ML20211A887
| ML20211A887 | |
| Person / Time | |
|---|---|
| Issue date: | 02/18/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20211A766 | List: |
| References | |
| REF-10CFR9.7 NACMUI, SECY-97-012-C, SECY-97-12-C, NUDOCS 9709240433 | |
| Download: ML20211A887 (2) | |
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r Action:
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UNITED STATCS Cys: Callan NUCLE AR REGUL ATORY COMMISSION Jordan C .u s . c a. :: :an m- 'noroson
'f February 13. 199~
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,,,taa MEMORANDUM TO: Leonard J. Callan
' Execut i to for Operations FROM: Joh . Hoyle, Sect tary ,
SUBJECT:
STAFF REQUIREMENTS - SECY-97-012 -
APPOIh'INENTS OF A PHYSICIAN PRACTICING NUCLEAR CARDIOLOC'" . A PATIENTS' RIGHTS AND CARE ADVOCATE. AND AN INDIVIDUAL WITH STATE OR LOCAL GOV?RNMENT PERSP",CTIVE TO THE ADVISORY COMMI'I" TEE ON THE MEDICAL USES QF ISOTOPES i
The Commission has approved publication of the proposed Federal Recister notice calling for nominations for the three positions <
on the Advisory Committee on the Medical Uses of Isotopes (ACMUI).
In addition to sending the notice calling for nominations to each of the State radiation control program offices, or equivalent of ficas, and soliciting the organi:atier,s listed in Attachments 3 and 4 for nominations, the. staff should also solicit the Conference of Radiation ControA !;ogram Directors (CRCPD) Addi-donally, and the Organization of A .eement States for nominations.
the staff should provide the notice calling for nominations to the Health Physics Society and any other national organizations the whose members include health physicists who could represent State or local government perspective.
Regarding the earlier direction of the Commission in the April 19, 1993 SRM on COMSECY-93-014, the Commission directed the staff to expand.its recruitment beyond individuals from Agreement States, b*ut it did not intend that the staff exclude them.
l SECY NOTE: THIS SRM AND SECY-97-012 AND THE COMMISSION VOTING
' RECORD CONTAIN PERSONNEL ISSUES AND WILL BE LIMITED TO NRC UNLESS THE COMMISSION DETERMINES mm op 9709240433 970923 PDR ADVCM NACMUI PDR
$4-w. r.
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,following changes should ce made :o the proposed Federal inter notice:
l / 1. The summary paragraph shculd be repeated in the Supplementary Information section by inserting it as the third paragraph, i.e., before the paragraph that-
' provides instructions on filing of resumes.
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/ 2. On page 1 of the Federal Recister notice, in the
SUMMARY
section, the following- should be added to the f
end of-the first tentence: 'to fill current and upcom!ng-committee vacanc ts.'
- 3. On page l'of the press release, the following should be added to the end of the first sentence: 'to fill current and upcoming committee vacancies.' -
(900) (NMSS) (SECY Suspense: 3/14/97)
-In addition, the staff should report back to the Commission on the pros and cons of havino AcMUI recommendations provided .
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_directly to the CommfssYon, concurrent with such provision to the starr. 9700032 79D0) (NMSS) (SECY Suspense: 6/27/97) cc: Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Dia:
Commissioner McGaffigan OGC OCA OIG-
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. ACTION - Bernero, NMSS
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- ' t NUCLE AR REGULATORY COMMISSION Cys: Taylor
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[4( )\' u OFFICE OF THE April 16, 1993 SECR(TARY COMSECY-93-013 MEMORANDUM FOR: James V. Taylor, Executiv irector for Operations FROM: Samuel J. Chilk, Secretar C
SUBJECT:
GUIDELINES OF THE ROLE, lhCJlDURES, SI2E AND COMPOSITION OF THE ADVISORY t:OMMITTEE ON THE NEDICAL USES OF ISOTOPES The Advisory Committee on the Medical Uses of Isotopes has served the Commission and the tiRC staff well t.nd should continue to do so. The Committee's role and function of providing sound Og technical and policy advice to the NRC are even more important Q now that medical use regulatory issues are under active, high-priority review. To help ensure continued high-quality support from the Committee, the Commission wishes to maintain direct access to the Committee and visibility of Committee activities.
For this reason, the Commission has determined tnat certain i adjustments are needed with respect to the Committee's role, size, composition and operating procedures. The purpose of these adjustments is to allow the Commission to take maximum advantage of the special resources provided by the Committee at minimum cost to the government, in keeping with the President's general direction on the use of advisory committees.
