ML20248E682
| ML20248E682 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1998 |
| From: | Stitt J NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20248B825 | List: |
| References | |
| NACMUI, NUDOCS 9806030410 | |
| Download: ML20248E682 (20) | |
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MEMORANDUM TO:
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety, NMSS 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 I hereby certify that, to the best of my knowledge and belief, the attached minutes for the meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) held on March 1-2,1998, are an accurate record of the proceedings for that meeting.
r./s.A Judith Ahhe Stitt, M.D., Chairman
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Date
Attachment:
Minutes - ACMUI mtg.
March 1-2,1998 l
9906030410 990528 PDR ADVCM NACMUI PDR l
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SUMMARY
MINUTES ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES MARCH 1-2,1998 The Advisory Committee on the Medical Uses r.,f 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 Anorew Kang, M.D.
WiHiam 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 government perspectives; Robed 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 Regulatob Commission: Carl J. Paperiello, Director, Office of Nuclear Materials Safety and Safeguards (NMSS) and Cathy Haney, Chairman of the Part 35 Working Group, Section Leader in the Rulemaking and Guidance Branch, NMSS (Designated Federal Official for the Committee).
Ms. Cathy Haney officially opened the meeting at 8:00 a.m. with general comments on the meeting and the function of the ACMUI. Ms. Haney stated that she had reviewed the Committee members' financial and employment interests, and had not identified any conflict of interest with items to be considered during the meeting. Ms. Haney stated that any ACMUI member who becomes aware of a potential conflict of interest during the course of the meeting should so inform her or Chairman Stitt.
Carl J. Paperiello, Ph.D. welcomed the ACMUI members. Dr. Paperiello discussed the Commission's directive to revise Part 35 to incorporate a more risk informed, performance based approach to the regulation of radiation for medical use. Dr. Paperiello went on to state that a number of topics had generated a lot of comments, (e.g., training and experience, precursor events, and patient notification). Dr. Paperiello ended his remarks with his thanks to the ACMUI members for meeting on Sunday with the NRC staff.
PREVIOUS ACMUI RECOMMENDATIONS 1
l Ms. Haney gave a brief overview of staff actions regarding the recommendations made by the ACMUI at the April and September 1997 meetings.
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April 1997 Staff actions on the recommendations from the April 1997 meeting were discussed with the Committee at the September meeting. Only one recommendation had not been resolved at that l
time. In particular, ACMUI requested that the staff re-examine the quality management l
inspection procedures. Ms. Haney indicated that tne quality management inspection l
procedures would be reviewed pending completion of the Part 35 rulemaking efforts.
September 1997 1.
1979 Medical Policy Statement (MPS)
The ACMUI made specific recommendations regarding how the MPS should be revised.
l 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 alene 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 Group deleted the requirement for a stand alone QMP but, maintained requirements in the strawman rule that was placed on the INTERNET on January 30,1998, (hereafter referred to as strawman rule) for written directives, records of administration, and audits.
Ill. Radiation Safety Committee (RSC)
The ACMUI recommended that RSCs be required for 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 complete a specified number of hours of training, focusing on radiation safety, and pass an examination that verifies competency in radiation safety. The ACMUI agreed that the boards would not be listed by name in the rule. The staff incorporated this approach into the strawman rule.
V. Medical Physicist Training and Experience Requirements The ACMUI recommended that the training and experierice requirements for a medical physicist be patterned after the requirements for an authorized user, with one exception. The medical 2
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physicist should not be required to be a physician but, should be required to have a Master's of Science degr3e. 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 redaced from three categories to two: a) radiopharmaceuticals not requiring a written directive; and b) radiopharmaceuticals requiring a written directive. Ms. Haney explained that the requirements for reporting medical events were modified to require a dose threshold and modality specific requirements for reporting.
- 2. Precursor Events The 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 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 Groug 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 comment period, the Working Group plans to hold two facilitated public meetings, one on the west coast and one in the midwest. Ms. Haney stated that the final rule is on schedule for submittal to the Commission in May 1999.
