ML20203C769

Submits Certification of Minutes of 970925-26 Meeting of Advisory Committee on Medical Uses of Isotopes

ML20203C769
Person / Time
Issue date:	11/04/1997
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
ML20203A565	List: ML20203A562 ML20203C769
References
NACMUI, NUDOCS 9712150419
Download: ML20203C769 (18)

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%, * . . . . p MrMORANDUM TO: Donald A. Cool, Director Division of industrial and Medical Nuclear Safety, NMSS FROM: Judith Anne Stitt, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes

SUBJECT:

CERTIFICATION OF THE MINUTES OF THE 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 September 25-26,1997, are an accurate record of the proceedings for that meeting.

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, U'/ M AIM (c k '41 Judith Anne Stitt, M.D., Chairman

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Attachment:

Minutes - ACMUI mtg.

09/25-26/97

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9712150419 971209 PDR ADVCM NACMUI PDR

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MEMORANDUM TO: Donald A. Cool, Director Division of Industrial and Medical !<uclear Safety, NMSS FROM*. Judith Anne Stitt, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes

SUBJECT:

CERTIFICATION OF THE MINUTES OF THE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES I hereby certify that, to tne 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 September 25-26,1997, are an accurate record of the proceedings for that meeting

/s/

Judith Anne Stitt, M.D., Cnairman 11/4/97 Date

Attachment:

Minutes - ACMUI mtg. -

09/25-26/97 Document Name: A:\ minutes.997 Distribution:

IMNS Central Files NRC File Center IMAB r/f SFonner, OGC SBuchan, IG RRaspa, IG HKaragiannis, AEOD ACMUI members C = Cover E= Cover & Enclosure ' N = No Copy 9

OFFICE IMAB '

ACMUI _j NAME PVacherton JAStitt - JM _ __]

DATE l

,s.

SUMMARY

MINUTES ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES SEPTEMBER 25-26,1997 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a rneeting on September 25 26,1997. A briefing book with background information for the issues under discussion was provided to the ACMul 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)

Danici F. Flynn, M.D. John Graham Andrew Kang, M.D William B. Nelp, M.D Dennis P. Swanson, M.S., B.C.N,P. Louis K. Wagner, Ph.D Theresa Walkup, C.M.D. Jeffrey F. Williamson, Ph.D.

2 invited guests: Manuel Cerqueira, M.D. representing cardiology perspectives; Ruth McBurney from the State of Texas, representing State perspectives; Cathy Ribaudo, representing the perspective of radiation safety concerns from a radiation safety office of a large institution; James R. Anderson, Chapter Chairman, US-TGO, a cancer survivor support group, representing patients rights perspectives.

Also present were staff members from the Nuclear Regulatory Commission: Cathy Haney, Section Leader, Medical and Academic Section, and Chairman of the c art 35 Working Group (Designated Federal Official for the Committee); Donald A. Cool, Ph.D., D, rector, Division of Industrial and Medical Nuclear Safety, NRC; and Barry Seigel, M.D , consultant to the Part 35 Working Group.

The Office of the General Counsel provided a briefing on ethics for NRC special employees.

The session was closed to the public to prevent u.e invasion of personal privacy of the members.

Ms. Cathy Haney officially opened the meeting at 8:30 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 ACMUl member who becomes aware of a potential conflict of interest during the course of the meeting should so inform her or Dr. Stitt.

Donald A. Cool, Ph.D., made opening remarks to the Committee. Dr. Cool discussed the Commission's direction to have the final rule (for Part 35) completed no later than June 1999.

Dr. Cool then discussed the tasks, and the schedule of those tasks, which must be completed in order to meet the Commission directive of a final rule by June,1999.

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- ACMUI Minutes 2 September 25 26,1997 ,

Dr. Stitt questioned Dr. Cool as to how he would like the Committee to proceed with the review of the siternatives for rule language in the next two days. Dr. Cool responded that, to the extent possible, he would like the Committee to give the NRC a consensus view of the option the Committee regarded as the best approach for the crosscutting issues that were planned to be discussed during the meeting.

PREVIOUS ACMUI RECOMMENDATION 3 Ms. Haney outlined the three previous recommendations the ACMUI had put forth during the Spring 1997 meeting. The first recommendations dealt with the revision to the medical policy statement. The ACMUI proposed certain wording to the NRC during the spring meeting. The part' 35 Working Group incorporated the ACMUI recommendations for revising the Policy Statement as one of the alternatives for the revision of the Medical Policy Statement.