The Commission has determined that the following guidelines should be implemented regarding the role, procedures and composition of the Advisory Committee on the Medical Uses of Isotopes (ACMUI):
- 1. In making future selections for Committee membership, consideration should be given to additional specialties which might enhance the Committee's operations. Also, more weight should be given to candidates who represent more than one area of expertise (e.g., a hospital administrator with experience as a nurse); such candidates should be sought.
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- 2. The Committee should be maintained at or near its present size of 12 members. The six-year limit on I length of service should b3 maintained. The Commission I does not believe that the approach to length of service J
and number of terms should be any different for State i representatives than for other Committee members.
Accordingly, the approach to length of service and number of terms currently in effect for all but the State representatives should be extended and applied uniformly for all Committee members. However, all Committee members should be clearly informed and understand that continued service is dependent on continued agency need, and that the mix of representation on the Committee will be reexamined as regulatory needs change. Therefore, members may not be asked to serve a second or third term if they are no longer needed for purposes of representation, or if
, their contribution to the work of the Committee has been lacking.
- 3. Although the primary function of the Committee is to serve the needs of the NRC staff, the Commission wishes to receive an oral report from the Committee annually 87002C l and will meet with the Committee at least once a year /
to receive the Committee's report. The Committee may,
' 0,' if it chooses to do so, also provide its report in letter form, but this is not required. The committee should interact with the Commission in accord with the following guidance:
- a. The Committee's report to the Commission should be a consensus report and be approved by the Committee. Members having views different from those in the report should be allowed to express them in writing or when the report is presented to the Commission.
- b. The Commission would encoueuge the Committee to adopt bylaws governing communications between the Committee and the Commission ilong the lines of the bylaws that have been adc9ted by the ACRS.
Such bylaws, applied to ACMUI would provide that members of the committee write to the Commission on medical matters only when it is appropriate to do so: (1) as committee business in a Committee report, (2) in carrying out assigned responsibilities as an NRC medical consultant; and
- (3) in commenting, during the official public comment period, as members of the public on matters where public comment has been requested.
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There may be occasions on which a member feels a subject is of medical significance, but is unable to persuade the majority of the Committee that it warrants a committee report. In such cases, the member should make a good-faith effort to persuade the committee to take action, whether by writing a report on the subject, or by conducting further
, exploration. If the Committee decides to do neither, or if the member involved feels that the j importance of the subject warrants prompt action, i
he/she is then free to write an individual report on the subject. Such a report should clearly state, up front, that the member is not speaking for the Committee, and that the committee has j
declined to act to his/her satisfaction on the subject. A member using this mechanism should make every ef fort to apply the same professional standards to the.r individual communication as is fair to expect from the committee as a whole. The Committee in turn will make every effort to protect members' opportunities to address individual views.
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( c. The staff should consider whether it would be advisable for the Committee to operate under a set of by-laws to address procedural and conflict-of-interest concerns, including appearances of such conflict as well as for expression of minority views. The commission also suggests con 11deration i of the by-laws of the ACRS in this regard.
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- d. Consistent with the foregoing, the Committee should continue to interact with the staff to
- provide such support as the staff may deem warranced to help accomplish its regulatory mission.
A As a separate but related matter, the staff should consider what changes to the Committee's charter may be appropriate to more adequately reflect the committee's role as delineated above. 9300064 cc: The Chairman Commissioner Rogers b@ N Commissioner Curtiss "0N"44)l4 Commissioner Remick Commissioner de Planque OGC i O b
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o WASHINGTON, D.C. 20kW4001 MEMORANDUM TO: Donald A. Cool, Director i Division ofIrdustrial and Medical Nuclear Safety, NMSS
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FROM: Judith Anne Stitt, M.D., Chairman Advisory Committee on the Medical Uses ofIsotopes
SUBJECT:
CERTIFICATION OF THE MINUTES OF THE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES I hereby cenify that, to the best of my knowledge and belief, the attached minutes for the meeting of the Advisory Committee on the Medical Uses ofIsotopes (ACMUI) held on April 10
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and 11,1997, are an accurate record of the proceedings for that mee;ing.
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Judith Anne Stitt, M.D., Chairman
,X _ :.. G;7' Date
Attachment:
Minutes - ACMUI mtg.
