to accept the training and experience criteria for users of materialin SS 35.100,35. 200 and 35. 300 as detailed in the draft proposed rule. The motion 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 j

when administering therapeutic quantities of radionuclides. Chairman Stitt commented that she j

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 ea:h of the rule sections. Mr. Graham withdrew his original motion and put forth the following one: ".. the ACMUI is recommending the acceptance of strwman 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. Nelp seconded. The motion passed 9 - 0 in favor.

Mr. Graham moved that:

. the ACMUI recommend acceptance of the strawman language for training related to S 35 300." The motion was dakated 5 opposed,4 in favor.

The subject of training and experience for authorized users of byproduct material used pursuant to $$ 35.100,35.200, and 35.300 was discussed again on March 2,1998. For continuity, that discussion is summarized here.

Chairman Stitt asked Dr. Alazraki if she would summarize the professional societies' views on training and experience for authorizec users ss presented in letters to the Commission staff (copies provided in Attachment 3). Dc. Alazraki summarized the comments received from three 7

i

p l

professional societies: American College of Nuclear Physicians (ACNP), American College of Radiology (ACR), and Society of Nuclear Medicine (SNM). Key points noted by Dr. Alazraki are outlined below:

ACNP The ACNP made the following 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."

ACR 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 requirements.

l 2.

Physicians who are not certified by ABR or ABNM should be required to meet specific training and experience requirements and to pass an exam. ACR recommends that the exam be established and conducted by a private sector organization with extensive experience in such matters, (e.g., ACR, ABNM, ABR or a consortium of those groups.)

3.

Preli.minary 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 0.0333 hours 1.984127e-4 weeks 4.566e-5 months of classroom laboratory training and 240 hours0.00278 days 0.0667 hours 3.968254e-4 weeks 9.132e-5 months 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-approved medicalinstitution. Entrepreneurial weekend courses should not be permitted as substitutes.

4.

Physicians, including those who are certified by ABNM or ABR, should be required to document at least 15 hours1.736111e-4 days 0.00417 hours 2.480159e-5 weeks 5.7075e-6 months of nuclear medicine CME (Continuing Medical Education) credits each year.

SNM 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.

8

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 suppoded. Dr. Flynn stated his disagreement in terms of the training and experience criteria for authorized users of byproduct material used pursuant to S 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 maintain 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 motion was seconded by Dr. Neip. The motion passed 9-0 in favor.

[There was no discussion of this topic.]

Radiation Safety Officer (RSO) Trainina Chairman Stitt called for a motion and/or a discussion regarding RSO training. Mr. Graham moved that the RSO training and experience criteria, as presented in the draft proposed rule, be accepted. Mr. Swanson seconded the motion. Mr. Zoon informed the members that he had attended a Health Physics Society meeting on this issue. He stated that the Society is very l

concerned about the strawman rule language, and cited the proposed requirement for an exam.

The ACMUI discussed whether an authorized user should automatically qualify as a RSO.

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 l

accept the training and experience requirements as presented in the draft proposed rule for the l

RSO. The motion carried 9-0 in favor.

l L

9 1

l L

I w

Nuclear Cardioloav Trainina Ms. Haney requested ACMUI's recommendation for training and experience requirements for cardiologists who wish to use intravascular brachytherapy sources. Dr. Cerqueira indicated that most procedures are being performed with strontium-90 or iridium-192.

He also described the current training curriculum for cardiologists that plan to practice interventional cardiology. This program includes a 6-year training program with an additional 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 appropriateness of having other medical specialists on the team to support the cardiologist, in particular, at least a medical 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.

NOTIFICATION FOLLOWING A MEDICAL EVENT Ms. Haney explained that the draft proposed rule language contains the current reporting (notification) requirements (reference current S 35.33). Ms. Haney informed the ACMUI that the staff plans to request guidance from the Commission on who should be notified following a medical event. She indicated that the Working Group had identified three alternatives:

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

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

3. Revise the current reporting requirement to require a licensee to inform only NRC of a medical event.

- Chairman Stitt clarified that the issue under discussion should be who 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 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.