Ms, Haney stated that Diane Flack would be going into this item in more detail ir, her presentation.

The second ACMUI recommendation was that the NRC would continue the current regulatory approach for Part 33 regarding the need for rulemaking. Ms. Haney indicated that the staff is in the process of preparing a Commission Paper that will address the rulemaking. ACMUI recommendations will be presented in the paper.

The third recommendation dealt with modifying the quality management inspection procedures At this time, no action has been taken to make those modifications. An update will be presented to the ACMUI at the next meeting Mr. Swanson inquired as to the status of the ACMUI comments on draft Regulatory Guide 8.39

" Release of Patients Administered Radioactive Material," and stated that he had not seen any response to the comments made by the ACMUI Mt. Haney stated that the final guide was issued in March. The guide contained significant revisions. Ms. Haney provided the Committee with a copy of a " note to file" that indicated how the ACMUI comments were addressed.

Mr. Swanson agreed to go through the document and bring any cuestions to Ms. Haney for further discussion.

EVALUATION OF COMMITTEE AND COMMITTEE MEMBERSHIP in SECY Paper 97-143, " Advisory Committee on the Medical Uses of isotopee, Re-Appointment of Members," the NRC staff requested reappointment of certain members. Tne Commission, in Staff Requirements Memo (SRM) dated August 1,1997, in response to SECY 97-143, approved the reappointments. The Commission also requested more lead time for review of reappointment requests and, for future reappointment requests, asked that staff provide sufficient information, in the form of brief performance evaluations, to permit the Commission to make an informed decision with regard to reappointmet.1 requests.

The Commission also requested that staff consider zppointing a radiation safety officer, with health physics experience, to the ACMUI at the next earliest opportunity so as to include RSO involvement in Part 35 discussions. In addition, once Part 35 is issued in fina! form, the

ACMUI Minutes 3 September 250,1997 I

Commission requested that staff, in consultation with the ACMUI, re-evaluate the composition of tne ACMUI to determine if changes are needed to meet the needs of the agency.

Ms. Haney indicated that staff verbally requested that the Health Physics Socbty (HPS) provide an individual who could address radiation safety officer interests at this meeting. The HPS was ,

abla to have such an individualin attendance at this meeting. In addition, Ms. Haney indicated l that NRC would formally request that the HPS provide an individual for future meetings until staff l has formally evaluated the request to seat a radiation safety officer permanently on the ACMUI.

Ms. Haney stated that the due date for the evaluation of the Committee composition is in the year 2000 and just wanted to note it for the ACMUI considerations during the next two years.

Ms. Haney went on to discuss SRM dated August 21,1996, regarding COMSECY-96-028,

Strategic Assessment issue Paper: Independent Oversight (DSI 19)," which instructed the staff to reexamine the role of the ACMUI following the determination of the NRC's role in the materials medical prog.am area. The staff plans to address this issue in a Commission Paper that is scheduled to be completed in December. Ms Haney requested any preliminary thoughts that the ACMUl might have on this issue for inclusion in the Commission Paper. After some discussion, Mr. Graham made the following motion:

"The ACMUI has an important role to play in any activities of the Nuclear Regulatory Comm:ssion which relate to regulation of radiation safety and extensions thereof in the medical community."

The motion was seconded by Dr. Nelp and discussion continued. A vote was taken and the motion pasted with no opposition..

Ms. Haney discussed SRM, dated June 5,1997, " Meeting with Advisory Committee on the Medical Uses of Isotopes," (Attachment A) in which the Commission directed four questions to the ACMUI. Ms. Haney briefly discussed the questions, ti,en directed the Committee's attsntion to the three specific items under Question 1 pertaining to industry standards. In addition, Ms.

Haney presented the issue of implementing a more positive enforcement program and the metrics to be used to decide whether the approach is working.

The Committee focused the discussion on the questions regarding industry standcig. The merits of adopting standards voluntarily adhered to by the various professional societies as regulatory requirements were discussed at some length. The discussion ended with a statement made by Mr. Graham: 'The fundamental role of this Committee is to continue to remind the NRC that there's a practice of medicine, that there are voluntary standards and groups that review those standards that have developed a state of practice of medicine that is higher than any other country in the world, and that there has to be an overriding concem about

the risk to the patient, worker, and public safety before any regulation is promulgated."