4/10-11/97
3
- , Minutes of the Spring Meeting of the j Advisory Committee on the Medical Uses ofIsotopes l Apiil 10 and 11,1997 7 The Advisory Committee on the Medical Uses ofIsotopes (ACMUI) held a meeting on April 10 and 11,1997. A briefmg book with background information for the issues under discussion was j provided to the ACMUI members in advance of the meeting, and is available through the Public 4 Document Room. '
ACMUI members present at the meeting:
- Judith Ann Stitt, M.D., Chairman Judith Brown Daniel F. Flynn, M.D. John Graham Andrew Kang, M.D. Will 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.
Also present: Larry W. Camper, M.S., M.B. A., Branch Chief, Medical, Academic, and Commercial Use Safety Branch, Nuclear Regulatory Commission (NRC), (Designated Federal Official for the Committee); Donald A. Cool, Ph.D., Director, Division ofIndustrial an.! Medical Nuclear Safety, NRC; and Cathy Haney, M.S.,'Section Leader, Medical and Academic Section, O NRC. Barry Siegel, M.D.; Aubrey Godwin; and Larry Satin, M.D. also attended the meeting as Q ' invited guests, representing nuclear medicine, the States' perspective, and Nuclear Cardiology respectively.
Mr. Camper officially opened the meeting at 8:17 a.m. with general comments on the meeting and !
the function of the ACMUI. Mr. Camper stated that he had reviewed the Committee members' fia%! and employment interests, and had not identified any conflict ofinterest with items to be considered during the meeting. Mr. Camper stated that any ACMUI member who becomes aware of a potential conflict ofinterest during the course of the meeting should so inform him or Dr.
. Stitt.
Donald A. Cool, Ph.D., made opening remarks to the Committee regarding the upcoming revision of Part 35 and the Committee's involvement. He stated that NRC is about to take a fundamental re-examination and re-crafting of the regulations pertaining to the medical uses ofisotopes. This will involve a whole new view, "a white piece of paper", at regulating the medical use of radiation. The new revision ofPart 35 will be risk informed and performance based.
Commissioner McGaffigan addressed the Committee. The Commissioner stated that he was there to give insight of how the Commission came to their decision regarding DSI 7. The Commissioner also discussed various topics including: the IOM report; DSI 12; linear no-threshold hypothesis (LNT); and ACMUI's input to the revision of Part 35. The Commissioner noted that regulations can not be totally non-prescriptive but we should strive to be as
/ performance based as possible. He also requested that the ACMUI give their input to the staff early.
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Hugh Thompson discussed how the other NRC Advisory Committees operate in comparison with ACMUI. Mr. Thompson noted that the ACRS has a full time NRC staff to deal with the Committee actions and each Committee member spends about half of their time on work related i
to ACRS. This is in comparison to the ACMUI which is supported by staffin NMSS. On this same topic he encouraged the Committee to give their input to the staff. He offered to give more feedback to the Committee regarding their recommendations and on the status of various projects.
Discussion of the Advisory Committee Process Larry Camper presented on the Advisory Committee Process. This presentation covered much of the history of the Committee and how it has evolved over the last ten years. Also covered was the current recommendation process of the Committee and recommended improvements of the process. There was a discussion of the recommendation process and a feeling that more feedback to ACMUI from the staffis needed to keep the Committee updated as to how their recommendations are used.
In accordance with the ACMUI bylaws and recent direction from the Commission, the Committee is expected to formalir~ its recommendations, including dissenting opinions, within the minutes of each me, ting. The minutes along with the meeting transcripts are provided to the Commission.
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N ACMUI recommendations and concerns a e considered by the staff and Commission in the development of regulations, guidance, and policy.
I Dr. Flynn observed that the Commission seems to still be very reactor oriented. He suggested that there be one Commissioner who has a medical background. He also suggested that the NRC staff be expanded to include individuals with medical experience or the medical fellow program be expanded to make individuals with medical experience available to the current staff. Mr. Camper responded by describing contributions made by Dr. Polycove as a visiting medical fellow.
Dr. Siegel, an invited guest, noted that the bylaws state a member's term is two years, as opposed to three years which has been the practice. Mr. Camper responded that this was a good
- administrative point and that appropriate action will be taken to address the discrepancy.
l Discussion of Staff Requirement Memorandum Regarding Direction Setting Initiative 7 Larry W. Camper discussed the Commission's Staff Requirements Memorandum (SRM) entitled
" Materials / Medical Oversight (DSI 7)" dated March 20,1997. He described the NRC staffs planned actions to complete the revision of Part 35 by the Commission's target date of June 30,1999.