10

i I

REPORTABLE EVENTS Medical Events Ms. Haney reviewed the draft proposed rule language and asked for comments. Th'e 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 sugge.sted 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 rom.. Finally, it was suggested that NRC consider a separate dose threshold for wrong treatment site.

Significant Precursors Ms. Haney presented slides of the three alternatives 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 other licensees. She then summarized each alternative. She indicated that the first altemative was used in the draft proposed rule. She stated that 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 manufacturer or vendor, that could lead to a medical event at that facility or have outside implications. Alternative 3 evolved from discussion at the last ACMUI meeting, where the ACMUI stated that a reporting requirement is not needed in the 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 Alternative 2, with modifications. Mr. Graham moved that the ACMUI recommend the adoption of Alternative 3 and the second portion of Alternative 2:

Deficiency in equipment (hardware and/or software), byproduct material, or procedure supplied by a manufacturer or vendor that, in the opinion of the licensee, could lead to a medical event at that facility or has implications for facilities outside of the licensees' facility

- (operating procedure).

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 necessary to require a licensee to have an RSC. After reviewing the list of duties that were assigned to an RSC, it was determined that some of the duties were already addressed in '

I 11 1

i

10 CFR Part 20. Duties that were not addressed in other rules were incorporated into the proposed S 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.

I Mr. Swanson moved that the ACMUI accept the wording in S 35.24, as written, with one change

- the word " licensee" should be replaced with the phrase " licensee's management." The motion j

was seconded. Mr. Graham stated that the only place where this change should take place is in i

9 35.24(c). The word " licensee"is appropriate for paragraphs (d), (e) and (f). The motion was l

carried 9-0 in favor.

STRONTlUM-90 (Sr-90) EYE APPLICATOR CALIBRATION l

Robert Ayres, an NRC staff member, discussed the number of misadministration 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 (lN), alerting j

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 misadministration involving these devices. Another IN was issued reminding the licensees that a OMP would require that a licensee ensure that the prescribed dose equals the administered dose. The NRC is still receiving reports of misadministration from Sr-90 eye j

applicators which, in some cases, resulted in significant overdoses to the patients. Dr. Ayres

)

introduced Dr. Chris 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 measuring 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.

l Dr. Soares continued his presentation with a detailed description of the calibration procedures used at NIST. Dr. Soares went on to discuss the non-uniformity problems associated with these sources, which causes the calibration difficulties. 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 and returned the floor to Dr. Ayres. Dr. Ayres informed the members that the full text of Dr.

Soares' recommendations was in their briefing books.

12 l

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 recalibrates to present standards. The motion was seconded.

After some further discussion, Dr. Swanson suggested the adoption of Option 3 and Option 5, which involved issuinq an IN that discussed the importance of decaying the sources. Further discussion resulted in Dr. Williamson amending his motion. Th3 amendment recommended the adoption of Options 3 and 5. The motion passed with 9-0 in favor.

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

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

The issue of what parameters should be listed in a stereotactic radiosurgery written directive (9 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 she ild 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 @ 35.41. Dr. Williamson indicated 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 plans of treatment.

13 J

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 I

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 implemerited as written.

DISCUSSION OF STAFF REQUIREMENT MEMORANDUM (SRM)

Torre Taylor, an NRC staff member, presented the contents of two Staff Requirement Memorandiissued 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 turn 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. Nelp 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 needed. Dr. Nelp withdrew his motion.

Mr. Graham moved that the ACMUI respond by stating that the questions posed in the SRM had been considered by the ACMUl 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 periodically, 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 ACMUI 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 [ March 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 Dr. Williamson announced his resignation from the ACMUI. He indicated that he planned to go on sabbatical to a Swedish University. In his capacity as an ACMUI member, he is considered 14

~

^

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. Mcney asked the members views on appointing an RSO to the ACMUI. Ms. McBurney 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 committee. Dr. Nelp seconded the motion. The motion passed 9-0 in favor.