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Mr. Swanson expressed his concem 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 concern. They offered examples, from their own experiences, 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 POLICY STATEMENT (MPS)
Ms. Haney described the purpose of the MPS. She indicated that a draft proposed MPS was placed on the INTERNET on January 30,1998, and discussed at the February 1997, ACMUI subcommittee meetings. She indicated that the proposed revision would be forwarded to the Commission in May. Staff would request Commission approval to publish t 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 high'ighted items from previous discussions on the MPS. In particular, he drew attention to the fol;owing 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 patients.
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 safety issue. "
Dr. Wagner stated that the MPS should reflect the answer to the following question: 'What radiation safety aspects of the patient does the NRC wish to regulate?" He also stated that the first three modified statements, as proposed by the ACMUI in September 1997, adequately addressed his concerns.
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.
l Paperiello discussed society's perception of the risks associated with radiation and how the NRC must respond tn that perception in its regulations. He indicated that the revision of Part 35 i
must address this perception yet, respond to the medical community's concern regarding overly l
prescriptive regulations.
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Chairman Stitt requested that the ACMUI reach consensus in a revised MPS.
Mr. Graham moved that the committee recommend the adoption 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 worker in the general public.
3.
NRC will regulate the radiation safety of patients only where justified by the risk to the patients and only where voluntary standards or compliance with these standards are inadequate.
4.
The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.
The motion was seconded. Dr. Wagner offered an amendment to include the second sentence from the recommendation made at the September 1997, ACMUI meeting into Statement 3
(" Assessment of the risks justifying such regulations will reference comparable risks and comparable voluntary standards and modes of regulation for other types of medical practice.").
A motion was made and seconded to discuss Dr. Wagner's amendment. Further discussion ensued among the members. Chairman Stitt called for a vote on the amendment and a vote on the motion. The vote for the amendment passed 9-0 in favor. Chairman Stitt then called the vote for the motion (reference following text). The motion passed 9-0 in favor.
[ Note, the following text differs from the motion made by Mr. Graham. In conversations between Chairman Stitt and Ms. Haney, following the ACMUI meeting, it became evident that the ACMUI did not intend to include Statement 4 because the concept had been incorpora'.ed into Statement 3. Statement 4 was deleted.)
ACMUI Recommended MPS:
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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 affecting patients except as necessary to provide for the radiation safety of workers in the general public.
3.
The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable voluntary standards and modes of regulation for other types of medical practice.
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TRAINING AND EXPERIENCE Ms. Haney introduced the topic of training and experience by providing the ACMUI with a brief synopsis of the training and experience criteria for authorized users, authorized nuclear pharmacists, medical physicists and radiation safety officers as it appeared in the draft proposed rule (Attachment 2). Ms. Haney indicated that, on the basis of the public input, the Working Group was proposing the following general criteria for these individuals: individuals should complete a structured educational program that consists of didactic training and practical experience; reference to speciality boards, by name, should be deleted; preceptors, when required, should certify that individuals have achieved a level of competency sufficient in function independently; and individuals should demonstrate sufficient knowledge in radittion safety by passing an examination given by an organization or entity approved by the
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1 Commission or an Agreement State. She also indicated that the term " structured educational program" replaced the phrase " classroom and laboratory training," as used in the strawman rule.
Section 35.400. "Use of sources for manual brachytheraov." and 635 600. "Use of sealed sources in a device for therapeutic medical uses" Ms. Haney indicated that there were several individuals present in the audience, who had l
expressed a desire to formally present their views on the training and experience requirements in Part 35, to the ACMUI. The presenters were: 1) Peter Blitzer, M.D., President-elect of the American College of Radiation Oncology; 2) William Bloomer, M.D., Chairman of the Public Policy and Law Committee of the American College of Radiation Oncology, tenured professor of radiology at the Northwestern University 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 Chancellors of the American College of Radiation Oncology, Director of Radiation Therapy for the Louisiana State University Medical Center and consultant for the International Atomic Energy Agency of the United Nations; 4) James Marks, M.D., a practicing radiation oncologist from St. Louis; 5) Frank Wilson, Professor and Chairman of Radiation Oncology at the Medical College of Wisconsin; 6) Larry Holder, M.D., a practicing nuclear medicine physicien 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 n, embers followec the formal presentations.