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ACMUI Minutes 4 September 25-26,1997 UPDATE ON THE REVISION OF 10 CrA PART 35 PROJECT AND ASSOCIATED ACTIVITIES Ms. Haney briefed the ACMUI on the schedule for the Pact 35 Working Group. Ms. Haney discussed the vanous tasks the group had already completed, such as deyeloping the Working Group charter, developing a draft outline for Part 35, formulating a tentative structure for the rule, and the developmont of several rule alternatives for review and ccmment.

Ms. Haney discussed the various ways the NRC was soliciting public input on the various rule attematives. 'hese methods include input from professional societies, public meetings, and posting via INTERNET where chat rooms have been set up to collect comments. The Working Group plans to meet in December 1997 to develop the proposed rule language. The Working Group will be working towards the Commission's direction to have the final rule ready for publication in Spring 1999.

Dr. Flynn asked about how the Part 35 Revision Writing / Working Group was handling the development of the eight Part 35 modality sections. Ms. Haney responded that one individual from the Working Group is responsible for each modality and that a similar breakdown of responsibility ;s anticipated for the corresponding guidance development.

M.. Swanson referred back to Question 2 from the SRM dated June 5,1997, that was discussed before the morning break, which asked the ACMUI for its thoughts on the transition steps to implement a more positive enforcement nrogram. Mr. Swanson indicated that the ACMUI believes that a more positive enforcement program is a critical part of the whole process of revising Part 35. Ms. Haney responded oy indicating that the Part 35 Work;og Group plans to review the enforcement policy and will discuss enforcement issues associated with Part 35 at future meetings.

Dr. Kang asked to be recognized so that he could provide information to the Committee on a possible structure for Part 35. Dr. Stitt asked that Dr. Kang pass out his har4d-outs rather than formally presenting the material to the Committee because of time constraints.

1979 MEDICAL POLICY STATEMENT Diane Flack presented an overview of four proposed options for revising the Medical Policy Statement. This was followed by Chairman Stitt emphasizing the Committee's view that "The Medical Policy Statement was of utmost importance and that everything else that the Committee did followed from the Medical Policy Statement "

• Discussion began with a proposal / motion by Dr. Williamsen to drop consioeration of Option 4, which was seconded by Dr. Flynn. After a short discussion of the problems with Option 4, the Committee focused on Option 2, which was their preferred option. There was a lengthy discussion of assessing risk in medical procedures with emphasis on determining the risks of various radiation medical procedures relative to those of other medical procedures. This discussion centered around Statement 2 in Option 2, partbularly the advisability of assessment of risk in other areas of medicine by NRC.

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ACMUI Minutes 5 September 25-26,1997 The issue that implementation of Statements 2 and 3 in Option 2 were presented as a " Con" was discussed by the Committes. Several comments were made that Statement 3 was of overriding importance and, as long as this poh ;y was adher d to, there would be no conflicts. This discussion culminated with a motion by Dr. Gruham to switch the positions of Statements 2 and 3 in Option 2. This motion was seconded by Dr. Wagner.

During the discussion of this motion, an additional motion was made by Mr. Swanson to insert the words

• voluntary standards and" between ' comparable

• and " modes' in the second sentence of Statement 2 (proposed Statement 3) of Option 2. Although this proposed amendment was never seconded, Chairman Stitt called for a vote on the motion which was approved.

Chairman Stitt then called for a vote on the original motion for reversing the order of Statement 2 and 3 in Option 2. This motion was approved.

The ACMul recommended that Option 2 be revised as follows:

1. No change

2. The NRC will not intrude into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.

3. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, ana 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.

R2quirements for a Quality Management Program Sam Jones presented the four alternatives for language for the Quality Management Program (QMP) developed by the Part 35 Working and Steering Groups (Attachment B).

Ms. Haney noted that the SRM (COMSECY 96-057) on the Ma'erials/Me ;ical Oversight (DSl 7) stated that the QMP provision should be re-evaluated and revised to focus on those requirements that are essential for patient safety, e g, confirming patient identity, requiring wntten presenptions, and verifying dose. She indicated that elimination of the QMP in Part 35 is not an option due to the Commission direction. She also pointed out that there are five key items that should be mnsidered in evaluating the attematives for the QMP: (1) establishing and maintaining a OMP. T) performing audits and recording results; (3) retaining written directives and records of adm#nsteed doses; (4) subraitting OMP modifications to NRC; and (5) maintaining recordable events. Since the SRM stated that the OMP should be re-evaluated and revised, but not deleted, key item 1, " establish and maintain QMP,* is common ta all of the options. Dr. Stitt noted that there was no choice but for medicallicensees to continue to establish and maintain QMPs, and the ACMUI agreed with that dae- n

ACMUI Minutes 6 September 25 26,1997 Discussion followed on the purpose of the OMP and whether QMP was the correct term for the purpose. Dr. Williamson desenbed the purpose as regulating the accuracy of the tre0tment delivery of the physician's prescription. Ms. Haney said that there would be flexibility to change the name during the rulemaking to more accurately reflect the purpose of the OMP. Chairman Stitt noted that the OMP, as used in Part 35, is not a OMP in the business sense, sind said that when a namo change is considered, the name should be appropriate to the purposs of the term.

