ML20235V122
| ML20235V122 | |
| Person / Time | |
|---|---|
| Issue date: | 11/07/1988 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| References | |
| FRN-55FR1439, FRN-55FR14391, RULE-PR-35 NACMUI, NUDOCS 8903100048 | |
| Download: ML20235V122 (240) | |
Text
{{#Wiki_filter:POR ORlGlNAL UNITED STATES NUCLEAR REGULATORY COhDdISSION In t?.-- Matter of:
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QUALITY ASSURANCE SUBCOMMITTEE ) OF THE ADVISORY COMMITTEE ON ) THE MEDICAL USES OF ISOTOPES )
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1 I l l l l f Pages: l' through 176
, Place: hashington,DC Date: November 7, 1988 8903100048 881107 PDR ADVCr1 NACM HERITAGE REPORTING CORPORATION l 0.0kielReporters 1220 L Street, N.W., Suke 600 Washington, D.C. 20005 (20236 a a q
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1 UNITED STATES NUCLEAR REGULATORY COMMISSION.
. QUALITY ASSURANCE SUBCOMMITTEE OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES November 7,. 1988 Holiday Inn 8120 Wisconsin Avenue -* Bethesda, Maryland Monday, , November 7, 1988 9:00 a.m.
APPEARANCES:- I i Panel Members VINCENT P. COLLINS, 'M.D. CHAIRMAN ACMUI j Houston, Texas ~ MELVIN L. GRIEM, M.D. Director, g Chicago Tumor Institute
^ University of Chicago NORMAN L. MCELROY Medical and Academic Section 6H3 NRC Washington, D.C.
EDWARD W. WEBSTER Department of Radiology Massachusetts General Hospital Boston, Massachusetts Speakers
.. MR. VANDY L. MILLER 1 Director, Materials Branch .
NRC j
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(: > r ,. I' f< l; Speakers (Continued)
- DR. STANLEY ORDER
American College of Radiology' DR. FAIZ KHAN
'American Association of Physicists ~in. Medicine i DR. NAGALINGAM SUNTHARALINGAM American College of Medical Physics MR. ROBERT MORTON National Cancer Institute
~- MR. TERRY JOHNSON Nuclear Regulatory Commission DR. JOHN LAUDE Society of Nuclear' Medicine \
American College of Nuclear Physicians t ~. Heritage Reporting Corporation (202) 628-4888
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. 3 TABLE OF CONTENTS 1
1 STATEMENT OF: -PAGE NO.: t VANDY L. MILLER, MATERIALS BRANCH,.NRC 6 DR. STANLEY ORDER, AMERICAN COLLEGE OF RADIOLOGY 11 DR. FAIZ KHAN, AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE 14 DR. NAGALINGAM SUNTHARALINGAM, AMERICAN COLLEGE OF MEDICAL PHYSICS 18
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MR. ROBERT MORTON, NATIONAL CANCER INSTITUTE 22 MR. TERRY JOHNSON, NRC 29 DR. JOHN LAUDE, SOCIETY OF NUCLEAR MEDICINE \ AMERICAN COLLEGE OF NUCLEAR PHYSICIANS. 4S i[
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- 1. 4 1 PROCEEDINGS '
-j 1 (9:00 a.m.)
3 DR. COLLINS: This is a' meeting of a subcommittee 4 of the Committee on Medical Uses for Isotopes for the 5 purposes of establishing quality assurance as has'been 6 - announced in the Federal Register. ' - 7 - This is a hearing so we are here to hear what you 8
- have to say by way of suggestions, objections, alterations, 9 progress. We're here to listen to what you have to say.
10 The meeting will be recorded and the transcript will be 11 available in the public document room. la To introduce ourselves, my name is Collins. I'm 13 I from Houston. And Dr. Webster here is the Director of 14 & Radiologic Sciences at the Massachusetts General Hospital. And on our left, we have Dr. Griem who is the [5 16 Director of the Chicago Tumor Institute at the University of 17 Chicago. 18 And here we have Mr. McElroy representing the NRC. 19 He is head of the Medical and Academic Section and oversees 20 HRC's medical and academic licensing and inspection 21 programs. 22 As I have mentioned, this is a forum to discuss 23 quality assurance in the medical use of -&h byproduct 34 material. 25 In preparation for this, three graphs have been Heritage Reporting Corporation (202) 628-4088
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1 prepared by the Staff as alternative approaches based on 2 performance for Quality Assurance Rule for the Medical Use 3 of Byproduct Material as v. ell as regulatory guide, and we l l 4 will discuss a pilot program. l 5 Now, these do not represent policy, these are . 6 merely suggestions for your consideration, approval, 7 modification or objection. We will review ideas for ~ 8 regulatory guide to go along with the proposed quality 9 assurance rule and the pilot program to measure the impact 10 of this quality assurance procedure or more including 11 evaluation of whether these procedures would interfere with 12 the proper delivery of medical care. 13 This subcommittee will report to the total 14 - committee of the Advisory Committee on the Medical Uses of 15 Isotopes and out of this will come our eventual i'26 recommendations. 17 Mr. Vandy Miller? 18 Mr. Vandy Miller is head of the materials branch 19 and is responsible for NRC's commercial, academic and 20 medical licensing and inspection programs. . 21 Mr. Miller, would you speak for us? 22
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1 STATEMENT OF MR. VANDY L. MILLER 2 MR. MILLER: First I want to say good morning'to 3 everyone, and welcome you here to this meeting today. The OpnN 4
- c;;;;f' director, Dick Cunningham, normally would be here.to 5 give this welcome because he's the Chairman of the. overall 6 committee. And he's away today meeting with the University 2
7 of Missouri on a very important issue. So it is my chance 8 today to welcome you and to give you a couple of comments. 9 First, I want to inform you, though, that we have 10 a lot of NRC representatives here today, and we have 11 representation from the Office of Research,-Tony Tse, who is 12 the main project manager. Why don't you stand there, Tony? 13 " And Norm McElroy is the Section Leader within the 14 branch, but his whole staff is right here to my left. So
'S they'll be here to talk with you somewhat.
16 We have Kathy Black and Hrri [..- 7farefenD I vm AEOD, and 17 we have operations branch here today, as well. And we also 18 have an individual that's going to replace me this week. 19 I'm going to be moving over to State Programs where I'll be 20 the Assistant Director for Agreement States, but I will 21 still be involved quite closely in the medical field as well 22 as the industrial uses of materials. So I'll be very close 23 to you still. 24 And this gentleman who's right here to my left, 25 Dr. John Austin, who is going to be the ActihkrBranch Chief Heritage Reporting Corporation (202) 628-4888
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-come November 14th.
. ' Stand there John?
;- 1 So now you see the whole Staff here'today so that 3 when we have a break, you'll be able to quickly meet these 4 individuals and discuss issues of mutual concern.
5 , Now, with that said,'I'now want to mention that J 6- ; the Nuclear Regulatory Commission has the responsibility to 7- - regulate the medical use of byproducts to protect the health 8 and safety of the public and hospital workers. The 9 ~ radiation safety requirements for hospitals, . clinics and 10 private physicians that use byproduct materials contained in et 11 the Code of Federal Regulations 10 C.F.R. 5, Title " Medical 41 12 . Use of Byproduct Materials. Safety requirements allow 13- programs and training experience requirements for essential 14 personnel working with byproduct materials as specified in f5 dr,#. 35 .
.16 &. Now, the NRC.also has the authority.to regulate 117 y the use of byproduct material for medical use to protect the-18 health and' safety of patients. However, the NRC recognizes 19 that physicians have the primary responsibility for 20 protection of their patients. An NRC policy statement
. 21 published in 1979 stated among other things that the NRC 22 will minimize intrusion into medical judgments affecting 23 patients and into other areas traditionally considered to be 24 part of the practice of medicine.
25 However, 27 misadministration from radiation l l Heritage Reporting Corporation (202) 628-4888
h 8 l' -therapy was reported to tho NRC from November 1980 through. +
- 1 July 1984.- Fourteen misadministration from diagnostic use 3 of Iodine 131 that led to doses and therapy range several-4 thousand rads to the thyroid were reported to the NRC'from E
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1982 to 1986. The specific causes of the' misadministration 6 e varied. depending on the treatment modality. . 7 n Nevertheless, three baric problems were found:
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B inadequate training, inattention'to detail, and a lack of-9 redundancy. The NRC believes many misadministration could 10 reasonably be avoided if certain basic quality assurance 11 procedures were included in the medical use of byproduct 12 a- material'for diagnostic testing and therapeutic treatment of-13 e patients. 14 NRC published two rulemakings on quality assurance 5- in medical use for comment on October 2, 1987, a notice of. 16 , proposed rulemaking on basic quality assurance and advanced 17 notice of proposed rulemaking on comprehensive quality 18 assurance. The Commission was. briefed on the rulemaking by 19 the Staff on March 22, 1988 and by representatives of the 20 medical community on April 7, 1988. 21 The Commission then directed the Staff to prepare . 22 an option paper. After review of that paper, the Commission 23 directed the Staff to, 1) develop a performance-based 24 quality assurance rulemaking; 2) a regulatory guide 25 containing prescriptive quality assurance elements which
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L p . . - 9 o 1 would meet the performance objectives in the proposed rule; 2 and 3) a pilot program to assess the proposed rule and I 3 regulatory guide. 4- Also, the Commission directed the Staff to work 5 with appropriate medical organizations, the Agreement States
.. -6' and other interested groups in development.of the 7 performance based quality assurance rule. I expect that i~ 8 this meeting will be an excellent opportunity to exchange 9 ideas on the development of the proposed rule, regulatory-10 guide and pilot program.
11 There was one individual I forgot to mention,. 12 that's the new office which I'm going to, we have Lloyd 13 lbhere'whoisrepresentingth greement;5 Program. 14- Lloyd, would you stand?
,15 Thank you.
- 26 A I'll turn it back over to you, now, Dr. Collins.
17 : Thank you very much. 18 DR. COLLINS: Next on the program we have 19 scheduled statements from several organizations here. I ; 20 won't read these t you since you'll have this in your hand. LV '
. 21 First, . Laude, whom I understand is not 22 available at the moment.
23 Ms. Brown? 24 MS. BROWN: He's on his way. I 25 DR. COLLINS: He's on his way. 9eritage Reporting Corporation (202) 628-4888
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m' 1 In that case, we shall move on to Dr. Order. . 2 (-
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- 1 STATEMENT OF DR. STANLEY ORDER 2 DR. ORDER: Good afternoon.
3 I think I'm reminded in what the Nuclear 4 Regulatory Commission wants to do about what the National 5 Academy of Sciences wanted to do in 1970's in irradiation of
. 6 benign disease. I think the fundamental issue at the 7 present time is that no one really knows objectively what 8 the quality assessment programs are for all the different 9 radiation centers, both nuclear medicine and therapy, 10 throughout the country.
11 My proposal would be to do an affirmative step, 12 rather than be defensive in the analysis of this problem. I 13 would suggest that we have a five-star panel formed by the 14 American College of Radiology. These would be people who 5 would be knowledgeable of the physics, the radiotherapy, the 16 nuclear medicine, etcetera. And they would also have a 17 knowledge about the cost impact of any kind of alterations. 18 The first thing this panel should do is survey the 19 nation as to the quality assessment programs presently being 20 used so we would all know what we're talking about
- 21 objectively. We presently do not know precisely the 22 different quality assessment programs used in all these 23 different departments.
24 That report or that committee could be funded by 25 the Nuclear Regulatory Commission. If they funded such a Heritage Reporting Corporation (202) 628-4888 i
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12 j) 1 committee, this' committee could then do an analysis of the _l
.l 4. ' nation by obtaining data-irom all-the different centers all 1 3 over the country. -They could then make recommendations as 4
to what they think the level of quality assessment is'and 5 what the level of quality assessment ~should be. 1 6 In addition to that, I don't think the situation - 7- is stagnant. I don't think that quality assessment in 1988 8 will necessarily be the same quality assessment in 1992 or 9 1995. I would suggest'that the Nuclear Regulatory 10 Commission, when they establish this panel with the American 11 College of Radiology, have an annual or perhaps every two 12 year review to see where assessment should be in the future 13 - as new things develop in these fields. I think all of this 14 tends not to be defensive but rather affirmative, and gives
/ 3 us the defined goals of what to do.
16 A grant that supports a panel for the American 17 College of Radiology which does a national assessment of 18 where quality assurance is in 1988. Secondly, a response to 19 that assessment with new ideas or whatever else has to be 20 placed in place, and then thirdly, the development of a 21 standard for everyone of a minimal quality assessment that 22 we all agree is realistic. 23 Thank you. I 24 DR. COLLINS: Thank you, Dr. Order. 25 Now, Mr. Jack Coffey of Syncor International? Heritage Reporting Corporation l (202) 628-4888
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.* 1. - MR. BROWER: Mr..Coffey was not able to come 1 a
2 today. He asked.me to give a letter to a Mr. No .f l ' . ]
- 3. McElroy. I don't know if it's appropriate- to read this buti 4 they wanted to make sure this was here for the record.
-5 3 MR. MCELROY: Okay. Could you identify yourself?
6 MR. BROWER: I'm Scott Brower, Regional Manager of 7 Syncor. I
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8 MR. MCELROY: Thank you.
-9 MR. BROWER: Would it be appropriate just to give 10 you this?
11 MR. MCELROY: Sure. 12 , DR. COLLINS: Next, a representative of the 13 American Association of Physicists in Medicine, Dr. Khan.
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14 *+ l- STATEMENT OF DR'. FAIZ~ KHAN a-
.DR. KHAN: I-thank the NRC for inviting the AAPM-
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- 3. 1 to attend this meeting. I have a written statement which I 4
would-like to read. 5 a The proposed NRC guidelines lay down the frame 6? work that could become the basis of a comprehensive QA . L7 ' program.. In, principle, no institution should operate' without minimizing the occurrence of' errors identified'in
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8 9 theJproposed guidelines. The only cautionary' note that'I 10- have is that in its implementation, the program must not 11 become so burdensome and bureaucratic that institutions are 12 forced to switch to non-byproduct materials to avoid the 13 L hassle. 14 u I think the ideas presented here are all good. Eg i : But we must make sure that the reporting requirements are
- 16. Y not unduly labor intensive and that the paper work involved 17 1 'is minimal. I must confess that we, the licensees, have:the 18 image of the NRC as a little bit bureaucratic. It often 19 . adopts a legalistic approach than a scientific or a 20 practical one.
21 However, we should strive to change its image to - 22 that of a regulatory body that's committed to public safety 23 and welfare in the overall delivery of health care. 24 Let me bring up another aspect of QA which is 25 probably more basic than a set of QA procedures. This is
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F. r*' .15 "b'" >1- the question of facility structure. 'If the best equipped 2^ radiotherapy department has an obsolete cobalt-unit, or.it's 3' n' .not qualified lwhat'I mean, a certified physicist is on the 4 staff, the whole QA program becomes' simply a ritual'of 5 ' checks with little relationship to the quality of patient'
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care. l 7 I think that the first order of business for-the-
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8 NRC should be to make sure that the facilities using the
.9 byproduct material have qualified personnel on its staff.
10 The-equipment'and staffing guidelines already exist. As you 11 know, the blue book-by the American College of Radiology is 12 there to assist the-NRC in this regard. 13 Human errors are committed by humans, and I think 14 that the-qualified individuals understand better both the 15 x scientific significance and the professional aspects of a QA
.(SJ6- 1 program. For example, a technician or dosimetrist can be 17 L trained to do the QA procedure step by step, but the 11 8 physical QA must be-designed, evaluated and supervised by a E19 qualified physicist.
20 Similarly, the clinical part of the QA must be
. 21 directed by the radiation oncologist or radiologist. I hope 22 .
the NRC will take the view that the regulatory guidelines
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23 are not substitute to a proper facility organization in 24 which the medical application of a byproduct material is 25 under the control of qualified personnel. 9eritage Reporting Corporation (202) 628-4888
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For example,~ requiring a facility to do a'certain 2 . number of QA procedures is not:as important to me as ( 3 requiring that qualified staff be.available to do or direct 4 - the QA program that's comprehensive and is integrated with 5 the quality efficient care. Unfortunately, the NRC cannot 6 go all the way in assuring quality treatment to patients' . 7 without interfering in the conduct of therapeutic 8 procedures. However, the NRC could require' appropriate 9 personnel support for the QA program considering the 10 equipment and the patient load the facility has. 11 In summary, the expertise exists within the 12 professional organization such as'the AAPM and the ACMP and 13 the ACR to assist the NRC in drafting appropriate QA 14 guidelines. The proposed guidelines are expected to
,15 minimize simple errors and therefore improve quality-of ka6 medical practice provided the attendant bureaucracy in 17 program evaluation and reporting is minimized.
18 In addition to these guidelines,-the NRC should 19 examine the facility structure of the licensees with regard 20 to equipment and staffing in light of the blue book 21 recommendations. - l 22 I'll be glad to respond to specific QA issues as 23 they arise in this meeting. l 24 Thank you. 25 DR. COLLINS: We'll be pleased to entertain any Heritage Reporting Corporation (202) 628-4888 h _ _ _ _ _ _ _ _ _ _ _ _ _
4' I' * ? 1 ' questions or comment the audience may have-following each'of _
,. 2 these brief presentations'.
j. 3 Y If none, we-may then ask from the American. College' 4 of Medical-Physics, Dr. Suntharalingam.
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18 *o 1 -STATEMENT OF DR. NAGALINGAM-SUNTHARALINGAM '4 L .(- DR. SUNTHARALINGAM: Thank you, Mr. Chairman, 3 , members of the Subcommittee and the U.S. NRC Staff. 4 . I'm here as the Current Chairman of the Board of 5 Chancellors of the American College of Medical Physics. 'the 6 , American' College of Medical Physics is a relatively young . 7 .. organization formed in 1983 to address professional concerns
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8 of the practicing clinical medical physicist. 9 We have been active in several areas of importance 10 during the last five years including establishing a close 11 interaction with regulatory agencies, both Federal and 12 ; state, and the Joint Commission on the Adult Education of 13 - Health Organizations, JCAHO. Its this respect, we welcome 14 the opportunity offered us today.
> The College of Medical Physics and its memberships (1
16 ; are dedicated to its providing and maintaining a high level 17 of linical physics participation to its optimal patient ur 13 . . We recognized very early the need for written 19 documenta and issued three separate protocols in January, 20 1986, copies of which I have given to Mr. McElroy, collating 21 radiation control and quality assurance procedures in . 22 diagnostic radiology, radiation oncology and nuclear 23 medicine. These collate the physical aspects, and I 24 emphasize, the physical aspects. 25 The purpose of these documents was to provide to Heritage Reporting Corporation (202) 628-4888
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*'- 11 hospit~als the JCAHO, a guide prepared by medical physicists 1 suggesting procedures which should be performed by or under l3 - the supervision of a qualified medical physicist.
4 Who is a qualified physicist or an expert has been a l 5 . very confusing question in the past. Our organization has,
. 6 after much deliberation, issued an unambiguous definition of )
i 7 a qualified medical physicist for use by regulatory. 8 agencies, hospitals and related organizations. A copy of. 9 that definition is also attached. We would encourage 10 adoption of this definition by the regulatory agencies. 11 The American College of Medical Physics is. fully 12 supportive of establishing, if one does not already. exist, 13 and I-emphasize, if one does not already exist, a 14 performance based minimum effective quality assurance g3 - program for all facilities using radiation in medicine. The 16 : program she:-1d include both the physical and clinical 17 L aspects of delivery of patient care. 18 The program should be established as a team effort 19 which with input from all relevant groups of supporting 20 staff with the physician or the licensee assuming overall
- 21 responsibility for its implementation.
22 We do feel most facilities have some QA program in 23 existence, though they might not be adequately documented or 24 followed. Thus, there should be no undue burden in 25 formalizing an effective program. Heritage Reporting Corporation (202) 628-4888
20 , i 1 Whatever programs are initiated, may I please make g 1 .a' plea to coordinate the efforts between all regulatory
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bodies, Federal and state, irrespective of the source of 4 radiation. An example is the New York State. A draft 5 document is in circulation issued in October, 1987, where 6 they are proposing a somewhat similar program to the NRC, - 7
- but it's also some major differences including a proposal 8 for an audit program where somebody from outside is expected 9 to go and audit the program and write a report and that 10 audit is to be initiated within 15 months of getting the 11 license. Now, they recognized individuals who could perform 12 this audit. I'm just citing that as an example.
13 The State of Pennsylvania has issued new radiation 14 laws and they have a tendency just to copy whatever is ( 5 available in the Federal system without giving much thought i 16 to what is happening in the on going development process. 17 And I'd like to endorse Dr. Order's suggestion that whatever 18 regulations we formulate and put forward have to be 19 continuously scrutinized, because we are living in a 20 changing world. 21 I did take the time,even though receive /rather - 22 late,to go through the specifics of some of the documents . 23 that were circulated. I can read some general statements 24 now, or wait for the specific discussion as we go along. 25 DR. COLLINS: Perhaps we should leave this for the . /" Heritage Reporting Corporation (202) 628-4888 I l l
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/=* 1 general discussion'and have these statements completed, 1~ first.
'3 x DR. SUNTHARALINGAM: Okay, thank you very much.
4 DR. COLLINS: Are there.any questions or comments 5 . at this' time?
... 6' ~ In that case r,is Mr. Morton here?
7 ; Mr. Morton from the National Cancer Institute. 8 9 10 11. 12 13 14 [. 3
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ii 22 1 STATEMENT OF ROBERT MORTON - 1 MR. MORTON: Good morning. 3 I'd like to thank the NRC for this opportunity to 4 give the opinion of the National Cancer Institute in this 5 affair. I work for the Radiation Research Program, Division 6 of Cancer Treatment of the National Cancer Institute. And . 7 we have as one of our goals the promotion of the safe and 8 effective use of radiation in the treatment of cancer. 9 The radiation research program strives to reach , 1 10 this goal by developing research funding, monitoring and 11 evaluating research, and by interacting with professional 12 and scientific radiation organizations. The research is 13
- funded by means of grants, contracts, and cooperative 14 ~ agreements with investigators in radiation oncology, (3 biology, physics and chemistry.
16 One aspect of the safe and effective delivery of 17
- radiation therapy is the assurance that the equipment is 18 operating safely and reliably. The most important component 19 of quality assurance in radiation therapy is the physician 20 in charge being committed to quality assurance. The tasks 21 of performing quality assurance may be delegated to other -
22 staff members but the responsibility for a good QA program 23 rests with the supervising physician. 24 In order to have an effective QA program, the 25 physician must allocate resources, that is, money for Heritage Reporting Corporation (202) 628-4888
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. l' personnel,' money for test tools and equipment, and time for 2 its performance. All three resources are mandatory. Each
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l J individual. radiation oncologist performs QA daily. Every 4 time a chart or port film is reviewed, a notation made, a ; 5 patient examined, QA is carried out. '
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But is what is being done enough? Are the 7 dedicated qualified personnel available to perform 8 comprehensive QA? Could a patient under treatment in one 9 facility be sent with their record to another facility to 10 complete their radiation treatment and expect the same 11 results? 12 Consider the extreme. Several facilities 13 attempting to perform identical treatments. If a clinical 14 trial was designed to answe scientific question using the
,15 greatest number of facilities in the shortest possible time, I' 6 r would the patient data from equipment and treatments in one 17 y facility meet the acceptance criteria established by the 18 investigational protocol?
19 It's immediately apparent that that clinical trial 20 data is intrinsically dependent upon rigid quality
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assurance. In order to assure valid and reproducible 22 results, quality assurance and quality records must be 23- integral parts of laboratories in clinical research. All of 24 the clinical groups have a quality assurance center to 25 perform protocol compliance review, including patient record Heritage Reporting Corporation (202) 628-4888
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-1 reviewT" port films, treatment planning and dosimetry record 4 2 review.
1 ~ The radiation oncology group is an example of such 4 r .a QA center in the United States. In 1969, the National 5 L Cancer Institute became convinced that quality control was 6 i required for clinical trials, and' began supporting the . 7
. Radiological Physics Center in Houston, Texas to provide 8 quality assurance to clinical. trial groups being funded by 9 the NCI.
10 At present, the RPC crovides a central external 11 quality assurance' program to 23 cooperative clinical trials 12 i groups involved in research protocols using radiation 13 2 therapy. The RPC provides assistance and data to each of-14 the quality assurance centers. The RPC's effort is not 15 meant to relieve the individual facility of its internal 4 16 ~ responsibility, but rather to provide assurance that the 17 quality assurance performed at that facility is adequate to 18 allow them to reliably participate in a national protocol. 19 Poor quality assurance before this program often 20 led to invalid prospective as well as retrospective studies. 21 Until April, 1986, NCI funded six regional centers for . 22 radiological physics which, as one of their functions, 4 23 assisted the RPC in this duty. In September, 1986, the RPC 24 received the funding and responsibility for the additional 25 RPC institutions, bringing their total for active monitoring Heritage Reporting Corporation i (202) 628-4888 l _ _ _ _ _ _ _ __--_______m.----a_m__ .________._____--_____m___m_____--_a.---
*#' 25 la' 'l to 648-institutions with about 1700 photon and electron
.j 2 beams-being measured.
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'3 . The Center for Radiological Physics made yearly 4 visits to their assigned' institutions'but this is not 5 possible for the RPC to do at their level of funding. The
. 6 RPC will be monitoring all beams twice a year by mailed
;7 thermoluminescent dosimetry and visiting about 100 of the 8 high priority institutions per year.
9 The visits by the RPC and the CRPs in the past not 10 only provide a QA for clinical trial protocol patients but 11 in fact for all patients treated on the same equipment in
'12 that facility. In the United States, the RPC has 13
- established defacto standards for many QA tests by virtue of-14 its existence, the number of institutions it has visited and 15 t its scientific foundation.
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M6 ?- The visits particularly by the CRPs to the smaller 4 17 s cooperative group affiliates provided a valuable learning 18 experience for physicians and technologists as well.as for 19 many physicists and dosimetrists on the staff. All too 20 frequently, the CRPs provided the only quality assurance
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22 - A presentation on the aspects of the RPC follow 23 this one. 24 The change in QA structure in the United States 25 demands an increase in the quality assurance performed by i-i Heritage Reporting Corporation (202) 628-4888 ma>--,- ----.--,-s--- - - , - _ _ - _ . _ - - - - . - - - - - -_--------_a_ - - - - - - - - - - - - - .---a------_.- - - - - - - - - - - - - - - - _ -._ -----r----x-.___--w------,--_-.-------n-.-- a-.- ,_ -u-___
26- ** 1 the individual' facility. Each facility lmust have its own *
, comprehensive written quality assurance program and must 3- -perform its own daily, weekly, monthly,-semi-annual and 4 1 annual quality assurance. Further, the facility should 5 . arrange for at least one annual external quality assurance 6 ? review. .
7 1 This is not only required-for_ acceptable clinical 8 ; trials research,-but is necessary for the safe.and effective 9 treatment _of cancer patients. The supervising radiation
'10 oncologist must provide for in-depth QA by delegating the 11 many. tasks to-the appropriate personnel. The physician and 12 physicists must collaborate on developing a written L13 ' a comprehensive quality assurance program which details the QA-14 4 tests,: their frequency, the action criteria, the records T7 E required, and the personnel required to perform them.
t 16 A: Each member'of the QA team must know his or her 17 rc responsibilities,.be trained to perform them, and know what 18 action to take should a test give a result outside the 19 limits of established acceptable criteria. l 20 Quality records documenting frequency and results 1 21 of a QA program are important in retrospective analyses'of , 22 trends as well as documenting current status. Quality 23 assurance is essential to the safe and effective treatment 24 of the patient, the analysis of data, and the design of 25 prospective research trials at the national and r. Heritage Reporting Corporation (202) 628-4888 : i ) l \ U
** 27 1 .*- 1. international level. Quality assurance requires the time and commitment of-the entire' staff and is thus a team effort
{' 3 .- supporting the statements earlier. 4 I've got a couple of other things to mention, that l l
'S the National Cancer Institute began funding a second j . 6 patterns of care study for radiation therapy in July, and as i
7 part of that, a facility survey will be made of all ' 8 radiation therapy facilities in the United States, which 9 numbers about 1200, and one of the questions on this survey 10 is, is there a quality assurance program in use in your 11 facility, and what are the number of hours per week devoted 12 to quality assurance. 13 . There is a quality assurance manual that was 14 . produced by the Center for Devices and Radiological Health, f'T i under contract to the American College of Radiology. This 16 manual is now under revision and is expected to be available 17 : by next October. I'll leave a copy of this manual with Mr. 18 McElroy. 19 Thank you. 20 DR. COLLINS: Thank you. A copy of your remarks
. 21 have been made available? Have they been made available?
22 MR. MORTON: I will make them available. I have a 23 copy. i 24 DR. COLLINS: Today. ' 25 MR. MORTON: Yes. I I l l Heritage Reporting Corporation (202) 628-4888 ,l l _ _ __ _ __ _ __ ___ ___ _ -______ ________-_ - _ - _ -
Il i 28 ' '*
'l 1DR. COLLINS: :Has Mr. Laude arrived?- . ,. ( : .All right.
3- . We-are now going to hear from Mr. Terry Johnson of.
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- 4. A the NRC on the Quality Assurance-Rule alternatives.
~5 !
6 ?- _ 7 I' 8 9 10-11 12 - 13- c 14 . 5 (' ; ;. 4,.
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l 24 25 Heritage Reporting Corporation (202).628-4888 i
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** 29 )
1 STATEMENT OF MR. TERRY JOHNSON
.( MR. JOHNSON: Thank you, Dr. Collins. Thank you 3 all for attending today.
(4 s The booklet that you received coming in contains 5 some of the draft materials that we are proposing at this
... 6 time. The current rulemaking itself proposes two things:
7 one is to revise the.old reporting requirements; and the 8 second is to add'a basic quality assurance rule to the 9 existing requirements. 10 Whereas, the old reporting requirements would 11 replace existing requirements, this QA rule would be 12 entirely new. 13 Now, these simple human errors that are addressed 14 are simply blunders in some aspect of the administration of byproduct material. The errors that we intend to catch do (A ' 16 not include some of the subtleties of physics such as the 17 differences between the new Task Group 21 protocol and the 18 older methods of calibration of the teletherapy beam. We're 19 simply for mistakes being made. 20 There are three alternative rules in the proposed,
. 21 in the briefing book that you have. They are drafted in 22 preliminary form in this briefing book. They start in each j i ~
23 alternative under Alternative 1, Alternative 2, and so 24 forth, where it says 35.35. 25 In other words, the first part is the reporting Heritage Reporting Corporation (202) 628-4888
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I 30 1 rule which is 35.33. Following that is the proposed QA rule
- l I- '
which is 35.35. And there are three alternatives, each has "
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3 a different author. Each is'quite different from the other.
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4 Now,.these alternatives are all just strawmen in 5' the language we use at the NRC. That is to say, they're
- very preliminary, they're without the full internal review 6 -
.7 at NRC that is normally accorded a rule before it goes to 8 publication, and therefore, they're not ready now for 9 publication.
10 Also in this same book, further on in the book, 11 there are strawmen of the regulatory guide that would 12 accompany the QA rule, and the pilot program. 13 Now, the three alternatives of the reporting rule 14 ' and the QA rule could each be disassociated from its alternate member, that is to say, in Alterative 1, the {'1 16 ' The QA-reporting' rule could be used but not the QA rule. 17 ' rule could be some other material. Or in Alternative 2, the 18 QA rule could be used, and the reporting rule could be used 19 from Alternative 3. Any combination like that is 20 acceptable. We have just proposed these things really to 21 stimulate comment. - 22 Also, we anticipate that we will have to write new 23 material, altogether new material because we don't expect l 24 that any one of the three rules that we've proposed is 25 really perfect. So we feel that any rule that actually goes Heritage Reporting Corporation (202) 628-4888
i
** 31 ?
. 1 out for public comment in the Federal Register will probably
,2 have some new material in it. And some of the material s deleted from our proposals.
4 Now, each of the alternatives for the quality 5 assurance rule, that is, where it starts with the 35.35, is j 6 intended as a performance-based rule. This is explained by 7 Mr. Miller earlier. What we mean by a performance-based 8 rule is that it specifies the performance criteria of the QA 9 program that must be adopted to provide basic QA. It does 10 not prescribe the actual procedures to be used to accomplish 11 the level of QA that we desire. 12 The individual procedures would be left to the 13 licensees. They would propose their own procedures and 14 would submit them to the NRC for approval. And if they were JS approved, then they could follow their own procedures. This
.i E_d . was done in response to some of the comments to an earlier 17 ; proposal which was more prescriptive and which met with a 18 lot of adverse comments that the particular rules that we 19 had chosen to set up, that is, the procedures that we had 20 chosen to set up were unduly prescriptive, unduly
. 21 inflexible. And many facilities had their own procedures 22 that were working already.