Dr. Wagner recornmended 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 would be filled immediately. He stated this would avoid the necessity 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 ACMUI. [ NOTE: Mr. Flynn and Dr. Williamson in 1998, Chairman Stitt, Dr. Nelp and Mr. Swanson in 1999.] Mr. Graham seconded the motion. The motion passes 9-0 in favor.

General Discussion on Rule Text A general discussion was held on specific sections of the draft proposed rule language.

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 I

and low dose-rate remote afterloader. Ms. Haney asked if the members 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 dose-rate.

Mr. Zoon commented that SI units should be used in the rule. Ms. Haney stated it the proposed rule would contain the appropriate units.

Section 35.62. " Possession. use. calibration. and check of instrt:ments to measure dosaaes of aloha-or beta-emittina radionuclides" Ms. Haney asked if the members knew of a NIST-traceable beta calibration source.

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?

15 I

l l

o I

l 4

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-103?

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 i

used by the licensee.

Spection 35.67. " Authorization for calibration and reference sources" Ms. Haney explained that the Working Group is considering raising the possession limit for i

l 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. "Trainino for imaaina and localization studies" Ms. Haney reques.ed the ACMUI'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 therapeutic 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. Wuliamson stated that ho thought this was a good change. It would eliminate problems of public access to new brachytherapy products as they come on the market and are approved by FDA.

I Section 35.315. " Safety precautions" i

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 @ 35.75, to receive a dose of 0.5 rem (S 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 l

500 millirem. The Working Group believes that this issue may be addressed by the proposed 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 to instruct the visitors in ALARA procedures, and whether the individual should be required to consent to the increased exposure, Drs. Wagner, Williamson, and Flynn stated their opinion 16

._s

o 1

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

1 Section 35.404. " Radiation surveys" Ms. Haney indicated that the Working Group had deleted the requirement in the current 35A04(b) which stated that "a licensee may not release from confinement for medical care a patien: or a human research subject treated by temporary implant until all sources have been l

removed." The Workir.g Group believed that this requirement was unnecessary in light of the provisions in SS 20.1301 and 35.75. Drs. Williamson and Flynn believed that this change would reduce burden on licensees since this class of patients would not have to be cor. fined 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 f

thought it was important to assure that, once the brachytherapy sources were removed, the sources were retumed to storage. Chairman Stitt commented that the draft proposed rule

)

allows for flexibility but still provides for source accountability.

Section 35.415. " Safety precautions" Mr. Zoon suggested a change to the rule language that requires the RSO to be notified in the 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."

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 brachytheraov 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 thought that if Paragraph (d) is interpreted correctly the licensee could comply with AAPM standards for verifying seed output based on a representative sample.

17

p i

I Sectior 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 systems. 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 th ra systems could result in hundreds of medical events prior to the discovery of a problem.

Section 35.615. " Safety precautions for remote afterloaders. teletheraov units. and aamma stereotactic radiosuraerv units" Ms. Haney asked ti,at the ACMUI focus on the requirements in the proposed 9 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 minutes. Dr. Williamson commented that it is excessively prescriptive, for low dose-rate afterloaders, to require both the authorized user and physician to be present at initiation of treatment. Ms. Haney proposed that the rule contain requirements specific to each type of treatment. The following criteria were suggested by the ACMUl:

1.

For LDR, a physicist a.,J 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.

Section 35.605. " Installation. maintenance. and repair" Ms. Haney asked the members if it was appropriate to allow the authorized medical physicists, or a person under the direct supervision of an authorized medical physicist, to maintain, adjust, or repair low dose-rate remote afterloaders. Dr. Williamson suggested that the rule should allow 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 direction of a medical physicist." Members believed the suggested language was adequate.