There was extensive discussion on key item 2

• performing audits and recording results."

Mr. Swanson felt that there did not need to be a regulatory requirement for audits. Most facil: ties have standard policies and procedures that result in events being reported to a radiation safety officer. Dr. Williamson said that his experience with audits has not turned up any incidents of clinical significance, and that audits are not the primary mechanism by which eirors are caught. He further stated that the way one avoids errors and detects them is by having a designed, prospectively designed and executed treatment delivery process with a let of checks along the way that monitor the diffarent actions that happen; not by retrospectively going over paperwork. Ms. McBurney noted that, coming from an Agreement State that has not implemented the QMP rule, her State felt that the QMP is a regulatory burden on the agency itself, as well as a regulatory burden on the licensees. Dr. Siegel noted that the requirement for audits was included in the onginal QM rule because it was believed that licensees would detect precursor events and would self correct them before they turned into real problems He noted that expenence has shown that these audits are not an effective mechanism for finding precursor events Mr. Swanson made a motion that the quality management rule not include an audit requirement. The motion was seconded by Dr. Wagner. The motion was carried, allin favor. Dr Flynn noted that this did not mean that a licensee cannot have a voluntary audit, just that there is no need for a regulatory requirement for audits.

The next item discussed was the requirement for key item 3, " retain written directives and records of administered doses." Dr. Siegel no:ed that the problems that led to the original QM Rule were a result of oralinstructions that were misunderstood. There was general agreement among the ACMUI members on the importance of having written directives. However, there was a lengthy discussion on whether there needs to be a Federal requirement to keep written directives and treatment records in an inspectable and auditable form and, in particular, whether such a requirement is conducive to the protection of the patient. It was noted by ceveral members that retention of patients' records is part of the standard practice of medicine. In addition, there are legal requirements for retention of medical records. After discussion of several motions and amendments, Mr. Graham moved that: "The ACMUI recommends the requirement of wntten directives and written records of administration.'

Dr. Williamson seconded the motion. Additional discussion followed on the need for a Federal regulation for retention of treatment records. A vote was taken on the motion and approved with none opposed. Mr. Swanson moved that the Committee say "the retention of written records does not need to be addressed in the Part 35 regulation." Mr. Graham seconded the motion. A vote was taken and epproved with none opposed.

There was essentia!!y no discussion on key item 4, ' submit QMP modifications to NRC."

Mr. Graham moved that the ACMUI recommend: "a licensee is not required to submit OMP l

ACMUl Minutes 7 September 25 26,1997 modifications to the NRC." Dr. Wagner seconded the motion, and the motion was approved with none opposed.

Chairman Stitt said thi Jiscussion of the requirement to " maintain recordable events"(key item 5), would be postponed until the next day when recordable events would be discussed in detail. However, some discussion on this issue followed. Dr. Seigel suggested that some minimal record retention requirement provides the NRC with a certain level of comfort and an insurance policy for the licensees that they do not have to open all their records for NRC review.

If specific records are not keot for NRC to do its job, then licensees may hme to make medical records available to NRC, so that it can understand the problem and determine whether corrective action is necessary. Mr. Swanson suggested that the concern about maintaining recordable events could be addressed if option two, item number 4, was modified to state that any intended deviation from the written directive is identified,Aocumented, evaluated, and that appropriate action is taken. This approach woule allow for documentation of a recordable event, out would not require a rule that specifically addressed maintaining records of recordable events. The members decided not to continue with any motions before they had the benefit of the discussion of recordable events the next day.