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23 Now, a performance based rule, when it is 24 proposed, promulgated, it must be accompanied with a 25 regulatory guide. That is because not all facilities would Heritage Reporting Corporation (202) 628-4888 i
l: 32 - 1 have the capability of-devising their own procedures. And
- L2 also.some of the' rules that are proposed would be
~3 s sufficiently unclear possibly to some of the licensees that 4 . a regulatory guide would be necessary to clarify the' rules.
5 So the licensees can use the regulatory' guide 1 6 r that's promulgated with the rule verbatim, or they can . 7 propose their own procedures which accomplish the same 8 - objectives as a regulatory guide. 9 Now, I'm particularly interested at this time in 10 the rules themselves for the QA program. There are three 11 proposals here under Alternatives 1, 2, and 3. I won't read 12 r; the proposed rules, but I will summarize them briefly. 13 Alternative 1 has performance criteria which 14 . concentrate on unclear instructions and on quantitative
/5 e steps involved with the administration of byproduct i
16 material. Also it specifically requires double checks of 17 i certain steps. That is to say, all calculations made and 18 all of the input values for all of the calculations, these 19' must be double checked. And the full calibration of a. 20 teletherapy machine when that is required. 21 Alternate 2 has other features. It has . 22 performance criteria which are fairly comprehensively 23 stated, more so than the other two alternatives. There are 24 nine general areas addressed in the text of the Alternate 2 25 rule. It does not specifically require double checks of e. Heritage Reporting Corporation (202) 628-4888 s
.** 33 + 1 calculations that are not required by other preexisting g regulations. A perusal of the nine general areas addressed 3 in the text of this alternative would give you an idea of 4 the total scope that might be encompassed by a QA rule and 5 by the performance criteria for a QA rule. . 6 Now, Alternative 3 is the briefest of the three 7 .
rules. It has only five lines of text. It has no
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8 performance criteria other than the statement that the QA 9 program adopted must avoid simple human errors, and that 10 these simple human errors must include the ones that are
-11 reportable. So the third alternative rule is workable only 12 in conjunction with a reporting rule that addresses the 13 types of errors that we want to correct.
14 a Also, since the text is so brief, for workability
.; ' Alternative 3 more than the other 2 rules possibly would 16 i require an excellent regulatory guide to really explain what 17 I we need from licensees in terms of the steps to avoid the 18 simple human errors that we intend to address with this 19 rule.
20 Now, as in Alternative 2, there is no specific
. 21 requirement for double checks that are not already required 22 by other NRC requirements or other QA requirements.
23 Now, all three rules address much more than dose 12 4 accuracy or dosage accuracy. This is best illustrated in i 25 Alternative 2. This is due to our conviction that possible
.Meritage Reporting Corporation (202) 628-4888 e
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34 ** 1 errorsicannot all be described mathematically, that is to. . ( say, as a percentage error. Some of the steps required do 3 not suggest the actual patient harm avoided other than that 4
- there is a much larger than-normal risk of patient harm if 5 i some of the steps are skipped. That is to say, things such 6
- as a required medical case review in situations where a .
7 - medical case review is required. The omission of that step 8 V- might not lead to any patient harm at all, but it might lead 9 to a larger risk that there would be patient harm. 10 And there are many examples in the performance 11 criteria of the rules that allude to more than just 12 mathematical accuracy in the delivery of a dose or dosage. 13 1 And that's all my comments are about the rules. 14 A We are available to answer any questions about any of these ('c 16 a rules. They were written partly by myself and partly by Anthony Tse and par 1 by Norm McElroy, so we certainly can 17 1 answer your questions as to what is meant by the three 18 alternative rules. 19 Thank you. 20 DR. COLLINS: I think before we start discussion, 21 it might be worthwhile to offer a definition or two. - 22 We're concerned with hazards involved with the 23 medical use of radionuclides, radio isotopes. This involves 24 both danger and risk. 25 I would define " danger" as the possibility of Heritage Reporting Corporation (202) 628-4888
** 35
_. 1 injuryvand " risk" as the probability of injury. The danger always exists. There is a danger that the floor will cave 3 - in-here, but the risk is so remote that no one has headed 4 _ for the door. There are hazards. Many of us traveled by 5 air to get'here, or at least by road, and you're aware of 6 - the hazards in the daily papers of crashes and deaths at air 7 t fields and on the highways. But this was a probability that 8 you considered remote and you did not hesitate to attend. 9 Sometimes or if our information is complete, then 10 the probability and the possibility may coincide and we have 11 no difficulty with this. On the other hand, there is a 12 perceived risk and an actual risk. Take smoking, for 13 instance. The actual risk is documented in many medical 14 publications. The perceived risk is ignored by the smoker. 4 - If on the other hand, the perceived risk and the t
'16 r real risk coincide, this individual may well stop smoking.
17 Now, when we come to our subject here, we're 18 talking in the main, we're certainly talking about radiation 19 and in the main about cancer. Two of the most feared words 20 in our language. To the degree that the perceived risk is
. 21 . understood, then the perceived risk and the actual risk are 22 the same thing. If, on the other hand, the apprehensive ~
23 patient or the apprehensive individual has a greater 24 perceived risk than the actual risk, then we have some 25 imbalance and inappropriate action may result. Heritage Reporting Corporation (202) 628-4888 t
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-1 :As we therefore' examine the evidence in' front of -
( us, we will certainly find differences in the perception of l' 3 the risk :and recognize the problem that assessment of the 4 risk means more information, more education for each of us 5 and for all of us who are here to deal with disseminating 6 .this information. - 7 Now, with regard to the procedures that we have 8 with the discussions that have been presented to us, do we 9 have some questions? 10 Yes?
-11 MR. MCELROY: Could you identify yourself;for the 12 reporter, please?
13 DR. ORDER: Yes. I'm Dr. Order from Johns 14 Hopkins. I'm president of ASTRO and I'm also representing ((
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the American College of Radiology. l 16 My very fear about what could happen with these 17 ~ kinds of rules is demonstrated with a lack of patient and 18 physician interaction with development of the rules. I'm 19 going to give you a few examples from the rules. 20 On Alternate Number 1, Rule No. 7, it states that 21 "a notification would be made to a referring physician and - 22 to the affected patient for every therapy event, regardless 23 of dose consequences." 24 The number of excited patients and legal 25 contingencies that this rule would generate is beyond your 1 IIeritage Reporting Corporation (202) 628-4888 l
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.- 1 imagination. Also, 'i f you had a quality assurance program
- 2. and if on a given day there was aus error and then the error
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s . .was corrected, such that there would be no outcome to a 4 patient, there would be no. reason _to do all these things. 5 Rule No. 8, "the referring. physician may prevent 6 patient notification if his medical judgment so dictates, 7 but he may not agree to notify the. patient himself."
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8- I would suggest to you that that's illegal, that 9 you will not be able to do that. That a physician giving. 10 information has the right to make his decision whether he
.11 does or does not notify a patient and that the' legal 12 ramifications of that kind of statement are beyond what a 13 commission could handle.
14 Rule No. 9, "all diagnostic events also 15 necessitate notification to the patient's referring I
"o
_ . physician regardless of the seriousness of the event." 17 n. You will have numbers of patients excited all over
'18 the nation for undue cause with undue stress and legal 19 contingency between physicians, patients and the Nuclear 20 Regulatory Commission if these kinds of rules are taken into 21 . effect.
22 I'd like to go further. Under some of the rules
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23 that you have for radiopharmaceuticals, for example, 24 Alterative No. 1, 35.33, Issue No. 5. "A dosage of 25 radiopharmaceutical differing from the prescribed dose by f f Heritage Reporting Corporation l l (202) 628-4888 l
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1 38 ** q 1 more than ten percent." -
- 2. '
If a physician prescribes 2 millicuries of P-32
'a -
for a patient and they give 2.3 millicuries, you're' going to 4 4' require a notification. That's totally unrealistic. It 5 :doesn't take into account the isotope, the impact on the 6 r patient, the time of the physicians and whether this is , 7 -
'really quality assurance or not.
8 - I'd like to continue just to show, as we go 9 through this document, the various kinds of things and.the 1-0 reason I believe that you need a committee to help write 11 this kind of structure. Later, we go to Rule No. 8, which 12 J is on page 4, the bottom is marked, 9-6-88. 13 I The Rule states, No. 8, " radiation from a 14 teletherapy source such that an error or errors in the 15 J- source calibration or source strength meas 2rement time of II so
- exposure treatment geometry, source geometry, other beam 17 1' modifiers results in a total dose for that~particular phase l
18 of treatment differing by more than ten percent from the 19 total dose intended prior to detection of the errors." l 20 Again, this is unrealistic. If the physician has 21 taken the patient to a threshold dose of radiation therapy, - l 22 the absolute maximum, and it's ten percent exceeded, it's l
~23 dangerous. If the physician has taken the patient to a 24 palliative dose and there's a ten percent error, it has no 25 consequence. And all of those things have to be considered.
p Heritage Reporting Corporation (202) 628-4888 w_-____-__-__-__-_________--___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .
** 39 h* 1 And Rule No. 7I find the most fascinating.
2 Because this is clearly not done from a physician viewpoint. l J "A brachytherapy treatment with combined source . ." and you 4 go on to describe if there's a variation in 20 percent. 5 Most people who do brachytherapy of the head and neck,
. 6 especially in the oropharynx, go in with a general idea of 7 what dose they want to describe. They have the technical 8 performance of doing that, and then there's realism at the 9 end.
10 Now, are you going to require the physician to 11 tell you before he goes in or after he comes out what dose 12 he's going to have? All these kinds of things are riddled 13 through the document only because there's no medical 14 experience represented by the document. 15 Again, I would say that we do not know what the 3 l ad v standards of quality assurance are in this nation. I do not 17 : see how you can write rules not knowing what the realities 18 are, especially rules which interfere with patient physician 19 relationships. 20 DR. COLLINS: Thank you.
. 21 -
Yes? 22 DR. SUNTRARALINGAM: I'm Dr. Suntharalingam from 23 the American College of Medical Physics. 24 I, while endorsing the remarks made by Dr. Order, 25 I also came prepared to identify a few areas in the proposed Meritage Reporting Corporation (202) 628-4888
40 '- 1 draft ~ documents that need clarification, but more so - 2 1 probably need further input from the appropriate individuals 'l,
'3 '
who are practicing out there in the field, whether they be i 4 representative clinicians, physicists, technologists. 5 . I am somewhat puzzled by the emphasis-on simple 6
- human errors. I think one needs to define a little better. .
7 : The implication is that there are more serious human errors 8 2 that the' Agency does not know how to handle, so they want to. 9 start by addressing simple human errors. 10 I have always been puzzled over the years by the 11 term " misadministration." Would this program have been more 12 I accepted by the community if'one chose a reporting mechanism 13 : of incidents rather than misadministration, but it's worth 14 thinking about. And this whole question of the reporting 15 2 levels. s A6 But in giving you some specific comments, I would 17 1 strongly urge whichever group works on this that you 18 separate the diagnostic and therapeutic incidents -- and I'm 19 going to keep referring to incidents -- with clearly defined-20 reporting requirements. I think we will endorse the concept 21 written in Alternative 3 regarding patient notification to . 22 be left entirely in the hands of the physicians. 23 We feel that listing of the reportable events as 24 in Alternative 3 appears to be too exhaustive. The whole 25 sections in all Alternatives on errors in brachytherapy Heritage Reporting Corporation (202) 628-4888
l , 41 1
- 1 procedures is very difficult to follow, rather cumbersome and probably whoever has written this is also very confused 73 -
and not knowledgeable enough on brachytherapy procedures. 4 And last but not least in those-sections, it is 5 not at all clear why incidents relating to an individual
. 6 fraction of an individual treatment need to be reported.
7 I"m very curious to find out from the NRC are they just 8 trying to get a handle on the statistics or the numbers of 9 times that somebody makes a simple error but corrects it the 10 next day, or are they really concerned about the welfare of 11 the patient. 12 - I have some comments pertaining to the regulatory 13 guide and the pilot program, but I'll save that for a later 14 time.
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DR. CHASE: Dr. Paul Chase from the AmericLn 16 / Osteopathic College of Radiology. 17 1 I would just like to support Dr. Order's remarks 18 and ask the panel to please consider the fact that under the 19 DRG system at the community hospital level, there is severe 20 shortage of personnel in all areas, particularly technical.
. 21 : And any rules that you impose will be difficult to 22 administer because of the scarcity and lack of technical 23 help to take care of patients. We barely have enough 24 technicians to do the clinical work, let alone unnecessary 25 QA. .
Heritage Reporting Corporation (202) 628-4888 1
l 42 ** 1 r of course there has to be radiation protection and . 2 ; there has to be necessary quality assurance. And that is 3 why we need physician and expert radiology physician input 4 - into any rulemaking. So I would support Dr. Order in all of 5 his statements. 6 ' Thank you. . 7 DR. KHAN: I think the major problem -- 8 MR. MCELROY: Identify yourself. 9 DR. KHAN: Oh. Faiz Khan. I'm representing the 10 AAPM, I'm President. Elect. 11 I think the major problem with this QA program 12 : here is simply of reporting misadministration. I think that 13 is a sticky point. There's nothing wrong with developing QA 14 guidelines and as a matter of fact, good institutions 5 already have them. But to report ten percent error in 16 2 teletherapy or 20 percent in brachytherapy and report errors 17 L in fractionation, I think that's the part that we have to 18 deal with. 19 I agree with some of the remarks before that if 20 there's an error of ten percent, it may or may not be 21 consequential depending upon the circumstances. However, . 22 this is true that ten percent is unacceptable in terms of 23 dose delivery in teletherapy, that's correct. The reporting 24 is the problem. 25 Twenty percent of brachytherapy, here I think Heritage Reporting Corporation (202) 628-4888 i
** 43 . 1 there'~s some misunderstanding because if you are talking 2' about 20 percent in accuracy of dose calculation, I think 3 4- that probably is unrealistic. However, if 20 percent error 4 . we're talking about simply what was calculated like the time 5 was calculated, and then by mistake the time was given . 6 wrong, that's a different thing. I think that kind of an 7 error can be eliminated, what you have been calling the 8 simple errors, by double checking, or whatever.
9 So I think if we concentrate on the reporting 10 problems, I think we'll be all right. A QA document I think 11 the development of a QA document I think the physicians of 12 - course, physicists, NRC officials, they can all get together 13 and develop an acceptable document. 14 The last thing that I would like to say is that
'S
- none of these things make any sense unless we have the 16 : proper people to carry out the QAs, evaluate the QAs and so 17 : on. There are facilities which are operating right now 18 without much physic support, without technical support and 19 so on. I think the document, the QA document which will be 20 required of those places would improve their practice, would
. 21 . minimize errors. The reporting problem, that's a legalistic 22 : jungle and I think that's one thing that we have to deal )
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. :2 3 ' with here.
24 Thank you. 25 DR. COLLINS: Any other comment? l Heritage Reporting Corporation j i (202) 628-4888
I i 44 ** { 1 Oh , Dr. Laude, yes. .
-2 Dr. Laude will make his presentation.
1 3 k 4 - 5 6 . 7 8 9 10 11 12 - 13 -- 14
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35 f t 16 5 17 - 18 19 20 21 . 22 23 ? Heritage Reporting Corporation (202) 628-4888 ____________-_______-______-___.-_a
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. l' STATEMENT OF DR. JOHN LAUDE Good morning, Mr. McElroy and members DR. LAUDE:
l- 3 of the subcommittee. My name is Dr. John Laude. I must A 4 apologize for being late. I ran into a ai cab driver who 5 was a Chicago Bear's fan.
. 15 I'm the Director of the Department of Nuclear 7 Medicine at Elmhurst Memorial Hospital in Elmhurst, Illinois ~
8 and I'm here today on behalf of the American' College of 9 Nuclear Physicians and the Society of Nuclear Medicine as a 10 member of the joint ACNP and S&M task force that develop our 11 formal comments to the NRC on both basic and comprehensive 12 quality assurance proposals. Additionally, I serve as 13 Chairman of the ACNP Quality Assurance and Practice 14 Certification Committee. p' This Committee is responsible for reviewing the ( 16 practice of nuclear medicine and recommending mechanisms and 17 procedures to insure the maintenance of high quality in 18 nuclear medicine, and for conducting voluntary inspections 19 and practice audits of nuclear medicine practices to certify 20 the degree of compliance with the guidelines for quality
, 21 assurance in nuclear medicine practice as published by the 22 ACNP.
23 These guidelines overlap the requirements of other 24 accrediting and licensing agencies. The college and society 25 are extremely proud of our commitment to quality and believe 1
.Meritage Reporting Corporation (202) 628-4888
46 ** 1 that the record of nuclear medicine demonstrates this .
,2 quality. I'm here today to provide the subcommittee with a organized nuclear medicine's views on the NRC's role in 4 i assuring quality in the medical use of byproduct material 5
and to comment on the NRC's misadministration reporting 6 rule. . 7 As regards quality assurance. The college and 8 society jointly submitted comprehensive comments on the 9 NRC's proposed basic and comprehensive quality assurance 10 requirements for medical use. Together with oral 11 presentation before the advisory committee and the 12 a commissioners, these comments stress that the NRC should 13 t avoid adopting burdensome costly prescriptive regulations in 14 an effort to reduce the already extraordinarily low rate of 35 : diagnostic and therapeutic misadministration. I h id e We argued that the NRC's proposed quality 17 assurance regulations are unnecessary and would constitute 18 the unprecedented NRC intrusion into the practice of 19 medicine. Dr. Carol Marcus, who appeared before the 20 advisory committee last January told you that in her 21 voluntary pilot test of the NRC's proposed basic QA $ 22 regulation, she found that it would adversely affect the 23 timeliness, appropriateness, quality and cost of medical 24 care. And that contrary to its intent, the proposal would 25 not decrease the already low incidence of misadministration. Heritage Reporting Corporation (202) 628-4888 L_.
.* 47 1 - The advisory committee headed the recommendations 1
of the college and the society and suggested to the 3 Commissioners that the nuclear medicine community is doing a 4 . good job in the area of quality assurance. And that if 5 anything, the NRC should adopt performance standards rather
, 6 than prescriptive regulations.
7 I must reiterate our major concern at this point. 8 We believe that the NRC has a mandate to regulate the 9 radiation safety of workers, patients and the general public 10 but that it does not have a mandate to dictate how medicine 11 is practiced. Recent activities we have learned about 12 within the NRC have led us to believe that the NRC is 13 embarking down the road of medical intrusion contrary to its 14 own medical policy statement.
.i 7 While we have the highest commitment to quality 1
16 1 assurance, we will not respectfully tolerate further 17 r. unnecessary and unwarranted NRC intrusion into nuclear 18 medicine practice. 19 The NRC has asked the Quality Assurance 20 Subcommittee to consider the types of performance based
. 21 quality assurance criteria that should be specified in the 22 -
regulations to avoid, detect and correct s.imple human errors
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23 in medical use. While perfection is unattainable, we would 24 suggest that the NRC look to the seven principles outlined 25 in the American College of Nuclear Physicians Practice Audit Heritage Reporting Corporation (202) 628-4888
'48 *. .)
1- ' Manuals We do have copies of those available for you if-you. '.
'2- u. have not: received same.
b tJ 6 . Firstly, theJnuclear medicine consultation should be performed by:a' qualified nuclear-medicine' physician who 4 : 5- e is responsible:for performing procedures in the best 6 interest'of the patient. . 7 : Secondly, the patient records shall be accurate 8 t and complete and-responsibility for each significant. 9 component of patient. consultation report is traceable. e. 10 Thirdly, that all nuclear medicine procedures 11 shall be identified and described in a technical procedure 12 manual. 13 = Fourthly, the physical facilities and practices in 14 " a nuclear medicine department shall be sufficient to 05 : maintain the dignity and safety of both patients and I16 e personnel. Adequate space and equipment shall be provided. 17 n Fifthly, procedures insuring control and recording 18 of the components of nuclear medicine imaging processes 19' shall be followed to assure image quality sufficient for 20 diagnoses. . 21 Next, the quality of pharmaceutical shall be . l 22 controlled, specifically radiopharmaceuticals. 23 And then finally, the quality control systems of 24 the nuclear medicine radioassay laboratory shall be designed l 25 to assure the medical and analytic reliability of test data. Heritage Reporting Corporation (202) 628-4888 L
= _ _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ - _ _
7* 49 J. ' ' 1 10 All of~these principles are supplemented with further guidelines and recommendations. We would recommend 3- that'the NRC simply adopt a requirement that-each byproduct 4~ licensee implement and maintain a quality assurance program 5 that espouses the seven principles plus a few modifiers that
- c. 6 are identified above.
7 The NRC should not however prescribe how-that 8 program should be fulfilled. Such decisions must be'left to 9 the discretion of the director of the nuclear medicine 10 department who must have the flexibility to achieve quality 11 assurance standards that meet-the needs"of.his or her 12 department and patients. 13 It is difficult to address withinithis oral 14 - presentation the complex balance between NRC's appropriate i radiation protection mandate and the inappropriate intrusion ( 16 1 into nuclear medicine practice or any medical practice. 17 # Further NRC action other than a simple requirement that'each 18 licensee must have and follow a QA program is unnecessary. 19 The NRC should not adopt prospective basic QA steps for the 20 licensee to follow.
. 21 L As regards the pilot program. The NRC has asked 22 L for comments on the number and type of hospitals or clinics
' ~ 23 that should participate in the pilot program and what l l 24 information should be collected during the private program 25 study. The college and society believe that the NRC should Heritage Reporting Corporation (202) 628-4888 ( i
50 *- 1 { 1; strive to obtain at least five pilot participants from each '
- of the following types of hospitals. i 3 - First, from academic medical centers stratified by 4' -
region, private versus public and urban versus rural. 5 Secondly, large community hospitals of over 500 beds 6 stratified by region, urban versus rural, and profit versus . 7 - non-profit type of hospitals. Third, medium community 8 ;. hospitals of 250 to 500 bed size stratifit 2 by region, urban 9 versus rural, profit versus non profit. Fourth, small 10 community hospitals under 250 beds in size with the same 11 level of stratification. And then finally, VA and other 12 = government hospitals stratified by region, urban versus 13 e rural, and bed size. 14 The types of information collected by these pilot f' s participants should be whether the QA standards enhance 1 16 2 quality and safety, what were the impact of the standards on 17 timeliness and cost of service, and whether the standards 18 are workable or burdensome, a cost benefit analysis and j 19 other alternatives. 20 At this point I would add that Dr. Order' s l 21 recommendations for a comprehensive study of quality . 22 assurance across the country is a good one.and is supported 23 by the ACNP and the S&M. 24 As regards misadministration reporting 4 25 requirement. As you know, the college and society oppose (~. Heritage Reporting Corporation (202) 628-4888 i L_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
** S1 .' 'l the NRC's reporting requirement for diagnostic misadministration. We believe these errors occur so 3 2 ' infrequently, that'is, about 1 in 10,000 doses administered 4 -
per year that the NRC's administrative expenses needed to 5 run this program are not justified. l
. 6 As the NRC has correctly noted, diagnostic 7 misadministration do not pose a clear hazard for the 8 patient. Requirements for reporting diagnostic 9 misadministration serve only to diffuse the focus and 10 deflect the impact from'the more important problem of 11 therapeutic misadministration.
12 In view of the documented exemplary record of 13- nuclear medicine, we believe the diagnostic reporting rule 14 is discriminatory and should be deleted. f With regard to therapeutic misadministration, we 16 a believe the patient notification requirement should be 17 e deleted. A decision to notify the patient of a therapeutic 18 misadministration and its effects should be left to the 19 referring physician. 20 In conclusion, the college and the society urge l
. 21 the NRC to exercise caution in the development of quality 22 : assurance standards. Any standards adopted should be 23 generic, flexible, cost effective and amenable to change and 24 updating. Finally, licensees should be allowed the 1
25 flexibility to implement quality assurance programs
. Heritage Reporting Corporation (202) 628-4888 w_____ _ - _ _ _ _ _ _ _ _ _
s t 52l *- l- .1 'according to their own'needs and resources without heavy handed prescriptive steps' dictated.by the NRC. II.. 2 3 C Thank you very'much for'this opportunity.to l 14'- I present our, views. 1
-S 0 Comments? . Questions?
DR. COLLINS: i 1 6' 1 Yes? .. 7 -
.MR. HERMANN: My name is George Hermann. -I
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8: E represent the College-of;American~ Pathologists. 9 And I.would like to ask:any members:of:the 10' committ'ee, in view of the data on.pages 2'and 3' documenting
.11- 23 diagnostic' misadministration over the past nine years, 12f a and furthermore an estimated number of diagnostic doses 13 L administered on the order of ten million per year, _ what I
14 ;- thought has been-given to the statistical. implications of-
. )5 1 this in the pilot program, and do you have an idea of how
-(16 2 much data that one needs to demonstrate a true decrease in 17 - E the diagnostic misadministration brought about by the 18 adoption of your quality assurance?.
19 DR. COLLINS: Do we have any. comment or answer to 20 this question? 21 - We will have a discussion of the pilot program . 22 later.on and that question should come up, and you might 23 raise it again at that time to be sure you do obtain an 24 answer.
- 25 No other question or comment at this time?
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53 l + Yes? DR. SUNTRARALINGAM: I have a general question to 3 - the NRC staff. I think one of the mandates from the 4 previous hearings was to work in close collaboration with 5 professional colleges and organizations. I was wondering . '6 whether the NRC staff can brief us on has there been or have 7 there'been any open discussions with the different' 8 professional colleges or organizations or.is this the type 9 of forum their presentations are being made. 10 DR. COLLINS: Mr. McElroy, do you have a comment? 11 MR. MCELROY: Yes. .This is the initial forum for 12 , those who are interested and expert in this topic to come 13 forward and volunteer their assistance. We will move 14 2 forward from this meeting to work with the individual ( c identified by each organization to allow them to help us 16 t improve on our regulatory efforts. 17 r It sounds like we haven't done & very good first 18 job here. We are very anxious to not do something that 19 would interfere in patient care. That's clearly the case. 20 But it should be noted that the Commission is concerned . 21 - about quality assurance. Most recently, we got the report 22 . of a case that was just uncovered about two weeks ago. ~ 23 Again, radiation therapy, a cobalt source was replaced and 24 the physicist who was using the treatment planning computer 25 didn't put the new source strength in the computer. And Heritage Reporting Corporation (202) 628-4888
54 ** 1 approximately 33 patients were affected over a 15-month . 2 r period. So we've used the term, human error, to
'J -
characterize that kind of thing. The term, blunder, has 4 been used. 5 This is the kind of thing we are grasping for at 6 this juncture. The more esoteric details or the fourth . 7 significant figure in your calculations might be left for 8 the comprehensive rule. 9 The commissioners perceive there is room for 10 improvement in the medical use of byproduct materials and we i 11 are here today to get your thoughts on how to best provide 12 - or assist in improvement of medical use. We appreciate your 13 I comments and we certainly appreciate Dr. Order's comments . 14 We are here to work with you. J5 " DR. SUNTHARALINGAM: I' d like to respond again. kto L It is somewhat distressing, but maybe that is how the 17 2 Government bureaucracy works at a slow pace. It takes this 18 much time, it has been almost nine months since the January 19 meeting and then the April meeting, but no attempt has been 20 made to have some sort of a roundtable discussion. l 1 21 I mean, we are all concerned about quality - 22 assurance. Every organization that is dealing with the uses 23 of radiation in medical care has some effort going on 24 pertaining to it. In the area of human errors, I think it l 25 is well established and documented in every discipline Heritage Reporting Corporation (202) 628-4888
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. 1 irrespective of whether it is medicine or otherwise, that there is going to be a certain small percentage of erro.s 3 performed by human beings who routinely do the same work day 4 in and day out. The question is what sort of program will 5 detect this, how can it be corrected, and what sort of
. 6 impact does this have on the outcome of treatment or 7 diagnosis for the patient.
~
8 Now, the appropriate personnel who can address 9 this are those of us who have been working in these areas
' 10 over the years and have tried to develop some programs. I 11 think, I will again strongly endorse the approach being 12 offered by the American College of Radiology which serves as 13 an umbrella organization for all of us in the practice of 14 use of radiation in medicine that let's get our act together, put a working panel together and come up with a 16 < document that will be acceptable both by the community that 17 e uses radiation in medicine and the regulatory agencies who 18 are trying to regulate the use of radiation.
19 MR. MCELROY: Dr. Khan? 1 20 DR. KHAN: Along the same lines, I think there's
. 21 no doubt that there are errors being made and it was 22 documented. There's no doubt that some places some 23 substandard radiotherapy is being done.
24 So I don't think we have any problem with the fact 25 that we should develop a QA program that will satisfy the Heritage Reporting Corporation (202) 628-4888 j i l 1
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56 1 agencies and satisfy the licensees and everybody concerned. . I would suggest that we should scrub the reporting
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3 -
. requirements. That's my main concern is the reporting 4- 1 requirements, and I think no problem with developing a nice 5 QA program.
6
- DR. COLLINS: Dr.. Laude? -
7 - DR. LAUDE: Dr. John Laude.
^
8 : Gentlemen, I realize that talking about quality ! 9 assurance is something almost akin to motherhood, the flag 10- and apple pie. I can understand the Federal concern-11 'regarding quality assurance when we're giving radiation to 12 ;'
' human beings, particularly American human beings.
13 N I feel strongly that there is good quality in the 14 L community right now In spite of recent reports in the Wall ( 5 Street Journal, I think the mandates of the Joint Commission 16 O on Health Care Accreditation or rather the Joint Commission 17 C of Accreditation of Health Care Organizations, JCAHO, those 18 mandates are very clearly stated, at least for nuclear 19 medicine. I will not cominent on how they relate to 20 therapeutic or diagnostic radiology. 21 But as regards nuclear medicine, they specifically - 22- state that one will have a mechanism in a systematized 23 fashion in place to find problems in the delivery of patient 24 care, to propose solutions to those problems, and to further l 25 follow up on those solutions as to their effectiveness. And l' Heritage Reporting Corporation (202) 628-4888 i 4 i N__.--__-_--
+' 57 1 -
that there must.be an annual reappraisal of such a program 2 in place. t 3 In my role as a second in command and then finally 4 - chief of a service of a nuclear medicine facility at a ; 1 1 5 community hospital outside of Chicago, several hospitals in.
] . 6 fact, I've seen many revisions of such quality plans. I've 7 been directly responsible for such quality plans. I 8 It takes a consistent vigilance, a constant 9 prodding of all concerned to make sure that such quality 10 plans are carried out. But they are carried out. It takes 11 a lot of snooping to find out if the quality assurance plans 12 : are not being met. I question greatly in this time.of a 13 very tenuous Federal budget, at a time when we all sit on 14 the verge of more tax increases and a new administration 25 -
coming in if any Federal agency would really want to 16 e increase their regulatory concern to the point of being able 17 m to hire enough investigators to perform the incredible task 18 of being able to verify that all concerned are in fact doing 19 their quality assurance procedures. 20 We try to do this in the private sector, and I
. 21 -
think we're pretty good. The people that want to be good 22 f are good. The people that don't want to be good or don't 23 care, I don't know that anybody can make them care any 24 better. I don't know that you all will have enough 25 capability of being able to inspect those people effectively Heritage Reporting Corporation l (202) 628-4888 l i _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . J
58 ** 1 and really finding out that they're not doing what they're . 2 supposed to be doing. 3 - The JCAHO makes an attempt to do this. But I've 4 been beset by inspectors who ask me questions from flash 5 . cards. You all show me your flood field. What's a flood 6 field? I could have been showing him last year's Wall . 7 Street Journal Calendar and he wouldn't have known the 8 difference. I don't mean to belittle those people but 9 nevertheless I do point out they're not experts. 10 I think in the private sector, there is enough 11 expertise right now to be able to assist you in developing 12 ; prescriptive sort of guidelines. But I dor.' t think that we 13 , have any way that we can really say that a Federal agency of 14 r any sort will be able to adequately inspect to do what you 5 7 wish to do which is make sure there's quality out there. (16 r Only by encouraging all the efforts on the part of the 17 specialt.'r societies and making sure that those people who 18 are members are fully following that, and those that are not 19 members are engaged in making sure that they do follow those 20 guidelines will we have any progress toward achieving what 21 is mom, flag and apple pie, quality assurance in the . 22 administration of radioactivity to humans. 23 Thank you. 24 MR. MCELROY: Let me ask a question of you. 25 How should the NRC as a regulatory agency go about Heritage Reporting Corporation (202) 628-4888
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. 1 getting the attention of.those'that you mentioned who may j not be as interested in quality assurance as others are?