Mr. Aubrey Godwin, an invited guest representing the States' perspective, remarked that the SRM did not specifically address the " enforcement issue." Mr. Camper responded that, although the SRM does not specifically address enforcement, DSI 7 does indicate that the effort toward risk-
- informed performance orientation should also be brought to bear in terms ofimplementatior, as it i
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- relates to inspection and enforcement.
l ~ Mr. Godwin and Mr. Camper diamead the need to reduce the inspection frequency for low risk activities. They were in agreement that a reduction in regulatory presence would, in many cases, i result in a reduction in inspection frequency.
Several members of the Committee expressed an interest in identifying the NRC Office that would i
lead the revision of Part 35. Mr. Camper explained that the lead for the Part 35 revision had recently been transferred to the NMSS program office; and the 05cc ofNuclear Research will be -
4 providing resources and contract support. Dr. Stitt questioned the difference she might see on a
[ rule developed by the program office compared to a rule developed by the Office ofResearch.
Mr. Camper responded that, because the program office imp'. ments the rule for both licensing
- and inspection, and because he interacts directly with the ACMUI, it may be more sensitive to
- changes that are needed.
1 j Mr. Camper proceeded to describe the plan for the staff revision of Part 35. This plan included j submitting a program for the rulemaking to the Commission by June 6,1997 and have the final j revision ofPart 35 by June 30,1999. Dr. Nelp asked ifNRC planned to revise each of the
- subsections of Part 35. Mr. Camper responded that we have "a clean piece of paper." We have j the opportunity to develop a completely new Part 35. However, if there are parts that do not ig need to be changed, the ACMUI should point them out. Mr. Camper proceeded to describe a i possible model that had been provided to the program office. If this model were adopted, Part 35
[ would be organized by modality. Each subsection would contain all of the requirements for that l particular use. This would enable the staff to easily make changes pertinent to a particular j_ modality ofuse when needed.
i Dr. Nelp stated that he believed the ACMUI could best be used in discussing " focused" issues j
rather than organizational writing.
l' Dr. Stitt encouraged the Committee to give the NRC staff feedback on the issue of risk.. Dr.
Williamson asked for definitions for risk 'mformed, and performance-based. Mr. Camper suggested the Committee begin with DSI 12, which defines the Commission interpretation.
Dr. Williamson asked, for the purpose of revising Part 35, what the term " performance-based criterion" means? According to Dr. Williamson, one of the major concerns of the regulated community he represents is enforcement resulting from " paper-work sorts of siolations that have no clinical significance."
Mr. Camper responded that NRC will license, inspect, and enforce the w.itten regulation. When the regulation changes, there will be a corresponding change in licensing and enforcement.
O At this point, Dr. Stitt allowed Mark Rotman to read a statement prepared by the American College ofNuclear Physicians / Society of Nuclear Medicine which discussed risk and their support
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!- Mr. Godwin, returning to the general topic of revising Part 35, pointed out that there was no
- apparent provision to take immediate action on current regulations that mi@t be determined to be unneeded.
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- Ms. Walkup questioned whether the revised rule would be implemented in steps, or all at once, i Mr. Cy responded that they can be implemented either way. However, he would expect that
! there would be an effective date, and implementation dates for NRC and Agreement States licensees.
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l Dr. Barry Siegel, an invited guest representing the nuclear medicine perspective, made the l- statement: " diagnostic nuclear medicine is low-risk." He stated the belief that the revision of Part j 35 should start with changes to NRC's Medical Policy Statement "so that the physiciar , atient interface is no longer the purview of the NRC."
Mr. Graham recalled the subject dia-ion, and moved forward to the Commission's directions to the staff for the revision. He reiterated the need to focus Part 35 on those procedures that pose the highest risk, and that the ACMUI further discuss the Medical Policy Statement, and how it would be modi 6ed to direct all ofits other activities. He suggested that the staff should consider
( oversight alternatives for low over-all risk activities; and regarding misadministrations the staff should only capture precursor events in the whole process of changing from " misadministration" to " medical event."-
-Dr. Swanson stated that, in discussions of" risk," you must first define risk of what? He questioned what NRC was trying to regulate - public, occupational, or patient exposure? He also questioned the components of a risk matrix. He believed regulators would probably factor in political and public perception consequences. He also believed that medical use is low risk if you used NRC's probabilistic methodology.