ACMUI next discussed which alternative the Committee found acceptable. Ms. Haney commented that it appeared from the ongoing discussion that the Committee favored Alternative

2. Ms. Haney described the differencc between the draft language and the current rule. Mr.

Swanson noted that Alternative 4 was a better approach than the current rule because it allows flexibility for new technologies and is a lot less confusing than t ying to remember modahty.

specific criteria for written directives. He restated his earlier recommendation that paragraph (a)(4) be changed to state that any unintended deviation from the written directive is identified, documented, and evaluated, and that appropriate action is taken. Discussion followed on the issue of whether " identification" really is implying the need for an audit, and whether audits protect / promote patient safety. In addition, it was noted that Federal regulation may be a good way of encouraging institutions, especially those with a week feedback mechanism, to use incidents and errors to improve their process of treatment, delivery, and planning.

l Chairman Stitt summarized the QMP discussion as follows:

a. The Committee agreed that Alternative 2 is preferred,

b. The Committee made the following statements regarding the draft rule text associated with Alternative 2, if this alternative is pursued:

1. In (a), the words *high confidence" really refers to " guidance

• l 2. The 50 rem limits in (a)(1) should be discussed at a later date.

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! 3. The requirement in (a)(3) should end after ' identity is venfied;" whether it is by i more than one method would depend on the institution's internal procedures.

4. Paragraph (a)(3) is accepted as written.

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ACMUI Minutes 8 September 25 26,1997

5. The requirement in (a)(4). I l

0. Clanfication is needed on the statement in the footnote about revision of an existing directivo and whether that has to be dor,e prior to when a patient's condition changes.

. l RADIATION SAFETY COMMITTEE Ms. Haney presented the requirement for having a radiation safety Committee (RSC). The key area for consideration is whether a RSC should be required by regulation and if so, when.

Ms. Haney presented four alternatives for the ACMUl's consideration (Attachment C).

There was discussion of the Altematives with focus on Alternative 2. Mr. Swanson noted that a definition of medicalinstitution would be appropriate in order for the Committee to clearly understand the issue. Ms. Haney explained that the staff considered a hospital setting with multiple medical disciplines to be a medicalinstitution requiring a RSC. In addition, Alternative 2 was not intended to cover those institutions which were only authorized to use byproduct materials listed in the current 10 CFR Part 35.100 and 35.200.

After additional discussion Dr. Flynn moved that the Committee support Alternative 2 with the modification that a RSC is not required at institutions who exclusively have diagnostic low dose, sealed and unsealed byproduct use. The Committee resumed discussion of the motion.

Dr. Flynn then restated his motion as follows. "That we accept Alternative two with clanfication that the institutions with only diagnostic, low dose, sealed and unsealed byproduct materials do net have to have a radiation safety Committee." The motion was not seconded; however, a vote was taken and passed with none opposed.

Chairman Stia turned the members attention to Altemative 2 and requested a discussion of the draft rule text for that alternative. A motion was made to turn to page seven of the RSC alternative paper to discuss the language and the motion was seconded.

Discussion of the draft rule text resulted in Mr. Swanson making a motion to: " Recommend that under option 2 we replace Sections A and B with the draft rule language th6t appears under Attemative 4, A through D, plus an additional statement E.* The new statement would appear as follows: " Membership must reflect the scope of operations respective to the use of byproduct matenals within the institution, and include the radiation safety officer and a representative of management other than the radiation safety officer," The motion was seconded by Mr. Wagner.

A vote was taken on the recommendation including the additional proviso that reflected

- composition of the RSC. The vote was passed with none opposed.

UNIVERSITY OF CINCINNATI PETITION ON 10 CFR 20.1301 The petition from the University of Cincinnati, received by NRC in 1996, requested an ,

4 amendment to 10 CFR 20.1301, which covers dose limits for the public, to authorize certain .

specified visitors of hospitalized therapy patients to receive 500 millirem. The request is intended to cover individuals that would provide support / comfort to the patients.

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, . 1 ACMUI Minutes 9 September 25 26,1997 The. proposed rulemaking p an went to the Commissioner for approvat in August 1996. The Commission appros ed the rulemaking plan in SRM dated September 9,1997. This SRM was in response to SECY 97177 (Attachment D) and requested that staff address severalissues in the proposed rule.

Ms. Haney indicated that the staff is reviewing the Commission direction and is considering the requirement to document the informed consent and the ALARA guidance. Ms. Haney then )

presented draft proposed rule language for discussion and comment. Dr. Graham moved that the ACMUI recommend the adoption of the rule as proposed with the revision to 10 CFR 35.315 and 35.415, removing the requirement for consultation with the radiation safety officer, Dr. Neip seconded the motion. Additional points were discussed, at the end of which Chairman Stitt requested a vote on the motion, which was to accept, with the amendment, that it would delete the clause under 35.315 and 35,415, 'after conspitation with the radiation safety officer." The vote was carried with none opposed.