3 We have regulations as an alternative, we have 4 e policy statements, we have regulatory guides. Again, the 5 - Commissioners, it's my impression that they perceive room .. 6 for improvement and we' re open to whatever suggestions you 7 : have. But the Commissioners may want'a regulatory 8 alternative to get the attention of those who are not 9 demonstrating an adequate level of concern for quality. 10 DR. LAUDE: That's an exceedingly difficult 11 question and I hesitate to give you a fast answer. My first 12 - sense would be hit them in the pocketbook. Which would mean 13 - make it so that those individuals who do not want to 14 2 practice quality assurance in an effort to make.this problem g better,.those individuals who don't should be prohibited 16 c from engaging in the administration of radioactivity to 17 7 human beings in this country. 18 Now, how can I do that without disenfranchising a 19 lot of people, I hesitate to say. And I don't mean to be 20 flip in this answer, but I do believe that somehow there has . 21 a to be an economic incentive for this. 22 : And yet at the same time, we don't want more 23 Federal regulation. It's sort of a paradoxical situation 24 nevertheless. 25 MR. MCELROY: One that we will come to answer Heritage Reporting Corporation (202) 628-4888 i
60 *. 1- somehow. But it may well appear that we can simply levy . fines on bad people but the foundation of that alternative 3 L is a regulation so that brings us right back to the need for 4 some kind of regulation that provides the licensee and the 5 public fair notice of what is expected of licensees when-6 '~ they use material. . 7 J DR. LAUDE: My sense, and I am speaking as a 8 - private individual, now, not having conferred with my 9 colleagues from the S&M and ACNP on this. But my sense is 10 that a general open-ended regulation that thou shalt have 11 quality assurance procedures as a systematized program in 12 L place willing to find problems, propose solutions and 13 - correct those problems and follow up on all the above, which 14 serves a dual role then of satisfying the JCAHO requirement,
.I believe if such a regulation that was sufficiently loose 16 L would be written, this may be enforceable. At least it 17 + would go on the books saying, you folks want honesty in 18 this, you want to show results, you want to demonstrate that 19 the Federal concern regarding this is well taken and that 20 there is oversight to protect the public. At the same time, 21 though, you don't want to be so limited that you have .
22 regulations that say every i must be dotted and every t must 23 be crossed. 24 Which again brings up the old paradox of how far 25 do you go, and yet you want to go far enough to show Heritage Reporting Corporation (202) 628-4888 i
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.. 1- concern. I think a generality would be the best applied .
i situation if you're going to propose a regulation, say that I 1 3 you must have a quality assurance program in place.and it 4 t must be utilized and used specifically to find. problems. 5 - But outside of being able to knock people for the absence of 6- that program, I don't know that you'd want to get into any
- 7. more deep situations regarding quality assurance.
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8 Would that satisfy the Commissioners to have that 9 level of generality if I may ask you the question? 10 MR. MCELROY: I don't know what satisfies-the 11 Commission. We took the Commission a;very prescriptive rule 12 , that was in some peoples' opinicn incredibly ridiculously 13 , detailed, and the Commission gave us the general directive to 14 r preparo a performance based rule. A prescriptive rule talks about dotting i's and f{ 16 c. crossing t's and stopping at red lights and so on. A 17 v; performance rule is generally worded and provides for 18 flexibility. The increasw' flexibility it provides leaves 19 some honest individuals wondering exactly what they have to 20 do to comply, so one individual has argued that it's subject
.. 21 to abuse by the regulatory agency because it doesn't provide 22 -
a clear statement of expected programs or expected behavior.
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23 But I perceive that the Commission is leaning 24 towards this more flexible approach that you've talked about 25 and it's identified in some of our handouts. Heritage Reporting Corporation (202) 628-4888
E' 62 o. y 1 , 3 DR. LAUDE: May I point'out.that I misspoke 3 several minutes ago in saying, prescriptive. I think I 3 - meant to say, performance. 4 V If I may offer the assistance of our specialty; 5 society as regards diagnostic and therapeutic nuclear 6 - medicine, we have ways in place, we can help individuals who . 7 ^ feel lost out in the wilderness trying to' maintain good 8- W quality'. and we offer that service to all comers. 9 MR. MCELROY: Is that a program that's up and 10 running now? 11 DR. LAUDE: We have the quality assurance practice 12 d' audit program that's been in place since 1980. Since 1985, 13 W it has inspected 15 institutions including my own, and it's 14 accelerating slowly. It costs $650. Now, that's just an p L inspection program that certifies that an individual ( 16 laboratory is in compliance with the quality guidelines 17 m promulgated by the American College of Nuclear Physicians. 18 We are engaging in negotiations with the College 19 of American Pathologists to provide a conjoint inspection 30 service when the CAP goes in to inspect a clinical 21 laboratory facility, we would be called upon to inspect the . 22 - nuclear medicine facility when such inspection is deemed to
- 23. be appropriate. Again, that is in a negotiating state. We 24 would love dearly to be getting some sort of deemed status l 25 on the part of the JCAHO but in light of the recent adverse r\
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* 'l criticism'of the JCAHO, I'm not sure that the JCAHO would
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want to dilute.their power and strength further by giving ! i 3 more power to individual specialist societies.
'4 Nevertheless, we offer this service and we. offer it to 5 r- anybody who's sincere about quality. , 6 What we have noticed, though, is that the places 7 4 that really need it are not coming to us.
That's something 8 that worries us greatly, but nevertheless, if you folks were 9 to put out a-directive that says, thou shalt have a quality 10 assurance program by such and thus a time, or this will be 11 the penalty and leave it general enough, we certainly can 12 advertise very well that we offer this service to members of 13 our profession to assist them in setting up their own 14 programs. { : MR. MCELROY: Who conducts the audits? Is this a 16 r full time job for them, or? 17 r DR. LAUDE: The audits are conducted by practicing 18 nuclear medicine professionals, a nuclear medicine physician 19 who's been trained specifically in performing practice 20 audits will perform an audit. He'll bring along an allied
. 21 health professional specifically a nuclear medicine 22 physicists. On occasion, the inspectors have brought along ~
23 a chief technologist or other technology staff to assist 24 them. The inspections can take anywhere from a day to two 25 days, depending on the complexity and the size of the place Heritage Reporting Corporation (202) 628-4888
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1: to be inspected. .-
]
1 If you'd.like, I1 don't know.if Melissa provided.
- 3. I 'you with the Inspectors' Manual'but that does detail more-
- 4. . fully.the process of requesting an audit and. going through 5
'an audit, and also' details in great detail the points'that' 6 Y we look at in performingjsuch an audit. .
7 51 Dr..Hermann is a member-of.our effort, also, and 8 x has recently inspected the National Institute of Health here l 9 in Bethesda. He may.wish to say something. I'm not
- 10. certain.
11 DR. COLLINS: Dr. Webster has a question for you. 13 0 DR. WEBSTER: That's me. 13 % You have gone on record that you don't want 14 L reporting and you also said you don't want inspection E presumably by the'NRC. Now, .if there's a performance t{ 16 % standard which is the.way the ball is rolling, why wouldn't 17 5 ~you want the NRC-to find out whether indeed these 18 performance standards are being met? And they can only do 19 that by inspection. 30 DR. LAUDE: I can see what you're saying. 21 What I wish to say is I don't think you'd want to . 22 have an NRC inspector, in addition to all the other duties
.23 he has to do in looking at a licensee's recordkeeping, 24' safety programs, etcetera, that he should have to be engaged 25 in what may take for the average facility more than a day, Heritage Reporting Corporation (202) 628-4888
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.* 1- two days, whatever, to go through the quality assurance
[ minutes, the reports of the hospital-wide quality assurance 31 committee, and etcetera. I believe it should be the 4 inspector's role, if I perceive correctly how you may go, if 5 x you have a performance base standard that says, thou shalt
. '6 have such a thing in place, a quality assurance program in 7 place, I would perceive that the inspectors role would be to 8 verify that such a quality assurance program is operating.
9 How well it is operating, I would hesitate to make 10 any statement to you about what level you'd want to say is 11 the criterion of goodness. But I think as long as it can be 12 demonstrated that a licensee shows good faith in operating a 13 quality assurance program, has found problems in the course 14 of the operation of that program, has proposed solutions to
- those problems and has taken efforts to correct them, it's
{- 16 : my belief that that demonstration which can be done by 17 t probably reading for less than half an hour, I believe that 18 an inspector will be able to see whether these guys are just 19 buggering up reports or whether they're actually doing this 20 on a systematized basis regularly.
. 21 . I believe that the inspectors should verify that 22 -
and that should suffice.
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23 DR. WEBSTER: Don't you think that an important 24 ingredient of the inspection might be to look at what errors 25 may have been committed by a given institution and dig into Heritage Reporting Corporation (202) 628-4888
66 ' *. 1 that a+11ttle bit, as to why it happened and what actually .
.2 was taken subsequently?
( 3 : DR. LAUDE: I think as a sort of random sampling ! l e '4 basis, I believe that's what an inspector would have to do 5 to verify that the program was. working. It doesn't mean he 6 r has to do it.for every problem identified, no. I don't . 7 think that the resources are there to allow an inspector to 8 : take that kind of time. 9 DR. WEBSTER: Inspections are always done on a 10 sampling basis. I mean, in my institution inspection takes-11 three days and two or three inspectors. And I know, 12 ; everybody knows that they only detect a certain percentage 13 of what they.might detect if they spent six months. 14 n. And so it seems to me that'the head of the f a unveiling so to speak of what is happened that has gone i 16 r wrong would be something that they might look at. I don't 17 i see what you would have against that specifically. 18 DR. LAUDE: I personally have no problem with 19 anybody inspecting anything they want to inspect. I bear my 20 breast to anybody who wants to take a shot at it. I think 21 that's a part of the honesty of medical practice, and I will . 22 confess in front of God and everybody else here that I'm not 23 the perfect nuclear medicine physician. I just hesitate to 24 want to feed a need for more Federal oversight where such 25 oversight could be, how shall I say, too all encompassing, Heritage Reporting Corporation (202) 628-4888 I l
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- might"not serve the process that you have, the' God, flag and apple pie issue of safety in'the administration of radiation
=3 . to human beings. It might get us entangled in more L
.4 r regulatory problems.
5 Outside of a generality and a general kind of 6 -- performance criterion, I would hesitate to go any further, 7 , DR. COLLINS: We're scheduled for our break and 8 then we'll. continue the discussion. We've gone a little 9 over our time. Return in'12 and a half minutes and then 10 we'll pick this up. 11 (Brief recess is taken.) 12 DR. COLLINS: We'll call the meeting to order 13 again. It should be unnecessary to repeat but the purpose 14 of this meeting is discussion and not the imposition of any g a rule. -There is no rule that exists with regard to the 16 -o quality of administration that we're talking about.
-17 t Now, if the discussion here at the microphone 18 should be as warm as the discussion in the intermission, we 19 may be here for the rest of the week.
20 Dr. Order?
. 21 DR. ORDER: Dr. Order from Johns Hopkins, American 22 i College of Radiology.
23 Mr. McElroy, I would like to demonstrate to you 24 exactly the problem and how we could deal with it of what 25 you described. Heritage Reporting Corporation (202) 628-4888
o 68 *. 1
- You described an accident, which is.what I would .
4 frame it as, with a cobalt machine where 33 patients were 3 e treated with an inadvertent dose because of an error. The 4 u present rules would not take that into account.' 'If you went 5 : through the process that I would like you to go through, it 6 t would. And I'll try to demonstrate what I mean. , 7 s The first time you become aware of the error with
' i 8 u the 33 patients is after the 33 patients have been treated.
9 If you had asked a professional group to design a program 10 for you that would quality assess cobalt units when a new 11 cobalt source would go in, I would tell you to do the 12 following: 13 a When a new cobalt source comes in to a machine 14- that's already a standard machine after the computer program
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! is designed, then five phantoms must be treated with the
( 16 4 various dose distributions and dose descriptions that are 17 i going to be used in the facility prior to any patient being 18 treated. Immediately, that would have been picked up that 19 there's something wrong. The prescribed dose and 20 administered dose are incorrect. The accident would have 21 been prevented. - 22 And it's very hard to write that rule unless 23 you're in the profession. But if you're in the profession, 24 you would know that any new cobalt source that comes in, you 25 just don't put it in the computer, you run some phantoms l' Heritage Reporting Corporation (202) 628-4888
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.' I before*you start treating patients.
And I would suggest to you that if we had a 3- <- national survey, the first thing we would identify is we 4 would identsiy what is quality assessment. There's a lot of 5 t words being bantered-around but the actual format of what
. 6 quality assessment is in radiation therapy with cources and 7 all the other devices we have has not been stated. 'Given
^
-8 that fundamental quality assessment overview, which would
'9 tell us what the lowest level is and what the highest' level 10 is, American College.with the people from all the various 11 societies could then pick what the realistic level ic for 12 quality assessment.
13 That would give us a format. And then we could.go 14 - to the nuclear regulatory commission and say, okay, all the { major colleges and all the major people doing this kind of 16 ^ 4 work agree that this is quality assessment minimal 1988 and 17 t it may or may not be modified in the future. 18 Then we come to the second part. I'm not against 19 inspection at all. I never worry about inspection because 20 the idea of all of this is to improve the facility in the
- 21 care of patients and I'm all for that.
22 - So the next step is how do we assess this in the 23 different places. Do we have a volunteer physician group, 24 does the Nuclear Regulatory Commission spend money to send 25 people around. But until you have the product, until you
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.1' , know'what' it isithat1 you'want_in the sense'of what.is 'a- i E
,,- T quality. assessment, I don't see howLyou're:reallyl going to I.
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.3 get:it;- tI_ don't.think'you1can_ write itilike it was written 4 C in the abstract awayLfrom_ practice.' And I don't think 5 ' practitioners should be afraid to have it applied.
6 5 'So'the= answer is to define it.- Once having it - 7 4 defined,1then to hold people to that standard, and then the-8 - last question is how-to implement that. 9~ MR. MCELROY: Would the chance that this consensus. 11 0 standard might be used hence those who wrote it perfect what 11 appears in that standard? 13 # DR. ORDER: I don't think so because_you have to 13 : look at the- history of the way things have worked out :in 14' L - radiology-in general throughf Vco11ege. We have faced a E variety of contingencies over the years and.have been able- _ g' S L 16 2 to bring uniformity to our field in a variety of ways. So I 17 # don't think so. 18 When R.V. Hughes came out,'which is a~ debate about 19 what we get paid, we got general agreement although there'll 20 be some people on the low side and some people on the'high 21 side, the profession accepted it. And I think you will get - 23 it accepted by the profession if you work with the 23 profession. I 24 MR. MCELROY: Dr. Khan? 25 DR. KILAN: Faiz Khan representing the AAPM. Heritage Reporting Corporation (202) 628-4888 __ = _ - - _ __ _ _._ ___ _ _ - _- ___ _ - _ - - _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ - _ _ _ - _ _ _ - _ _ . l
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.- 1 - It:was stated earlier that several agencies are
- , interested in the problem of quality assurance. JCAHO also 3 has a document right now that addresses the quality 4 . assurance. Is there any effort being made on the part of 5 . NRC to make these documents consistent with each other so
. 6 that there is no undue overkill or that they are compatible 7 - with each other?
8 MR. MCELROY: We are doing the best we can to use 9 existing standards as foundations for our work, and one 10 alternative which has been posed by some of the commentors 11 is to use some voluntary program or voluntary standard in 12 place of one drafted by us pointy headed bureaucrats in the. 13 ivory tower. It might be more realistic,-it might be more 14 . palatable. Yes, we intend to use the literature that you ( ., refer to in this initiative the very best we can. We 16 3 certainly don't want to provide confusion or guidance that's 17 different from what other experts provide.
-18 DR. LAUDE: I would wish to -- I'm sorry, Dr. John 19 Laude.
20 I would wish to state or ask please, that if you
. 21 do develop some sort of performance standard and base it on 22 JCAHO or whoever guidelines, that you not stray into the
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23 issue of anything other than safety to the patient in the 1 24 administration of radiation. I believe that that is the 25 main purview that you have and your chief thrust. Heritage Reporting Corporation j (202) 628-4888
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I 72' ' L 1- I would very much caution against straying into . things that aren't touched on in JCAHO, specifically the s 3 appropriateness and the effectiveness of whatever service it 4 - is that is offered that involves the administration of 5 r radiation to human beings. Because then I believe you stray 6 L into the realm of the practice of medicine and I do not . 7 believe that that is the charge of the Nuclear Regulatory 8 Commission, unless I am in great' error. i 9 Also, I'd like to again reiterate, we welcome 10 inspections and we don't think that inspections per se are a 11 bad thing. 12
- DR. SUNTRARALINGAM: Suntharalingam from the 13 American College of Medical Physics. I had a couple of 14 2 questions to the NRC staff again, because when this program was first initiated, some of us did have serious concern as
[9 t 16 - to, one, would one really identify almost every 17 r misadministration that is happening within the United 18 States. 19 Obviously, it is a requirement of the report, but 20 my question to the NRC Staff is did the NRC Staff at any 21 time uncover during their inspection programs, any - l 22 misadministration that was never reported? That may be also 23 some useful info.:mation to look at the statistics of the 24 number of happenings. 25 The second aspect which I want to again emphasize l l Heritage Reporting Corporation (202) 628-4888
** 73 i' 1 is this whole quality assurance or quality assessment is 2 again a team effort. There seems to be a greater emphasis
..,- on the physical aspects, equipment related measurements, and 4 , .so on. It's something I think more than that, because even 5 . -these incidents that we now hear, whether it has affected a-
. 6 large number of patients, it might have been initial error 7 cn one individual's part.
8 But the delivery of that treatment centers around a large 9 number of people. Therefore, it impacts on sometimes even 10 common sense and' care being exercised by every team member 11 in the. delivery of treatment. So any program that we may 12 address, I think we need to emphasize the role played by 13 every team member. I 14 We from the College of Medical Physics, I think, 15 t would favor requiring all facilities implementing some QA
?
.s program if they don't have one. And that I think is also 17 m the requirement of the JCAHO. And make it available either 18 for inspection or at any time of application renewal of the 19 license.
20 Similarly, even incidents that happen, I'm sure
. 21 -
every hospital, every organization has some requirement 22 within their structure of reporting incidents and they
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23 define what are reportable incidents. Now making that list 24 of reportable incidents available during inspection will 25 also uncover and indicate wnat has been going on. l Heritage Reporting Corporation ! (202) 628-4888 _ _ _ _ _ _ _ _ _ _ _ _ - - _ - - - . - - . _ - - - -- - - - - _ _ _ . .- - __ m .
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+ Now, the question again, it may not be uniform but .
can one really_get approach it in a uniform manner. What is l l 3' an incident that a report has to be made, an in-house report 4 and filed with the administration of the hospital or the j 5 t health care organization. I think that is.what probably 6 - would be widely accepted than trying to spell.out very . 1 7 specific programs. 8 The one other statement I would like to make 9 regarding these redundant checks by second individuals, as 10 an example, that'll be useful only if carried out again by a 11 qualified individual. I think I was surprised to see a 12 L statement being made that it doesn't have to be a qualified 13 individual. Now, a second redundant check made by an 14 unqualified individual is of no value at all. ( a Now, also the whole discipline of providing 16 3 medical care to the patient is being influenced no doubt by 17 r high technology is advancing to the extent that there are 18 many players, there are many people who help the physicians 19 and each one is an expert in their area. So to say that 20 somebody else can double check someone else's work, I have 21 some serious concern whether a technologist has enough - 22 knowledge to double check the work of a physicist, I might 23 even at the expense of being criticized by my physician 24 colleagues, I think they have their job to do which is to 25 provide medical care for the patient. I doubt very much (' Heritage Reporting Corporation (202) 628-4888
u e* 75 1 .*l 1 .that'today a physician would.be able toidouble check a very- [--
. complex ~ calculation that is done by a physicist using a 'i 3 computer.
l 4 t- So this whole question of double checking and 5 - redundancy raises another whole area unless'you have the
. 6 -- qualified suppor. personnel. This will become a burden to 7 society.
8 DR. STANTON: I'm Robert Stanton, a physicist at 9 Cooper Medical Center in Camden, New Jersey. 10 One point that hasn't yet been addressed which I 11 think ought to be addressed in our evaluating how to 12 regulate, is.the question of the inspectors or regulators 13 themselves. 14 In reading the-several.different versions of the proposed rules, I've noticed various levels of detail that 16 L are required to evaluate programs, the latest being a less 17 r- detailed amount of detailed, a less detailed' approach. But 18 in all of them,'the performance based criteria of saying a 19 certain dose level must be breached to have a problem, and 20 therefore that has to be evaluated, reported, etcetera,
- 21 1 assumes that the investigator \ inspector can make an 22 evaluation of what dose level has indeed been reached. . ;i, 23 It implies that when a person come'in, for A
24 example, scenario, you write a couple of letters about l 25 various incidents during the year. An inspector comes in.
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_ _ . _ - _ _ _ _ _ - _ _ _ _ _--____________-_a
76 '- l' .I havei no qualms withithe NRC inspectors. They are well , 2 trained for what is currently required of them in the-areas f 4 of safety. .They come in to,the institution and have to 4- evaluate a medical situation. Exactly what dose was given 5 to that person's media stannum.through the'three field 6 cobalt plant. Was 'it indeed ten percent off-the first . 7 > treatment? Was that reported properly?- Or was there an 8 incident that happened that wasn't reported? 9 This is-one that goes to the level of management-10 oversight, one of the most important areas of evaluation of 11 safety programs. Were people covering things up? The V inspector who comes in has to be able to evaluate, if we 13 13
- promulgate such a regulation, was an error made? How bad 14 was the error, etcetera.
,15 I. don't think we have the current training among
.t o i NRC investigators to be able to evaluate those medical l 17
- questions, dosimetric questions particularly. If we have i
10 such a regulation, we must have investigators who can do 19 this evaluation. That would imply that the investigator 20 coming out should have medical 6xperience, physics training 21 at at least the level of a dosimetrist. Looking at the - 22 field as a whole, there aren't sufficient personnel to do 23 that task. 24 Setting aside whether they ought to do that task, 25 now, I want to address this little question, this technical Heritage Reporting Corporation (202) 628-4888
.* 77
.- - l' question.- Can this regulation in any format be done? Can there be enough people to do the task? In looking at the 3 number of jobs for medical physicists going unfilled, the l 4 7 number of jobs in my area for. therapeutic-. technologists and 5 ,7 dosimetrists, there are just not enough trained people to do
, 6 ,
it. 7 We need more trained people to do these tasks for 8 the patients. I don't think there are people'around who 9 have that expertise who can do investigations. I think 10 we're putting ourselves in a situation where we say, yes, we 11 need to do quality assurance. Big brother.has to look over 12 your shoulder to make sure it gets done. We can question 13 whether tha+.'s necessary. I think the proposals of peer 14 review are better.
.But if we say in the affirmative, big brother 16 e needs to look over our shoulder, does big brother know what 17 e he's doing, or she's doing? Sister -- well anyway, that's 18 the question. I don't think it can be implemented even if 19 its' agreed to and promulgated. !
20 If we implement such a program with insufficient
. 21 e personnel, then we get into the question of a bureaucrat )
l 22 coming out, not knowing what they're doing, and just 23 stamping a fine of $2500 and that's totally the wrong 24 direction to go. It's against the way whatever 25 administration's getting elected wants to go. But it's also Heritage Reporting Corporation (202) 628-4888 l l l
78 1 against the way that medicine should go. . DR. COLLINS: Dr. Khan? 3 DR. KHAN: Faiz Khan representing the AAPM. I would like the NRC staff to give me this reasons 4 5 2 why this reporting the way they have suggested is important 6 in this endeavor compared to if there were a system in which . l 7 1 an inspector could come in and see a log book and which, if i 8 there were any errors made, were recorded in that log book, 9 could go over it as to what happened, and may suggest that 10 your quality assurance program probably is not adequate or 11 whatever. 12 1 I would like the staff to tell me why the way 13 they're asking for that the incident has to be reported 14 within a certain time frame, and then it has to be reported
;' a to the patient, to the doctor, I would like to hear 16 -
something in favor of that. Because I cannot comprehend why 17 2 is it important to do all these things compared to just 18 keeping a record of what is happening in your QA program. 19 MR. MCELROY: Dr. Khan, the reportable events 20 appear in the regulatory text. I would like to note that we 21 have reserved time in the afternoon to discuss that. It - 22 appears in the text as an attempt to frame the scope of the 23 QA rule. But I repeat, we do have time set aside in the 24 afternoon to discuss some very important things that have 25 been raised regarding the reporting requirement. It is a Heritage Reporting Corporation (202) 628-4888
79
. fl. separate section.or separate topic for us.
DR. COLLINS: Dr. Griem? 3 DR. GRIEM: Yes, Dr. Griem on the Advisory Board. 4 I would like to ask the question of several of the 5 1 people here in the audience whether there is a database'out
.- 6 -
there in the NRC or in the NIH of these events and can we 7 - give any demography of where these events are occurring? 8 Are they in cancer centers?- Are they in small hospitals? 9 Are'the hospitals of a thousand beds or-200 beds? Are they 10 urban or are they rural? And I want to address specifically 11- in radiation oncology'these incorrect administrations of 12 dose called a misadministration, and whether we should be 13 focusing what we finally develop at the specific area of-14 where the problem lies. MR. MCELROY: Kathy Black from our Office for { 16 c Analysis and Evaluation of Operational Data has helped do 17 some report analyses. She might have some information on 18 this. 19 MS. BLACK: Yes. My name is Kathy Black of NRC, 20 the Office for Analysis and Evaluation of Operational Data. - 21 - We enter records of all the diagnostic and 22 misadministration reports that we receive from NRC licensees 23 into a database. 24 DR. GRIEM: I'm interested in the therapeutic 25 ones. Heritage Reporting Corporation (202) 628-4888 I
80 - l' MS. BLACK: Okay, let me first discuss- . diagnostics, since'I looked at those, and then perhaps talk
' s -?
' bout therapy misadministration.
L4 H I looked at the distribution _of diagnostic 5 r misadministration as.a function of hospital'bedLaize'and 6 that was a substitute measure for the number of . 7 misadministration of diagnostic procedures per year. 'And I-
~
8 could find no group that stood out'in terms of having a very 9 large proportion of misadministration. The only group that 10 might appear to have a statistically large number were 11 hospitals of 100 beds or so where even one single 12 U misadministration would appear to elevate them to some high 13 > level. 14 # In terms of therapy misadministration, we've not n done the same kind of study because we had fewer than 35 fks
- perhaps 50 reported. Now, except for three or four cases 17
- where there are multiple misadministration at a single 18 hospital that could be classified as a singular event,.even 19 though the event occurred repetitively, where there were 20 errors in computer programs, where there were errors in 21 wedge factor evaluations, we probably have not had any 22 hospital with the possible exception of one that has had 23 more than a single therapy misadministration that was 24 reported to us.
25 I cannot tell you that -- well, this most recent Heritage Reporting Corporation (202) 628-4888
l, I a' . 81 I CLi l' - one that Norm spoke of which was in an reement State was 4 probably a small hospital but I cannot.tell you.that these 3 are very small hospitals where these. occur. In many cases, 4 these are fairly large hospitals. But we have not. looked at 5 4 them. They are a small enough number, though, that one
. 6 1 could do a detailed review of the hospital size which is 7
- easy to obtain and attempt to get the number of therapy 8 procedures' performed at the hospital. But that has not been 9 done for the therapy misadministration.
10 DR. WEBSTER: I think that question that's been 11 raised and your answer is significant for the choice of 12 , which kinds of hospitals would you include in a clinical
.13 trial and what would the weighting be. I mean,-if all these 14 -
things happened in small community hospitals, that would be one thing; if they happened in university hospitals, it's 16 e something else. And you'd like to know. 17 r MS. BLACK: Yes. Well, going back several years 18 ago when I did the study, the hospital that had reported the 19 most diagnostic misadministration, and that was the only 20 one I really looked at, one of the ones was in St. Louis and
. 21 -
it was a combination of Jewish hospital and I've forgotten 22 the other hospital that's associated with it. Is it the St.
~
23 Louis Hospital is it, Norm? But they had 17 24 misadministration, but because they had so many beds, that 25 was not an unusual number to have reported.
, ' Heritage Reporting Corporation (202) 628-4888 o ;
82 '. 1 I mean, you may argue about whether it's a good .
,' number or not, but if you just turn the number crank, it did 3 - not appear to represent an excessive number of 4 - misadministration. There are well, another thing that you 5 should perhaps be aware of that only a relatively small 6 fraction of licensees have ever reported a single .
7 1 misadministration. Diagnostic I'm now talking about. it 8 goes without saying that if you have only -- I don't know 9 what the number is -- 33, 27, therapy misadministration, 10 that very few licensees have reported any. But fewer than 11 50 percent of NRC licensees have ever reported a single 12 :- misadministration over a six or seven year period. 13
- So it is very hard if you were going to sample, I 14 . don't know, one percent of the hospitals, and i have no 3G : idea of what number is being thought of in terms of this 1
16 r test program, that the question of how you select these 17 - relative to the distribution of misadministration is 18 something to look at. 19 And again, the only easily available variable that 20 I had was hospital size, which is not really a good measure 21 perhaps of the frequency of the use of diagnostic - 22 procedures. I mean, if you have a cancer center perhaps you 23 have many more administrations ordered per bed than you do l 24 in a general hospital in a very small community in the 25 western states. It's just hard to know how to do this. Heritage Reporting Corporation (202) 628-4888
- .* 83 1 F But we can certainly retrieve for you and for the study where all those misadministration have occurred and 3- -
we can append to.that hospital bed size and I think Norman 4 and some of his people have been doing that so you can look 5 e at the distribution of where these things occur.
. 6 4 DR. SUNTRARALINGAM: Dr. Suntharalingam from the 7 .
American College of Medical Physics. In response to the 8 question being asked about are.there any specific regions or 9 specific facilities, my remarks would be, I think you'll be 10- treading on very dangerous ground if you try to identify any 11 particular type of facility or region. 12 These type of human errors that have been reported and have 13 been documented, if one looks at them, that type of error 14 - could' happen anywhere, because it was either misreading a ( a physician's prescription or making an error in calculation-16 e or forgetting to put in a particular factor into the 17 u computer. That could happen anywhere. 18 Now it has happened also I think in different 19' spectrum of facilities. But what one has to I think try to { 20 find out is, based on the evidence that we have to date, and . 21 a that's why I asked the earlier question, has the NRC 22 inspection program identified any incidents that were not 23 reported, and since I didn't get a response to that, my 24 assumption is that there are no such incidents or j 25 misadministration uncovered by the inspection program, so Heritage Reporting Corporation (202) 628-4888
84 - 1 that we have a reasonable handle on the number of incidents . [ that-have been reported. 3 - MR. MCELROY: There have been a handful'of 4 ; -incidents that were uncovered during our unannounced 5 compliance inspections, but they do not change the apparent 6 frequency of these events. . 7 U DR. SUNTHARALINGAM: The handful implies that it 8 is less than those that have been reported? 9 MR. MCELROY: That's correct. But of course, it's 10 also been pointed out that we just spot check here and 11 there. We don't do a rigorous examination when we make our 12 visits. 13 DR. SUNTHARALINGAM: I think the thing that we 14 - need to emphasize is the impact of try to develop anything g a new-to the society in terms of do we have adequate trained 16 L' personnel. And that was emphasized by Bob Stanton. Because
'17 : even this recent incident, and if I am talking about the 18 same incident that was reported about an Agreement State, 19 now there was a clear indication that an unqualified 20 physicist was hired by another senior physicists, put down 21 into the radiation therapy department and asked to function -
22 as a radiation therapy physicist. 23 Now, he made a mistake putting something into the 24 computer. It affected only those patients where that factor 25 had to be used in the computer program. But I still Heritage Reporting Corporation (202) 628-4888
e* 85 i
;* 1 . question the inadequacy of the entire team that was j . delivering the type of care there not to have identified 3 during the five months or six months or.whatever time frame 4 .it was that such an error was continuing to happen on a
.5 ; certain series of patients.
. 6 So, again, I want to emphasize this whole thing.
7 will alter the impact on count, the availability of 8 qualified personnel, be they physicians, physicists, 9 technologists or even administrators. 10 MR. MORTON: I have a few things to say in this 11 regard, but first I'd like to -- 12- MR. MCELROY: Identify yourself? 13 MR. MORTON: I' m sorry. Bob Morton from the 14 - National Cancer Institute. First, I'd like to disagree that the NRC data bank ( 16 n indicates where the most misadministration have occurred. 17 They only indicate where the most have been reported from. 18 And I would think that they only get reported if the 19 caught. And they're only best caught when there's qualified 20 people running a quality assurance program. So we now know
. 21 ; where the best programs are.
22 These of course are generalizations, but it 23 - certainly follows along that you don't catch something if 24 you don't look for it, and you have to be qualified to know 25 to look. Heritage Reporting Corporation (202) 628-4888
86' .
- 1. w One of;the. places where some of this data does .
( - exist in'a scientific study is the Patterns of Care' Study j
^)3 that was performed by the American College of Radiology l L 4 '
under a grant from the National Cancer Institute over a 5 number of years. It's now presently been refunded as a 6 contract to the Cancer Institute. . 7 - What they did, first of all, is look at. patient 8 outcome as compared to the process which takes place'in a 9 facility. And they stratified facilities according to size, 10 number of patients, number of beds, number of physicians, 11 number of physicists and so forth, types of equipment. 12 And for instance, they found that the patient got 13 - the worst outcome -- and again, this is statistically 14 a supported but I'll probably miss some of the A characteristics, so I'll just say, it's a generalization, 16 that the worst case was where it was a small facility with 17 one physician with one cobalt unit shorter than 80 18 centimeters treatment distance and no physicist. 19 I mean, it follows along pretty obviously where 20 these places are. And this data can be accessed through the 21 journals that the American College of Radiology has reported - 22 in and it can be accessed on the kinds and types of 23 facilities. They don't, however, give out the names of 24 which facilities are which. 25 I think that the NRC and its agreements states c. Heritage Reporting Corporation (202) 628-4888
1
... 87 ,
1
.. I already'know then what types of facilities we're talking.