The ACMUI members debated the various issues surrounding the training requirements. The discussion focused on whether it was possible, or prudent, to separate the hours required for radiation safety training from clinical training. In addition, the issue of practitioners of non-radiological specialties becoming authorized users was discussed at length. Chairman Stitt suggested that the ACMUI try to come to a consensus on those training and experience issues that were important to the ACMUI.
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Dr. Williamson proposed a motion to retain, as is, the training and experience for $@ 35.400 and 35.600 (e.g., retain the 3-year clinical training experience in an accredited program as an alternative to board certification). It was believed tnat radiation safety handling experience could not be separated from clinical experience and that current requirements are needed to provide 6
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assurance that authorized users have adequate training and experience to handle material safely. Chairman Stitt, after some additional discussicn, called for a vote. Mr. Graham offered an amendment to the motion to retain the requirement from the strawman rule for a written exam to verify competency. The motion was seconded. Chairman Stitt called for a vote on the amendment and the motion. The amendment carried 9-0 in favor. The motion carried 9-0 in favor.
Section 35.100. "Use of unsealed byproduct material for uptake. dilution. and excretion studies" Section 35.200. "Use of unsealed bvoreduct material for imaoina and localization studies for which a written directive is not reauired." and Section 35.300. "Use of unsealed svoroduct material for therapeutic administration" Chairman Stitt directed the discussion to the ireining and experience requirements for authorized users of byproduct material used pursuant to @@ 35.100,35.200 and 35.300. The members debated the issues of relative risk levels for these uses. In particular, they focused on 35.300, because it addresses the use of radionuclides for therapy. This use poses greater risk than diagnostic use of radionuclides ( $ 35.100 and 35.200). Dr. Alazraki commented that she thought the use of iodine-131 for therapy should require the same training and experience as materiallisted in @h35.400 and 35.600, since the radiation risks are similar. Dr. Flynn stated he thought that radionuclides with the potential for bone marrow suppression should be treated the same as those radionuclides used pursuant to @@ 35.400 and 35.600.
Mr. Graham proposed a motion to accept the training and experience criteria for users of materialin @@ 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 when administering therapeutic quantities of radionuclides. Chairman Stitt commented that she did not believe that the discussions were heading in a direction where the ACMUI would reach a resolution, therefore, she called for a vote. Mr. Graham suggested that there be separate votes on training and experience requirements for each of the rule sections. Mr. Graham withdrew his original motion and put forth the following one:
. the ACMUI is recommending the acceptance of strawman language or training for @ 35.100."
Dr. Nelp seconded. ine motion passed 9-0 in favor.
Mr. Graham moved that:
the ACMUI recommend the strawman language regarding training for @ 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 @ 35.300." The motion was defeated 5 opposed,4 in favor.
The subject of training and exprience for authorized users of byproduct material used pursuant to @ 35.100,35.200, and 35.300 was discussed again on March 2,1998. For contmuity, that discussion is summarized here.
Chairman Stitt asked Dr. Alazrakiif she would surnmarize the professional societies' views on training and experience for authorized users as presented in letters to the Commission staff (copies provided in Attachment 3). Dr. Alazraki summarized the comments received from three 7
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 Counci! 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.
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.
Preliminary safety and isotope handling, field experience and education should be required prior to the exam. The training and experience should be no less than 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of classroom laboratory training and 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> of supervised practical experience or a 3-month training program in nuclear medicine. This field experience should be obtained only in an ACGME-approved training program in an ACGME-approved medicalinstitution. Entrepreneurial weekend courses should not be permitted as substitutes.
4.
Physicians, including those who are certined by ABNM or ABR, should be required to document at least 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> of nuclear medicine CME (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 i
component has to be described for those physicians who are not certified. The SNM suggests that competence in nuclear science be demonstrated in a performance based manner. The SNM does not believe a number of hours can be associated with this education. They agree that an exam should be used to assess competence in nuclear science.