- Dr. Williamson sugges:ed that, in discussing relative risk, the ACMUI should discuss three '
different populations that can experience consequences: the public, the workers, and the patients, and rank modalities separately. Depending upon how the issue of the Policy Statement is resolved, patients could be dropped. Dr. Stitt agreed with that approach.
Dr. Stitt called for a lunch break at 11:50 am.
Discussion of the Medical Policy Statement of 1979 The importance of the Medical Policy Statement of 1979 to the entire process of revising the medical use regulations in 10 CFR Part 35 was brought out by Barry Siegel in the preceding discussion of DSI 7. Dr. Siegel believed the ACMUI had to start with the policy because it was
5 the driving force that set the boundaries on the Commission's regulatory oversight of medical use programs Extensive distmasion followed.
Dr Siege' proposed dropping Statements 2 and 3 from the Medical Policy Statement (once the 2nd statamant is dropped, the 3rd becomes irrelevant). This would remove the physician-patient interface from NRC's purview and have NRC focus its efforts on the workers and the general public. He recommandad the ACMUI develop its recommendations based on both the track "without" and the track "with" patient safety as a part of NRC's medical regulations. Dr. Siegel pointed out that in the past the Commission's perspective was if one or several patients could be hurt because of the application of byproduct material then that risk to the patient justified the regulation.
Several members pointed out that the Medical Policy Statement did not need to be changed ifit was interpreted differently. Mr. Swanson stated that if a probabilistic risk assessment approach is used (the probability of risk times the potential outcome), for risky procedures with low probability the result is low risk. Dr. Nelp believed that the policy did not need to be changed, all that was needed was for the ACMUI to determine that regulation of the patient radiation safety was not e y orjustified. Dr. Stitt proposed focusing on the phrase "where voluntary standards or compliance with these standards are inadequate " She pointed out that from 1979 to 1997 many adequate standards have been developed thus, the current policy statement could be used to support that there is no need for regulations.
Dr. Stitt also supported the idea that the Medical Policy Statement should be composed only of Statement 1 (NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public).
Others explained their reasons for supporting Dr. Siegel's proposal. Dr. Wagner believed regulations addressing radiation safety of patients are not justified by the risk, since the probability of an event occurring is extremely low, even if the once-in-a-while incident has a high risk. He -
also thought as long as individua.s have the proper training to handle radiopharmaceuticals, the risk is low. Dr. Williamson made the arFument that although not substantially different from that of other medical subspecialties practicing procedures of similar intensity and complexity, the Medical Policy Statement allows NRC to impose an artificially low acceptance probability for misadventures upon the small discipline of radiation medicine. Dr. Flynn thought Statements 2 and 3 are covered by State licenses, which can be revoked by the State, and the patient was protected by various malpractice laws.
Ms. Brown did not agree with Dr. Siegel's proposal. She likes nuclear medic'me's attention to detail and accountability, items that she believes may be lacking in the rest of medicine.
A significant amount of time was spent discussing whether user training and experience reouirements could still be imposed if Statements 2 and 3 were dropped. Dr. Siegel tho . - 3e training and experience requirements needed to protect the workers and general public wu ' -Jso
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insure well trained physicians and indirect protection for the patient. Mr. Godwin believed if Statement 2 was omitted from the Medical Policy Statement all clinical experience requirements would be droppad and only minimal radiation safety training would be needed.
i Mr. Swanson's indicated rather than trying to argue for a new Medical Policy Statement, it may be better to ensure that the regulations reflect the Medical Policy Statement.
l Dr. Nelp made the motion that Statements 2 and 3 be omitted from the Medical Policy Statement.
The motion wu seconded and opened for discussion. Both Mr. Swanson and Dr. Kang had reservations about the motion. Mr. Swanson's concern was that the NRC answers to the public, and it would be difficult for the NRC to take out any statement that makes it appear that they are giving up regulatory authority over a risk issue. Dr. Kang agreed with Dr. Siegel's position that NRC should not interfere in medical practice, but was concerned that Statement 2 should be changed and not dropped. He thought NRC has a particular duty with respect to reasonable assurances for the radiation safety of the puMic, including the patient.
After a lengthy discussion about whether the NRC could have training requirements without the 2nd and 3rd statements, and Mr. Graham's suggestion that Statement 2 be changed and not dropped, the motion to delete Statements 2 and 3 from the Medical Policy act was withdrawn.