7 1 about. They have licenses in all of these facilities. .They 1 1
. _; must k'now the kinds of people:that are-there.by the license. -4 l
4 : They know what types of equipment is there. And, as I said, i 5 n. the less equipment, the less qualified personnel, the more 6 -likely errors will occur. 7 The case that was often talked about today of a 8 physicist being hired that didn't know what he was doing is 9 ready made for an accident to occur. It doesn't take a 10 regulation to do that. In fact, you can't regulate against i 11~ stupidity. It will always occur no matter what-you write 12 down. 13 So I suggest you look at the references provided 14 by the Patterns of Care Study.and look at the tendencies of p5 the quality of care of the patient which then indicates also k<, the possibility for misadministration.
'17 2 Thank you.
18 MR. TELFORD: My name is John Telford. I'm with 19 the Office of Research, the Regulation Development. Branch. 20 I would like to ask all the people that have come today for
. 21 :. a little help. All the remarks so far have been very 22 helpful, but I'd like some specific help.
23 For instance, could we assume for a moment that 24 there are misadministration? Fact one. 25 Fact two, there are good performers and there are Heritage Reporting Corporation (202) 628-4888 i _ _ - - _ - - _ - _ _ _ _ _ - - _ _ _ _ _ a
l 88 **
- 1. poor performers, okay. The NRC'has probably no problem with- .
p'
-~
good performers.- We all take'that for a-given. l 3 Another given is that the Commission has.given us 4 7- the directive or stated desire to have a rule for poor 5 performers. What we have given you are three alternatives,
^
6 three rules. . 7 What I'd like to ask for are for you to tell me 8 what's good or bad about those particular rules. I haven't 9 seen anybody focus on those rules. Let me be specific. 10 Alternative one in the handout, this is page 4, is 11 this correct? Alternative 1, page 4, the part that's marked 12 2 35.35 A and B. 13 r The Staff would really like to know what you think 14 C of that? Is it crummy, throw it out? Amend specific parts?
'9 0 What?
I 16 J Alternative 2, this starts on page 6 of
'17 r Alternative 2 where it says 35.35 A and B. Same question or 18 questions. What should we do with this? What's not 19 workable?
20 Alternative 3, page 7, I think it is, 35.35, the 21 basic quality assurance program, that single paragraph. 22 That may be in the spirit of what Dr. Laude was talking 23 about. If you can give us the Staff some feedback on those 24 specific statements, what's wrong with them, I think in the 25 spirit of the agenda, what was planned this morning under Heritage Reporting Corporation (202) 628-4888
9
** 89
*' 1- the Rule alternatives, if we could step through this a. step l at a-time to find out what's good or bad, workable or non- -"
3 workable, enforceable or not, about that specific rule 4' , ' language, then do the same with the reporting requirements,
/5. e that's some help that I for one as a member of the Staff
,c 6' would like to have. If we don't.do that, I don't know what 7 '
we'll come.away with today. 8 DR. COLLINS: The man in the rear row, did you 9 have your hand up? 10 All right, Dr. Suntharalingam. 11 DR. SUNTHARALINGAM: A specific request was made
-12 by the previous speaker. I have some serious concern 13 because it has taken the Staff six months to put something
'14 r4 out for comment or discussion and asking us representatives j to look this'over in 48 hours or 72 hours, and come up with t
16 7 useful specific suggestions whether to incorporate this or 17 c that, I don't think is a fair methodology to be followed. 18 And even the follow-up time by which one can put in some 19 written statements is only another additional week. 20 And I don't think, and that my serious concern is
- 21 that your Commissioners are going to be sonewhat informed 22 rather erroneously that you the staff have gotten feedback 23 + from all the professional colleges and societies and this is 24 your recommendation. I think we go back to the original 25 request made by Dr. Order of the College of Radiology and l
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90 *. 1 - supported by all of us, establish a working group to come up . ( with an appropriate document, and then work on that. i 3 These may be useful starting points, but I don't 4 - think we can in two hours or three hours time here with only. 5 72 hours preparatory time try toicome up with a fair useful 6 - interaction because you may leave this meeting with the . 7 impression that you got appropriate and adequate feedback, 8 now you can submit some'to the Commissioners. 9 'DR. COLLINS: Yes? 10 DR. LAUDE: Dr. John Laude speaking on behalf of 11 the ACNP and S&M. We'd like to ditto thos3 last remarks. 12 < 2 We. feel very strongly that this represents a starting point, 13
- but having been just given this, in my case at the time I 14 2 walked in, and in the case of my assistsnt here, at the time of the beginning of the meeting, it is very difficult to 16 a prepare any kind of comment that I believe it's Mr. Telford, 17 x is that correct, would find helpful. If we can get a little 18 time, I think we'd be more than-happy to try and take a look 19 at this.
20 If I may make one other comment or at least a 21 - congratulations, in the past two years there was a - L 22 celebrated case of a physician who did not report a 23 misadministration or a series thereof. And this particular 24 physician made great efforts to demonstrate a lack of 25 honesty in his non-reporting things. And this was a very Heritage Reporting Corporation (202) 628-4888 l
.- 91
. 1 celebrtted case which I think ought to be trumped up even more by the NRC to its licensees because it puts the fear of 3 God into the licensee. I think it should be something that 4 should be read by every practicing nuclear medicine 5 a physician what went on as detailed in the Federal Register
. 6
- concerning that particular case. And I'm sure Mr. McElroy 7 would be able to detail that for you more if necessary.
8 I cannot state all the facts right here. But I 9 know certainly in my case there was never a better impetus 10 to understand what a misadministration was nor to understand 11 how to report it than that last particular case of the last 12 several years, which only recently was decided in an 13 Administrative Law Court and resulted in a substantial 14 - penalty to the physician engaged in practices that were
- found to be aberrant.
I 16 MR. MCELROY: In response to the point about 17 2 getting the good word out, some people think that for the 18 Agency to put out any information on that would be kicking 19 somebody who has been badly kicked. 20 We have provided the background information to 21 newsletter editors. And as part of the Agency's increased 22 emphasis on medical use, we would like to work with 23 newsletter editors to get out the events that have been 24 reported to us when we have to go so far as to take 25 enforcement action that might get the attention of a few Heritage Reporting Corporation (202) 628-4098 _-_-_______-_----_______D
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)
i 1 folks.4 So we would very much appreciate your assistance on . 4 that. We are trying to help reduce mistakes and there are 3 lots of different ways to do that. And getting the word out j i 4 2 so that people can learn from experience is one of them. 5 DR. COLLINS: Dr. Order? 6 - DR. ORDER: Dr. Order from the American College of . 7 Radiology. 8 I'm a little bit surprised at your comments, 9 because I specifically addressed some of the things which I
- 10. felt the medical community would not accept. So I'll 11 reiterate them again.
1:2
-- Under alternative number 1, points 7, 8, and 9 are 13 L. an infringement on practice. Notice to the referring 14 ; physician and to the affected patient is required for every g
;i therapy event regardless of dose consequences. The content 16 > of notification is not specified.
17 I do not think that that will aid in the treatment 18 of patients or improve the quality of care, but will create 19 a lot of legal contingencies. 20 Point No. 8, the referring physician may prevent 21 patient notification if his medical judgment so dictates but - 22 he may not agree to notify the patient himself. 23 I do not believe you have the right as a 24 Commission or anyone else to tell a physician what he may or 25 may not do. l' Heritage Reporting Corporatier (202) 628-4888
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~ . - 1 m Number 9, all diagnostic events also necessitate 2 notification to the patient's referring physician regardless
's .
.of the seriousness of the event.
4 1 I think that also creates undue anxiety for 5 patients. . It does not contribute to the quality of care.
. 6 , And I-find all three things to be totally unacceptable.
7 Then I went on'to look ta the next.page, Item No. 8 5. And I gave a specific example where~trying-to determine 9 from a percent of error what an error is incorrect. A 10 dosage of radiopharmaceutical differing from the prescribed 11 dose by more than ten percent. If you're giving 2 12 millicuries.of F-32 and'you give 2.3 millicuries, this is 13 reportable. It would have no consequence to the patient. 14 _ If you're giving 200 millicuries of iodine and you 35 . made a ten percent error and you gave 220, you would have no I io consequence really to that patient. 17 : If you gave one curie, I wouldn't want to be in 18 the room.. 19 If we go to page number 4, where you had a Rule 7 20 and 8 at the top, the seventh one was about brachytherapy is
. 21 ; unrealistic. When head and neck implants are carried out 22 the prescribed dose going in to doing the head and neck
;23 implant and the reality that the physician is left with 24 because of the technical procedures are quite different.
25 Which dose do you really want reported?
, Heritage Reporting Corporation (202) 628-4888 i
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" Again,'it demonstrates that we'have to work -
1 together if we' re going to have a meaningful document, which 3 we're willing to do. 4 ' Item No. 8 which talks about.it again from a 5 " teletherapy source would not prevent'the very accident that
- 6. '
Mr. McElroy has reiterated at this particular hearing. That -. 7 33 patients were treated with a cobalt machine that had the 8 wrong information in the computer because they didn't have a 9 qualified physicist, because no phantom checks were done, 10 and all the things that are necessary to do the job' right. 11 I believe the community is willing to write the
# document with you, which is the kind of message I brought, 12 13 an affirmative message: yes, we will work together. But it 14 has to be on the basis of some realism, for us to take the i reality of clinical practice and the reality of trying to tv.
16 # regulate this area so we get high quality. 17 Now, I think that specifically addresses some of 18 the document in a review which we're allowed a half hour 19 review. I.think we need more time, and I think we need a 20 cooperative group and the American College of Radiology has 21 offered to do that with you. L 22 ' MR. MCELROY: Dr. Order, is it fair to summarize 23 your statement by saying that the draft.a we have prepared 24 are technically naive? 25 DR. ORDER: Well, I tried to be kinder than that. Heritage Reporting Corporation (202) 628-4888 L
.. 95 1 But I would say this: If I were in your position and you
? were in mine, I think it would be very hard to know the i
3 technical aspects of the other person's position. 4 I'm sympathetic to the viewpoint that we want to 5 have a high quality assurance. I'm sympathetic to the , 6 - viewpoint tlat we want to support your Commission in 7 establishing what that is and what the standards are. And I 8 have no problem whatever way you want to inspect the system. 9 But let's find out what the reality is.
\'
10 I'm always reminded of my day in college in 11 philosophy course when all the Englishmen sit around and 12 they argue about how many teeth are in the horse. The 13 American gets up and says, let's count them. So they kick 14 him out. 15 I'm asking you to do the same thing. Let's find i 16 out what the quality assessment program should be, which we 17 . could generate from the college and from all these special 18 people. Then let's take that format and them we can really 19 debate about something that's worthwhile. 20 I think the document as it stands is what I would . 21 expect from a Nuclear Regulatory Commission that doesn't 22 practice medicine, just as if I tried to write the document 23 for a nuclear power plant. 24 MR. MCELROY: Before you head back, could I ask 25 another question of you? Heritage Reporting Corporation (202) 628-4888 < e
96 ** 1 The ability.for the audience to critique these on . g' such short notice, your concerns about that are well taken. 3
~
If we can generalize a little bit, the four things I've 4 heard mantioned, and I'd like you to give me your response 5 to each of these four alternatives. 6 Dr. Suntharalingam has mentioned several times of . 7 simply perhaps having a rulemaking that would speak to 8 training an experience criteria for the individuals involved 9 and trust them to do their jobs well. 10 DR. ORDER: Could we answer them one at a time? 11 MR. MCELROY: Sure. 12 DR. ORDER: Because I can answer that specifically 13 for you. 14 The American College of Radiology has a blue book.
/'
- The blue book is clearly the standard of practice in running
(
# And if people can't satiate or 16 one of these facilities.
17 satisfy the blue book, in my opinion, they shouldn't have 18 the facility. Now, that's a personal opinion. I think the 19 College would stand behind it since they wrote the book. 20 So I think that we've helped you in that we can 21 say there that the blue book standards are the standards for - 22 practice and what we expect of facilities within a rational 23 sort of environment. 24 (Continued on the following page.) 25 Heritage Reporting Corporation (202) 628-4888 1 1 l _ _... .__._._.._______________________w
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.T9-11tasr + MR. MCELROY: Does that publication include !
2 , training and experience criteria? 3 DR. ORDER: Yes. It includes technical people. 1 4 - It includes everyone on the faculty. -It includes everyone 5 and what they can do, whether it is private practice, or
. 6 . academic or whatever. It sets the standards for the numbers 7 4 of machines, and the numbers of treatments. It goes through
~
8 the whole array. And it is a very' carefully written 9 document. And it has been refined, and it has been recontly s 10 updated a year ago. 11 MR. MCELROY: That has. spoken to the second 12 , alternative that I had written down here. The first was 13 staffing criteria, and the second is implementation of 14 voluntary standards that are already in the public domain. 15 - So I believe that you have spoken to that. I 16 9 DR. ORDER: Well, I do not think entirely. 17 7 Because you see, one of the failures that I see in the 18 system is that we do not have a program that is called 19 quality assessment. You may think we do. All of us in the 20 field think that we do, because we each run individual
. 21 . departments and we know how hard we strive to get that.
22 But we do not have a universal quality assessment 23 program which is what I am trying to suggest that we need to 24 generate, a universal quality assessment parallel to what 25 the blue book was but for quality assessment. We do not Heritage Reporting Corporation (202) 628-4888
98 . 1 have that document. .
? And if you use.what I do in own particular J institution, it would be over-burdensome perhaps in a small 4 -
. hospital.- And one has to take the whole spectrum into 5 account.
6 r MR. MCELROY: Another alternative that has been . 7 -- mentioned is the use of third party inspections.- .There are 8 apparently some voluntary initiatives-that are already. 9 underway in which the experts could inspect the experts and 10 leave the bureaucrats out of this. 11 Do you think that that'is a better alternative 12 ; than what has been presented here,~do you think that it is a 13 : workable' alternative? 14 DR. ORDER: Well, first'of all, let me tell-you a-
,/ 5
'- personal experience. I belong to the international t We lo r cooperative group in radiation oncology called RTOG.
17 site visit other institutions that wish to join the 18 cooperative group. Their physics goes through a very 19 strenuous pre-inspection even before the inspecting group 20 gets there. When the inspecting group gets there, we have a 21 whole array of things that we go through as part of our . 22 assessment, and we reject groups. 23 Now whether it is better for us to reject the 24 group or for you to reject a group. It is more cost 2
.5 et'ficient if the medical community does its own policing 7
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'** 99
. 1 because they really know intrinsically more about it. But
.if you do not trust them and you want to do it, it does not 3 disturb me either way.
4 - I think that it has to be funded. You-cannot ask 5' the medical community to run around and do this kind of . 6 thing without funding some kind of program. And whether it 7 is more cost efficient to fund it and have the medical 8 community do it or whether have yourselves do it, it is 9 something that you would have to intrinsically decide. 10 .The level of expertise brought by someone who 11 practices in the field is obviously going to be-greater. 12 Also to address what Sunthar had said, we have a physicist 13 as well as a radiation oncologist do these inspections. The 14 radiation oncologist is not alone.
,i ' ~
MR. MCELROY: Would recognition of these programs 16 perhaps taint them over the long run? 17 c DR. ORDER: I am not sure that I comprehend what 18 you mean. 19 MR. MCELROY: If a regulatory agency were looking 20- to a voluntary inspection that the Commission itself did not 21 'r participate in, what might suggest that there is the chance 22 that the inspector does not want to find things that would 23 endanger his colleagues' practice. 24 DR. ORDER: I would suggest that the best way to 25 do that in order to eliminate that component would be to
.Meritage Reporting Corporation (202) 628-4888
100 *. 1 make a* third person part of that site review. So I would .
- " 'have someone from the Nuclear Regulatory Commission, someone j
3 who is a physician and practices, and someone who is a 4 - radiologic or a radiation therapy physicist.' And then the 5 - Commission would be reassured, because they would be 6- L participating in it. Yet they would not necessarily have to . 7 - have the expertise of someone who is displaying the 8 information. 9 MR. MCELROY: For the sake of completeness, the 10 fourth alternative which some of you have spoken to is a 11 concept called negotiated rule making, and I mention this 12 2 simply for the sake of completeness at this time. It is an 13 2 idea that has been used on occasion by regulatory agencies 14 f where they identify something that requires regulatory
< 2 action in their opinion, but recognize that they need wide
's 16 3 cooperation among individuals in the regulated industry to 17 develop the regulation, to develop something that is
{ 18 workable and does not hinder commerce or in our case deliver l 19 medical care. 20 Am I correct in perceiving that your organization 21 would be willing to participate in that concept of - 22
~
negotiated rule making? 23 DR. ORDER: Yes, the American College of Radiology
)
24 would do that with the other associations that have all been 25 named, the APM, ASTRO, etcetera, and all of the different Heritage Reporting Corporation (202) 628-4888
- - _ --- _ _ O
.- 101' I .
. ' 1 nuclear ~ societies, etcetera. That would be a more cohesive document and one that would-be representative of our
! 3- community. .Yes,.I think-that is correct. 4 MR. MCELROY: If you were in my. shoes and you had 5 c. to'tell the Commission what to do and you had to tell the
. 6 . Commission what to do in February, what would you tell them?
7- DR. ' ORDER: Yes, I will tell you exactly what I 8 would tell them. 9 MR MCELROY: Assuming that you were going to be
-10 in my shoes the following month.
11 DR. ORDER: Sure. If you want to lend me your 12 shoes, I will even come and do it for you. But I think that 13 the thing that I'would tell them is that the first series of 14 , documents that came to this particular meeting led to the
. acceptance of the concept that this would be done, that it.
16 : could be more efficiently done and a better program designed 17 e in cooperation with all of the major groups. 18 That a survey would be done of the nation to give 19 us an idea of where quality assessment is today. And from 20 that, a document would be generated which they would have ,
-i
. 21 for their approval which would guide us in quality 22 assessment in the future. And that this represented a first 23 step towards bringing the community together with the 24 Nuclear Regulatory Commission.
I 25 MR. MCELROY: If somebody said to you that is a ) Heritage Reporting Corporation (202) 628-4888 l 1 I w__m_____________ m_ ____. _ _ _ _ _ _ _ _ . A
102 *. 1 good idea but we see a problem and we want you to do . something to fix it now, how would you respond to that? 3 DR. ORDER: Well, I think that your most immediate 4 - problem, if you look at the accidents which is what I view 5 them as that are reported, it could be easily satisfied in 6 terms of cobalt. I would immediately mandate a rule that . 7 - any.new cobalt source going into a machine after the 8 physicists have done all of their perambulations including 9 putting the information in a computer, that they are 10 required to take five different treatment plans, irradiate a 11 phantom, and demonstrate that the dose that is being 12 - received by the phantom corroborates with what they expect 13 - in clinical experience. 14 - I think that that would help eliminate a lot of i' - the accidents that occurred, even the ones with the t 16 accelerator that had some machinations in Texas. So that if 17 phantom measurements on new machines are a requirement, it 18 helps eliminate the error that could be made in computers 19 which are very hard to check relative to what is really 20 being delivered. That would be the very first step. That 21 would be something that would immediately close this type of . 22 accident. 23 MR. MCELROY: Thank you. Dr. Order, Dr. Webster 24 has a comment for you. 25 DR. WEBSTER: No. I wanted to react somehow to Heritage Reporting Corporation (202) 628-4888
-.* 103 .;
1
* 'l what'you and Dr. Order have both said. I am sort of struck i by'a precedent really which the NRC has established with 3 regard to the acceptability of training of physicians to 4 , work with radioactive materials. It seems to me that they 5 x have accepted essentially a peer review in many situations . 6 by organized medicine, because they accept Board 7- certification without any further adieu. No credentials 8 need to be submitted.
9 And what you have both suggested is essentially a-10 peer review of a quality assurance program by a group of 11 trained professionals, and have the NRC accept their report 12 as being objective. And I think that that is not to be 13 ruled out in my view. Because there is this precedent 14 already that the Board's honesty so to speak has been
/ ,. accepted. And that seems to me to be a very interesting and 16 useful parallel.
17 n DR. ORDER: Thank you. Well, I want to point out 18 one other. thing to Mr. McElroy. The therapy community does 19 not want to have these accidents. It neither enhances our 20 position within the community. But more important to most
. 21 - of us, it damages patients, and we certainly do not want to 22 see that happen. So we are not opposed to the concept. We ~
23 just want it to be realistic relative to what has to be 24 done. l 25 DR. COLLIliS: Dr. Khan. Heritage Reporting Corporation (202) 628-4888
1. ll 104 **
#' Faiz Khan representing AAPM. In 1 DR. KHAN: .
3 response to the last_ question that. Norman McElroy asked 4-
'3 Dr.' Order as to what should'be done immediately about these
.4 " problems,-I think that the'AAPM document to the Board on 5 quality assurance includes practically everything that'we 6 Y are discussing here related as to what kind of tests and
- L what kind of procedures should have to be done.
7' 8 I think if you require that they follow those 9 procedures which have been well researched and been 10 practiced in most institutions, I think that you will solve 11 the majority of'the problems. That is Report No. 13, I 12 believe. 13 1 DR. COLLINS: One more.
' Suntharalingam representing 14 DR. SUNTRARALINGAM:
1 the American, College of Medical Physics. I very rarely { 16 disagree with Dr. Order. But since I was on the committee 17 of this now famous blue book, I can mention the following 18 things that pertain to this. 19 This is a report of an Inter-Society Council for l20 Radiation Oncologists. They have representatives from seven 21 organizations that are involved with radiation oncology. It 22 was published by the American College of Radiology within 23 which structure the Inter-Society Council exists. 24' This does not go into the specific requirements of 25 qualifications of individuals. It only goes into the p Heritage Reporting Corporation (202) 628-4888 j 1
- - . _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ l
1
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.- 1 structure, the type of facilities, and the type of personnel
; that one needs for patient care. Tais does not address the 3 qualifications.
4 Now going to Dr. Webster's remark pertaining to 5 , the acceptance of Board certification as a requirement for a
. 6 .
practicing physician, and similarly I think that we have f 7 accepted Board certification as sort of an endorsement of 8 qualified radiological physicists. And I might just read 9 the "est recent unambiguous statement that the American 10 College of Medical Physicists put out regarding physicists. 11 And we said, "A qualified medical physicist is an 12 individual who is competent to practice independently one or 13 more of the sub-fields of medical physics. An individual 14 would be considered competent to practice one er more of the
; sub-fields if he or she is certified in that sub-field by 16 any of the following certifying organizations."
17 And then we went on, and this is something that I 18 think that you will like the regulatory agencies to 19 consider. And that is that there has to be a transition 20 period. One of the areas of concern has been
. 21 "or equivalent", I mean Board certification or equivalent.
22 And that I believe is put in for legal reasons, because 23 otherwise it is a restriction. And one essentially opens 24 the flood gates whenever you say "or equivalent training." 25 What we have proposed here is that during a Heritage Reporting Corporation (202) 628-4888 l
f , 106 4 1 . transition period not to exceed five years from the time of- . Ladoption of this definition by a regulatory: agency that an 4'
\-
3' . individual may in lieu.of. certification be deemed by'that~ 4 .t: agency competent to practice in.one or more of the
~
5 sub-fields provided that he or she, and then we have put-on-6
'three requirements.that they could satisfy. .
- 7. Now' technologists are licensed. I mean they go 8L through an educational program and are licensed. Some of us 9 are ashamed t'o stand before an audience like thisfand'say 10 that medical physicists have no" formal training programs. I 11' mean there are a few scattered around the country. But 12 1 ~ medical phys'icists up to now have: essentially been brought 13 ( into the' field and they learn on the job.
14 2 But the certification program-has at least (~ & provided a real measuring of a minimum level of competence. 4
'16: r And the physics community is addressing at least for the 17 future the need for an equivalent type of residency programs 18 regarding qualifications of medical' physicists. Thank you.
19 DR. COLLINS: It is now five minutes into lunch 20 time. We will return here in 55 minutes. 21 (Whereupon, at 11:50 a.m., the subcommittee - 23 recessed, to reconvene at 12 45 p.m., this same day.) d9E3sr 124 25 Heritage Reporting Corporation (202) 628-4888
o ,
** 107.
U,e IL w lA.F-T,E R.N-O O-N S E S'S I.'O N-' L j. ' (12 : 55' p.m. )
- 3. DR. COLLINS: Well,-now that those hunger' pains 4 p. -are satiated and blood sugar sufficiently raised, I hope it
'5 : won't;put anybody asleep. The warmth of'the discussions; I- .- 6 2 think,'is guaranteed.to keep us all awake.
t 7 4 At 12:45, we are scheduled'to hear from Mr. Tse.
-8 -
MR. TSE:. .Thank you, Mr'.' Chairman. My name is 9 Anthony.Tse. I work in the office of Nuclear Regulatory
-10 Research. My specific task,' currently, is to work on the-11 1 rule, the QA rule, the regulatory guide and the. pilot 12 program. I was assigned this job about a year lago and I o 13 really appreciate the effort-from the subcommittee. members 14 . and members of the associations to comeLhere to help us out.
But, I need to make a couple of points, just as a-16 a reminder. One, we. currently have about three rulemaking 17 r actions -- 18 MR. WEBSTER: Mr. Tse, would you please move 19 closer to the microphone. We can't here you back here. 20 MR. TSE: Sorry about that.
. 21 . Currently we have the NRC. In medical areas we 22 have about three rulemaking actions. One is a basic QA rule
;23 which is what we currently discussing today. A second one 2 4 -- would be a comprehensive QA rule. And the third one is the 25 training requirements in the medical area.
Heritage Reporting Corporation l (202) 628-4888 _ - _ ~
108 *. 1 Although they are interrelated' but we need to . emphasize in today's discussion is the basic QA rule-- 3 MR. WEBSTER: Louder please. 4 : MR. TSE: Thank you. Basic QA rule, and is 5 intended to try to avoid the simple human errors in the 6 medical use of radio isotopes. . 7 The purpose of the rule is trying to avoid the 8 simple human errors. And as a result of our previous 9 discussions, we are going ahead to try going towards the 10 performance based rule. And with that we need a regulatory 11 guide to explain what do you mean by acceptable QA program 12 as a -- acceptable as far as regulation is concerned. 13 So, this is the purpose of the regulatory guide. 14 And you have a copy of a working draft we are thinking
,'"- about. And the copy, the criteria stated in the guide, 16 essentially is similar, very similar, to the proposed 17 regulation NRC published in October of 1987. With certain 18 changes, modifications, per public comments.
19 Now, although you heard this morning the effort 20 for discussion purposes through alternatives in the QA rule, l 21 whatever the final version of the QA rule will -- the . 22 regulatory guide certainly will be modified to follow the QA
~
23 rule. 24 In the Federal Register Notice we asked two 25 questions about the regulatory guide. One is what type of Heritage Reporting Corporation l (202) 628-4888 l _ __ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
** 109 1- QA procedure you think should be in. Whether the'ones 2 already in is good or not to good.- Or, additiional ones.
s Also,-we-asked what'in your facility you have a. good QA 4 program which demonstrated to be a useful one. You.can'make 5 e those suggestions-to us. , ~. 6 Thank you, Mr. Chairman. That's my prepared-7 statement. 8. 9
'10 11
'12 13 14 15 .
i
.O 1 17 a 18 19 20 l .- '21 22 ..
23 l l 24 25 Heritage Reporting Corporation (202) 628-4888 l. l L__-____________ _
110 * 6[ : 1, > DR~.-COLLINS: Do we'havelany discussion of this? "
. j
,. ; 2 - Do you care to proceed with your second'
! t --
p 3 presentation then? On the draft pilot program. 4- -MR. TSE: Yes. Thank you again Mr. Chairman. J 5' I think I heard it this' morning-and previous 6 presentations -- the medical community and NRC staff.-- I 7 think we have a common goal. Which is to reduce the
>1 8 misadministration or so called incidents.
'9 But the problem is how to approach it. Because 10 there is a' potential, from the previous discussions, if it's
'll a prescriptive rule that's prepared, then there's a j I
- 12. potential of interfering with the medical community.
13 Because they would not offer flexibility to physicians or 14 the institutions to change from the rule. Therefore, we 19 thought that in addition to go to a performance based rule k
- l 16 and regulatory guide, we thought that perhaps it would be 17 very useful, and that's a suggestion also made by a 18 representative at the previous meetings, a pilot program 19 should be conducted.
]
20 The purpose of a pilot program -- the main 21 purpose, is trying to identify any procedures that may be - 22 some way interfering with the medical practice. We all know l - 23 that the probability of an incident in a medical facility is 24 very very low. And therefore, to design a pilot program I l l: 25 trying to demonstrate the usefulness of a particular h (~ Heritage Reporting Corporation (202) 628-4888 _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _)
111 the probability of
'"l' procedure, trying to catch an. incident, l that is very small.
So, the main purpose is to see whether { J in certain regulatory documents, 3 the procedures indicate, 4' whether they will'be interfering with the medical practice But, in certain ways. Now, people can make a judgement. 5 ~
- 4 certainly, if it's put into practice use for a short while, 6
7 l' they would be even more assured that they will not be 8 interfering with the medical practice. In that particular reason we proposed a short 9 10 protocol that is attached in the very last document of the In there, of course we 11. briefing -- of'the handout material. 12 think the best we can of how to select the institutions, 13 hospitals, clinics to participate. What kind of factors What information should be collected, 14 should be considered.
- etcetera.
But we thought that consulting the people'who are g the 16 3 actually working in the hospitals -- of course also, j 17 a subcommittee members -- would be useful to give us some 18 additional suggestions or comments how this particular test' This will be very beneficial to 19 program could be conducted. 20 the future rulemaking actions.
- Thank you.
21 1 DR. GRIEM: Did you get any statistical help in 22 designing this matrix? In other words, how did you come up 23 with one month. You know, I wouldn't even find this without 24 look, 25 consulting with Paul Meyer right up front and saying, Corporation l l Heritage Reporting (202) 628-4888 i d
r- -- __ - _- - - -
. p.
1 112 we.,want to go'after those questions.- -i 2 And'he would tell me. ~ immediately, (, . from'our Department of Statistics, and he does-3 a lot of drug. testing' consultation where the question of how 4-to get.the-answer out i's important,from the standpoint of 5 such testing, he'll tell you,<well, you really need six 6, weeks or-two months. .And you need this sample size'and all 7:
-this sort of stuff.
- 8. .
I mean, it would seem to me that you need a lot 9 o f, d or you should get some help from a~ statistician in this 10
-thing before you move into something like this. 'You might 11 be a week short of getting a valid answer. Your P is .07.
12 Then'where do you go? 13r 'MR. TSE: Here is my statistician. 141 (Mr. :Tse indicates Mr. Telford.) J5! DR.'GRIEM: But'I mean, the question is'if we're-b going to spend some money on this let's do it right.
-17 MR. TELFORD: My name is John Telford. I'm with 18 the NRC. I happen to also be a statistician.
19 For your information, the' design you're looking at 20 on page 2, it's the third from the.last page in this, is a 21 completely randomized design. If there's any statisticians . 22 in the audience they'll know what I'm talking about. The 30 23 , days you're talking about might.be relevant to a 24 pharmaceutical trial. However, in this case, 30 days is 25 mandated by the commission. ( ~'s s, Heritage Reporting Corporation (202) 628-4888
113 DR. GRIEM: But suppose it's 40 days to get a
'1 Why do 30 days when you needed 10 more days?
valid answer. 1 MR. TELFORD: What I'm trying to say is I don't 3 4 see how days are relevant. DR. GRIEM: Well, but you may need a certain 5
- number to prove something. I'm no statistician but I know 6
7 where to go. No, no. The factors -- MR. TELFORD: 8 DR. GRIEM: And I've factored this box once 9 before. Never again, you know. 10 MR. TELFORD: As Dr. Laude was.saying this 11 the 12 morning, he would-look at the size of the hospital, 13 location across the U.S., whether or not it's urban or region, he would stratify the selection of those five across 14
~ those regions.
Those are the kinds of parameters that you 16 ought to look at. How long you conduct the trial may be relevant for 17 a drug trial. In this case the length of time that you 18 what may be 19 conduct this test for a given QA procedure, relevant is whether or not you can reach a decision in that 20 For instance, you may say let's do it for 21 amount of time. 30 days. But if in your hospital you've done it for 10 days 22 why 23 and you know it's an absolutely terrible procedure, 24 continue? So, I submit that the number of days is not 25 Meritage Reporting Corporation (202) 628-4888 i
- - - - - - _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _i
1 114* relevant -- is not a relevant parameter for what you're " 2 I interested in. What you're interested in is what has an s affect on -- 4 DR. GRIEM: 5 Well, here it says, on the first page, test period is 30 calendar days. 6 MR. TELFORD: Certainly it does. 7 That's what the
- Commission told us to do. That's all they gave us.