RADIOPHARMACY GulDANCE Ms. Haney presented an update on the guidance documents associated with the radiopharmacy rule. Ms. Haney stated that three guides were issued for comment in the March time period.

The comment period on these guides is coming to a close in the near future. The NRC staff will review the comments and move to finalizing the guides. It is anticipated that the guides will be finalized in the Sprbg of 1998. Ms. Haney then asked if the ACMUI had any questions. There were no questions or comments.

CARBON 14 PETITION FOR RULEMAKING Ms. Haney stated that the proposed rule was published on June 16,1997. The comment period for the proposed rule ended on July 16,1997. The staff is in the process of resolving the comments. A final rule package will be forwarded to the Commission for approval. There was some discussion about how the C-14 urea capsule will be regulated if used for research. Some Committee members did not feel that it was appropriate that the C 14 urea capsules be used for research under 10 CFR 35.6, once the capsules were distributed under prescription.

Dr. Howe explained that under the current Statements of Consideration in Part 35, the capsule fell under 10 CFR 35 6, if used for research, in order to protect the human subject. Mr.

Swanson stated that he believed that it was inappropriate for the capsule to fall under 10 CFR 35.6. Ms. Haney stated that NRC staff would provide additionalinformation on the matter and report back during Friday's meeting.

PART 33 RULEMAKING Ms. Haney stated that this subject was covered earlier in the day under " Previous ACMUI Recommendations," and referenced Committee members to that discussion.

FINAL DISCUSSION OF THE DAY ,

Dr. Stitt suggested the Committee begm the discussion on training and experience or definitions

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AM'< a e v 10 i f c r%x b26,1997 0 3 ' Ortable/ recordable events. Dr. Stitt requested Ms. Haney to lead a discussion to examine b iecommendations for thresholds of reportable events. Ms. Haney discussed how the Part 35 Working Group developed the rule alternatives in this area, and highlighted the Commission's direction to capture precursor events. ,

l Dr. Cool then presented the Committee with a brief history of why the Commission is interested i in precursor events. He indicated that the Commission is interested in identifying occurrences i that have potential to cause harm early enough so that other licensees can be alerted.

a Chairman Stitt stated that the discussion provided background for the next day's discussion on 1 precursor events. The members were asked to take the pertinent section home with them for review so as to be ready for the discussion on Friday, September 26,1997.

TRAINING AND EXPERIENCE Ms. Lanzisera presented the six alternatives for training and experience of authorized users.

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(Attachment E) i Discussion followed regarding the training and experience focusing on radiation safety versus clinical experience. Some members believe that clinical experience is an important part of I radiation safety training. The Committee believes that it is worth validating the training and experience with an exam.

The Committee recommended that the NRC include the draft rule language for the current 10 CFR Parts 35.100 and 35.200 in the public meetings. As the current altrnatives only addressed t use of materials under the current 10 CFR 35.300.

1 Dr. Flynn and Dr Stitt recommended including medical response to incidents involving radiation safety under the clinical experience component.

Mr. Swanson cautioned the NRC against listing specific radiopharmaceuticals or radionuclides in the training and experience criteria since the rule would need to be changed every time a new {

radiopharmacoutical or therapy source is developed.

Mr. Swanson moved that the ACMUI accept the approach addressed under Alternative 3 with the following changes, 'M.D. plus Board certification, or specified number of hours of appropriate modality specific training and clinical experience, which focuses on radiation safety, plus an exam *. Dr. Stitt called for a vote on the motion. The vote was carried with none

. opposed.

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ACMUl Minutes 11 September 25 26,1997 RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE Ms. Lanzisera presented the options for the training and experience for radiation safety officers (Attachment F).

Discussion of the various alternatives ensued, resulting in a motion to adopt Alternative 3 if the phrase 'to include experience with the types and forms of radioactive material to be used at the facility

• was excluded. The vote was carried with none opposed. The finallanguage is as follows "coard certification by a board approved by the NRC or specified number of training hours plus exam."

Ms. Walkup asked if the NRC had given any consideration to the training and experience requirements for medical dosimetrists, radiat;on therapists and nuclear medicine technologists.

Ms. Haney indicated that there had been some preliminary discussion in the Working Group and that the issue would be discussed at greater depth during subsequent meetings.

There was no formal recommendation in this area.

rat'lATION PHYS!clST TRAINING AND EXPERIENCE Ms. Haney presented a brief overview on the Part 35 Working Group's views on training and experience for radiation physicists. The Working Group proposed the same alternatives for training and experience of the medical physicist as that proposed for the radiation safety officer.