Dr. Siegel suggested two additional modifications to Mr. Graham's suggested change to Ststement 2. The first was to have the beginning read "NRC will regulate the radiation safety of g patients only where justified by the risk to patients, and only where voluntary standards or compliance with these standards are inadequate" and secondly to add another sentence at the end.
The second sentence was " Assessment of the risksjustifying the regulations will reference comparable risks and comparable modes of regulation for other components of medical practice."
Dr. Siegel concluded that it defines the universe, and the reference framework. Mr. Graham suggested revisions to Statement 3.
Mr. Graham made a motion to revise Statements 1 i of the Medical Policy Statement. Mr.
Swanson suggested a minor change to Mr. Graham's recommendation. The ACMUI recommended by a 9 to 1 vote that Statements 2 and 3 of 1979 Medical Policy Statement be revised to read as follows:
- Statement 2: The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
- Statement 3: The NRC will not intrude into medicaljudgements affecting patients and into other areas traditionally considered be a part of the practice of medicine.
N The dissenting vote was cast by Ms. Brown. She indicated that the current Medical Policy 1
f 7 Statement is adequate and that no changes were needed.
Discuss Criteria and Ranking of Medical Procedurts Involving Byproduct Materials by Risk Cathy Haney led the discussion on the criteria and ranking of medical procedures by risk. Ms.
Haney asked ACMUI to discuss the following items: identification cf key wodalities and the relative risk; ranking of the modalities by their relative risks; identification ofcriteria to be used in the ranking; description of the level of regulatory presence needed for each modality; and identification of the key items to be regulated under each modality.
The Committee began with the first discussion item, identification of key modalities and the relative risk. Due to time constraints, the Committee did not address each item separately however, some of the discussion did touch upon related topics, such as, ranking the modalities by their relative risks.
The first issue discussed by the Committee was defining what was meant by risk, particularly in a medical context. It was generally agreed that overall risk for a given modality is defined by the product of the probability of occurrence of an error multiplied by the severity of the consequences p of that error.
This was followed by a discussion on whether risks, for a given modality, to the patient, worker, and public should be treated separately or combined. To simplify the discussion, it was proposed that only risks to the puient be considered. However, after further discussion, it was generally agreed that most modalities presented some risk to all three populations. Thus, a determination of the overall risks associated with a given modality would need to consider all three populations.
The point was made that risLs to the patient differed in one substantial way from those to the workers and public. Namely, the patient risks were single short time span events, whereas, the risks to the workers and the public tend to be cumulative over time.
In order to better focus the Committee's discussion, it was recommended and agreed upon to begin by discussing the risks associated with diagnostic nuclear medicine. There was general agreement among the Committee that this was readily classified as a low risk modality with little risk to either the patient, worker, or the public. This classification was based on the Committee's perception that the risks associated with this modality had both a low probability of occurrence anf that the non-stochastic consequences of an error were negligible. It was, however, pointed out that this was not the case for many diagnostic quantities ofI-131 due to the significant probability for damage to the thyroid from a misadministration or medical event. Also, t-recognized was the potential for injury to the workers and public from the use ofI-131.
The potential for patient harm from misadministrations ofI-131 led to a discussion of how a (9 diagnostic procedure or isotope could be classified in terms of risk. While generally agreeing that V most diagnostic procedures should be classified as low risk, it was recognized that not all could be
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so classi6ed. It was generally agreed that the Committee wanted to avoid doing an isotope by
! isotope evaluation of risks ===~iatad with diagnostic nuclear medicine procedures. This led the 2 l proposal by the Committee to define the risk associated with a given diagnostic nuclear medicine L procedure as follows:
"Diagnoetic isotopes should be classified as low risk unless there is the potential for observable clinical injury to the whole body or an individual organ".
Disenss the Regulatory Use ofIndustn Standards Susanne Woods led the di-alaa on the regulatory use ofindustry standards. She indicated that item 7 of that SRM directed staff to consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they may meet NRC's needs. The Committee was asked to discun how to bring available industry guidance and standards into the regulatory framework, where they should be located, and how to keep the information current.
The Committee did not reach a consensus but actively explored a number of perspectives and issues associated with Item 7.
Dr. Siegel thought the partial answer was in the medical policy statement already, i.e., NRC will make a regulation where voluntary standards or compliance with voluntary standards are inadequate. He believed that it was not necessary to reference standards in the regulations, but rather look to see if the standard of care is being defined by the existence of those voluntary standards; then decide whether or not there's general compliance with those voluntary standard.