8 DR. WEBSTER: . 9 You might think of such an aspect as learning. A learning experience. 10 Maybe the second 30 days won't be quite so onerous as the first 30 days is what I'm 11 saying. And that often happens in the procedures. And if 12 you're trying to get reactions back from these pilot 13 institutions that might be very important. 14 MR. TELFORD: Maybe what you're thinking of is an
,15 .
interdict procedure, where you have a pilot program for X o-number of days. You have an assessment and you refine it. 17 And then you go for Y number of days. 18 Which would account for and be able to use a learning curve. Sure. 19 DR. WEBSTER: Yes. 20 So, the 30 days isn't binding on this. 21 MR. TELFORD: That's right. The 30 days is --
- 22 there's nothing absolute about it. That's just the maximum 23 amount of time which the Commission gave us.
24 MR. AUSTIN: John Austin, NRC. 25 I think this might be an area where the subcommittee might want to comment . Heritage Reporting Corporation (202) 628-4888
115 have-a 30 You know).the Commission did direct the staff to 1 I am unaware of anything driving that 9 day pilot program. 3 number 30. And if the subcommittee would offer an 4 additional insight to it, I think the staff would be 5 receptive.
. MR. TSE:
I think the purpose of offering these 6 ditional for discussion is really trying to collect some ad 7 input. Which people can give it to us so we can consider 8 is to it. It's not -- that's the purpose for the meeting 9 collect common suggestions. 10 do you have a comment on Dr. Order, DR. COLLINS: 11 12 this test period or a pilot plan? There only needs to be one comment if DR. ORDER: 13 that you've got to know where you're going. 14 your a pilot: I mean I was sitting back there g" For example, on page 9, What do you want the t 16 trying to figure out what 4.6 is. 17 people to do?
" Physical measurement of I'll read what it says.
18 the total the output should be made before 20 percent of 19 i t's dose 20 prescribed dose has been administered if thehpat of things. en
. calculations include," and then you name a bunc 21 Now, if 35 patients waiting outside of this 22 d machine, this is the patient's first day on the machine an 23 And we' re going to everything 24 they' re quite apprehensive.
I mean, I don't 25 and run it and do a dose calculation. Heritage Reporting Corporation (202) 628-4888
l-t 1 ~ 11"6' understand how-we're' going to do 4.6. It's very hard to '" g : understand this. 3 And I would also tell you that if we look at'our 4
~-own quality assessment program and compared it to other 5
centers, they would find it burdensome.
- 6. Because we do a lot more. . We demand more. Different programs will demand
- 7 different amounts. So, 8 wouldn't it'be nice to define first what a real quality assessment program.is? .
9 But maybe you could answer 4.6.
'10 Because I don't understand'it.
11 MR. TSE: On the QA Regulatory Guide, 4. 6, page : 9, 12 it says,
" physical measurements of output should be made 13 before 20 percent of total prescribed dose has been 14 administered."
If the patient's dose calculations, ( including the field size and so on, which has.not been 16 measured before or is being modified device has not been 17 measured before. Now, the rationale we are -- the idea -- 18 DR. ORDER: Well, I don't question the idea. I'll 19 just so you the practical parts which may be useful in this 20 exchange. 21 MR. TSE: Oh, sure. I agree with that.
- 22 DR. ORDER:
You have 35 patients on the machine. 23 . This patient is going to start therapy that day . Now, the 24 technologist has to know did they measure the beam or not 25 for the beam that day. Now, she has to go get a physicist
, Heritage Reporting Corporation (202) 628-4888
117'
.s; When the simpler
~'l- who has'to come out and measure the beam 4 answer to 4.6 is that every week the dose from a machine and
[' 13 some field size representative should be measured on all 4 machines in all departments. 5 MR. TSE: But the problem is that, suppose 6 somebody wants a field size which has not been measured before. Should they go ahead with the full treatment? 7 DR. ORDER: If we did it.your way, then the 35 8 there's going to be a dose 9- patients who are on the machine, 10 field size that's different for every patient in modern radiotherapy. Because the fields are all being varied with 11 irregular blocks. There's' practically no modern facility 12 So, ever patient, 13 that doesn't have different field sizes.- 14 before they get 20 percent of the dose, has to have their specific beam calibrated for that particular patient. { It's only outside the range of 16 MR. TSE: No. Interpret instead of extrapolate, 17 those measured before. 18 that's the difference. DR. ORDER: Well, now, on all conventional 19 20 machines, all field sizes that are used within the And they're all recorded 21 departments are always calibrated. 22 on computers. MR. TSE: Yes. 23 DR. ORDER: They're all recorded on computers. 24 25 So, the only th ag that you can have from one week to the Heritage Reporting Corporation I (202) 628-4888
m [. 11$ L 1 next iis some variation in the output._ Which could.be seen' ' ( at any field size. The field size won't' influence it.. If 3 the' output is correct, then the right field sizeE- .it'll be 4 right-for the. rest of the field sizes. 5 So~, you have.to decide what is quality assurance. 6
~
To me' quality assurance is a standard field, produces a ~ 7 standard dose at a standard depth-and every week the machine 8 is' checked. 'Rather than put the burden on individual . 9 patients. You would have these departments, they would be 10 totally chaotic if you followed rule 4.6. And that's why, 11-I'll come back to the same original point, if you had some 12 of the radiation oncology community sit with you and.go. 13x through these things I think you'could come up with a 14 program. li That comes back to Dr. Griem's point. I don't 16; whether 30 days or 60 days or what number of days should be 17 studied, but again, if we can't all agree to what's quality 18 assurance, you're going to measure nothing. Because none of 19 us will agree that that represents quality assurance. And 20 I'm not trying to be obstinate or anything. I'm just trying 21 to point out, just by picking a simple example, how ' 22 difficult it would be to take something like t'aat. 23 . The department, our department, treats 1775 new 24 patients a year. Five accelerators are going all the time. 25 And people are walking in and out and having all this done.
- f. ,
Heritage Reporting Corporation (202) 628-4888
119 1 You can't start with an individual patient and start measuring all that. You' d never get your work done, 9-k MR. TSE: True. 'But would you, in your view, 4 4 would you think that if some wedge is,.some other parameter 5 has not been measured, would you like to use that iri the ~' 6 treatment without being measured? DR. ORDER: No treatment should be given without 7 . And weekly 8 any device that hasn't been measured. 9 calibration of the machines should be a standard or 10 requirement. And I guarantee that in the United States not That's why, again, I think we 11 every department does that. 12 have a common goal. But the problem is that the format for
-I think 13 achieving the common goal hasn't been put on paper.
14- you've done a very good job of trying to do that. MR. TSE: Thank you. JE , it's always the problem of the
- DR. ORDER: But, 6.
And I'm just 17 actual trying to bring it to real practice. 18 trying to pick this as an example. 19 MR. TSE: And I think that's precisely the reason 20 why we want to interchange with the medical community and Thank you. 21 the subcommittee on those kinds of questions. 22 23 24 25
. Heritage Reporting Corporation (202) 628-4888
i 126 !. 1 DR. KHAN: Fiaz Khan from ABM.
- 3 I.think so far as the elements of'the QA procedures are concerned, I don't find any problem. I thinkL 4
those procedures can be done -- are being done'in good 5 1 institutions -- double-checking or veg factors and all this 6 stuff. 7 What I don't understand is what this pilot program 8- is going to do. .. Is that going to establish that we should 9 be doing these procedures or is it going to establish we 10 should not be doing these? 11 I don't think it's going to add any new 12 information, because if you investigate and find out that 13. many institutions actually are doing these procedures, and' 14, it works very well there based on common sense, most of them,
.I don't think it's worth the effort to go through.
16 these pilot procedures. I think we should be concentrating 17 more on the elements of the QA program, and, of course, if 18 you take the deporting rule off, I'm all for these QA steps. 19 I have no problem with it. 20 DR. SUNTHARALINGAM: I am Suntharalingam from the 21 American College of Medical Physics. ' 22 This seems to be somewhat rapid duty and we must 23 . must be some circus performers coming one behind the other 24 and essentially trying to give a message to the NRC staff 25 and to the Subcommittee. Heritage Reporting Corporation (202) 628-4888
l l 121
- Now, obviously, the three programs that have been 1
outlined for discussion are interrelated. as I said, I will address 3 In my written statement, 4 them as we come to the specifics and, regarding tEi test 5 program or the pilot program, the comment that our "Is this program really necessary? 6 organization made was, 7 Will one really get any more information than what we already know?" And implied in that is it's going to be a 8 9 tremendous just wasted effort, but you can't do this pilot 10 program until we agree on what should be included in the 11 regulatory guide, because I have not found a good reason as What information or 12 to why do you need this pilot program? That has not been 13 what questions do you want answers for? 14 spelled out in terms of you do a pilot study to answer some
;[ questions, and those questions have not been clearly 1
16 identified. I Now, regarding the need for a regulatory guide, 17 18 think this morning -- I've come up here many times and said, 19
" Don't try to write down specifics in terms of a QA program.
20 Why don't you collect what are the current QA programs, but ask that every facility 21 information pertaining to them, and submit that QA program for your 22 implement a QA program, review, where that be during a license application or during 23 24 a renewal." And the plea I will make again is you people whether it be 25 are in a hurry to satisfy some requirement, Heritage Reporting Corporation (202) 628-4888
122 1 the. Commissioner giving you 30 days to answer a question or. '
'2 i 9' months to come up with some sort of.a document, forget the
\s impact of such a document on the entire community and there 4
are all others standing by the wayside, whether it-be state 5, regulatory agencies or others, are just going to pick this 6 up and incorporate into their state requirement.
- 7 That, then, goes beyond just the use of only 8
isotopes that are regulated by NRC. So, there's'a lot more . 9 thought process necessary and I think if anything can come 10 of this meeting, the recommendation should be, and which our 11 organization will strongly endorse, the need for a rapid 12 development of a consensus from participants from the 13 different organizations regarding what approach should be 14 taken to influence and impact on the regulatory requirement. 95 E There is no doubt there is a need for regulatory le , regulations also, but how do we implement regulations and 17 try to balance what it is current practice? 18 DR. COLLINS: Yes. 19 MR. MORTON: Bob Morton, National Cancer 20 Institute. 21 I second that.
- 22 I'd also like to ask a couple of questions or 23 .
point out a couple of things about the pilot program. It 24 says the purpose is to determine the impacts of the proposed 25 QA procedures. Heritage Reporting Corporation (202) 628-4888
123
- I looked just now at the QA procedures for 1
13, Physical
' teletherapy units alone in the AAPM Report No.
There 3 Aspects of Quality Assurance in Radiation Therapy. only one of which is 4 are 29 tests suggested for teletherapy, only seven 5 donc daily, only five of which are done weekly, Twelve are done annually. 6 of which are done monthly. 7 Another four have no frequency recommended. This means that in a 30-day test, you' d get to 8 9 test most of these 1 time, because that would be your initial test of it, whether it was worth doing or could be 10 done or you had the personnel. You' d have no record in 30 11 and 12 days whether you could do it continually or repitively, 13 I' d like to ask what is the cost set aside for such a pilot 14 program?
~~ MR. McELROY:
We' re relying on the volunteer Let me clarify -- 16 spirit to implement this pilot program. MR. MORTON: If you choose the little places that 17 18 can't do it at all, you'll be able to close them down immediately and be really cheap and those would be the ones 19 20 that are a problem, anyway.
~ MR. McELROY:
The original intention behind the 21 22 pilot program came from comments we received here last . She had 23 January from Carol Marcus from Los Angeles. 24 implemented her own pilot program in her nuclear medicine 25 clinic to test out the earlier rule that was published and Heritage Reporting Corporation (202) 628-4888
~~ __
4 124 1 fou,nd many portions ofLit very,.very uneconomical or not ^ t. useful and the directive that this initiative include a 3 pilot program'to test the rulemaking, I believe, was driven 4 primarily to insure that whatever rulemaking'is. implemented 5
.does not adversely. impact on-delivery 1 of medical' care..
6 It is not intended to validate the rule or the
- 7 regulatory guide.
It's simply to look for : adverse' impact. 8 MR. MORTON: . I feel that such effort, not only 9 money, but effort of people's time.could be better put into
~ 10 the recommendation of Dr. Order of having a group sit.down 11 and write a proposed basic QA rule and help write the draft 12 regulatory guide and use their effort there, because I think
.13 we feel at this point we haven't enough time to comment on 14
( the proposed. alternates on the basic rule, and to:just try
.( and fix up something and then.try and get it through and 16 A have your pilot program done by some projected time,.and I'm 17 .
not sure when you're supposed to get back to the 18 Commissioners, but I think that it should in the beginning 19 instead of trying to fix it up in the end. 20 Thank you. 21 DR. ORDER: It's Dr. Order from American College ' 22 again. 23 . If look at the quality assurance steps in your 24 pilot program, I would suggest to you that the cobalt 25 accident you enumerated could go through this quality () Heritage Reporting Corporation (202) 628-4888
.* 125
.-.*- 1- assurance program, and if you actually look at what happened
- in that program and what your quality steps ars, you would
( 3- not pick up the error, and that's exactly the problem. 4 To pick these errors up and to do the prevent 5 defense that's necessary is a very sophisticated job. 'I
.: 6 mean every time we hear of anything that went wrong in any 7 department, we go through our whole program and see if that 8 error could occur in our program or not. If it could, we do 9 a measure to prevent such an error.
10 In this particular prescription, you could go 11 through and those 33 patients could have been treated, and 12 you wouldn't pick it up, and, again, that's what I'm going 13 to say, that the number of errors that are made in the 14 different accidents you've enumerated, this quality ( assessment program, have you checked to be sure that it , 1 s 16 - would pick the errors? 17 1 Would it have picked up the error'in Texas where 18 people put things in the computer and bypassed the system, 19 and would they have known? Does this quality assurance 20 program direct itself to that error? I think you'll find 21 that it may not necessarily do it, not until the accident 22 has already occurred, which, of course, is the whole purpose 23 of the quality assessment is to prevent the accident from 24 occurring in the first place. 25 So, I really think you need the professional help Heritage Reporting Corporation (202) 628-4888 L 1 t _ _ - _ _ _ _ - _ - _ _ _ _ - - - _ _ _ _ _ _ _
126 ' 1 of the community. It sort of reminds me a little bit, all
- of this, of the one guy who went to Yasha Hifis's concert, l.
3 you know, and he did a lot of work, and he went through a 4 blizzard, and he arrives there and Hifis is warming up, and 5 he sees there's only this one fellow. So, he says to him -- 6 he sees he's inebriated, he says, "Wouldn't you like to
- i 7 have a drink?" He says, "Yash, you don't realize all the 8 trouble I've gone through. I've been 5 miles on a subway, 3 9 blocks in the snow, and then I crawled all the way in here 10 to hear you perform. Come on, sing me a song."
11 MS. ROTHSCHILD: My name is Marjorie Rothschild. 12 I'm an attorney in the Nuclear Regulatory Commission, Office 13 of the General Counsel, and one of the staff members asked 14 me to address the frequent comment that we're hearing today g about one way to solve this problem of coming up with a QA s 16 program in which there's a consensus, an agreement, which I 17 think nobody would dispute the advisability of doing that. 18 However, from a legal point of view, there are 19 problems with a regulatory agency such as the NRC staff 20 sitting down with just selected groups, whether you -- 21 especially if you view them as the regulated entities. The 22 staff, from a legal point of view -- there are constraints 23 on a Federal agency sitting down, if you're talking about a 24 closed meeting, although it sounds like it might be the 25 fastest way, the most efficient way -- the staff cannot just Heritage Reporting Corporation (202) 628-4888
127 l s
*' 1 -
sit down,-with selected individuals or individuals representing particular viewpoints or associations and in {. 3 that' manner write a rule. There are ways it can be done, and what I think 4 since the Commission 5 the attempt of the NRC staff here was, i in 6 was asked to get the input of the medical associat ons namely, using the advisory 7 developing a rule, this means, committee that the staff already has in a forum in which not 8 but any other 9 only the views of the medical associations, this is a way where 10 interested. groups or agreement states, 11 their views would also be obtained. as we grapple with So, I think we should be aware, 12 13 how to come up with a rule that's workable and in which what sounds like the easiest way,.which 14 there's a consesus, would be sitting down together with just the medical associations is, from a legal point of view, just not 16 M There are ways that these views can be obtained, 17 A possible. and I think they're being obtained now, but it has to be 18 19 done in a manner which is legal. I'm not suggesting that anybody is advocating 20 21 something that's illegal, but I think we have to be aware of but we're subject to how it is the Agency can proceed, i' 22 constraints, and there are various ways of soliciting views, 23 but the idea here was before we get to the proposed rule 24 In other words, once we get to the proposed rule 25 stage. Heritage Reporting Corporation (202) 628-4888
I 4 1 128'. 1L 1 stage,,we-have a rule thrl's published'in the Federal' '
/.
. t, - ..
Register-for comment by anybody who wishes to do so. 13
-This is before that' stage,-getting a bite at the.-
4- apple, v ,so to speak, but we.have to'be-very careful in how we 5 get the input of the'aither individuals or associations that 6 we're' regulating, and I hope I may have clarified some of
- 7 the constraints on the staff and the' Agency itself, because t 8 from a legal point of view, just sitting down with, .if you c 9 want to call it the regulated industry, and the Agency-and 10 the industry sit down and they write their rule, there are 11
- many legal problems with that..
12
-DR. COLLINS:
Perhaps you.would go a little 13 further and tell Dr. Order how to stay out of jail. What 14 were your suggestions?. MS. ROTHSCHILD: Pardon?
-16 i DR. COLLINS:-
17 You've said what he shouldn't do. What should he do? 18 MS. ROTHSCHILD: Well,.I've talked about the 19 const;aints on the Agency, and I think you've raised a good 20 point z may have neglected to address. 21 Any individual, whether representing an . 22 association or just himself, can submit a formal document, 23 , like a petition for rulemaking, would be one means by which
- 34 either an individual or representative of associations or 25 representative of a group of associations can seek to have Heritage Reporting Corporation (202) 628-4888
1 4 I 4
' 129
.' 1 Agencyrregulations changed or amended, and, of course, this g
particular forum is a way by;which the associations, as they
~
3 have been doing, can submit their views to the Agency, but-l 4 if they had a particular proposed rule or a particular way i 5- in which they wanted a rule amended, they can submit a
- 6 petition for rulemaking.
7 Now, it would be in parallel. It would be treated 8 separately. The Commission would have to -- there would be-9 a response. It would not, as I see it, replace the 10- procedure, the process, we have going right now. So, that 11 would be one way that they could proceed, and, of course, 12 this way is the way I guess that it was felt would best 13 utilize the staff's own advisory committee and get the input 14 that was offered or which the association said they wanted to have back in the spring. 5 16 DR. COLLINS: Do you feel safe, now, Dr. Order? 17 DR. ORDER: No, I'd like to respond to that. I 18' won't have lunch with you, though, so, we'll be all right. 19 I think there are several things that are 20 contradictory in that. First of all, the object of the
+ 21 American College of Radiology was to produce a document, not 22 a rule. The document would indicate what the standards of quality assurance are in the United States today, which I 23 24 challenge you, if you' re honest, that you don't have the 25 answer to. None of us know what the standards of quality Heritage Reporting Corporation (202) 628-4888
._ _ _ _ .___--_____ __ - _ a
130 '- 1 assurance in the United States are this afternoon at all the
- 7 facilities that do radiation oncology.
's So, first you have to have evidence, scientific 4 evidence, of what's going on in order to make rule. We're 5 not telling you what rule to make. We're not proposing that 6 we make the rule. We're trying to get for you the -
7 information so you can make intelligent rules that can be 8 applied in this field, So, the first thing would be to 9 survey the nation and find out what quality assessment is as 10 it stands. 11 The second thing would be that those people who 12 are expert enough in the area might recommend more than what 13' we find today, and the final step would be your own step, 14 which would be you, as an independent agency, independent of-19 :- the profession, could then review that information and draw 4 E l i# up the rules that you see-fit. That's a different thing. 17 We're not in the rulemaking process, but we are in 18 the process of trying to identify what quality assessment 19 is, and, further, to see if we, as a profession, think it 20 needs to be refined. Then, you can make rules, but to make 21 rule without knowing what quality assessment is is arbitrary - 22 and damaging to patients and the patient-physician 23 relationships, and I've shown you a number of things in the 24 documents you've drawn up, and the reason is you don't have 25 the experience, and, so, therefore, I think it's quite is Heritage Reporting Corporation (202) 628-4888
131 i-i different. We' don't have'to be involved in the rulemaking l' at all. 3 3
~
MR. MORTON: Bob Morton for the National-Cancer 4 Institute. 5 Prior to working for the National Cancer 6 Institute, I worked for the Food and Drug Administration, 7 which is ' also known as a regulatory agency.- 8 It is legal to develop your proposed rule in any You must then-
-9 way you want,- but it's only a proposed rule.
.That is 10 publish it in the Federal Register for comment.
11 where it is heard and read and commented on by all sides, 12 and it is not impossible to take something that's developed-13 entirely by a voluntary agency, such as the National finally, if 14
- Standards Institute,.and make that into a law,
# you go through the proper process.of publishing it as a l taking comments, 16 Y proposed rule in the Federal Register, 17 5 responding to those comments, and publishing your final 18 rule. I'm sure the NRC knows this.
I agree. We do that, but I think 19 MS. ROTHSCHILD: 20 just to put this in perspective, just to reiterate, is that 21 we are trying to get input before we get to the formal We certainly don't dispute about what 22 proposed rule stage. 23 will happen and who gets input when we get to the proposed 24 rule stage and publishing in the Federal Register proposed 25 rule for comment and responding to that.
. Heritage Reporting Corporation (202) 628-4888
132 1 The idea here was that since the medical ' { community, in particular, asked the Commission to listen to 3 them, to solicit their input in developing this rule, that 4
'that is what we're trying to do now is to get that input 5
before we get to the formal rulemaking stage, and I think 6 that's what, at least from a legal point of view, is'the
- 7 stage we're at.
8 . DR. COLLINS: Ms. Brown? 9 MS. BROWN: Melissa Brown with the American 10 College of Nuclear Physicians and Society of Nuclear 11 Medicine. 12 I just wanted to say a few words about input, and, 13, first of all,.I would like to say that I think that the 14 College and Society would endorse everything that Dr. Order (( has said and everything that Dr. Morton has said. 16 We want to provide input, and our comments today
.17
.were directed toward what we don't think is necessary, but 18 we didn't have an opportunity to review this draft prior to 19 the meeting today, and I think there are several other 20 people that are in the same position, and we could provide 21 much better input if we had received a copy of the draft "
22 before. 23 . DR. SUNTHARALINGAM: Suntharalingam from the , 24 American College of Medical Physics. 25 When I heard about this meeting and expressed our Heritage Reporting Corporation (202) 628-4888
- 133
. 1- desire-to come here, I was warned, " Don't go to Washington without a lawyer by your side", and now we have gotten into l
3- the legal aspects of what can be done and what cannot be 4 done. 5 I'm rather curious, again, for a definition of 6 what appeared in the Federal Register. It says, " Work with 7 the Department of Health and Human Services and existing 8 groups such as the professional organizations, professional 9 colleges, and the Joint Commission of the Accreditation of 10 Health Care Organizations, to assist in developing uniform 11 and compitable voluntary standards", and our interpretation 12 of " work with" our College is so that we can offer our 13 assistance in trying to come up with the appropriate
-14 information that one needs to make a rule, and, therefore, we certainly welcome the chance, but I would hope that this 16 ) chance doesn't end with a meeting of this type, but we go 17 ) and formulate a working group of representatives of the 18 different organizations, so that we can work with 19 representatives of the Commission, so that some meaningful 20 information is produced in the documents.
21 I am rather curious to find out where did all 22 these numbers come from? Where did the 20 percent or 50 23 percent or whatever percentages that have been proposed, 24 even, come from? Who gave information to the NRC staff or 25 did the NRC staff just pick these numbers from some Heritage Reporting Corporation (202) 628-4888
? I' J 134* 1 : statistical 1 input as:to_what might-be valid in_' terms of ' ( errors-or no errors at all7 31 MR.'McELROY: As was pointed out early-in the day,
- 4 these.three alternatives were developed simply to initiate 5
- discussion, and I think they've been quite successful.
'61 We were making a humble,' naive attempt at
- 74 -characterizing blunders and putting that characterization 8 into what is referred to as regulatory text. There is no 9 scientific or statistical foundation for the 20 percent 10 number that you see in one draft there, nor is there any 11 such foundation for.the110 percent number that appears in 122 the current rule.
134 It was, it's my understanding, simply generally 14t agreed that once the. dose to the center of a tumor ~is off by [* s 10 percent, something has gone wrong in the therapy system,- 16s 'so none of these reporting rules have's scientific-17 E foundation that I perceived you're looking for. They are 18 judgement calls,-and regulatory agencies _have to make 19 judgement calls. 20 .If someone has a better way of characterizing when 21 something has gone wrong in a process, we are certainly
- 22 anxious to hear about it.
9 23 DR. ORDER: I'll be glad to answer that, because, 24 first of all, most modern groups do not give a dose to the 25 central axis. They usually give tumor minimums, and, Heritage Reporting Corporation (202) 628-4888 i
.+ 135
*' l' ordinarily, the tumor minimums are plus or minus 5 or 10-percent, depending on the particular thing, but there are 3 situations where we' re far beyond that in radium 4 applications, etc.
5 The real issue could be divided in an entirely
+
6 different way. For example, there's a class of patients 7 that come to us that are palliative. They are there for 6 8 relief of pain and discomfort or some sign or symptom. They 9 have one range of dose which we could give to that class of 10 patients. 11 Compare that to the patients who are treated radically for curative purposes. The dose ranges for the 12 13 different diseases have another range in that kind of setting. We know what those ranges are. We are capable of 14 ' g
,a a writing them down either in more global terms or in more 16 1 refined terms.
17 4 That's exactly the kind of interaction I would 18 like you to have if you' re going to write rules, so that the-19 rules are intelligible and relate to reality in some way. l 20 So, a 10 percent or 15 percent excess in a 21 definitive radical dose is a dose beyond the standard for 22 the disease, and that's what you really want to know, or the ! dose in a palliative situation, which goes beyond what's 23 24 reasonable, is a dose beyond the standard for that disease, 25 and that can be enumerated, but it can't be done on percent. Heritage Reporting Corporation (202) 628-4888 i l i l L I --- - - - - _ - - - - - _ - - _ _
t-136'* 1 - If you gave 2,400 rad to.a palliative case, and '
- I
( you're 10 percent over'or 15 percent over,-it won't make a 3: difference, but if it was a definitive radical case, it ! 4: could make a radical difference in injury and other kinds of 5= things. 6: So, there are ways of dividing the cases and - t 7 .. enumerating principles, but that's not simply on percent. 8 MR. McELROY: But don't the same people in the 9 clinic setting work on both kinds of cases? 10 DR. ORDER: Surely. ; 11 MR. McELROY: Is it not simply a matter of chance 12 where they make this mistake? l 13<. DR. ORDER: It's a matter of chance when you look i 14i at the mistakes that are made on the mistakes that.are made, [
- 4. but the impact of the mistake relative to patient well-being I
16E and delivery of care, which is, I thought, what you're < 17; addressing, is quite different in the different ! 18 circumstances. 19 MR. McELROY: We are aware of palliation versus a 20 curative attempt, but this whole initiative began because 21 there were serious blunders made, and whether they're made ~ l 22 with one particular patient or another is not driving this, 23 and the fact that it was a palliative patient -- 24 DR. ORDER: But you used the word " serious", and 1 25 that's quite different. f') Heritage Reporting Corporation (202) 628-4888 I l i l i I 1 1
137 most of
- The errors that have been reported to you, 1
.They' re all in excess 2
the ones I've read, are very serious. J of the standard doses, and another'way you could phrase 4-what's in your report is that if it's 10 percent beyond the then you don't 5 standard dose acceptable for the disease, 6 have to know all the diseases, and you don't have to know People also 7 all the different-aspect of what goes on.
. their treatment dose during the conrse of l8 change, sometimes, 9
therapy because they find some event that they want to 10 alter. You have to have some realistic application of 11 12 your quality assessment to the program if you want to have real data, and that's why I don't think you' re ready to do a 13 because you really don't have good. rules 14 pilot study, yet, down at the moment, J5 0 I mean if you want to pilot study something that e you can have 17 will give you the same answer you went in with, 18 that, but if you want real data, I would suggest you need a and you 19 national survey to find out -- you ought to fund it, and then, what they 20 ought to find out what people really do, because you'll have the data
~
21 need to do, you can decide, then, and then the community can help you write some dose 22 23 rules that are realistic. I just picked one out of the hat to demonstrate 24 I none 25 that the 10-percent rule has no meaning at all,
. Heritage Reporting Corporation (202) 628-4888 1
13'8' 1 wha,t soever, and any therapist at any-facility can so move ' y the doses in different ways, that if they didn't want to 3 tell you, you wouldn't know it anyway. 4 DR. KHAN: Faiz Khan from AAPM. 5 I think this question of percentages are being 6 raised primarily from reporting point of view, because, to ^ 7 me, even 2 percent is unacceptable in some cases, and these B . percentages really do not mean that anything below that is 9 okay and anything above that is not okay. 10 I think the whole idea, and Norman,-actually, just 11 in the morning, he said that they are going to talk about. 12 the reporting thing as a separate issue, but if you drop the 13 reporting business, then all you are concerned with is what 14 procedures should be used as a quality assurance s- irrespective or what the percentage differences are. You do 16
% not want to make errors. That's it, irrespective of whether 17 they're 20 percent or 10 percent or 1 percent.
18 So, I think the percentages.can be very misleading 19 in thin case. Ten percent under no -- I mean 5 percent is 20 not acceptable to me, either, and also, I may comment about 21 the brachytherapy 20 percent that has been talked about. . 22 That doesn't make any sense either, and then 150 rads, 23 , listed there, total dose difference 150 rad. I don't know 24 where that 150 comes from. Things like this. All these 25 numbers, really, are being put forth primarily for reporting Heritage Reporting Corporation (202) 628-4888
.- 139 1 reasons, and I think the basis of all this does not make
? sense to me, the reporting in itself.
1 J So, until we get some explanation about why we 4 have to report all these things, I will not be able to 5 understand what 10 percent, 20 percent, mean. 6 MR. STANTON: My name is Bob Stanton from Cooper 7 Hospital, Camden, New Jersey. 8 My question is precipitated by the discussion on 9 the pilot study, but goes to a much more basic question. 10 That is, when we look at the pilot study, many people in the 11 audience said, " Gee, what are the questions that are being 12 asked. Is it going to be able to answer the quesitons. 13 Therefore, how long should it be? Therefore, how many 14 people should be involved?" And when we go down to the basis of it, we're not really answering any question except
}R 16 is what is being proposed going to be inconvenient.
17 That's basically what that was supposed to answer, 18 the pilot study. Is it going make the physicians not be 19 able to get to the patients. Is it going to make the 20 technologists quit or what? And that's not quite the 21 question that needs to be answered, and I'm not sure if 22 we've gone beyond asking the basic question, which is why 23 are we going through all this. 24 In the last few minutes, people have been 25 discussing exactly what is quality assurance, what is this, Heritage Reporting Corporation (202) 628-4888
140 .. I what is that,~and it-all comes back to we had this several . dozen misadministration. ( We want to do something about.it, 3- and a basic question should be, how much do we want to do. 4 In much of the legislation I've read about, just , 1 5 as a non-legiclator, a non-regulator, environmental impact f 6 ~ statements have to be done. Studies have to be done. That . 7 is, if there's a problem, how is it proposed that the 8 problem be solved and will the problem be worse than the 9 solution, basically. 10- We're faced with some misadministration, and we 11 haven't really answered the question,-is what is proposed, 12 the general category of what we're proposing, going to solve 13 anything? Several of the misadministration mentioned 14 wouldn't be covered by the specifics that'have so far been promulgated in the proposed rules. {& So, we're getting a 16 + fairly reasonable amount of expense, according to the 17 1 drafters of the rule, and absolutely no benefit. So, cost 18 to benefit ratdo is infinity. 19 I think the questions have to be answered when 20 you're going to write rules. Are we going to get something 21 for what we're investing.in this, and that hasn't really - 22 been answered. I'm not sure if that shouldn' t be the 23 question asked first, 24 That goes along with the proposal by the American 25 College of Radiology and other groups of let's look at what Heritage Reporting Corporation (202) 628-4888 1
.* 141- ..* 1 the problems are, look at the general situation. I think if i
i 1
- we don't see what are the problems and will they be solved 3 by what we're talking about, then we' re just running around q 4 in circles, giving more work to already overworked 5 regulators, because.I don't see -- the comment I made this 6 morning about having enough people to do the job.