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Dr. Alazraki went on to state that the ACMUI should consider adopting the ACR recommendations for training and experience criteria for authorized users. In a further discussion, Dr. Cerqueira stated that he strongly believes, the training and experience criteria for authorized users in these sections, as described in the draft proposed rule, should be supported. Dr. Flynn stated his disagreement in terms of the training and experience criteria for authorized users of byproduct material used pursuant to @ 35.300. The members discussed 'he 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 Trainina 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. Nelp. 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 concemed 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 training was commensurate with the types of uses listed on the license. Mr. Swanson requested confirmation that an individual's credentials would be examined by the NRC or Agreement State, prior to being listed on the license. Ms. Haney confirmed this. Chairman Stitt called for a vote to accept the training and experience requirements as presented in the draft proposed rule for the RSO. The motion carried 9-0 in favor.
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Nuclear Cardioloav Trainina l
Ms. Haney requested ACMUI's recommendation for training and experience requirements for cardiologists who wish to use intravascular brachytherapy sources. Dr. Cerqueira indicated that l
most procedures are being performed with strontium-90 or iridium-192.
I 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 i
year of specialized training in interventional cardiology focusing on the use of the intravascular j
brachytherapy sources. Dr. Cerqueira stated that this type of therapy would be done at select i
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 thic 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 g 35.33). Ms
,ney informed the ACMUl that the staff plans to request guidance from the Commission on wt should be notified following a medical event. She indicated that the Working Group had iaentified 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 medicai 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 l
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 l
seconded. After some additional discussion, the motion was voted on and carried 8 in favor, 1 abstention.
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r REPORTABLE EVENTS Medical Events Ms. Haney reviewed the draft proposed rule language and asked for comments. The members i
discussed the rule language [in 35.3045), but did not offer any formal recommendations. One member suggested that staff make it clear in the rule that a medical event is an avoidable technical error. It was also suggested that NRC clarify that the 50 rem threshold, stated in the draft proposed rule, applies only in the case where an unintended dose to an organ exceeds the anticipated dose by 50 rem. Finaily, it was suggested that NRC consider a separate dose l
threshold for wrong treatment site.
I 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 alternative 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 nardware 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 needeJ 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 ACMUl 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 hr.s implications for facilities outside of the licensees' facility (operating procedure).
l 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 l
precursor events.
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RADIATION SAFUTY 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 i
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
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10 CFR Part 20. Duties that were not addressed in other rules were incorporated into the proposed @ 35.24, " Authority and responsibilities for the radiation protection program."
The members discussed the merits of having an RSC; many of the members believed that large institutions would still retain an RSC in spite of the rule change. Mr. Graham stated that in his opinion, the proposed rule would not prohibit a large organization from continuing to use RSCs and would benefit the small rural hospitals where an RSC is not needed. Dr. Cerqueira stated that the proposed rule would allow smaller facilities to opcste under the direction of an RSO and still allow the larger institutions to have an RSC.
e Mr. Swanson moved that the ACMUI accept the wording in 35.24, as written, with one change
- the word " licensee" should be replaced with the phrase " licensee's management." The motion was seconded. Mr. Graham stated that the only place where this change should take place is in 6 35.24(c). The word " licensee"is appropriate for paragraphs (d), (e) and (f). The motion was carried 9-0 in favor.
STRONTlUM 90 (Sr-90) EYE APPLICATOR CALIBRATION Robert Ayres, an NRC staff member, discussed the number of misadministration that have been taking olace due to improperly calibrated Sr-90 eye applicators. Dr. Ayres reminded the ACMUI that this issue had been brought to their atte ntion during a meeting in November 1993.
At that time, the ACMUI recommended that the NRC issue in an information Notice (IN), alerting 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 additioncl 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 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.
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.
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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 Opt lon 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 issuing an IN that discussed the importance of decaying the sources. Further discussion resulted in Dr. Williamson amending his motion. The amendment recommended the adoption of Options 3 and 5. The motion passed with 9-0 in favor.
QUALITY MANAGEMENT PROGRAM Ms. Haney stated that the Commission had directed the staff to reevaluate and revise the QMP requirements (current @ 30.32, " Quality Management Program") to focus on those requirements that are essential for patient safety, e.g., confirming patient identity, requiring written prescriptions, and verifying dose. The Working Group developed rule language which addressed these three items (reference draft proposed rule @@ 35.40 " Written directives" and 35.41 " Procedures for administrations requiring a written directive").