The Committee believed that the medical physicist training and experience should be patterned after the authorized user, but the M.D. Should be replaced with an M.S. or B.S. degree.

Committee members believed that the medical physicist should have at least an M.S. degree and that there be a requirement for an exam.

DISCUSSION OF REPORTABLE / RECORDABLE EVENTS Ms. Haney opened the discussion with a review of the rule alternatives proposed by the Part 35 Working Group (Attachment F). Ms. Haney reiterated the Commission's directive to try to develop a process for reporting events to ensure that NRC is aware of potential or generic issues.

The Committee discussed the purpose of reporting precursor events and expressed concerns that this kind of regulatory process was not only a bad way to collect data but also the requirement would be used to take punitive actions and punish licensees. One member believed a performance based requirement should be developed that would allow licensees to establish policies and procedures for reporting and evaluating precursor events, but allow them to come up with their own internal policies and procedures.

The Committee members supported voluntary reporting of precursor events provided there would be no enforcement ramifications. They expressed the belief that gathering the information was acceptable as long as the requirements were kept out of the Part 35 regulations. The members thought the reporting criteria should be ' inherently fuzzy

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ACMUI Minutes 12 September 25 26,1997

-level of knowledge of human errors and factors analysis. The concept of a clearinghouse receiving the reports and the possibility of an organization like the United States Pharmacopeia being the clearing house was discussed. One member recommer.ded against a voluntary mtem moving forward, if it was going to have significant cost. .

The Committee reviewed the NRC Abnormal Occurrence (AO) reporting thresholds. During discussion on the AO Reporting criteria, the point was made that there was a major deficiency in the current misadministration definition, i.e., that there is no threshold dose for wrong site.

There was agreement on this point. One member raised the question of whether the Committee could throw out the AO criteria and propose something else. The Committee was informed that, if the Part 35 reporting was set higher than the AO criteria, then NRC could no ,

longer meet the statutory requirements to tell Congress, and to change the AO criteria for

'misadministrations would require notifying Congress of the change.

Ms. Haney brought to the Committee's attention the questions raised in the SRM dateo June 5,1977, (Attachment A), regarding event identification. She indicated that the Committee should consider these questions when evaluating the Alternative Paper on events.

Two questions in the SRM dated June 5,1997, (Attachment A), were raised during this session but they were not discussed. The ACMUI believed that the rule alternatives paper did not present one possible alternative that would keep the reporting threshold at the current level, but would delete the requirement for recordable events. The Committee, while favoring this approach, recommended that certain modifications be made to the current criteria. The Committee also believed that the reporting of precursor events should be voluntary.

The Committee reached a consensus that the current criteria for radiopharmaceutical misadministrations be reduced from three categories to two. The two categories are

'radiopharmaceutical not requiring a written directive' and 'radiopharmaceutical requiring a written directive

• The Committee did not believe any changes were necessary for those not requiring a writ'en directive. The current misadministration definition of therapeutic radiopharmaceuticals would be changed as follows "The recordable event definition for those requiring a written directive would add the

" wrong radiopharmaceutical' and replace 'the administe,ed dosage differs by greater than 20 percent.." to 'the administered dosage is greater than 20 percent, or an underdose of 20 percent or more, that is left uncorrected in a clinically timely fashion ,.*

(The wrong mode of transport was deleted because it did not occur in the current regulation.)

The Committee was in agreement that all the radiation therapy out.nitions be prefaced with the phrase " wrong site that involves unintended delivery of a dose equal to at least 10 percent of the total prescribed dose in the written directive

• This was added to provide a dose threshold for wrong sites.

The Committee felt strongly that the reporting mechanism should be decoupled from patient reporting and should not be used by NRC as an excuse for escalated enforcement. It should be

ACMUI Minutes 13 September 25 26,1997 used only by NRC to identify generic problems They also agreed that an underdosage, if it could be, and was corrected in a clinically timely manner, would not have to be reported.

PATIENT NOTIFICATION Ms. Rothschild presented a brief overview of the ethical standards of the American Medical Association (AMA) relevant to patient notification as well as a brief history of the first proposed rule on misadministrations.