7 I think that's an important point, but.I think we're' going around in a circle, giving an impossible task to 8 9 the regulators,.and generally, the environmental impact of 10 it all will be negative. We'll end up'giving worse' care'to 11 'the patients, not better care to the patients. 12 = MR. NIBHANUPUDY: I'm from Howard Hospital, 13 Washington. 14
- On the basic QA, page 8, section 44, your check i for the dose calculations should be made before 20 percent.
m 16 h So, the prescribed dose could be different. .Could be 4,000 17 - in one case,.could be 6,000 in another-case, or 2,000 in 18 somebody's case. So, we cannot say 20 percent of prescribed 19 dose. 20 I think it will be better if a time limit is put 21 on, like 3 days -- 3 treatment days or something like that 22 for the 441 as well as 442. 23 DR. COLLINS: Have we run down on input here? 24 DR. KHAN: Faiz Khan from AAPM. 25 I must give credit to the NRC for drafting these. Heritage Reporting Corporation (202) 628-4888
f 142 ** 1_ I'm sincerely-'saying that, because I'm quite aware of the " {- fact that'there are institutions, hospitals,-where standard < 3- of practice are not being maintained. There are also 4- institutions where the staff is not there to provide any 5 semblence of the quality assurance, and 1 think -- I mean we 6 have go all kinds of quality assurance documents, the AAPM,
- 7 ACR, and ACMP. They're all coming up with all kinds of-8 guidelines, but nobody looks at them.
9 The only people that they are going to listen to 10 or pay attention to are the regulatory agencies like the 11 NRC. So, I will not really discourage them from formulating 1:2 guidelines which will be regulatory in nature, and AAPM'and i 13 other organizations will cooperate in coming out with rules 14 which will solve the various problems. j { e There are serious drawback or serious problems 16ir with the proposed items which have been discussed this j
-17 morning and this afternoon, like the percentages and things )
18 like this. I think those things can be worked out. My 19 serious objection, as I mentioned before, had to do with the 20 reporting and until we hear that discussion, I'll reserve my 21 judgement about that.
- l 22 Pilot program to me is useless, but I would 23 encourage the NRC to come out with some document which will
]
24 be mandatory for people to follow and reduce the risk or j J 25 minimize the risk to the health of the general public. t-Heritage Reporting Corporation (202) 628-4888
o a* 143 t l-
** 1 DR. HERMME: Dr. Herman from the CAP.
l l ! Listening to what has transpired here in the past 1 . 3 several hours, I get a drift that the NRC has had an aroma 4 conveyed to them. They smell a rat. Their conviction is 5 that someplace out there there are bad actors and we wish to 6- deal with them. 7 I believe that the data conveyed by the 8 misadministration have been false avitars of this 9 information. I would agree with the NRC that there are, in 10 fact, bad actors out there, but that the misadministration 11 which have been concentrated upon, are essentially dealing 12
^
with the statistic of rare events. They are poissant 13 statistics, and, as such, do not act as informative agents 14 that define better or worse operations. The College of American Pathologists has run a 16 i series since 1971 of outside proficiency testing in nuclear 17 r medicine facilities, and these have included both dynamic 18 and static models of imaging, and I assure you gentimen that 19 the bad actors in these groups, for instance, cannot tell 20 the difference between a 50 percent ejection fraction and an 21 81 percent ejection fraction, nor can they, with any degree 22 of certainty, define targets from non-target areas with any 23 degree of statistical difference than flipping a coin in 24 many instances, so that the quality of performers in nuclear 25 medicine facilities is highly variable. Heritage Reporting Corporation (202) 628-4888
144 *
- l l 1 I think what needs to be done, rather than '
( specific addressing of what are, I believe, in essence, red 3 herrings, as far as the misadministration goes, is a 4 strengthening of the overall quality assurance procedures 5 and enhancement of the already embryonic, and to some 6 extent, existent programs, so that there can be - 7 identification of these poor performers and more than gentle 8 persuasion imposed on them to improve their performance and 9 to bring it up to standard, and for that the Nuclear 10 Regulatory Agency is being looked to by the profession. 11 Thank you. 12 DR. COLLINS: No other comment at the moment? Mr. 13 McElroy, would you be a word for the alternatives for 14 characterizing report work?
$ MR. McELROY: Before we get into the technical 16
- matters here, it might be appropriate to spend just a minute 17 or two looking at this reporting requirement. It's not been 18 one of our more popular regulations.
19 It started in about 1972 when the Government 20 Accounting Office auditied the Agency and learned somehow of 21 event that had occurred at hospitals and asked what we had
- 22 done about them, what rulemakings were in place to catch or 23 mitigate these events, and we had started on some kind of 24 reporting and QA requirement in the mid-70s. Nothing came 25 of that initiative.
Heritage Reporting Corporation (202) 628-4888
145 4
**'1'
*, We got back into the quality assurance business where a 2
with the event that happened in the mid-west, d physcist was uncorrected decaying a cobalt source and some 400 patients were impacted. Following that' event, we 4 5 required that licensees have some kind of annual calibration
'6 and safety check for the_ unit,' monthly check and annual 7 calibration.
The misadministration reporting rule was' initiated 8 9 as an attempt to collect'the information that we've all been 10 talking about, the missing information, and we've gotten 11 some events reported, and in the case of the. therapy events it looks as though we get 12 where patients are hurt sometimes, There's just not 13 a new event every time we get a report in. too much repetition of mistakes. People make new mistakes. 14 I guess that means they learned from the old ones.
,15 I
The Commission went ahead and implemented-the o 17
- reporting requirement in 1979. Many of the concerns we've 18 heard this morning were expressed at that time.
19 Nonetheless, the Commission went forward with that.
!ht staff touched on this again, this concept of 20 when we prepared revision of the 21 reporting certain events, 22 medical use regulations in part 35, and suggested that the 23 Commission may want to reexamine the reporting requirement, 24 because we had had a lot of information come in and it was a 25 large enough set of information to be analyzed.
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148-* 1 The Commission decided to keep the reporting '
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I requirement and also directed that it be made an item of i 3 compatibility with the agreement states. The agreement 4 states, in some cases, have to adopt exactly the regulation 5 we have in place. I believe part 20 is an example where the 6 regulations have to be word-for-word identical.
- 7 Part 35 is not a matter of compatibility. Each 8
agreement state has to have some kind of program for . 9 licensing and inspecting hospitals, but they're free to have 10 whatever requirements they think are most appropriate. 11 When the staff presented the Commission the 12 suggestion that the misadministration reporting be 13 reexamined, the Commission directed that misadministration 14 reporting be made a matter of compatibility. Now, that r directive came out about 2 years ago. I think-that 16 a indicates that the Commissioners feel that we should 17 continue with some kind of reporting requirement to collecte 18 information It will tell us whether our rule are 19 effective. It will identify new problem areas. 20 So, I perceive we are going to have some kind of 21 reporting requirement. Now, we are free to recommend to the ' 22 Commission changes in the reporting requirement, and I 23 imagine, from what . I've heard today and what I've heard in 24 the past, the two key issues in the reporting requirement 25 are its scope and -- or perhaps three issues -- the scope of Heritage Reporting Corporation (202) 628-4888 _ . _ _ _ _ _ _ _ - _ _ _ _ ___ - O
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1 the reporting requirement, whether the patient should be f notified of the event, and whether the report should be
! 2 i 4 submitted to the Agency or simply be held in the hospital's 4 files for review at time of a compliance inspection. 5 So, we would like to hear your comments on those 6 three key issues that are raised in this reporting 7 requirement. It has also come out in this discussion that 8 we didn't separate the reporting text out. The purpose of 9 that was simply to frame the scope of the QA rules, so they, 10 in each case, go, to some extent, hand in hand. 11 Very quickly, the first alternative you have is 12 not far reraoved from the current reporting rule that has 13 been in place since 1979. Similarly, I think we have just 14 about the same text in the second alternative. The third J5 alternative poses a very wide range of events -- a first-16 pass attempt at identifying every place in the treatment 17 system where a mistake might be made. 18 So, we have, essentially, two different scopes 19 here, and then the questions of reporting to the patient and 20 reporting to the Agency versus holding the report at the 21 hospital. 22 DR. KRAN: Faiz Khan from the AAPM. 23 Our institution did not go through any pilot 24 program, but we have in place this practice of reporting in 25 the institution. What we do is that any incident which was Heritage Reporting Corporation (202) 628-4888
14 8 ' a 1 due to a human error, whether the actual. dosage error was 1 *
,. 2, percent, 2 percent, or 10 percent, that incident actually-(
3 goes under incident report, and it'is compiled. It's 4 available at any time for JCHO or any other organization 5 that comes along. 6 It also helps us to, once in a while, get together
- 7 and review the incident reports, so that we can minimize the 8 recurrence of that incident. So far as reporting to the 9 referring physcian or the patient is concerned, that's left 10 to the physician himself, depending upon the type of case, 11 they would or would not report this to the patient.
12 I think this kind of a system probably exists in 13 many other institutions, and here you can take advantage of 14 that system which works, and I think that's your sort of 15 pilot program. If you survey various institutions, they can lo tell you what's going on in those areas, and I would 17 strongly support the idea of incident reporting as practiced 18 in our institution as I stated earlier. 19 MR. McELROY: Those reports are held internally, 20 then, I gather? 21 DR. KHAN: Yes, they are held internally, but they
- 22 are available at any time any agency wants them.
23 MR. McELROY: Well, how would that help us know if 24 our rule were complete or help your colleagues at another 25 institution to look out for a similar mistake that might be Heritage Reporting Corporation (202) 628-4888 l \ _ _ _ _ _ _ _ _ _ - _ _ _ _ - _ _ _ _ _ - _ - _ _ _ _ _ _ _ _ _ _ _ _ _ -
__~_ - - _ __ _ __ 149 d' I made? DR. KHAN: 'Well, I think if it is done in a l t.
.t If 3 anonymous fashion, I think that could be taken care of.
communicated. 4 you want to notify people, those areas-... However, we are talking about the simple errors which happen 5 ~ C because somebody did not understand certain prescription or 7 did not understand certain procedure and did this. and then, I So, these things can be kept on file, 8 think, maybe NRC can come out with some way of disseminating 9 10 the information without requiring that they get on the phone and then.go through a 11 every time something happens, tremendous amount of paperwork to report'to the NRC and then 12 I think 13 be forced to talk to the physician or anything. for l 14 I that route really discourages people to report anything, ,
- one thing. So, I think we should look at those things 16 i before we come out with some reasonable alternative to 17 # reporting as has been in the past.
Suntharaligam from the 18 DR. SUNTHARALINGAM: i 19 American College of Medical Physics. I would assume, based on the remarks made by Mr. 20 21 McElroy, we have to accept the fact that Commissioners are What we did not hear 22 committed towards a reporting program. was reporting to whom. If they' re committed to the f act 23 then, now the question , 24 that we have to report to the NRC, ! 25 arises, what is reportable and at what levels does one want i
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= _ - - _ _. -- -- r 1 150' to report them? ~ ( Now, i f, also, based on your question to Dr. Khan, 3 you phrased a question, how would NRC find out-what error 4 are happening that will impact on our rule or how-will the 5 rest of the community find out whatever.is. happening, so 6 that they may be on the alert, then I believe we are ~
-7 addressing, again, the whole question of " education" as well 8 .
as at what level of incidents do we want the Agency as. well-9 as the community to become aware? 10 As most of you know, there is a voluntary program 11 regarding malfunction of equipment. ~It's a voluntary 12 program, but it has been a very useful program because if 13 those who are committed to the profession, committed towards 14 good patient care,
/' want that information to be known to the public, they fill out a form and send it to U.S.
16- Pharmacopeia, and then through the Bureau or the National 17 Center for Devices, semi-annual reports are made available 18 to the community, and therefor it's putting everyone on 19 alert that there are potential problems. 20 I think again I want to emphasize, we who are in 21 the field are fully aware that there are problems in certain n 22 areas, and we are all trying to do everything possible to 23 , try to minimize them, and we are also aware and we are 24 alerting people that, if nothing is done, regulatory 25 agencies are going to force something down our throat which j Heritage Reporting Corporation (202) 628-4888
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*1 we may not like, because the question is at what level'is something significant and important?
3 Now, if you go and look.at programs that are 4 currently existing, in fact, the programs.have become even more complex. I mean Cobalt 60 is nothing. Cobalt 60 5 6 teletherapy is nothing compared to the fairly complex 7 treatment procedures we have to accomodate ourselves to with accelerators. Now we record and verify systems that are 8 If something is recorded.into the 9 built into the machines. that 10 computer system in error on the first day of treatment, 11 gets carried out for 30 treatments if it is not properly scrutinized, because it goes into a computer automation 12 13 process. 14 ' So, as a result of these, there are more and more sophisticated QA programs that have been incorporated into
' our practice, and all that we need to find out, are these 16 programs of value? Can it be implemented by the smaller 17 facilities? Can we identify errors?
18 There has been, obviously, a reluctance regarding 19 Now, 20 the need for reporting at what level of reporting. 21 even though there has been a reluctance, it is somewhat 22 disturbing to find that as a working document or a preliminary document, whatever you want to call this, you 23 and maybe there's 24 people have now even started thinking of, Why does one want to 25 a reason. I haven't heard the reason. Heritage Reporting Corporation (202) 628-4888 f
15d
- 1 know:even if an incident happens the first day and it gets '
-{ corrected, you want to that to be reported.to the NRC?
3 Now, that's way I read some of the alternatives, 4 that if an incident happens during any section of your 5 ' treatment, and somebody has come with the magic number of 6 the cumulative error is more 150 rads, it becomes a ~ 7 reportable incident. 8 . Many institutions have a program whereby every 9
. procedure has to be checked and double-checked before the 10 second treatment is delivered, so that if at all an error is 11 made only.in the first treatment, that it will get caught.
12 Now, you are telling us, if such an error is 13, detected, please let us know, because we want to know what 14 these types of' errors are. If you tried to put that~as j rule,
': people are even trying to do these checks within the 16.
second day of treatment, might be reluctant to do these 17 checks, because they'll say, "Only those facilities that are 18 checking will have to now report this to NRC." 19 DR. WEBSTER: Yes. I was concerned that that may 20 not be correct, what you just said, that the reporting to 21 , the NRC of a misadministration is related to the total dose 22 after the treatment is finished and it's no longer 23 correctable, whereas on the first day it would clearly be 24 correctable. 25 DR. SUNTRARALINGAM: That's in the past, but in Heritage Reporting Corporation (202) 628-4888
'l 153 j
'the new$ documents,that have just been' circulated, the
~
- 1 2, or 3, I
. proposed documents, whether;it be alternative 1, q don't remember what..
The implication'is that.if-you detect 3'
-4; an error even first day of treatment and it gets corrected, !
'5 they want that reported to the NRC.
~ DR. WEBSTER: My question is is it an' implication 6
7 or is it quite definit. DR. SUNTHARALINGAM: The NRC has to answer that. 8 DR. WEBSTER: I should say 'that I'm not that 9 10 familiar with this either, because:I didn't get this until Lil quite recently. DR. SUNTHARALINGAM: This is why I'm again being-12 rather cautious. I hope you don't leave this meeting 13-14
~ feeling that this has been adequately ~ thrashed and If you give me a discussed. There has not been much time.
t 16 / few minutes, I'll try to get back at a specific session. teletherapy dose
/ Alternative 3, item number 6, 17 18 errors in individual treatment fractions are reportable 19 unless discovered and corrected during the same phase of 20 treatment, prior to accumulation to 150 rads of error.
21 In the past if it was total and if you discovered 22 something during the treatment, you either would give one
-23 less treatment or give one more treatment and catch up with 24 the total dose, but hern this says -- and there was
- 25 something else.
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154** 1 f DR. WEBSTER: I think you need -to not < jump to
- j
- I i
l conclusions on this. 3 DR. SUNTHARALINGAM: Well, we can only read what 4 is right here in terms of the QA. 5-DR. WEBSTER: Maybe Mr. McElroy is more familiar 6 with it. . 7 MR. JOHNSON: Terry Johnson of the NRC. 8 Dealing with the third alternative first, there is 9 wording such as Dr. Suntharalingam was talking about in item 10 21 of the reportable events, and here a dose -- this would 11 be in the third alternative, item 21. 12 An individual treatment fraction of teletherapy 13 with a dose area would be reportable if it's over 10 percent 14 7 if enough fractions are administered that the total dose error exceeds 150 rads. Now, presumably if this were done 16 on the first day, although it is possible for a typical 17 5 fraction of, say, 200 rads, the error that would have to be 18 administered would be virtually 100 percent. 19 DR. SUNTHARALINGAM: And it's possible. 20 MR. JOHNSON: It is possible, true. It is 21 possible. " 22 DR. SUNTHARALINGAM: And it's possible because, 23 . I'm sure incidents have been reported where a treatment 24 calls for the use of wedge, and that first day, 25 inadvertently, the technologist didn't put wedge, and
'r '.
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q
** '155 4* - 1- sometimes these wedge factors can be accounting for 50' j percent or more, and what one is saying is that if such'a.
3 thing'is detected, you want that immediately reported to the 4 NRC, even if it's the first day of treatment. 5 MR. JOHNSON: Yeah, that's true.. If it were more 6 than this 150 rads, so what we need, perhaps, as feedback 7 from the medical community, is not only the framswork of the 8 language that should be used to report these errors, but 9 also the number of rads, the number of days, the percent 10 error and so forth that is acceptable or that was 11 reasonable. 12 So, for instance, if this alternative, item 21, 13 could'oe made to appear much more sensible to the medical 14 I community if the 150 rad error were-changed te 300, that's p the type of.information we'd like garner here today. 16' ) On the other hand, we could specifically change 17 the rule to say that errors that persist past the first day 18 of treatment, however we are thinksng about the smaller 19 facilities, Dr. Suntharalingam, and, very often, the smaller 20 facilities will have a consulting physicist who-comes by 21 once a week. Now, if treatment if initiated on a Friday, 22 say, after the physicist has already been there -- the 23 visiting physicist who's there every Friday -- it may not be 24 that any error that's made is identified for correction 25 unti? uay, 7 or 8 days have passed, possibly 6 treatments, Corporation
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.15 6 *
- 1 so we have to have language that is compatible with the *
( smaller facilities that are forced to treat the patients 3 .that they have, perhaps in a rural area, to deal with a 4 physicist who comes by once a week. 5 DR. COLLINS: Mr. Griem has a comment. 6 DR. GRIEM: Yes. On the same page, under item 3, - 7 some generic errors and so forth, could you give me an 8 exmaple of them at your definition of a generic error or 9 list several? 10 MR. JOHNSON: Yes, Dr. Griem. 11 DR. GRIEM: It says some generic errors related to 12 , dose or dosage are reportable. Gee, that's vague as all get 13 out. That sounds like something in the Internal Revenue
.14 Service Code.
{ MR. JOHNSON: Oh, I see. Well, each of the 16 alternatives does have a summary page. I think for the 17 > purpose of the discussion, though -- 18 DR. GRIEM: Could you just give us an example for 19 the audience out there. They just have this document. 20 MR. JOHNSON: Okay, some generic errors related to 21 dose or dosage are reportable. That item, for teletherapy,
- 22 in particular, is dealt with in item 20 of the reporting 23 rules, whereby a calculation that is based upon the wrong 24 wedge factor or rather a treatment that is initiated with 25 the wrong wedge, the wrong bolus, the wrong tissue i
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,* 1 *' 1 compensator, would be reportable -- the wrong beam block 2' tray. !
L For instance, blocks that are intended to' patient' 4. 4 A are used for patient B, or a bolus that's intended for 'a 5 patient'is ommitted. Those would be reportable immediately. 6 That is not to say the report will be due immediately, but 7 any treatmentL that's made with a wedge ommitted when it's 8 intended to be used or a bolus omitted when it's intended' to-9 be used would be reportable. 10 Also, there's an item that deals with the caluclations, too, in the same rule. That's item 17. It
.11 indicates'that if a calculation of a dose or dosage is made f
12. 13 ' using the wrong wedge factor or data from the' wrong data 14 table. For instance, data from a depth-dose table when a TMR table was intended, those would be reportable. p5 i ' I think Mr. McElroy made the point, well taken,
'l o -
17
~
that this is simply an information-gathering tool, or at 18 least one of the -- the most important purpose of this data 19 is to gather information about the errors that are taking 20- place. DR. KHAN: Faiz Khan from the AAPM. 21 22 I would like to have more discussion-as to what 23 NRC's going to do with that information. 24 MR. McELROY: We analyze the information and see if our rules are complete. Do you have more to ask? 25 Heritage Reporting Corporation (202) 628-4888
158 1-DR. KHAN: I was thinking are you going'to take ' t any action or you're going to take any --
'3 MR. McELROY: We're taking action today, Dr. Khan.
41 DR. KHAN: No, what I mean is are you going to 5' take the license away if somebody reports, say, too many 6 errors or is there anything in that regard? . 7 MR. McELROY: To date, we have not taken any 8 . action such as that for the events that have occured. I 9 can't tell you what the Commission will decide to do in the 10 end in some particular agriegious case, but I think that 11 that kind of action would be very rare, if it'ever occurred. 12 On some occasions, where events have been reported chat
.13 affected a large number of patients, we have negotiated a 14 site-specific quality assurance program with the licensee 1"
and made that a part of the license document, so it's 16 inspectable for matters of compliance. That' what we have 17 done to date. 18 DR. GRIEM: What's to prevent some inspired 19 Chicago attorney from using the Freedom of Information Act 20 to get at all this information for monetary purposes? You 21 know, here you have the data on people making errors, and we 22 l have some clerks sit in our conferences to help develop l 23 business. 24 MR. NIBRANUPUDY: I'm from Howard Hospital. 25 I just need clarification from NRC staff here on Heritage Reporting Corporation (202) 628-4888 1 I L - _ _ !
159 item number 7. Notification to the deferring physician is' 1 required only for events likely-to.have an' acute.'effeet or
~
This-3' likely to result in a dose greater-than 50. rems'. 4 notification is to include estimates of doses and 5 foreseeable damage. I just need' clarification.on what they
'6 mean by that from NRC staff.
7 8
.9 10-11 12-
'13 14
't 16 17 18 19 20 21 22
~23
-24 25 Heritage Reporting Corporation (202) 628-4888 i I
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16D* 1-l ' MR. JOHNSON: I'm Terry Johnson from the NRC. ' We - 7 do have a reporting requirement on the books now. And ia there's a lot that we feel is possibly in error in our 4 present reporting requirement. One think is that we use'the 5 word misadministration where we feel now that that's 6 inappropriate. . 7 But one other error we might have made is that 8' . while we specify notifications and reports in the present 9 requirement, we don't.in any way intimate what should be 10 included in any report or notification, either of the 11 physician, the patient or whatever, that is required. 12 t Simply that a notification is required. 13 So, the wording in the rule that you alluded to 14 would indicate that in the rare instances when a, when a 45
$' referring physician would be included in the notification io- loop, a that certain specific information should be conveyed 17 i
to the referring physician. Now, what the referring 18 physician does with this information is his business. Based 19 upon his own personal relationship with his patient and his 20 interpretation of his medical responsibilities. 21 It could include, for instance, his notifying the ~ 22 patient. But it might not. It's not specified here what 23 . the referring physician would do with the information. But 24 it appears to us at NRC that the referring physician 25 couldn't take any reasonable action with a notification,- ( Heritage Reporting Corporation (202) 628-4888
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1 unless the notification included the foreseeable damage to 4
' any critical organs. If there was to be any damage that'was i
4 a reasonable sequel to the reportable event. So that's why 4 this new language is included. 5 When I say the rare occasions when it would be 6 reported, in this third version of the rule, the only 7 instances when a dose would be reported to the referring 4 8 physician would be if the dose to a particular organ exceeds 50 rems in a reportable event. Or if there was likely to be 9 10- an adverse effect. So, that is quite a bit different from 11 the current requirements where any therapeutic
-12 administrations reportable to the referring physician and to 13 the patient, regardless of whether it's likely that there 14 will be consequences of the administration event or not.
DR. WEBSTER: Before you go away, could I ask you r
/5
'o l in what context this section 7 is written? Are we talking 17 about teletherapy still? Or, are we talking about 18 diagnostic doses in nuclear medicine?
19 MR. JOHNSON: Both, actually. 20 DR. WEBSTER: Both? MR. JOHNSON: Dr. Webster, yes. The way the third 21 22 alternative is written, the reportable events are stated in 23 such a way that they apply to any therapeutic event or any 24 diagnostic administration that fits the one of the criteria. 25 For instance, made by the wrong root for that particular
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162*o 1- administration. That would mean a therapeutic
- administration made by the wrong root or a. diagnostic 3' . administration made by the wrong ruot.- And so for.the 4 others.
- 5) When there are reportable -- that means it would 6 be reportable to1the NRC. "
7' DR. WEBSTER: In the context of nuclear medicine O though? 9 MR. JOHNSON: .Yes. This would include nuclear 10 medicine. 1:L DR. WEBSTER: By root, IV, mouth, or what? That's 12: what you.mean, right? 13: MR. JOHNSON: Yes. Right.
- 14 DR. WEBSTER: Nuclear medicine.
(' MR. JOHNSON: Right. 16" DR. WEBSTER: Not therapy. I' don't understand the 17; therapy context. Because you're giving 250 rads or 200 rads 18 per day to organs in therapies. Where does the 50 rads come 19 from? 20 MR. JOHNSON: Oh, 21 DR. WEBSTER: I don't' understand what it means.
- 22 Personally.
23 MR. JOHNSON: Okay. I think I understand what you 24 mean. It's reportable to the referring physician only if a 25 dose greater than 50 rems is given to any tissue in error. Heritage Reporting Corporation (202) 628-4888
163' I
** 1 Other than tissue within the intended treatment volume of a
- cancer.
DR. WEBSTER: You mean the wrong site is treated? 3 Exactly. The wrong site is IdP . JOHNSON: Yes. 4 That would be the perfect example. Wrong patient 5 treated. 6 is treated, wrong side is treated. in I know working as a medical physicist myself, 7 the therapy setting, I often had difficulty interpreting 8 And I was always SF some of the port films for right and left. d But 10 _very careful not to make an error in those regar s. 11 it's surprising how difficult it is sometimes to sort out right and left. And sometimes they are actually incorrectly 12 13 labeled too, by the technologist. They have markers to put 14 down on simulation films. And I've found more than one And to my instance where right was misplaced with left. (6 No reportable 16 knowledge no misadministration resulted.
' event.
But I had some difficulty catching those things 17 18 sometimes. DR. WEBSTER: It would be interesting to have some 19 20 interaction with the group here about that particular 4 21 problem. MR. STANTON: I know a lot of people don't want to 22 23 talk about the details because -- MR. MCELROY: Identify yourself please. 24 I'm sorry. Bob Stanton, Cooper 25 MR. STANTON: Heritage Reporting Corporation (202) 628-4888
l 16'4' 1-Hospital, Camden, New Jersey. * ( Many people want to talk about the more general 1 ( 3 basic problems. This is one example of even a clinical } 4 { physicist now in the regulatory setting writing a regulation 5 that needs a lot more input. 6 If I am directing the treatment with an external " 7 beam, say, to the maxillary (ph) sinus of the patient, I.am 8 . going to deliver 50 rads to the opposite eye.- That is, the 9 other side of the head. 10 I don't want to deliver.50 rads to the opposite eye. But there is no way I can get the 11 radiation in. Even though, according to all the definitions 12 of treatment volume that I know, the eye on the opposite 13. aide of the head isn't part of the treatment volume, 14 Now, if I'm giving a therapeutic dose of iodine to the thyroid, I'm going to deliver more than 50 rads to many 16, adjacent structures to the thyroid. I'm not trying to treat' 17 the thyroid. But I'm going to give 50 rads. I don't think 18 either of those are events that are abnormal. 19 I think we're opening ourself up to a vast amount 20 of paperwork for many things that aren't - shouldn't be 21 reportable incidents because they have no detrimental effect . 22 to the patient involved. 23 . DR. WEBSTER: If I could respond to that just 24 quickly. That would be the normal practice of medicine that 25 you're talking about. Suppose somebody makes a mistake and l Heritage Reporting Corporation (202) 628-4888 l t
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+ ' :1 gives th'e dose to the left' lung instead of the right lung.
You wouldn't normally do The 50~ rads. That's different.. ( 3 that. Right? So, you have to distinguish the context. This is supposed to be an event. That's what it 4l 5 says. An event that is presumably an error.
. IMt . ORDER:
Dr. Order from the American College. 6
- 7. I just want to'show you what I think is spinning the wheels
. Your own experience indicates'that 8 in quality assessment.
9 quality assessment would've defined a rule that all port 10 films should be marked left and right. And should be checked before they're put up for review as left or right. 11_
~ Also, how many times do facilities take port 12:
13 films? If you go around this country you'll find that they 14- don't'take them'every week. Sometimes they only take one Just one at the very
< before therapy. Sometimes not at all.
h beginning. So, if you really want to address quality 16
" assessment, I would rather see you address the real prcblem.
'17 That 18 Which is to find out that there are weekly port films.
And that we know 19 the port films are marked left and right. 20 that the technologist who took the film knows that left is Rather than worry about 50 21 left and has marked it properly. 22 rad extra. I could just see it now that we call a urologist 23 24 up on the phone for 6000 rad delivered to the prostate 25 because somebody delivered 6200 rad to the prostate or some Heritage Reporting Corporation (202) 628-4888
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- 1
'other defined area. I mean, with these people ~who are '
referring physician, they don't a rad from a riddle. And 3 they don't want to be bothered knowing this information. 4 And I assure you, if you have a complication, they don't 5-take care of it either. Usually the people who do the 6c radiation therapy make all the arrangements of taking care . 7 of a complication. 8 So, . you're trying to address it properly but the 9 structure isn't there. That's what disturbs me. Not to 10 address it is fine. I think we should address it. I think 11 we ought to have weekly port films. 'I think we oughta know 12 left from right. And I think that's more important than 13 whether it's 50 rads in or out of a volume. And that's 14
.. r where you rely, in essence, on physicians telling you the truth about a case. Because it's very hard to make rules.
16 All of us in the practice of this field can tell 17 you that any rule you make, I can take a circumstance where 18 it's appropriate and a circumstance where it's 19 inappropriate. But we all know one thing, we know what the 20 standards of care are for the general diseases we do. We 21 would agree with you that left should be marked left and . 22 right should be marked right. 23 . But why not really address the quality assessment [ 24 the way it should be addressed? How many faciliti'es in the l-25 l United States take port films every week? What about the C Heritage Reporting Corporation (202) 628-4888 l l
167 Are these things you're
*1 errors you've addressed?
2 amplifying, going to put as rules, going to prevent these I'd tell you they're not. You're going to get a
'a things?
You're not 4 replica of exactly what you've gotten so far. And 5 going to get the information you really want to have. 6 you're not putting in the right quality assessment to get at that information. And that, to me, is to me the difficult 7 8 problem. Not that we don't want you to have the quality 9 We do. But every problem you've addressed you 10 assessment. You have not, in any 11 haven't answered with your.own rules. one of the accidents, including left to left and right to 12 13 right, including this kind of thing, addressed it in this. 14 And you've opened up a Pandora's box by having physicians call another physician to tell him you gave 150 l5 o rads more. They wouldn't know what to do with that one way or the other. And you may get into legal contingencies if 17 That's why in the benign 18 you have this in an open arena. 19 disease book, when w'e dealt with the National Academy of Science, that we had people write in. We had them write in 20 21 anonymously to us. So that there could be no tracebacks so Which 22 that we could find out what people were really doing. 23 is, after all, what you really want to know. MR. MCELROY: I'm sure there's no question I'll be 24 25 getting some anonymous letters by next week.
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S 1 g (Laughter.) ' ( DR. WEBSTER: At the risk of talking too much, I'd 3 like-to react to this because as I see this, it has to do 4 really.with the Commissioners and their general attitude to 5 unneeded radiation dose. For example, if somebody was 6 y working in a plant occupationally and-they got 50 rads to ,' 7 the right kidney, for some reason or other, that would be.a 8 . cause celebre. There would be a big stink about that. But 9 if it happens to a patient, you say, you give 50 rads to the 10 right kidney and it really wasn't intended, you're saying 11 that's not -- ' 12 DR. ORDER: No, it depends on what it is. No, I 13 didn't say that. 14 DR. WEBSTER: You said that. 4 DR. ORDER: You have to take it into context of 16; what the entire program is. As to whether it's significant 17 g or not significant. That needs the physicians interaction 18 with the patient and knowing what the patient details are 19 about. And what the risks and gains are for a specific 20 patient. And ultimately, no matter what you make the 21 reporting, the physicians are going to report it. And if 22 you make enough rules most physicians will be so confused by 23 , the rules that they won't report anything because they won't 24 understand what they're reporting in the first place. 25 And I think that since the example was given that Heritage Reporting Corporation (202) 628-4888
169
,. 1 some patients had something identified as being on the right j side but it was on the left and that error was made, I would 3 rather see port films weekly and properly marked. So you 4 knew you got it. I mean that's going to do you a lot more 5 good.