Appendix A to 10 CFR 35 "Examinina Organization or Entity" 18

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 apsed to delete the last clause of item 7 and to revise the language in item 5 to read:... have a committee whose members could carry out their responsibilities impartially to review complaints by examined individuals."

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 photon-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 susay 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 & 32.72. Ms. Haney confirmed this fact. She added that, if the licensee chooses to perform a corroborating assay, the dose calibrator used must be calibrated in accordance with S 35.60.

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 safe 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 iterns into the NUREG.

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

19 l

i l

l l

ATTACHMENTS 1

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 continue 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 sefety of patients to assure that the physician's prescription is correctly delivered.

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

l l

l.

l l -

L i

s U

ra s

s A

s r

e e

r Y

e s

s o

s a

a 2

h a

r t

c c

c a

O 5

5 e

5 2

2 y S M

1 ECNE IR E

P

)

X s

r E

h 0

0

(

0 0

0 D

2 4

4 l

N ma 5

5 a

c A

i r

t g

c G

o a

r r

N P

P I

N 0

la 0

IA n

7 R

o i

t T

acu

)

d s

0 0

0 r

0 0

0 E

h 0

0 0

4 8

8 2

2 2

(

d c

e i

r t

u c

t a

c d

u iD r

tS 0

0 0

0 O

P P

1 2

3 4

6 S

M N

5 5

5 R

A A

3 3

3 I

I l

ATTACHMENT 3

{

\\

'f i

-3

a-_-----

_1 l

February 27,1998 i

i l

Cathy Haney Chairperson, Part 35 Working Group Mail Stop T8FS 1

U.S. Nuclear Regulatory Commission I

Washington, DC 20555-0001

)

Dear Ms.' Haney:

The American College of Radiology has followed with interest the current NRC re-evaluation of Part 35 CFR. We have testified in this regard at the IOM hearings and

-j hade maintained a continuous dialogue with NRC throughout this process. The ACR i

agrees that the revised Part 35 should be risk irformed and can be more specifically I

related to each modality.

)

i Training and Experience l

l The following comments focus on the training and experience requirements for each modality identified by the NRC. However, in keeping with the " risk ir. formed" appoach, we have classified the modalities into two general categories -- higher-risk and Jower-risk.

HIGHER-RISK MODALITIES l

t

' brachytherapy sources, teletherapy, remote afterloaders

\\

& gamma stereotactic radiosurgery-1 The A' CR believes that medical board certification requirements under current 6 35.940

f are essential to the safe practice in the higher-risk modalities under Part 35 that include

)

both low-and high-dose rate brachytherapy, as well as teletherapy, remote afterloaders and gamma stereotactic radiosurgery. In addition to basic training in mdiation protection and source handling, safe therapeutic administration of applicator-coofired radioactive material requires comprehensive training in the placement of applicators and sources, use of complex planning tools to accurately deliver treatment, and directic's of developing of

, a safe treatment' delivery program with a quali6ed 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 adequately protect the safety of patients for these higher risk procedtues. For a l

reasonable level of patient safety to be assured for these higher-risk modalities, the y

y-P physician directing treatment must also possess extensive clinical experience in f

appropriate patient selection, follow-up evaluations of the radiation's effects, j

l 3

i:

1

A M;E-R I C A' N C O L L'E G' E OF R A D 'l O L O G Y j

n ha.,

- ~

2 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 limited 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 misadminL,t ation reporting shows that such reportable events are rare and almost never lead to signific.nt adverse consequences for the patient. The three-year supervised clinical experience requirements incorporated into radiation oncolc,gy residency programs has been the critical factor in assuring that these events are as close to zero r,s possible. Substantially relaxing the training and experience requirements for the higher-risk modalities by eliminating the three-year residency program wih almost certainly ;ead to a significant rise in the number of and adverse complications resulting from misadmirdstrations.