If this was the case, he believed a regulation was not needed.
Mr. Graham pointed out that each standard has a potential to be handled differently. For example, the potential ANSI classification of a sealed source that might be used in brachytherapy, might be put in the regulations as a minimum standard for the type of sealed source. On the other hand, AAPM guidance documents should be put in guidance so tnat the documents can be modified by an institution. He also pointed out a number of problems in using industry standards.
First, NRC will be lagging the industry practice as updates come out. Since an update has to be reevaluated and put in the Ecdcral Register to give people a chance to comment on it before it is adopted. heMiy, users of standards may not be wilhng to adopt revised standards although NRC has endorsed the revision. The community then continues to follow a document that is no longer accepted by NRC. Dr. Siegel pointed out an additional problem in that industry standards, in substantial part, were predicated on existing NRC requirements. He stated a concern that if regulations did r'ot exist, standards may not be developed. Dr. Flynn pointed out that some standards, while applicable to a medical use NRC regulates, really have very little to do with NRC.
Mr Swanson concluded that the Medical Policy Statement says NRC will regulate where
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} compliance and standards are inadequate. Ifinclusion in the regulatory guidance does not F constitute regulations, then by de6nition, NRC would have to put industry standards and guidance
! in the regulations. Others had concerns that documents meant to be flexible would become
- engraved in stone if they were incorporated in regulatory guides. Dr. Flynn recommended
- referencing the standards in regulatory guides and updating the
- guides annually, i
i Dr Williamson concluded that simply saying' standards of practice will be in the licensing guide
- j. for implementing a given regulation might not be appropriate. He indicated that it udght be better j to go through the various standards one by one and isolate the recommendations pennining to the j issue ofdirect concern. -
Discussion of Quality Management and Misadministrations
- Sally Merchant requested that the ACMUI identify the incidents, events, and occurrences that l should be reponed to the NRC Patient harm, including a dose to the wrong patient or wrong j treatment site, and the following possible failures were provided as potential reports.
! Mr. Swanson discussed his preference that medical events be reported to one organization, rather j than establishing reponing levels. He believed that this organization need not be the NRC. He j; ( also provided the following positions. Diagnostic events should be captured to (1) provide more l
( data and (2) identify poor therapeutic practices that are likely to accompany poor diagnostic practices. The reporting environment should not be punitive, in order to encourage reporting for i the purpose ofcause determination.
l Dr Swanson cited the USP medication errors reponing program of voluntary and, possibly, i anonymous reporting to FDA as an example of a reporting program. Dr. Swanson further i
commented that the nuclear medicine community does not appear to be following this standard well, and, as such, the Medical Policy Statement would need to suppon initiating requirements to
, participate in the USP program A peer group would identify the need to examine a site identified l for several events. Participation would be identified upon inspection.
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- Dr. Williamson agreed that all precursor events should be reponed, including near misses and
, irregularities. He emphasized that few radiation oncology events are likely to result from machine l failure. Dr. Nelp commented that diagnostic miMministration have a very low incidence. He
' believed that a tremendous amount of data would not be collected. _ He felt that the concept is punitive, and the determination has been made that there is no risk.
l Mr. Graham indicated the need to explicitly define, at a natioaal level, the cost-benefit for a j national tracking system. He preferred that the reporting and analysis be kept within the health
- care system. He believed that the system is large enough to collect a large amount of data and j small enough to analyze it, while changing the way care is delivered.
. Dr. Kang commented that the FDA Center for Device Evaluation receives all machine failure i
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l- reports. Mr. C-ar commented that NRC will need to avoid duplication ofFDA efforts.
1 i Mr. Godwin commented on several areas He indicated that the listing provided by FDA is a j data-base print-out with both time-line and organizational problems, and that an analysis is not provided to address generic failure, single event failure, or whether the community should be i alerted. He also diammaad the need to add." wrong pharmaceutical" to the reporting listing i provided by NRC, and the need to include listed items in Part 21 requirements. He introduced the FAA pilot-reporting system u demonstrating a non-punitive approach to reporting. ,
i- Mr. Williamson suggested that the term " medical event" be reserved for events with a high j probability of resulting in an adverse medical effect on the patient. This type of event should be
! distinguished from (1) " bookkeeping" errors, (2) treatment delivery errors without redical consequences, and (3) precursor events. Dr Stitt indicated that " medical event" appears to be a
, health care / patient related term.
i Mr, Camper emphasized that the definitions used are as important as the actual terms they define.