.. 6 If we just want to report in retrospect, that is 7 every time an accident occurs, then we go back and analyze 8 it and find out where the accident occurs, then we have the i '9 position to do that now. What I would rather see is quality 10 assess up front. So the mistakes aren't made. That would 11 be more productive.
- 1.2 DR. WEBSTER: Thank you.
13 DR. COLLINS: Yes. MR. JOHNSON: I'm Terry Johnson from the NRC. I 14
- think Dr. Order has touched on a very very basic issue about
( 16 . how the rules could or should be written. He's indicated 17 s that he would like to see more detail about what quality 18 assurance steps would be taken. Rather than the areas that 19 are reportable. 20 We could take a tact like that. We could, first, 21 solicit the quality assurance procedures from the flagship 22 hospital in the nation for cancer treatment. 23 DR. ORDER: I think that would be excellent. 24 MR. JOHNSON: Yes. And then we could promulgate - 25 - this is regulations. But I think if we did that, upon Heritage Reporting Corporation (202) 628-4888 i
.p
170
- 1 1 thinking about it for a minute, you would see that the
- smaller facilities would be irretrievably disadvantaged.
3 DR. ORDER: I have to answer that. We have two 4 private practice facilities. One in Baltimore and one in 5 Pennsylvania. Both private practice facilities have decided 6 that they wanted to associate with a major center because of - 7 quality assurance. I would suggest to you that one of the 8 reasons that the smaller facilities can't afford all the 9 different things the big facilities do is the way their 10 arrangements are. And that arrangements can be made where 11 physics and other things do qualify all these other 12 facilities. 13 And it's possible to do. That would put pressure 14 on a smaller facility. And you would certainly have to give them time to respond. That's why it's very important, { 16 before you take the flagship stance, to have at least some 17 read across the community. So you would know at the low end 18 of it in the smallest community practice what does that man 19 do for quality assurance? What does he do all the way at the 20 other end in the zenith programs. And what represents a 21 rational approach to quality assessment. It's the very 22 point that I was trying to make. l 23 But there are private facilities that use 24 consortium groups to do their quality control. You would 25 force small units to join consortium groups to have their I Heritage Reporting Corporation (202) 628-4888
** 1~71
** 'l quality' assessment up at a certain level. .But that's the very thing I thought you wanted.
3 I thought what you wanted, Mr. McElroy, is to have 4 quality assessment to be high. So that the accidents were 5 reduced. I thought that's what the NRC was after. If 6 that's the case, if that means that smaller facilities have 7 to join larger facilities in order to have that quality 8 assurance, then I would say it's an affirmative step from 9 the regulations you'll make. 10 DR, COLLINS: So much for the spoken method of
- 11. reporting. Anything more to be said on'that?
12 In that case, we have come to the last item of 13 F summary of quality assurance subcommittee deliberations. 14 Now, if you would like to stay for the rest of the week I think we can achieve this. Dr. Griem, do you have a 16
- contribution to make?
17 " DR. GRIEM: Well, I think it's going to take a 18 while to digest all of the things that we have heard today. 19 And come to some sort of definitive position which reflects 20 the input from the floor and the needs of the Commission. 21 DR. COLLINS: Dr. Webster, would you have anything 22 beyond that? 23 DR. WEBSTER: Well, I have rather similar views to 24 that. I can see that what might be useful in some ways is 25 to issue some draft rules right now and lay them on the Heritage Reporting Corporation j (202) 628-4888 i j i l
- l. _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
f 172 *- 1 first practitioners and see'what happens. Because I suspect *
?
that there will be.a lot of interaction, right now, from a-3e generalized grcup of people. 4 For example, it's been suggested ~several times 5 today that there'are some small hospitals that have 6 practically no quality assurance programs at all. And it is'
- 7 possible that you could conclude that they shouldn't be in 8 the radiotherapy business. And if they want to -- if,they 9 are the responders, if they say there is no way we can do 10 this,'that's very revealing.
11 And I think that it would be interesting for the 12 Commission and for us, for example, and the actuary 13 . committee as a whole, that's what, 11 people, to know this. 14 Because it would give them some guidance. 19 tz
, But I personally feel that I can't react-in any i
1G specific way, right at this moment. Because I haven't had 17 s enough input or enough discussion or.enough time to digest 18 these alternatives. 19 20 21 ' 22 23 24 25
/ '
Heritage Reporting Corporation (202) 628-4888
- 173 j
1
"" DR. COLLINS: The summary of what has been discussed today will be made available. And I think until 3 it is, we cannot, off-the-cuff, summarize the subject of the 4 discussions here. When that is available, the subcommittee 5 is to review that, submit it to the full committee and, with 6 these recommendations, the staff would proceed to draw the 7 requested rule.
8 It does seem to be the consensus here that a pilot l 9 plan is in order. Whether this pilot plan should be 10 instituted before a set of quality assurance elements is 11 submitted, or, whether it should be the result of surveying 12 a group of hospitals to determine what quality assurance 13 steps are in place, would be the first question. If the 14 latter is acceptable, then that is what we need before we
> proceed further. If it is not acceptable, then I think we 16 de need to draw up such a set and test it in the pilot plan.
17 With regard to the more detailed elements of 18 reporting, I think that would be the result of the pilot 19 plan rather than a part of it. 20 Dr. Order, is this in line with your thinking? 21 DR. ORDER: Yes. 22 DR. COLLINS: Any other suggestions or comments? 23 MS. BROWN: I'm interested in what's going to 24 happen after the subcommittee reaches its recommendations or 25 whatever. I guess my real question is whether or not the
.Meritage Reporting Corporation f (202) 628-4888
174 * - ) 1 college and the society as organizations and ACR and AAPM *
, and any other groups here will have a little bit of time to l 1
3 read through the draft and provide you with written l 4 comments? Would that be helpful? Is there time for that? l 5 DR. COLLINS: I think it would be distinctly 6 helpful. And the proceedings, of course, will be available
- 7 to all on or about the nineteenth of the month. And 8 certainly it would be most valuable to have analysis or 9 comment from these interested and informed groups.
10 MR. BROWN: Great. Thank you. 11 DR. COLLINS: Any additional comments? Yes. 12 MR. MCELROY: As Dr. Collins just mentioned, the 13 record of the meeting will be kept open for about another 14 two weeks. So, you can digest what happened here today and present us with your additional comments on what was said. 16 The topic we have discussed today has been one of 17 intense Commission interest and staff interest and ACMUI 18 interest and particularly interests on the part of the 19 medical community. It's my understanding that some people 20 think we perhaps shouldn't be meddling in this. But, the 21 Commissioners have made a determination that we should " 22 review our regulations to see if they can be improved. 23 It's not always a fun job to work on. But, we 24 very much appreciate the time that all of you have taken and 25 the expense that you've borne to help us. We do appreciate Heritage Reporting Corporation (202) 628-4888 }
e 175 that very much. 'And the things that have been said will enter into the rulemaking process as it proceeds. 3 The calender for this initiative was directed by 4 the Commission. We will present the Commissioners with a 5 proposed rule approximately in February. Along with a
'6 design for a pilot program. And at this time we anticipate
. 7 a 90 day public comment period. Commencing approximately, 8 the.first of April next year..
,)
9 Based on the comments that come in during that 10 comment-period, we would plan on developing a final quality 11 assurance rule. We anticipate that the 30 day pilot program 12 would be implemented in the middle month of the 90 day 13 comment period. 14 That is the schedule we have drafted now. It is subject to change if we receive additional directives from 16 the Commission. 17 But, once again, I'd like to thank you for taking 18 time today to participate in this. 19 Dr. Collins? 20 DR. COLLINS: With regard to the proceedings of 21 this meeting today. Will you receive the comments that the
. 22 audience here would like to submit? And then will you pass 23 this on to your subcommittee?
24 MR. MCELROY: Yes, if any of you have additional 25 comments to submit, my address is in the Federal Register Heritage Reporting Corporation (202) 628-4888
176 1 Notice that's in the handout. And mail those to me and they *
'will be incorporated with the transcript so we will have all
-3 of this in one package.
4 : DR. COLLINS: And what do they need to do to 5 ebtain a copy of today's activities? 6
- MR. MCELROY: The transcript, if you would either 7 write or telephone me, it should be ready -- well, the 8 transcript will be ready in a couple of days.
9 DR.. COLLINS: If there are no further questions, 10 we call the meeting to an end. 11 (Whereupon, at 2:58 p.m. the hearing was 12 - adjourned.) 13 14 ~
.c 16 x 17 18 19 20 21 22 23 24 25 Heritage Reporting Corporation (202) 628-4888
1 CERTIFICATE 2 3 This is to certify that the attached proceedings before the 4 United States Nuclear Regulatory Commission in the matter 5 of: 6 Name: QUALITY ASSURANCE SUBCONITTEE CF THE ADVISOPY CCM4ITIEE CN 'IHE MEDICAL USES CF ISCTIOPES.
~
8 Docket Number: NONE 9 P1 ace: HOLIDAY INN, 8120 WISCONSIN AVENUE, VEPSAIILES IV, BETHESDA MARYIAND 10 Date: 11/7/88 11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the United States Nuclear 13 Regulatory Commission taken stenographically by me and, 14 thereafter reduced to typewriting by me or under the 15 direction of the court reporting company, and that the 16 transcript is a true and accurate record of the foregoing 17 proceedings. 18 Inl WM s I9 (Signature typed) : CAPIG HAIASZ j 20 Official Reporter 21 Heritage Reporting Corporation 22 23 24 25 l l Heritage Reporting Corporation (202) 628-4888
n
~
MEETING AGENDA QUALITY-ASSURANCE SUBCOMMITTEE OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES NOVEMBER 7, 1988 HOLIDAY INN 8120 WISCONSIN AVENUE BETHESDA, MARYLAND 9:00 Call to Order - Vincent Collins, M.D., ACMUI . 9:05 Purpose of the Meeting - Vandy L. Miller, NRC 9:15 Statements Society of Nuclear Medicine /American College of Nuclear Physicians - John Laude, M.D. American College of Radiology - Stanley Order, M.D. Syncor International - Jack Coffey American Association of Physicists in Medicine - Faiz Khan, Ph.D. American College of Medical Physics - Naga11ngam Suntharalingam, Ph.D. National Cancer Institute - Robert Morton 9:50 Quality Assurance Rule Alternatives - Terry Johnson, NRC Discussion of Scope and Alternatives - Dr. Collins 10:30 Break 10:45 Discussion of Scope and Alternatives (continued) 11:45 Lunch 12:45 Draft Regulatory Guide - Anthony Tse, NRC Discussion of Scope and Alternatives - Dr. Collins 1:45 Draft Pilot Program - Anthony Tse Discussion of Design Parameters, Implementation, and Evaluation - Dr. Collins , 2:30 Alternatives for Characterizing Reportable
~ Events - Norman L. McElroy, NRC Discussion of Scope and Method of Reporting - Dr. Collins 3:30 Summary of Quality Assurance Subcommittee Deliberations 3:40 Adjourn
____-_--_____--__ _ - a
i .p .
.s..,
I MEDICAL QUALITY ASSURANCE PROGRAM AND REPORTING REQUIREMENTS
.,d
. MATERIALS FOR' DISCUSSION AT THE MEETING OF THE QUALITY ~ ASSURANCE SUBCOMMITTEE OF THE. ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
.2 U. S. NUCLEAR REGULATORY COMMISSION-4 L
November 7, 1988 I 9 Bethesda, Maryland
TABLE OF CONTENTS
~
NOTE: The draft documents contained in this package (Items 3-7) are being made available to meeting attendees for the purpose of accomplishing a meaningful discussion during the QA Subcommittee meeting. Final documents may or may not reflect the alternatives provided in this package.
- 1. Notice of meeting and request for comment (Federal Register, October 12, 1988)
- 2. " Misadministration" rule currently in effect (Federal Register, October 16, 1986)
- 3. Draft reporting and QA rule - Alternative 1 s
- 4. Draft reporting.and QA rule - Alternative 2
- 5. Draft reporting and QA rule - Alternative 3
- 6. , Draft Basic QA regualtory guide
- 7. Draft protocols for QA pilot program
~
1
W
' ans .. i Proposed Rules ,
y ,e! e,,,,,, Vol. 83. No. ter ( Wedaeedes . October 12. taas
\
f The section of the FEDERAL REGISTER poa Puertuca empoessanos coerygg.y.. * %!on uw wsys for NRC to comare notaces to the pec of the Norman L McElroy. Office of Nuclear provide information to the medical proposed *s ** o' '** and Material Safery and Safeguards. (301) community to ensure wide distnbution a e noaces 492-3417 or Dr. Anthony N. Tse. Offica of safety information and regulatory
,, , ,, ,g, of Nuclest Regulatory Research.(301) concerna. Continue to participate in !
, I 492-3737. U.S. Nuclear Regulatory regional and national meetmas to rnamg pnar to ew adopton of the W Commission. Washington. DC 20688. provide health and safety and quality Suppt.ssstaff Aary espostatattest assurance information.
]
NUCLEAR REQULATORY Sackground ,,*,[,, " " inst adoNpr cnp$v COMMISSION On October 2.19s7 (52 FR 3e042). the based approaches.
- NRC published a proposed rule that On April 7.1988 members of the 10 CFR Part Sg medical community, including members would require its medical use licensees
! Qualfty Amaurence Subcommittee of to implement certain quality apurance of the ACMUL briefed tfie Comminion steps to reduce the chance of on their concems regarding the the Advisory Committee on the Medical Uses of footopes; Meeeng misedministrations in medical use. Proposed rule.They suggested that a
- Public comments indicated that, pilot program may be usefut in Notice and Requeet for Comments
. although these proposed steps may identifying whether certain quality aossocyt Nuclear Regulatory reduce the chance of assurance procedures would interfere CoWaalon. misadministration, the imposition of with t.hnical practice. Also. they stated f Am>c Nme of meeting and request the prwenptive steps as regulatory that. under existing NRC regulation of for ammr:t. requirements may interfere with the the medical use of bypioduct material
- practice of medicine because the (to CD Part 35), the definition of she suesssa.stvt T1.dClear Regulatory p,gp,,,d ggje may not provide sufficient term "misadministr9 tion"is unclear and i Commission (NRCl will convene a flexibility for clinical practica. that reporting requirements are I meeting of the Quality Assurance gn a public meeting held on January confusing.
Subcommittee (Q A Subcommittee) of 2e.1943, members of NRC's Advisory The Commission directed the staff to
. the Advisory Committee on the Medical Committee on the MedicalUses of continue the rulemaking ininative.
Uses of tactopes to assist in the Isotopes (ACMUI). beard public stating that the staff should:(1) prepare consideration of amendments to NRC comment and made the following for public comment a new proposed rule l regulations that apply to the medical use general recommendations for regulating with performance based basic quality of byproduct matenal.The amendments the medical ne of byproduct material: assurance requirements. and a revision, would require medical use licensees to . Adopt a regulatory approach to if needed, of the anisadmirustration implement quality assurance picgrama, quality sesurance programs similar to definition and reporting requirements.
, and would teviu misedministratmo that taken for ALARA (as low se (2) prepare a regulatory guide with reporting requirements. Public reasonably achievable) programa. presenptive QA steps that would be comments on the issues discussed in Require the licensees to submit their acceptable to the NRC staff in this notice are welcome in writing prior own quality assurance program as a implementing the performance-based to the meeting. and at the muting. part of theirlicense application.These QA rule, and (31 conduct a pilot prograrr
. cafes: Meeting will be held Monday. programa would be revtewed by the to evaluate the effectiveness of the
- November 7.1968. at 9.00 a.m- NRC and used as the basis for specific measures in the regulatory comments must be received by October enforcement if they were not followed. guide.
31.1988.
- Work with the Department of The staff was also directed to aoonessss: Meeting Hohday lan. 3120 Health and Human Services and continue its analysis of public comment Wisconsin Ave Bethesda MD. . existing groups such as professional received in response to an advance Comments: Submit comments to organiza tions, professional colleges, and notice of proposed rulemaking on Secretary U.S. Nuclear Regulatory
- the joint Commission of the r. comprehensive quality assurance Commission. Washington.DC 20555 Accreditation of Healthcare (October 2.1987; 52 R 309491, and make
- ATTN. Docketing and Service Branch. Organizations ()CAHO) to assistin a recommendation to the Commission Submit requests to make oral statements developing uruform and compatible on that project at a later date.
to Norman 1. McElroy. Office of Nuclear voluntary standards. Camments Mater al Safety and Safeguards. 6H3.
- Endorse existing and developing U.S. Nuclear Regulatory Commission, voluntary standards that meet To help develop the new proposed l rule regulatory guide and pilot prograrn I Washington. DC 20555. regulatory needs. Develop these
- Comments must be received by standards into regulatory requirements the Quality Assurance Subcommittee of
! October 31.1988 for consideration at the aftLr a pilot study testing their the ACMUI has been fonned.The NRC rneeting. Comments received after this practicality. impact on patient care, cost. would like to invite public comments on date will be considered if it is and benefits. the issues set forth below. P.iblic J
comments should be submitted to the l (. practicable to do so.but assurance of consideration cannot be given except as
- Suppert a pilot study prior to adopting any other medical regulations NRC under the heading aponessas.
Copies of the comments will be l' to information received on or before this resultmg from changes and new date. technologies in patient care, forwarded to the Subcommittee for l
l l 39748 Toderal Resister / Vol. 53. No.197 / Wednesday. Octobtr 12. 1968 / Preposed Rules
- ensure consideration at the meeting The connquently from the provision of l consideration.The Subcomn}ittee will (331.1(e) of FDIC regulations which .,
nport its recommendat2ons to the transcript of the meeting wd! be kept require that trusts which are registered t open until November 15.1986 for the ACMUI for review and transmittal to or subject to registration under the . the Commissiert. Inclusion of written comments. l
- 2. Persons who want to make oral Investment Company Act of1940 be Ret 'ing the proposed rulemaking.
statements should inform Mr. McElroy treated as corporations for purposes of ubb .nment in response to the fonow.ing questions is requested;(11 in writing by October 14.19es. Insurance coverage hmits. F.tisting What types of performance based QA Statements must pertain to the topics at ngulations result in deposits of such band.ne Chairman will rule on truste being insured to the maximum . enteria should be spectf.ed in the regulations to avoia, detect, and correct requests to make oral statementa. amount of 3100.000 as to the trust.The sitrple human errors in medical use? (2) Opportunity for members of the pubbe proposal, if adopted, would result in What are the problems anociated with to make oral stataments, within the time deposit insurance up to 3100.000 as to available, will be based on the order in each beneficial owner, the current def.nition of the term
" misadministration ** and nporting which requests are received. In genwal. DAMI commenW must be matted by '
requirements specified in 10 CFR Part oral statements should be limited to December 12.19e8. 357 What alternatives are availablef approximately 5 minutes. Oral + anonssa: Comments should be Regarding the regulatory guide, public statements may be supplemented by addrened to Hoyle L Robinson, omment is requested on the following detailed written statements for the Executive Secretary. Federe! Deposit . questions:(1)What types of prescriptive record. Rulings on who may speak, the Insurance Corporation.15017th Street besic QA steps should be included in order of presentation, and time allotments may be obtained by calling NW Washington.DC30429. i the guidef (2) Do you have a set of QA steps that have been demonstrated to Mr. McElroy at (301) 492-3417 between roa pusmesa eroansAnos costraam help can avoid, detect. and correct. 900 a.m. and 5.00 p.m. EST on Friday. F. Douglas Birdsall. Special Counsel to : simple human errors? If so, what are October 21. less. the Deputy General Counsel or Gerald J. they? 3. At the meeting. questions bom Gervino Senior Attorney. Federal In the pilot program, selected attendees che than Subcommittee Deposit Insurance Corporation. 50017th volunteer hospitals and clinics (which members, consultants, and NRC staN Street NW. Washington. DC 3042s. (3D2)
- are NRC or Ayeement State licensees) will be permitted at the dimetion of the seek-371s or (302) se64723.
would implement the proposed basic Subcomanittee chairman euestanserraat soonesatoss Since QA steps. report to the NRC the beneSts 4. De transcript. minutes of the 1877, the FDIC has treated any trust or cad impaeta of the procedures, and meeting and written comments will be similar business arrangement which is mesmmend ways to improve the available for inspection and copying for registered or subject to registration procedures.no NRC would appreciate a fee, at the NRC Public Document ander the Investment Company Act of - public comment on the following questions:(1) How many haspitals or Room.2120 L Street NW. lower level' Washington. DC 3065% on er about 1940 as a owpwetion for purposes d deposit lasurance. Prior to that time. C' clinics are needed to participate in the November 1a.1se0. mutual funda, unit investment trusts and l pilst program? W hat characteristics. 5. Seating for the public willbe se a other investment vehicles created as such size (large or small) population first come/Aret served basis. trusts were treated as other trusts under ! serv. ural or urban). and ownership ne meeting willbe heldin . k aguladone wie b rwult est (private or public) should be used when accordance with the Atomic Energy Act beneScial ownere' interests were selecting participating hospitals? (2) of 1954, as amended (primarily section tel mcognised andinsured up to seP What information should the tels), the Federal Advisory Committee h aaminium amount.By tradas such participants collect during the test . Act (5 U.S.C. App) and the trusts as corporations, the beneScial periodt (3) What criteria should be used Commission's regula tions la Title 10. owners are treated as if they were f:r evaluation of the pilot program Code of Federal Regulations. Part F. shareholders in a corporation and are , woultsf Deted at Washington. DC this edi day of not recognised as beneScial owners of Other comments and information that October tala- the deposita.De result is that an ! may be helpfulin developing the Fw he Nuclear Reghry f*-w= investment trust's deposits in any one . proposed rule, regulatory guide, and Andrew L Bams, insured bank are insured to the ,
'" '" == =d === i 'WCJd@e:"L'Tieacensees 4* + - -'om-r-thet me hke to artici ste in the pilot (H Doc. as-assos Filed to-11.et ses ae)
De FDIChas been mquested to ! reconsider its position in this matter as asumeesserum.e e . Program are invi ed to contact Dr.Tse it applies to unit investment trusts. Such ' (ou pon samaa maoassanow"). a trust consists of an identined, static Coeduct of the Meeting FEDERAL.DEpotif WeSURAleCE portfolio of time deposits with the same - CORPORATION or nearly es same maturity datea. Vincent Collins. M.D will serve as BeneScial laterests in the portfolio are Chairman of the Subcommittee and will 13 CPR Part 330 sold to investors who receive their chair the meeting. Dr. Colline wiu anoe . al y an and wiS1 facih ate the rderly con the trust dissolves when the depoelta Trusts business mature and am paid. Such trusts differ ne following procedures apply to Aamsevt Federal Depeeltlasurance from money market mutual funds or public participation in the meeting. Corporation. other managed mutual funds which buy ;
- 1. Persons may submit written ag. nose proposed rela. and sellinvestments,incbding bank comments by sending a repmducible time deposits, on a continuing basis and g copy to the Seentary of the Commission sumataav:ne FDICis considering have a continuing existence. Both types ,
(see "Apontesse" heeding' Comments exempting unit investment trusts arom ofinvestment trusts am subject to must be received by Octob. A 19e.P to the provisions of $330.5(b) and m e.
rederal Register I-Vol. 51. No.100 / Thursday. October 16. 1988 / Rules and Regulations 36953
,. I relative (or guard;en). s'id if not. My~ {
L \, not.The report must not include the ? patient's name er other mfonnation th.a couldlead toidentfication of the patient. (c) When a misadministration involves a diagacetic procedure. the I Radiation Safety Officer shall prompt:y investigate its cause make a record for i NRC review, and retain the record as
' directed in i 35.33(d).The licensee shall ,e' also notify the referring ph> sician and the appropriate NRC Office specifird tr i 30.3 of this part in wnting on Form l NRC--
- within 18 days if the misadministration involved the use of byproduct material not intended for -
medical use. administration of a dosage -j five fold different from the intended dosage, or administration of byproduct l SSJ3 Aseeres and reports og material such that the patient is likely to i362 DeAP'elena. receive an organ dose greater than 2 tem m'aeemanistremone.
"Missaininistration" means the or a whole body dose greater than 500 administration of. '
(a) When a misadministration millirem. l.icensees may use dosimetry involves any therapy procedure, the : licensee shall notify by telephone the tables in p.Jage inserts. corrected only
. (1) A radiopharmaceutical or for amount of radioactivity appropnete NRC Regional Office listed 4 radiation from a sealed source other in Appendix D of Part 20 of this chapter. administered. to determine whether a I an th the one intended; NPort is required.
The licensee shall also notify the
' - (2) A radiopharmaceutical or - refemns physician of the affected (d) Each licensee shall retain a record t radiation to the wrong patient patient and the patient or a responsible of each misadministration for ten yer.rs.
? (3) A radiophannaceuticalor relative ( guardian). unless the The record must contain the names of f ; radiation by a route of administration refemns p sician agrees to inform the allindividuals involved in the event other than that intended by the patient or lieves, based on medical (including the physician. allied health Ql presenbing physician: Judgment. that telling the patient or the personnel the patient. and the patient's patient's responsible relative (or refernas physician), the patient's social ~
(4) A diagnostic dosase of a i" radiopharmaceutical differing from the guardian) would be harmful to one or secunty number oridentification presenbed dosage by more than to the other. respectively.These numberif one has been assigned a bne! E percent notifications snust be made within 24 desenption of the event. the effect on 2 (s) A therapy dosage of a hours after the licensee discovers the the patient. and the action isken,if any.
, radiopharmaceutical differing from the rnisadministration. !! the referring to prevent recurrence.
' ' presenbod dosage by more than 30 physician, patient. or the patient's (e) Aside from the notification responsible relative or guardian cannot requirement, nothms in this section percent or be reeched within 24 hours, the licensee (e) A therapy radiation dose from a affects any nghts or duties of licensees shall notify them as soon as practicable. and physicians in relation to each other.
sealed source such that errors in the source calibration, time of exposure, and The licensee is not required to notify the patients, or responsible relatives (or patient or the patient a responsible guardians). treatment geometry resultin a nlative or guardian wiscut Amt calculated total treatment dose diffenns from the final prescribed total treatment [8",e
, ag[ rrmg[gicia dose by more than 10 percent. medical care for the patient because of this.
(b)Within15 days after aninitial therapy misadministration report to NRC. the licensee shall report. In wnting to the NRC RegionalOf!!ce initially telephoned and to the referring physician and furnish a copy of the report to the patient or the patient's responsible relative (or guardian) if either was previously notified by the licensee under paragraph (a)of this section. The wntten report must include the licensee's name: the refernas physician's name: a brief desenption of the event the effect on the patient the action taken to prevent recurrence: whether the licensee informed the patient or the patient's responsible
1 1 1 1 I 38942 Federal Resister / Vol. 51. No. 200 / Thursday. October 16, 1986 / Rules and Regulations _ l potentialinjury The hazard to workers for administmd millicuries. to '{ and the public is altr.ost non.eustent. determme whether a report is requirn! I i h Maadministrations are precipitated in order to assure that diagnostic by hurnan error, such as momentary misadmmistrations are not occumna 'n distraction or miscommurucation. not a particular licenwe s program with radiation safety program deficiencies. emcessive frequency. the NRC belieses Although a fail. safe system might be that there should be an intemal < I achieved through multiple levels of inn estigation and report by the checking and cross. checking. the added Radiation Safety Officer. The NRC will I costs would far outweigh the marsmal review these reporta during its field i bensfit that would accrue to society. inspections. In addition. the reports will' ] Aesponse:The NRC is well swore that usist h licensee in carrying out the - 3 the misadministration rate for AIARA pnnciples of parts ao end 35 1 radiopharmaceuticals is much lower Because of th. sublic health and i i then for other drugs, that there is no safety nature c; .no reporting reporting requirement for requirement the NRC will require - misadministration of cyclotron. Age,ement States to implement produced radiopharmaceuticals. x.rsys, compatible requirerr ents. and nonradioactive drugs. and that the Comment While it should be retained. nok to patients. workers, and the public the therapy misadministration report is small. None of the assertions are et trigger should be relaxed from10 issue. percent error to 3D portant error. That The fact that there are other greater rense better reflects the diversity of potential hasards found in the medical - medical opinion on the optimum dose stena does not relieve NRC ofits for a prticulu puent. - moponsibility to eseure public beelth Aesponse:The NRC has not changed and safety as it may be affected by uirements that apply to therspy metenal under its jurisdiction. Rather, etmis its haistrations because of their issue is whether there is a safety importance te public health and safety.
? problem. and, if so. con it be corrected The NRC reiteretes that the to percent F st an expense that is reasonable trigger levelis not based on the diversity compared to the hasard. ' i- 1 M medicalopnion regarding h Therapy clinical procedures. in the optimum radiation does for a certain view of the NRC.present a greater risk to the public and patients than disease stage.Rather, the NRC recognizes there are uncertainties in the
'h.
e diagnostic clinical procedures. Given the musurement and administration of increased nok to the public health and radiation that make itimpossible to c safety, the reasoned judgment of the demonstrate that the exact radiation NRC requires the maintenance of the dose that was presenbod was delivered. current misadministration tule for However.when the does delivered is therapy vees of byproduct material.The more than to percent different than the NRC will contmue to carefully review dose prescribed. It is clear that a therapy misadministration reports.The - mistake has been made.De mistake i' NRC staffis also considenne sa should be investigated and steps should advance notice of pro sed rulemaking be taken to prevent its recurrence. Section M.m Aecords andreperts of that would request pu lic coriunent on Comat NRC should take misodmmistrations. regulations regardmg quality assurance enforcement action against licensees Comment:The level of public in radiation therapy as wellas other who administer radioactive material emphasis that NRC has placed on NRC actions result from therapy . when it might have serious ' reven to be an misadministration. is request for consequences fa the patient misadmimstrations effeetive mechamsm to hasknit their early public comment will be published Commet4nforcemut schens may number. No change is needed. et a later date. reduce compliance with the Comment: At least to the extent that it The NRC believes that misadsunistreuen uponmg , deals with diagnostic clinical misedministrations that result in a dose mquimmet. procedures, the misadministration rule to the patient smoter than a dose to a Aesponse:The diagnostic should be deleted or substantially member of the public permitted under misadministration reportmg requirement modified.The case for its deletion is t 20.105(e) should require a sport to the will continue to require reports to the made by the misadmimetration reports NRC and the referring physician. NRC for certain diagnostic Furthermore. licensees should keep submitted to the NRC. misedministrations that are listed in the The misedmimetration rate for , records of all misadministration. As a regulations.The mportmg requirement rediopharmaceuticals is much less than result, the diagnostic administration for all therapy misedmirustrations has for non. radioactive drugs. The huard to reporting requirement has been changed the patient is much less than that to require reports for misedministrations been retaines. when such misadministration result in The NRC deals with associated with the misadministration of a whole bod) dose gnater than 300 misadministration case by.csse. g ph) biologically active drugs or with Various levels of enforcement are W.
%er medical mistakes. In virtually all millirem or at organ c'ese greater than 2 rem. (!)censece may vee dosimetry available.
;ances. the patient sustams neither *s. r.or.e:ted crdy actue' nor theoretically significant tables m pac se in.
FORKING FAPER
. ALTERNATIVE I
SUMMARY
OF REPORTING RULE
- 1. Diagnostic errors and therapeutic errors handled in separate sections.
- 2. Only errors in administration steps previously identified as prone to error, are reportable.
, 3. No generic errors related to dose or dosage are reportable, other than specified percentage errors that result.
- 4. Therapeutic radiopharmaceutical dosage may not differ from the prescribed dosage more than 105.
- 5. Brachytherapy cases have an error limit of 20%, which is applicable to the prescribed dose itself, as well as to each specified quantity related to dose in the prescription (sue.h as total source strength, treatment i time, or milligram-hours).
- 46. Cumulative teletherapy dose delivered at any point in the treatment, must not differ from the intended dose at that point, by more than 10% of the total dose prescribed (no separate section is added to require reporting C '*. , of other errors corrected during treatment).
- 7. Notification to the referring physician and to the affected patient is required for every therapy event regardless of dose conse reportable teletherapy errors corrected during treatment)quences ; the content (including of the notification is not specified.
- 8. The referring physician may prevent patient notification, if his medical judgement so dictates, but he may not agree tc notify the patient himself.
- 9. All diagnostic events also necessitate notification to the patient's referring physician (no content specified), regardless of the seriousness of the event.
- 10. Written- reports are directed to the NRC Regional Office (source of the inspection and licensing program).
BASIC QA PROGRAM
- 1. Performance criteria concentrate on unclear instructions and on l quantitative steps.