Dr. Williamson sugges'ed that the proposed @ 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 <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of a given directive, was too restricuve and suggested that the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> be changed to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />. Ms. Haney acknowledged Dr. Williamson's suggestion.
The issue of what parameters should be listed in a stereotactic radiosurgery written directive
(@ 35.40) was discussed. Dr. Williamson stated that the requirements in the draft proposed rule were too prescriptive. Ms. Haney stated that the Working Group will contact AAPM for input as to what should be included in the requirement for the gamma stereotactic radiosurgery written directive. Chairman Stitt agreed with this approach. She believed that there should be consistency between modalities.
Mr. Swanson commented on Footnote 1 to the proposed 35.40 that references " patient record." Mr. Swanson stated that he wasn't sure what constituted a " patient's record" as it could refer to a number of different things. He suggested that the words " patient's record" be deleted from wherever it currently appears in Footnote 1. Ms. Haney said she would look into the reasons that " patient's record" was included in the current rule and would determine if the words were still required.
Ms. Haney asked ACMUt members to list the requirements that they believed should be included in 35.41. Dr. Williamson indicated that the proposed rule should contain a l
requirement for verifying treatment time calculations and for verifying that programming parameters are consistent with the written prescriptions, treatment time calculations, and/or i
plans of treatment.
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Dr. Williamson stated that important elements, for pmviding high confidence that the prescription l
is implemented as written, should be listed in S 35.41, in general terms instead of making a de facto requirement in the regulatory guide. Ms. Haney responded that the Working Group had discussed this, and had determined that 9 35.41 should be revised to list the minimum
)
requirements for a program that would provide high confidence that the prescription was I
implemented as written.
DISCUSSION OF STAFF REQUIREMENT MEMORANDUM (SRM)
Torre Taylor, an NRC staff member, presented the contents of two Staff Requirement Memorandi issued by the Commission. The first SRM, dated June 5,1997, and addressed to Chairman Stitt, requested that the ACMUl 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 notion 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 ACMUI prior to making recommendations on the revision to Part 35 to staff. The motion carried,9-0, in favor.
The second SRM, [COMSECY-96-028), requested that all advisory committees to the NRC develop self-evaluation criteria, under which the advisory committee would be reviewed 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 ACMUl 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 l
Dr. Williamson announced his resignation from the /sCMUI. 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 government employee" therefore, he cannot accept any financial compensation from foreign public universities.
Ms. Haney described the procedures for filling vacancies on the ACMUI as well as the reappointment procedures. Ms. Haney also discussed the Commission directive (SRM-SECY-97-143) to consider the appointment of an individual, to the ACMUI with the perspective of a RSO from a large institution. Ms. Haney asked the members views on appointing an RSO to the ACMUI. Ms. 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 recommended that the process to fill a vacancy be started at least 18 months ahead of the anticipated vacancy. This should be done so the vacancy 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.
I 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 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 that the proposed rule would contain the appropriate units.
I Section 35.62. " Possession. use. calibration. and check of instruments to measure dosacas of alpha-or beta-emittino 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.
I 3.
What to do about sources where no primary standard exists at all?
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i that there should not be a requirement to instruct visitors and that they did not believe this was an informed consent issue.
Section 35.404. " Radiation surveys" Ms. Haney indicated that the Working Group had deleted the requirement in the current q
@ 35.404(b) which stated that "a licensee may not release from confinement for medical care a i
patient or a human research subject treated by temporary implant until all sources have been removed." The Working Group believed that this requirement was unnecessary in light of the provisions in @@ 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 confined in the hospital when their medical condition did not warrant hospitalization.
Section 35.406. "Brachytheraov sources inventory"
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Mr. Swanson directed the members' attention to 9 35.406 and commented that he thought Paragraph (b) was very prescriptive and unnecessary. Ms. Haney explained that the staff thought it was important to assure that, once the brachytherapy sources were removed, the sources were returned to storage. Chairman Stitt commented that the draft proposed rule allows for flexibility but still provides for source accountability.
Section 35 415. " Safety precautions" 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 use, 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 c.nange. 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.