! Events such as software failures, machine failures, and leaking sources may be reported without j calling them misadministration. He indicated that reporting levels need to be defined for those i events that result in exposure to a patient. Dr. Nelp commented that the threshold would be high, ifbased on harm to the patient.
! Mr. Williamson commented that a case-by-case review would have to be made to isolate events
!- involving patients with significant risk of being harmed and establish reporting requirements. He
! referred to a definition of misadministration that he and Ms. Brown submitted to AS TRO and f ACR, which established a threshold overdose ofgreater than 20 percent, when the entire course
! of therapy (i.e., external beam and radioisotope therapy) is included. The lower threshold for
} wrong site was at least 2 Gy to a site that was not planned to be in the treatment field, or 10
! percent n' ore than the dose that would have been delivered via the planned treatment, whichever L was greater.
j Mr. Swanson commeated that the complexity of the current misadministration definition is a problem that is confusing when, in practice, it differs from state requirements for reporting events associated with accelerator-produced products.
t i The discussion was summarized by Mr. Graham as falling into two areas of thought: (1) a non-l threatening system that collects as much data as possible for identification of system or process
- issues / patterns to be corrected; and (2) a system of reporting only those things that clearly j represent probable damage to the patient.
j At this time the meeting ended and reconvened at 8:12 am Friday April 11,1997.
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States Report on Ralesnaking and Guidance
! Cathy Haney gave a status report on the following topics: patient release rule and guidance;
- NUREG-1569, Program Specific G#aar* for Medical Use Licenses; TI QM analysis; ANPR for
- Part 33; Carbon-14 petition for rulemaking; and a new petition from the University of Cincinnati
) Ma. Haney in<lir= tart that the patient release rule (10 CFR 35.75) becomes effective on 5/29/97, j and that the ==aar4=ed Ragulatory Guide would be available in about two weeks.
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[ She indicated that NUREG-1569 was due to be published in draft during the spring of 1997. This
! h-* was being issued for public comment and is not to be used in the preparation or review i of applications for medical use licenses I She provided a brief summary of the public comments received in response to the advanced notice
[ of proposed rulemaking (ANPR) on Part 33. This presentation resulted in the ACMUI bringing s the following motion to the table: "ACMUI recommends retention of the current regulatory
- . approach for (Part] 33." The vote was 9 for and 1 opposed. Dr. Williamson stated in opposition l that "[he does not] feel able to assess the rigidity and flexibility of the current process relative to j what might happen at this time."
i Ms. Haney indicated that revised inspection guidance on performing inspections of the quality l management (QM) rule has been provided to the regional staff. She indicated that a summary of
! the QM inspection procedures was provided to ACMUIin the briefing book The ACMUI l diam ==adt he nature of the QM immion procedures and brought the following motion to the l table: "[the ACMUI recommends that the NRC] modify the QM 'mspection procedures with the intent to reflect the spirit of the Commission direction in the SRM [regarding DSI 7]." The vote
- was 9 for the motion and I abstea. tic::. Judith Brown abstained because she was not familiar with
! all of the elements of the issur,. Dr. Wagner wished to go on the record stating that the QM rule j ss a regulation was unnew.ssary.
t l Cathy Haney introduced the subject of the carbon-14 petition which'was received in 1994. This
- prompted a discussion of the rulemaking process and the timeliness of the process The l rulemaking plan to resolve the petition will be forwarded to the EDO th:s month.
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! Ms. Haney informed the ACMU1 that the staff was reviewing a petition submitted by the University of Cincinnati This petition requested the the NRC amend 10 CFR 20.1301, " Dose
[ limits to individual members of the public," to authorize "specified visitors" of hospitalized i radiation therapy patients, as individual members of the public, to receive 500 mem. per year.
I Ms. Haney indicated that additional information on the resolution of this petition would be made i available at the next meeting of ACMUI.
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Preparation for the May 8 Commission Briefing The Committee members prepared for the Commission briefing on May 8 at 9 am. Dr Flyrm suggested that the Committee spend only 15 minutes on the Medical Policy Statement and the remaining 45 minutes addressing the 8 items of the SRM regarding DSI 7, Larry Camper requested that the Committee prepare their recommendations on the revision to Part 35 and submit them to the staff before the May 8 Commission Briefing. The Committee
- indicated that they would use telephone conferences to discuss issues associated with the revision
! of Part 35.
The meeting closed at 12:25 pm.
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