The higher risk procedures need to be reviewed not only for the efficacy of the procedure itself, but also for its acute and long cerm effects ou normal rissue tclerance and possible caremogenic effects on scnsitive 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 radiatica de ses must be delivered to precise areas with precise margins. These decisions, which impact patient safety and control of the disease, require the broad training that is obtained in the three-year training program.

The current requirements for these modalities ensure that authorized physicians have the appropriate skins 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 provihrs are wcl! sewed.

1OWER-RISK MODALITIES Low-dose rate byproduct materials (diagnostic nuclear medicine)

Recerd NRC regional meetings at which the revision of Part 35 has been discussed have creged serious concerns among ACR members. These concerns relate to the proposed drastic reduction in training and experience requirements for the use of low dose rate diagnostic radionuclides to 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months classroom / laboratory and only 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months of supervised practical experience. The ACR convened its leaders in nuclear medicine and conducted a state by-state poll ofits 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 l

detrimentally affecting patient safety and quality of care for these procedures:

l t

1. Physicians who are diplomates or in the future become diplomates of the American Board of Radiology (ABR) or the American Board of Nuclear l

Medicine (ABNM) should be licensed to use diagnostic radionuclides without additional education or examination requirements.

l l

h p

{

v-Ly

3-t

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.9 examination 1

should be esutblished 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 education 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 0.0333 hours 1.984127e-4 weeks 4.566e-5 months of classroom / laboratory training and 240 hours0.00278 days 0.0667 hours 3.968254e-4 weeks 9.132e-5 months of supervised practical.

1 experience, OR a three-month training program in nuclear medicinc. This I

field experience and education should be obtamed only in an ACGME-

)

approved training program in an ACGME-approved medical institution.

Entrepreneurial weekend courses should net 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 range of radionuclides clinical applicatic ns.

j

4. Any physician -including those who are diplomates of the ABNM or ABR-4 who wishes to continue to use diagnostic radionuclides in clinical practice should be required to document at least 15 hours1.736111e-4 days 0.00417 hours 2.480159e-5 weeks 5.7075e-6 months of nuclear medicine CMB credits each year.

The training and experience proposals given above are substantially below those currently required by the current %35.920. Thas, the reduction is consistent with the risk-informed position that the ACR continues to take with respect to revision Part 35. The ACR believes that the standards proposed tire reasonable.

Substr #y rehtxing the supervised practical experience to 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months (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 mtot 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 0.0667 hours 3.968254e-4 weeks 9.132e-5 months of supervised pmetical 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. Inadequate training and experience requirements for lower risk diagnestic nuclear medicine procedures will also likely prornote increased i3

. ovemtillation and self-referral abuses potentially leading to improper use of additional L

radiation exposures.

7 j' '

The ACR believes that the requirements proposed above would be best developed, administered and monitored by medical specialty organizations with experience in t

clinical applications ot radiation-related technologies. The ACR's role in the j

3 implementation of regulations for the Mammography Quality Standards Act (MQSA),

v.

y

l l

4 a cooperative public/ private partnership utilizing the strengthr of both established accreditatiordcertification programs and the federal government enforcement authority, should. serve as a raodel for such a process in nuclear medi::ine.

High <kae rate ansealed materials (nuclear medicine derapy)

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 j

for diagnostic nuch ar medicine. In addition to radiation safety, the use of high-dose rate i

uncealed materials require; additional training and supervised work experience. We believe that fu ther classroom and laboratory training in radioisotope handling techniques for therapeutic radiopharmaceuticals is necessary to assme patient safety. For physician.;

not board certUled in nuclear medicine, radiology or radiation oncology, we recommend l

i 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months of combined training and experience in addition to the training and experience reg'tirni for daignostic nuclear medicine. The physician should document at least 10 cases involving thyroid function and treatment of hyperthyroidism or cardiac dysnmetion, plus at least 10 cases involving the treatment of thyroid carcinoma.

i The ACR appreciates this opportunity to comment cn the program for revising the l

regulations governing the uses of radionuclides in medicine. In addition to the training l

and e.v.pvience requirements, the College plans to submit further comments cn the other portions of the proposed revisions to Part 35 in the near future. We lock forward to the comments of the NRC and to an opportunity to continue our involvement in these l

important Part 35 developments.

i Sinceiely, l

r.