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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-1037 Dr. Williamson suggested that the rule could read: "Where there exists an appropriate primary standard, then the user's calibration technique should be traceable to that." He also stated that for photon-emitting sources, AAPM guidance suggests that, at a minimum, a constancy check be developed to assure that the vendor's calibration does not drift from the calibration factor used by the licensee.
Section 35.67. " Authorization for calibration and reference sources" Ms. Haney explained that the Working Group is considering raising the possession limit for calibration sources to give the licensees more flexibility. The Group does not, however, want to put the licensee in a position where they would be required to have financial assurcnce.
j Ms. Haney asked the ACMUI if the possession limits listed in the draft proposed rule addressed licensee needs. The members had a brief discussion of this issue but no resolution was reached.
Section 35.292. "Trainina for imaaina and localization studies" Ms. Haney requested the ACMUl's opinion on whether the authorized user should have experience with preparing reagent kits. Dr. Wagner commented that he did not believe it was necessary.
Section 35A00. "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. Williamson stated that he 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.
Section 35.315. " Safety precautions" 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 Q 35.75, to receive a dose of 0.5 rem ( 35.315(a)(4)). Ms. Haney stated that this section was written to address the University of Cincinnati petition that would allow visitors of inpatients to receive a dose of up to 500 millirem. The Working Group believes that this issue may be addressed by the proposed revision to S 20.1301 and planned to review this section in detail after the ACMUI meeting.
Ms. Haney asked, if the requirement were to remain in @ 35.315, should a licensee be required to instruct the vis; tors 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 1
r e
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Section 35.657. "Theraov-related computer systems"
]
Ms. Haney asked Dr. Williamson how he would comply with the requirements in the proposed
@ 35.657. This section requires that a licensee assure that the computerized operating system I
and treatment planning system associated with the therapy device are operating appropriately.
l It also requires acceptance testing on treatment planning systems. Dr. Williamson commented I
that the word " assure" should be replaced with " verify" Dr. Williamson stated: ".. by doing some tests you can, at most, confirm the operation of a system under certain laboratory circumstances. You cannot guarantee, no matter how much quality assurance you do, that it'll function perfectly under all circumstances." Dr. Flynn indicated that it is extremely important to perform these tests since errors or malfunctions in these systems could result in hundreds of medical events prior to the discovery of a problem.
Section 35.615. " Safety precautions for remote afterloaders. teletheraov units. and aamma stereotactic radiosurgery units" Ms. Haney asked that 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 I
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 and an authorized user should be on-call.
2.
For HDR, a physicist and physician, designated by the authorized user, to remove the applicators on an emergent basis, should be physically present.
3.
For PDR, an authorized user and physicist should be present to initiate treatment, and l
an individual, trained to execute emergency procedures should be on-site during the whole treatment.
Section 35.6C3. " Installation. n.aintenance. 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 j
direction of a medical physicist." Members believed the suggested language was adequate.
Appendix A to 10 CFR 35 "Examinina Organization or Entity" 18 L
Mr. Swanson commented on Appendix A, specifically, items 5 and 7. He said that item 5 and the last clause of item 7, which reads: "and any sanctions imposed against examined individuals," should be deleted Ms. Haney agreed to delete the last clause of item 7 and to revise the language 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-emittina radionuclides" and Section 35.62. " Possession. use. calibration. and checkaf instruments to measure dosaaes of aloha-or beta-emittina radionuclides" Mr. Swanson suggested that the Working Group contact dose calibrator manufacturers to identify the quality control tests that should be routinely performed. Dr. Wagner stated that it is important to determine what the instrument is being used to assay prior to establishing testing criteria. He indicated that there would be different criteria for each type of use.
Dr. Wagner wanted to confirm that a licensee did not have to assay unit doses and that a licensee could determine the dosage for a unit oose by mathematically decaying the activity provided by the manufacturer or preparer licensed pursuant to S 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 cautior,ed that the information should be provided in a manner that would not result in personnel refusing to care for the patient because of undue fear of radiation. Dr. Flynn stated that, in his experience, nurses have received just enough training to scare them but not enough training for them to be able to integrate nursing care with good radiation safety practices. Ms. Haney stated that she will look for the material that Dr. Flynn described and incorporate these items into the NUREG.
The meeting was adjourned at 4:14pm on March 2,1998.
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