The Committee discussion first focused on a number of perceived problems with the current rule, i.e., too much discretion is given to the referring physician who is not an NRC licensee, what to do if there was not a referring physician of record, and defining the responsible relative, The authorized user is put in a awkward position when the referring physician says not to inform the patient because *there is no need" and yet the rule requires notification unless there is

• harm" The discussion moved to a more fundamental point of whether there should be a Federal requirement to notify the patient or whether one should rely on the standard of medical care that the patient would be told, it was pointed out that the alternatives, as presented may be interpreted to mean NRC is saying it's "ok' not to notify the patient. The Committee agreed that the language used to define the alternatives should only state who had to be notified. The Committee discussed the role of the patient physician relationship, practice of medicine, medical ethics, and state law on notification of patients Mr. Anderson summarized the discussion with the following statement:: "what we're saying is the ACMUI does not support any regulation requiring notification of physician and patients as redundant to existing state laws and medical ethics in existence or words.. ' All members agreed that this is what the ACMUI was saying.

At 3:57 p.m. Ms. Haney adjourned the meeting.

Attachments:

A. SRM,6/5/97 B. Summary of Alt., OMP C. Summary of Alt , RSC D. SRM,9/9/97 E. Summary of Alt., Trn & Ex., Auth. Usr F. Rec. for Threshold, Reportable Event

- . _ . .~ _- _ . _ . _ . . _ _ _ _ _ _ - _ . _ . _ _ _ _ . _ _ _ _ . . _ _..._._

. -c ACMUI Minutes 14  !

September 25 26,1997  !

PART 35 - QUALITY MANAGEMENT PROGRAM 9/15/97 i Summarv of Alternatiyas l

1. Maintein current requirements in $35.32.

2. Only require a written quality management program. .

3. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and perform audits. 7

4. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events.

l .

I i

i  :

Attachment B 1,  !

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. +  ;

ACMUI Minutes 15 ,

September 25 26,1997 i

PART 35 RADIATION SAFETY COMMITTEE 9/15/97 j 314mmanLefRiemativas

1. Status quo: A Radiation Safety Committee (RSC) is required for all modalities in a ,

medicalinstitution.

2. "A RSC is required for a medicalinstitution and all moda!ities, with the exception of  ;

diagnostic low dose sealed and unsealed byproduct material uses. I

3. A RSC will not bE required for any medical licensee,

' 4. A RSC will not be required, but medical licensees will be required to establish and

_ implement a program for administrative and technical oversight of radiation safety. -

4 4

3

/ b s 4.-

r d

1 Attachment C 1

, . _ . - - - , - - . -,u..-__ , , - _ _ _ _ _ _ _ _ _ _ . - , _ - . . - . _ _ _ . _ - . . . - _ _ . _ . _ - . . _ . _ _ . _

b ACMUI Minutes 16 September 25-28,1997 PART 35 TRAINING AND EXPERIENCE 9/15/97 SummaDLef AlternativeseAuthetized User

1. Status quo (i.e., M.D. + Board certification or specified number of hours of training and ,

experience).

! 2. M.D. + Board certification or specified number of hours of training and experic nee (with a

- change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the rule,  ;

but instead will be a certification that is approved by the NRC.

t

3. M.D. + Board certification or specified number of hours of training (with a change in the ,

number of hours to focus on radiation safety, with minimal requirements for clinical r experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

4. M.D. only.

5. M.D + exam.

6. M.D, + exam + clinical experience.

h Attachment E

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ACMul Minutes 17 September 25 26,1997  !

PART 35 - THRE8 HOLD FOR REPORTABLE EVENT- 9/23/97 Kummaty9f Altematlyta r

1. Thresholds for reportable event (misadministration) and recordable event remain os  ;

listed in the current $35.2, with the addition of a statement in the reportable definition to address precursor events that are outside the area defined by the term misadministration."

2. Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting criteria. In addition, the definition for reportable event willinclude a statement to address precursor events that are outside the area currently defined by tne term "misadministratiore." Threshold for recordable event is raised to the current threshold for

' misadministration." -

3. Threshold for reportable event is raised to the level of the NRC abnormal occurrence l' reporting criteria. In addition, the definition for reportable event will include a statement to address precursor events that are outside the area currently defined by the term

" misadministration." (No requirement for recordable event.)

1

4. Threshold for reportable event is lowered to the current level of recordable event, with the inclusion of items such as wrong patient, route, or dosage that are not covered by the .

current ' recordable event" definition. In addition, the definition for reportable event will include a statement to address precursor events. (No requirement for recordable event.) '

5. Thresholds for reportable event and recordable event, if applicable, would be set according to the outcome of discussions on Alternatives 1,2,3, and 4. Licensees wou~

voluntarily report precursor events that are outside of the area currently defined by the term ' misadministration."

Attachment F

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