Jan es (, Potter Dir

, Federal Progrcans 4

,C i v-

s %

3 E S O C.:. ~ Y O

N UC_ EAR MEDIC Vi w

h...

1830 $amuel Morte Orbe ReconNA. l.Olo0,3 316 W, '08-W IW W N8-W 5 s

/

p Td February 27,1998 Cathy Haney Chair Medicine Section Working Group, NMSS One White Flint North Buildmg j

i15555 Rockville Pike i

Rockville, MD 20852

Dear Ms. Haney:

On behalf of the Society of Nuclear Medicine, I would lik.e to submit the following comments on 4

Training and Experience and ask that you consider them when maldng revisions to Part 10 CFR l

35. We are currently working en additional comments and will be submitting them to you on a i

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 mirdmum ia not sufficient for an Authorized User Physician. An Authorized User Physician demonstrating competence in nuclear science as described below will be competent to direct the use of unsealed by-product material in both diagnostic and therapeutic settings.

l 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 l

competence criteria are best defined by relevant medical specialty organizations, such as the L

ACOME approved training progmms and the ABMS-sanctioned Certifying Boards. For I

example, the training criteria endorsed by the ACOME for nuclear medicine and nuclear radiology have been recognized for many years by NRC as indicators of clinical competence in the human use of radioactive materials.

a Yh,9.X)GDy ( 0 f*

h A 4-i _ t"4

E l-l c

1

.l The SNM suggest.; 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) rhould be inserted here (in replace of the proposed 120 hour0.00139 days 0.0333 hours 1.984127e-4 weeks 4.566e-5 months rad safe training)

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

Attainment of or compliance with these train ng requirements in the area of radiation safety i

should not be c< astrued to represent adequate trainir 3 or clinical competence in the proper f

diagnostic or therapeutic uses of radiopharmaceuticals.

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 'oe l

I a requirement for evidence of mastery of comprehensive nuclear and radiation sciences. This involves the understanding of the following: Radioactive decay and its calculation, radionuclides production, radionuclides detection instruments and their capabilities and calibration, radiation imaging devices and their capabilities and collimators shielding, radiation protection and radionuclides handling and manipulation principles and techniques,intemal dosimetry calculations, extemal dosimetry calculations, radionuclides generator operation and calculations, radiation biology, radiopnarmacokinetic modeling, statistical analysis, and the application of basic nuclear and radiation sciences to all aspects of 10 CFR Part 20, radioactive waste disposal, and transponation requirements.

3) The SNM recommends that a component of the training and experience requirements contain a level of practical " ham's 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.

\\

I I

1 J

l-1

4) There are two mechanisms that the SNM suggests be used by the SRC 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 verification 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 NM) can potentially fulfill a dual role: (A) In the area of clinical training & competence, we advocate that they (together with ACOME 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 important that any examination, either through a third party 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 lanpuage in the training and experience sections of 10 CFR 35. 290,292,390.

For further information on this topic please feel free to contact Mr. David Nichols, Director of Government Relations at (703) 708-9773.

Sincerely N

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

)

1 J

h..

270 AMERICAN COLLEGE OF NUCLEAR PHYSICIANS 4400 jensfer Street, N.W. e Suite 230. Washington. D.C. 20015-2113 e 202/244-7904 e FAX: 202/244 7355 E,h s

l M

_ 2 no.

February 4,1998 a

l cama, a ni.

m c_ o

7. W 8

o m

l r,*

-a.a~'

ua 1",,,,.

Director, Industrial and Medical Nuclear Safety Division g' eh

~~'

z*h Donald A. Cool, Ph.D.

,;U '

l am v Two White Flint North Building cm%.,r o

o

".< s".'n'". "S s

a 11545 Rockville Pike

-h.,

'd"' *# ""

Rockville, MD 20852 DOCNET M h:;

s,

,y E

Mm no.

Dear Dr. Cool:

(WDFR4 sat 4) r n xi cm.i n

c

,en.

C.ry L DW.it.y, RD.

wa As you may recall, I met you, Cathy Haney, and other members of

@ 2,0.'*8*'

the NRC staff on December 18,1997, to discuss the proposed revisions

"'"8"aa. "1 of 10 CFR.

M ai ' Ta.I '*'

QC As President of the American College of Nuclear Physicians, a nearly 1000 member professional organization of practitioners of nuclear T - s a.wa U,"*, o,,',",,,,,,.

medicine, I am writing to inform you that at the annual convention on

- j y "S January 31,1998, both the ACNP House of Delegates and Board of Regents overwhelmingly passed the following " resolution:

M**

""*""m n w AMEo?

ma,4..,, p.u.,w.xwe:

,I Z ua "Be iiresolved that the American Co'llege of Nuclear Physicians 8'ea 8v. u encourage the Nuclear Regulatory Commission to maintain the six

'",',,',N'"""

months /1200 hour rule for NRC licensure for use of radioactive u

a a 5 c-r i. ua

'in humans, and Be it further resolved that the American College of i

Na*c[wa

, Nuclear Physicians supports the rendering of such training in the future l

uivalent amaa. programs &,"

o.am,r. cr

. only in ACGME accredited or m x.w muummw.mn re, s.n.e u.na w c,rr. a v. m w s,v.,, a ver v @

"Jr="

The members of our organization strongly feel that whereas many d**" "a portions of 10 CFR 35 could be simplified or eliminated, the safe prachce c is.m w a.r6.a L*""i,'

of nuclear medicine is contingent on a cadre of practitioners well versed in C

both the theoretical and practical aspects of handling (byproduct) t*==n. n C " g "'

radioactive materials, and this could only be achieved by sufficient training u.naan.*v. na and experience. We furthermore feel that the unprecedented safety Z^

record of our specialty is a consequence of meeting the historical wa standards of Paragraph 35.920, and as a result of this training and

=

experience, practitioners have the necessary expertise to practice with public, patient, and professional safety in mind.

eaa w, a cw o 7"f'"" ""

There are those who argue that the safety of our specialty is not the result of adhering to the excellent standards outlined in Paragraph 4%

MLP*=. ua 35.920, but that the risks associated with handling byproduct material in y

medicine are so small that the training and experience requirements can o

ow p,q,, y

-48%MY@c91' N'/2

i 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 and 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 tith the higher dosages empl) yod with therapy - and to make l

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

Finally, although as stated above issues of competence are not l

legally a concern of the Nuclear Regulatory Commission, it must be realized that as a practical matter, a holder of an NRC license to l

administer byproduct radio-pharmaceuticals is generally deemed to be competent by virtue of such licensure by hospital credentiating committees, almost always composed of members unaware of the distinction between licensing for safety and certifying for competence.

We are concerned that the proposed reduction to 120 hours0.00139 days 0.0333 hours 1.984127e-4 weeks 4.566e-5 months of the training and experience requirement might result ia the credentiating 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, Wf a

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

l l

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

1.

Is life-threatening; 2.

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

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

Sjanificant 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 OR 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; MOU with FDA: and monitor USP database.

n n

i e

h h

t i

y w

w

+

y l

f i

l m

e r

f o

a t

t o

m c

s r

i f

t a

e e

a fs h

l i

t b

n ta o

a i

l s

t s

i o

n a

e?

t o

v uy a

sc i

s t

a a

t sn o

e i

m n

su re r

sq A

n o

s e e f

i r

I n

n h

df r

R a

c d g i

E m

u h

a n l

i T

f a

e w

ot i

IR s

t e

h C

u e

h e c

c gm i

N u

y v

u s

l O

e d

o e n

a nh m

I

/

t T

?

i e

e t

it o

A ce s

yt U

ae e

i t

l d

r t d

r t

L ei e

n e t

i A

nm t

v p

ed o

x u

V m

e qee i

r E

p IUo e n

-F M C s

e r

f r

d s

L e

i t

E Ce v

e e b

h o

eg S

At m

m r

n p

a ee e

o m

e eh r

h f

e e c t

d e e

t t

t t y nb e

in i

m ma a

t s

t f e m

m me i

f au o?

or s

m?

Cy C A t

s s

od c

ei Ce en e?

h s t

h e h r t s e s t.

t e

g s e h e s a s n r

t u e

en ed od oq oe oa Da Dr Dh Dm e

t 1

2 3

4 I

h 3

6 s

y tn t

e C

e i

u e

n m

R u

h r

s A

N m

c s

a i

t l

m A

f t

?

o s

u e

r s

f o

e e

h e

n c

t r

s n

o d

u n

n a

l it d

h a

n c

i a

y t

m e

id i

l t

y e

w t

e y

a i

m m

e e

/

l m

l ro t

i t

o m

h c

c e

r i

i t

f t

l a

d o

b

?

e a

f i

t u

s v

s l

o e

b n

y p

i t

u a

a r

i t

e i

s p

s n

h l

s i

o d.

s a

e u

t v

u m

n i

t n

f a

s A

s a

o s

m e

t a

f e

f t

o o

I i

R r

a h

n s

c w

E e

t g

s t

s e

a be T

n s

l is i

r n

r r

h d

c IR a

o e

n i

f c

d d

C m

v s

o h

a e

o i

it N

a e

w o?

m a

u d

t y c

O h

s n

e c

e i

h c

s a

c n

h n

IT u

g i

i t

u e

A s

e w

v u

u m

m e

d o

U n

n ?

q a

n o

m i

i t

e d v

/

L i

f e

r e

e e

er f

o A

c d

f r

s y

s c

V a

s t

i l

g e

r l

t E

r y

t e

a r

t u

c e

nn u

e e

r l

i t

F a

p et s

s i

n q

t e

r x

ue s

o L

i i

e c

e qe f

i l

E c

r I

em g

/

S U

e sn e

e r

n t

M f

r e d

d e

r a

i C

eh v

v eh b

i i

i t

t b

t l

w o

o e

s c

A mf i

r r

o e

ef p

p mt a

e?

re f

a h e mt e

e ed b

e t

t s

e e

e e m

e t

di e

t t

t de e

t nm e e t

t t

t i

i i

t h m

m me m

m i

a m t t n

f o mt m

m m

e m

i f

o o

o o s e

aC mn C

C Cg o

e t

ts t

c ?

e oo i

e e?

en m

e C eh Cit ht a

h h y h a m

h R

t e

e t

t t h t

m c

s s n sc o ?

s N sr h

c f

t r eo f

o e

e e ey f

e d o e of o

og o n o

a_

o n Db Din D

Da Da D

s_

D a t

e 1

2 3

4 5

E L

~

,l}LLill ll lliL L

-

ML20248L189

Contents

Text

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUMMARY

SUBJECT:

Attachment:

SUMMARY

Dear Ms.' Haney:

Dear Ms. Haney:

Dear Dr. Cool:

Navigation menu

ML20248L189

Text

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUBJECT:

SUMMARY

SUMMARY

SUBJECT:

Attachment:

SUMMARY

Dear Ms.' Haney:

Dear Ms. Haney:

Dear Dr. Cool:

Navigation menu

Search