- 2. Specifically requires double checks of input value accuracy, of actual )
l - calculations, and of full cal.ibrations. -
- +-
FORKING PAPER fC Q, , ALTER!!ATIVE I ( 35.33 Reports and records of incidents involving byproduct material (a) Telephone notifications and written reports for therapy events (1) Each licensee who administers a therapeutic dose or dosage to a person incorrectly, regardless of the cause, shall notify ' the NRC Regional Office listed in Appendix D of Part 20 of this chapter by telephone, within 24 hours of discovery of the event. Events requiring notification include any administration for therapy of: . (i) A radiopharmaceutical (including physical or chemical form) or radiation from a sealed source, other than the one intended; (ii) A radiopharmaceutical or radiation to the person other than the patient intended; (iii) A radiopharmaceutical or radiation by a route of administration other than the one intendsd; (iv) A radiopharmaceutical or radiation to an organ or anatomical site other than the one intended; ^ (v) A dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10%; (vi) A treatment dose (or other specified parameters, such as milligram-hours, or total activities) in brachytherapy such that errors in the treatment planning and execution result in a difference from the final prescribed parameters by more than 20%; or (vii) A cumulative dose at the conclusion of any fraction of teletherapy, which differs from the dose intended for the number of fractions actually delivered, by more than 10% of the total dose prescribed for the - entire course of treatment. (2) Each licensee shall also, within 24 hours, notify the , referring physician of the affected patient and the patient or a responsible relative or guardian of the patient. If the referring physician, patient, or the responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to~ notify the patient or the responsible relative or guardian without first consulting the referring physician. 2
i
)NORKil$3 BAEER If the referring physician believes, based on medical judgment, that informing the patient or the responsible )
relative or guardian would be harmful, this notification is i not required. (3) Within 15 days after the telephone report to the NRC, the licensee shall submit a written report to the NRC Regional Office initially telephoned, and to the referring physician.
- A-copy of the written report shall be furnished to the patient or the responsible relative or guardian if either was previously notified by the licensee under paragraph (2) of this section. The written report must include the licensee's-name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative (or guardian); and if not, why not. The report must not include the patient's name or other information that could lead to identification of the patient.
.(b) Written reports for diagnostic events (1) In addition to any report required by Paragraph (a) of this y section, each licensee shall make a written report on NRC-er g Form-473, to the appropriate NRC-regional Office listed in Appendix D of Part 20 of this chapter, in the event of an
. , error in a diagnostic administration, within 30 days of.
. discovery of the event. Events requiring reports include any administration of:
(i) A radiopharmaceutical (including physical and chemical form) or radiation from a sealed source, other than the one intended; (ii) 'A radiopharmaceutical or radiation to the person other than the patient intended; (iii) A radiopharmaceutical or radiation by a route of
- administration other than the one intended; (iv) A radiopharmaceutical or radiation to an organ or anatomical site other than the one intended; (v) A dosage of radiopharmaceutical differing from the prescribed dosage by more than 50%; or l
(vi) A dose from a diagnostic device apparently differing
- from the intended dose by more than 50 %.
(2) The licensee shall also promptly notify the patient's referring physician of the event. 3
WORKING PAPER (c)- Recordkeeping Each licensee shall retain a copy of each report for ten years. The copy must be annotated to include the names of all individuals involved in the event, including the physician, allied health personnel, the patient, and the patient's referring physician. e (d) Aside from the reporting requirement, nothing in this section affects any rights or duties of licensees and physicians in - relation to each other, to patients, or to responsible relatives or guardians. 35.35 Basic Quality Assurance Program (a) Each licensee using byproduct materials for diagnoses or therapy shall develop and implement a written basic quality assurance program. The basic quality assurance program shall be designed, to the extent feasible, to detect and avoid simple human errors that could lead to the events described in section 35.33 (a) of this Part. 3(b) The basic quality assurance program must include elements for
- ensuring that simple human errors in the following areas are avoided.
(1) Order, prescribe, and administer byproduct material correctly; (2) Write prescriptions and clinical procedures clearly and unambiguously; (3) Seek clarifications in case of unclear instructions or obvious discrepancies. (4) Double check input values and calculations in manual dose calculations and input values in computer calculations to avoid arithmetic or transfer errors; (5) Double check the full calibration output of teletherapy machine;
^
(6) Make-physical measurements of devices associated with teletherapy that will affect the dose to be delivered to j the patient. 4
- WORKING PAPER ALTERNATIVE II
SUMMARY
OF REPORTING RULE -
- 1. Diagnostic errors and therapeutic errors handled in separate sections.
- 2. Only errors in administration steps previously identified as prone to error, are reportable.
. 3. No generic errors related to dose or dosage are reportable, other than specified percentage errors that result.
- 4. Therapeutic radiopharmaceutical dosage may not differ from the prescribed dosage more than 105
- 5. No actual dose error specified for brachytherapy; but errors are specified for combined source strength and for treatment time (>20% is reportable), and for the product of source strength and treatment time (error >10% is reportable). ,
- 26. Total teletherapy dose at the conclusion of each phase of treatment may not differ from prescribed dose for that phase of treatment more than 10%; a separate section (c) is added to require reporting of teletherapy errors corrected during treatment, but after undue delay.
- 7. Notification to the referring physician and to the affected patient is required for every therapy event regardless'of dose consequences (but not for the reportacle teletherapy errors corrected during treatment); the content of the notification is not specified. i 1
- 8. The referring physician may prevent patient notification, or may agree to notify the patient himself.
- 9. No diagnostic events necessitate notification to the patient's referring physician, regardless of the seriousness of the event.
- 10. Written reports are directed to the NRC Regional Office (source of the inspection and licensing program).
~
BASIC QA PROGRAM
- 1. Performance criteria are fairly comprehensive.
- 2. Does not specifically require double checks of measurements, calculations, or the full calibration, unless required by separate policies, license conditions, etc.
MORKING PARE 8 . 1
. i 8
ALTERNATIVE II I i l (;
$ 35.33 Records and reports.
(a) If the diagnostic medical use of byproduct material results in actual administration of: (1) A radiopharmaceutical or chemical or physical form other than the one intended, or radiation from a sealed source other than the one intended; (2) A radiopharmaceutical or radiation to a person other than the : patient intended; (3) A radiopharmaceutical or radiation to an organ or anatomical site other than the one intended; ' l 09/06/88 2
,. WOR. KING PAPER (4) A radiopharmaceutical or radiation by a route of administration other than the one intended; (5) A dosage of a radiopharmaceutical differing from the prescribed dosage by more than 50 percent; or (6) A dose from a diagnostic device differing from the intended dose by more than 50 percent; the Radiation Safety Officer shall promptly investigate the cause, and notify the appropriate NRC Regional Office specified in S 30.6 of this chapter on Form NRC-473 within 15 days of the occurrence.
(b) If the therapeutic medical use of byproduct material results in actual administration of: (1) A radiopharmaceutical or chemical or physical form other than the one. intended, or radiation from a sealed source other than h the one intended; (2) A radiopharmaceutical or radiation to a person other than the patient intended; (3) A radiopharmaceutical or radiation to an orgt,n or anatomical site other than the one intended; (4) A radiopharmaceutical or radiation by a route of administration other than the nne intended; (5) A radiopharmaceutical or radiation by an administration schedule other than the administration schedule intended; (6) A dosage of a radiopharmaceutical differing from the prescribed i dosage'by more than 10 percent; 09/06/88 3 _ _ _ _ - _ _ _ _ - _ _ _ - _ _ _ _ - O
)NORKING PAPdR (7) A brachytherapy treatment with combined source strength or treatment time differing from the intended _ combined source strength e- treatment time by more than 20 percent, or with the 1 product of the combined source strength and treatment time l f differing from the intended product'of the combined source strength and treatment time by more than 10 percent; or i
(8) Radiation from a teletherapy source such that an error or errors in the source calibration or source strength measurement, . time of exposure, treatment geometry, source geometry, and/or beam modifiers, result in a total dose for that particular phase of treatment differing by more than 10 percent from the j total dose intended prior to detection of the errors, the licensee shall notify by telephone the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The licensee.
^
shall also notify the referring physician of the affected patient and the patient or a responsible relative or guardian, unless the refer- ! h/ # ring physician agrees to inform the patient or believes, based on medical judgment, that telling the' patient or the patient's respon-sible relative or guardian would be harmful to one or the other. t These notifications must be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practic-able. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting . the-referring physician. Within 15 days after the telephone report I to NSC, the licensee shall report, in writing, to the NRC Regional , Offic6 initially telephoned and to the referring physician, and furnish a copy of the report to. the patient or the patient,'s respon- -l I sible relative (or guardian) if either was previously notified by i the licensee due to requirements of this section. The written report m'ust include the licensee's name and license number; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the referring physician and the patient or the patient's 09/06/88 4 _. _ - -_____ . . .~
,, -WORKING PAPER r
responsible .rlative (or guardian),.and if not, why'not. The. report J must not-include the patient's name or other information that could lead to identification of ;.he patient. (c) If in the course of the therape'Jtic medical use of byproduct material the licensee makes an error in calculating or administering a patient dose or treatment plan, which is detected after treatment has begun; that, if uncorrected, would have resulted in a total dose for that particular phase of treatment differing by more than 10 percent from the total dose intended prior to detection of the error;'the licensee shall report, in writing, within 30 days of detection of the error, to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The written report must include the licensee's name and license number, a brief description of the circumstances of the error, and the action taken to prevent recurrence. The report must j
; not include the patient's-name or the other information that could '
, lead to identification of the patient. An error in the dose for individual treatment fractions of teletherapy may be excluded from y this reporting requirement if the combined error from the erroneous
; treatment fractions administered is less than 300 rads,-and if the
.. error is reported to the authorized user and corrected, before the and of the eleventh calendar day subsequent to the day of administra-tion of the first erroneous treatment fraction, and before administra-tion of the last two treatment fractions originally planned for that particular phase of treatment.
(d) The licensee shall submit the reports required by paragraphs (a), (b)..and (c) of this section without regard to whether the error was precipitated by human error, miscommunication, patient intervention, or incorrect use or failure of a computer, computer program, calculator, treatment plan, measurement device, administration device, radiation device, beam modifier, or recording system. (e) Each licensee shall retain a copy of each report for ten years. The copy must be annotated to include the names of all individuals involved in the event, including the physician, allied health personnel, the patient, and the patient's referring physician. 09/06/88 5
$0RKING PAPEit (f) Aside'from the notification requirement, nothing in this section
- affects any rights or duties of licensees and physicians in relation to each other, patients, or responsir.le relatives or guardians.
S 33.35 Basic Quality Assurance Program. ; (a) Each licensee that uses byproduct material for medical use shall j develop and implement a written basic quality assurance program that will: (1) Reduce the risk that the administration of byproduct material to patients will be attended by simple human errors related to patient handling, medical reviews, calculations, measurements, communications, documentation, and executions of procedure, including the errors described in S 35.33 of this Part; and (2) Increase the chance of early detection of such errors. ( (b) The program must include quality assurance measures for: (1) Ensuring that patient referrals, initial patient case reviews, supervisory reviews by an authorized user, and periodic or follow-up case reviews, are executed according to the policies of the licensee, and are adequately recorded; (2) Ensuring that medical use procedures, and individual patient orders, prescriptions and treatment plans, are recorded clearly and completely;
~
(3) Ensuring that patient orders, prescriptions, and dose - snstraints are explained clearly to all personnel involved in planning and/or administration of byproduct material, and that treatment plans are explained clearly to all personnel responsible for patient treatment; i 09/06/88 - 6
g(ORK1NG PAPER (4) Ensuring that the patient, family, referring physician and/or nursing unit staff, receive adequate explanation of the proposed procedure, when appropriate, to provide reasonable assurance that they will cooperate in completion of the procedure; (5) Ensuring that physical measurements of dosages, source strengths, and associated parameters are made and/or checked as required, and are recorded according to the policies of the licensee; (6) Ensuring that calculations are complete and accurate, are based on correct assumptions and input data, are checked as required, and are documented according to the policies of the licensee; (7) Ensuring accurate administration of the doses and dosages intended, and ensuring prompt and complete recording of all patient doses and dosages actually administered; (8) Ensuring that individuals handle and use byproduct material,
) and related devices, computers, and computer programs, with full understanding of the materials, devices and functions used, and in accordance with licensee policy and procedures,
{ manufacturers' recommendations, and NRC regulations; and (9) Ensuring prompt reporting of errors, and ensuring intervention by any' participant in the patient planning or administration who observes a significant discrepancy or misunderstanding. e 0 09/06/88 7 l
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, WORKING PAPEH ALTERNATIVE III
SUMMARY
OF REPORTING RULE
- 1. Diagnostic errors and therapeutic errors are described in a single section.
i
- 2. Most persible errors in communications, execution, and calculation methods, and other serious anomalies and lapses of procedures, are reportable.
l ,
- 3. Some generic errors related to dose or dosage are reportable, in addition to specified percentage errors that result. Some of the percentage error limits are relaxed.
- 4. Therapeutic radiopharmaceutical dosage may not differ from the prescribed dosage more than 20% (same limit applies to diagnostic radiciodine '
administrations greater than 0.25mC1, diagnosis of thyroid metastases, for example).
- 5. No actual dose error specified for brachytherapy, but errors are specified for combined source strength (>20% for temporary implants, or
>15% for permanent implants), and for the product of source strength and treatment time (error >10% is reportable).
" Teletherapy dose errors in individual treatment fractions are reportable
-) 6.
(>10%), unless discovered and corrected during the same phase of treatment prior to accumulation to 150 rads of error (no separate section is added to require reporting of other errors corrected during treatment).
- 7. Notification to the referring physician is required only for events likely to have an acute effect or likely to result in an organ dose greater than 50 rems; this notification must include estimates of organ doses and foreseeable damage.
- 8. Patient notification is left to the referring or personal physician notified, unless the latter cannot be fully notified within a reasonable time.
- 9. Diagnostic events necessitate the same notifications as ther6peutic events.-using the same criteria as to likely effects or organ doses.
. 10. Written reports are directed to NRC Headquarters. .
- 11. A requirement-is added to report manufacturing defects to the '
manufacturer by telephone when appropriate. BASIC QA PROGRAM
- 1. No performance criteria are specified other than to avoid sigle human errors, and to detect and correct the errors that occur.-
- 2. Does not specifically require double checks of measurements, calculations, or the full calibration, unless required by separate policies, license conditions, etc.
1 l ' WORKING PAEER ALTERNATIVE III C S;35.33 Reports, Notifications and Records of Administration Events If any individual is administered radiation or radioactive material, in conjunc-tion with an activity involving the use of byproduct material, under circum-stances in which the actual administration, or any significant aspect of it, is unintended, unauthorized, incorrectly executed, unacceptably hazardous or meritless, affected by failure of equipment or computation, unacceptable under medical standards, or contrary to any license condition, order or regulation
, of the NRC or any other agency with appropriate jurisdiction; then the licensee shall promptly-investigate the circumstances of the administration event and shall make the reports, notifications and records described in Sections 35.33(a), .
(b), and (c). These reportable events include, for example, any internal or external human administration:
- 1. Leading unexpectedly to life-threatening or incapacitating harm in the person given the administration; 10/25/88 2
$0RKING PAPER
- 2. Involving any special nuclear, source, or byproduct material which is not authorized on the licensee's NRC license for that particular use, or which is not supplied to the licensee as required in $35.49;
- 3. Including any material or physical agent which is not safe, is not approved when required, or is repudiated by the manufacturer, either for all human use or for the particular use made, if administered in
, conjunction with the use of byproduct material;
- 4. made without a prior medical case review required by regulation, by accepted standards of medical practice or by license conditions of the licensee, or made without a required prior written order;
- 5. made without supervision by an authorized user, or made by personnel without the training or authorization required by regulation, by accepted standards of medical practice or by license conditions of the licensee;
- 6. made without prompt recording of the administration actually executed, g in the appropriate record, with sufficient accuracy and completeness to serve the purpose of the administration;
- 7. given to an individual not intended to receive that particular administration;
- 8. given to an individual who is pregnant, if pregnancy is an absolute contraindication to the administration made;
- 9. given-to an individual with a medical condition that absolutely contraindicates the administration made, if the condition is known, prior to-the administration, to any physician involved with the individual's care;
- 10. made using.a radiation source, a radiopharmaceutical, or a radioactive material formt'ition, which is wrong for that particular administra-tion c. s deg .ied in its safety or effectiveness;
.LO/25/88 3
i
,WORKING PAPER
- 11. made to the wrong organ, tissue or anatomical area for that .
particular administration;
- 12. made by the wrong route for that particular administration;
- 13. made by the wrong administration schedule for the intended purpose of the administration;
- 14. made with a radiation device with a malfunction, misadjustment or procedural error which could apparently change the safety or efficacy
- of the administration greatly, or increase the patient dose signifi-cantly (50% or more for diagnostic devices, or 10% or more for therapeutic devices, when quantitative determination is possible);
- 15. given in a dosage of I-125, I-131, or P 32, which differs from the correct dosage by more than 20% for uses requiring administration of 0.25 mci or more,. or by more than 50% or 50 pCi, the lesser amount, for other uses; given in a dosage of any radionuclides which is not known, is not 16.
assayed correctly prior to administration, is incorrect for the intended purpose of the administration, is different from the intended dosage by more than 50%, or is bound or unbound unintentionally to an extend that negates the safety or efficacy of the administration; i
- 17. made in any therapeutic, pediatric or radioiodine administration using patient data from '.he wrong source, using a dose, dosage or treatment time _ calculated with the wrong numerical table, graph, nomogram, com-puter program, assumptions, wedge factor, or calculation procedure, or using_a critical calculation by a person untrained or unauthorized -
to make the calculation;
- 18. made in a brachytherapy administration in which any radioactive source is used or omitted unintentionally, is not recognized for its actual source strength or physical characteristics prior to administration, is located in the wrong position or is removed from the treatment 10/25/88 4 i
WORKING PAPEN volume during part or all of the treatment, is not removed as planned,
'I or'isleaking, contaminated,orlackingnormalintegrityduringatime span that might have included the administration;
- 19. made in a brachytherapy administration with the total source strength differing from the prior intention by more than 15% in a permacent implant or by more than 20% in a temporary emplacement, or with the final product of the treatment time and the total source strength, in a temporary emplacement, differing by more than 10% from the
, intention formed upon assessment of the actual source placement geometry;
- 20. made in an individual treatment or fraction of teletherapy involving the unintended use or omission of a wedge, bolus, tissue compensator or beam block, or using a treatment depth or any parameter of beam geometry in error by more than 10 degrees or 2 cm (determined in
[. relation to.the treatment volume) including error in position or orientationofthegantry,collimator,collimatorjaws, wedge, bolus, tissue compensator, beam block, treatment couch, or patient setup (but not error due to patient movement after setup); or
- 21. made in'an individual treatment or fraction of teletherapy in which the dose to the point in the patient intended as the prescription point, differs from the intended dose for that fraction by more than 10%, if this difference is not reported to the radiotherapist and corrected prior to administration of the total number of fractions l previously planned for that phase of treatment (distinguished by a change in beam parameters or by cessation of treatment), and prior to administration of treatment fractions with dose errors totalling to more than 150 rads.
- a. The licensee shall report any such event on NRC Form , within 15 days of discovery of the event, to: Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555. The report shall include a rief analytis of possible ways to prevent recurrence of the event ars a description of cne action taken to , 10/25/88
i y/ORKING PAPER prevent recurrence, or a brief analysis indicating that no harm was done
- S and that no harm would be likely to affect any individual in a recurrence of the event. The report and any attachments shall each include the 1 licensee's name and license number, but shall exclude the name and all personally identifying data of the person given the administration.
The licensee shall retain a copy of each report for ten years. This copy ' shall be annotated so as to name all-individuals involved in the event, including physicians, allied health personnel, the person affected, and his or her referring or personal physisian. -
- b. If any reportable event appears to be caused predominantly by a defect in materials, equipment, or computer programming supplied to the licensee, and the defect appears not to be caused by any error of the licensee, then the licensee shall promptly telephone notification of the event to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter, and also to the manufacturer, radiopharmacy, or supplier of
.y. the defective item. If the manufacturer, radiopharmacy, or supplier cannot be notified within a reasonable time, then the licensee shall promptly notify the NRC Regional Office of this fact by telephone.
- c. If a reportable administration is likely to cause any acute adverse effect in the person receiving the administration, or a dose greater than 50 rems to any tissue (other than tissue within the intended treatment volume of a solid cancer), or a dose greater than 0.5 rem to any tissue of a fetus, then the licensee shall promptly telephone notification of the event to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter, and also to the referring or personal physician of the person who received the administration. This telephone notification-shall include.esti'ates of the doses received by critical organs, and
- estimates of the foreseeable damage, if any, to the organs receiving the highest or most damaging doses. The written report required by Section 35.33(a) shall include these same estimates, and the name of the physician notified; and a copy of this written report shall be given to the physician who was notified of the administration, within 15 days of discovery of the event, this copy to contain a full identification of the person affected.
l 10/25/88 6 1
- l. - _ . __ _ _ _ . _ . _ _ _ . _ _ _ _ _ - . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
WORKING PAPER If the physician cannot be notified fully within 24 hours, then the licensee sh'all notify the NRC Regional Office of this fact by telephone, in a second notification if necessary, and shall notify the physician as soon as practicable. If the telephone notification or the written report cannot be given to an appropriate referring or personal physician within a reasonable time, then it shall be given directly to the person affected by the administration (or to a responsible relative or guardian), unless the
. licensee believes that it would harm the recipient and explains this belief in the written report to the NRC.
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- d. Aside from the additional notification and reporting requirements, nothing in this section affects any rights or duties of licensees and physicians in relation to each other or to patients.
5 35.35 Basic Quality Assurance Program. Each licensee that uses byproduct material for medical use shall develop g,, and implement a written quality assurance program that will avoid
; simple human errors related to the administration of byproduct material or radiation to patients, and promptly det'ect and correct errors that l occur, including the errors described in S 35.33(a) of this Part.
s l i l l 10/25/88 7 '
OOEO @RKING PAPER
** FIRST WORKING DRAFT BASIC QUALITY ASSURANCE IN RADIATION THERAPY AND CERTAIN DIAGNOSES FOR REDUCING HISADMINISTRATIONS DUE TO SIMPLE HUMAN ERRORS A. INTRODUCTION
.. The NRC has proposed a new regulation, Section 35.35, " Basic Quality Assurance Requirements in Radiation Therapy and Certain Diagnoses," of 10 CFR Part 35, " Medical'Use of Byproduct Material," for 90-day public comment'(53 FR xxxxx, April xx, 1989). The proposed regulation would require medical licensees to. implement basic quality assurance (QA) steps to reduce the chance of therapy misadministration and diagnostic misadministration that could result in doses in the therapy range. The purpose of this proposed regulation is to avoid misadministration caused by simple human ({} errors. This preliminary regulatory guide, published for public comment concurrently with the publication of the proposed rule, describes some QA st'eps.that would be acceptable to the NRC staff for meeting tne performance-based criteria stated in the proposed Section 35.35. Public comment period ends on July xx, 1989. l The NRC staff is also conducting a pilot study using the steps contained in this preliminary draft guide. The purpose of the pilot study is to determine the practicability and feasibility of . certain proposed QA procedures. Furthermore, the pilot study.
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should identify whether the proposed QA steps would interfere with the prompt delivery of the medical care. Based on public comments and the results of the study, the NRC staff plans to revise this guide as necessary. I
1
)
2
$0RKING PAPER .
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The revised guide will be published as a draft regulatory , guide, in conjunctie, with the final regulation, for one-year trial l l use by licensees for implementing Section 35.35. A final l regulatory guide vill be published after results.of the one-year trial use are considered by the NRC staff. Therefore, comments on this preliminary regulatory guide are encouraged. Any information collection activities mentioned in this draft regulatory guide are contained as requirements on 10 CFR Part 35, . which provides the regulatory basis for this guide. The information collection requirements in 10 CFR Part 35 have been cleared under OMB Clearance No. B. DISCUSSION f*- < (
+ Radiopharmaceuticals labeled with byproduct materials are used in nuclear medicine to locate tumors, assess organ function, or monitor the effectiveness of a treatment. Large quantities of radiopharmaceutica3s are administered to treat hyperactive thyroid conditions and certain forms of cancer. Byproduct materials, as sealed radioactive sources, are used in radiation therapy to treat cancers. Teletherapy machines can be adjusted to direct a radiation beam to the part of the patient's body to be treated. In brachytherapy, smaller sealed sources with less radioactivity are -
~~
designed to be implanted directly into a tumor area or applied to the surface ~of an area to be treated. An estimated 10 million . diagnostic nuclear medicine procedures are performed annually in the United Stetes. In addition, there are about 30,000 radiopharmaceutical therapy treatments, about 100,000 teletherapy treatments, and about 50,000 brachytherapy treatments annually.
3 EORKING PAPER
.' In the past nine years, 52 misadministration in radiation therapy and 23 diagnostic misadministration that led to doses in the therapy range were reported to the NRC. The misadministration involved human errors and.resulted in dosen significantly different from prescribed doses, wrong radiopharmaceuticals, wrong target locations, or wrong patients. Although the probability of misadministration is low, the Commission believes that certain past misadministration could have been prevented if certain QA steps were followed by the licensees.
If adopted, proposed Section 35.35 would require licensees who use byproduct material in performing radiation therapy or diagnostic procedures that could lead to doses in the therapy range to have a QA program. The QA program should include steps, such as independent checks of dose calculations in teletherapy and brachytherapy, for eliminating calculational errors. However, proposed Section 35.35 provides only the performance criteria (- ,ithout w specifying the detailed QA steps to allow flexibility for the medical licensees. This flexibility is desirable to avoid interference with prompt delivery of medical care to patients. 1 C. REGULATORY POSITION This regulatory position provides a set of QA steps acceptable to the NRC staff for complying, if adopted, with the proposed Section 35.35. The NRC staff believes that certain misadministr_ations caused by simple human errors can be avoided by I implementing the basic QA steps contained in this guide. However, a licensee may propose different QA steps for NRC approval as long as the steps satisfy the performance criteria of the regulation.
$0RKING PAPES ,
o Compliance with the QA steps contained in this guide does not indicate that the licensee has satisfied all QA requirements in performing diagnosis or therapy using byproduct material. Other QA steps, such as various checks of a dose calibrator, may also be necessary. (For example, see Regulatory Guide 10.8, " Guide for the
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Preparation of Applications for Medical Use Programs.")
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- 1. QUALITY ASSURANCE STEPS FOR ALL THERAPEUTIC AND CERTAIN DIAGNOSTIC PROCEDURES All procedures involving the use of (1) byproduct material for teletherapy, brachytherapy, or radiopharmaceutical therapy and (2) the use of more than 30 microcuries of I-125 or I-131 as sodium iodide for diagnosis chould include the following quality assurance elements.
(. *
; 1.1 Before prescribing a diagnostic procedure or therapy, the authorized user or a physician under the supervision of an authorized user should personally review the patient's case to ensure that the procedure and the dosage (for a radiopharmaceutical) or the therapy and the dose (for-teletherapy or brachytherapy) are appropriate for the patient.
1.2 Before administering byproduct material, an authorized user or a physician under the supervision of an authorized user should personally make, date, and sign a written prescription or other written instruction in the patient's chart or record.
5 FORKING PAEE8
- 1.3 Any change in the prescription or other written instruction should also be made in Friting in the patient's chart or record and should be dated and signed by an authorized user or a physician under the supervision of an authorized user.
1.4 Prescriptions and other records regarding the medical use
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of byproduct material should be legible and unambiguous. 1.5 The licensee should require that all workers involved in the medical use of byproduct material request clarification from the prescribing physician (or a designee if the prescribing physician is absent) if any
- element of a prescription or other record is unclear, a ambiguous, or apparently erroneous.
1.6 The licensee should stop the medical use of byproduct (
- material on a patient if there is an apparent discrepancy
" in records, observations, or physical measurements that I may result in a misadministration. The licensee may resume use after resolving the discrepancy.
- 2. QUALITY ASSURANCE STEPS SPECIFIC TO RADIOPHARMACEUTICALS All procedures involving (1) the use of radiopharmaceuticals for therapy and (2) the use of more than 30 microcuries of I-125 or I-131 as sodium iodide for diagnosis should include the following quality assurance elements.
2.1 Prescriptions and other written instructions for use of these radiopharmaceuticals should include the patient's name, radiopharmaceutical, dosage, and route of administration.
'6 l
WORKING PARE 8 ,, 2.2 Before administering a radiopharmaceutical, the identity - l of the patient, the radiopharmaceutical, and the dosage should be confirmed to agree with the prescription or other written instruction. 3; QUALITY ASSURANCE STEPS SPECIFIC TO BRACHYTHERAPY , 3.1 Prescriptions should include the source of radiation and one of the following.
- 1. Total dose at a specified location,
- 2. Isodose rate contour and treatment time,
- 3. The source strength, number of sources, and the treatment time, or
- 4. Other appropriate description of the planned
- treatment, f~
(" , 3.2 The patient's chart should be promptly updated to reflect t the actual loading and dose to be delivered. 3.3 A check of dose calculations (by a physicist, dosimetrist, technologist, or physician who did not make the calculations) should be made before 50 percent of the prescribed dose has been delivered. - 3.3.1. Manual dose calculations should be checked for: ,
- 1. Arithmetic errors,
- 2. Correct transfer of data from the ~
prescription-, tables, and graphs,
- 3. Correct use of nomograms (when applicable),
and
- 4. Correct use of other pertinent data in the calculations.
7 WORKING PAP.E8 3.3.2 Computer-generated dose calculatient should be checked by examining the computer printout to ensure that the correct inputs for the patient were used in the calculations. 3.4 If the prescribing physician determines that delaying treatment in order to perform the checks of dose calculations (see Section 3.3) would jeopardize the patient's health because of the emergent natura of the patient's condition, the licensee may provide the prescribed treatment without performing the checks. The prescribing physician should make a notation of this determination on the patient's chart. The checks should be performed as soon as practicable.
- 4. QUALITY ASSURANCE STEPS SPECIFIC TO TELETHERAPY
(: , 4.1 Prescriptions should identify the modality, the portal or field arrangement, the total dose at a specified location, and the dose per fraction or the number of
. fractions.
4.2 Full calibration measurements should include the determination of the output for the range of field sizes, the range of distances, and beam modifying devices (for example: trays, wedges, and stock material that is used for making compensators, except blocks). 4.3 An independent check of the output for a single specified set of exposure conditions should be made within two . months after a full calibr,ation that resulted from:
- 1. Changing the source, or
- 2. Finding a difference of more than 5 percent between a spot check measurement and the output obtained at the last full calibration corrected mathematically
'or radioactive decay.
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FORKING PAPEfl The independent check should be performed by either
- l. An individual who did not perform the full calibration, by using a dosimetry system other than the one that was used during full calibration. This I individual should meet the requirements specified in ,
Section 35.961 of 10 CFR Part 35. The dosimetry system should be as described in Section 35.s.c'a), . or
- 2. A teletherapy physicist (or a dosimetrist, ,
technologist, or physician under the supervision of a teletherapy physicist) using a thermoluminescence dosimetry service available by mail that is designed for confirming teletherapy dose rates and that is accurate within 5 percent.
. 4.4 A check of dose calculations (by a physteist, dosimetrist, technologist, or physician who did not make the calculations) should be made before 20 percent of the
[ + prescribed dose has been administered. 4.4.1. Manual dose calculations should be checked for:
- 1. Arithmetic errors,
- 2. Correct transfer of data from the prescription, tables, and graphs, and
- 3. Correct use of other pertinent data in the calculation.
4._4.2. Computer-generated dose calculations should be checked by examining the computer printout to , ensure that the correct inputs for the patient were used in the calculations. 4.5 A weekly check should be performed for errors in the daily cumulative dose calculations and for implementation of prescription changes that have been made in the patient's chart.
l 9
.- l60RKING PAPER 4.6 Physical measurement of the output should be made, before 20 percent of the total prescribed dose has been administered, if the patient's dose calculations include:
- 1. Field sizes or treatment distances that fall outside the range of those measured in the most recent full calibration, or
- 2. A beam modifying device (except blocks and bolumes) not measured in the most recent full calibration.
4.7 If the prescribing physician determines that delaying treatment in order to perform the checks of dose ; calculations (see Section 4.4) or physical measurements (see section 4.6) would jeopardize the patient's health because of the emergent nature of the patient's condition, the licensee may provide the prescribed treatment sithout performing the checks of dose calculations or physical measurements. The prescribing h + phusician should make a notation of this determination on the patient's chart. The licensee should perform the checks of calculations or physical measurements as soon as practicable. i D. IMPLEMENTATION )
- The purpose of this section is to provide information to medical licensees and applicants regarding the NRC staff's plans
~ - for using this regulatory guide.
This preliminary draft guide has been released for public omment to encourage public participation in its development.
10 WORKING PAPER Except in those cases in which a licensee or an applicant propones ! an acceptable alternative method for complying with specified portions of the Commission's regulations, the method to be described in the active guide reflecting public comments will be used in the evaluation of basic quality assurance programs for medical use of byproduct material for radiation therapy and certain diagnoses. 4 e i
.- SEP 23 m l WORKING PAPER DRAFT PROTOCOLS FOR PILOT PROGRAM
, 1. Purpose of the pilot program The purpose of the pilot program is to determine the impacts of the proposed QA prodedures, including whether these - procedures would interfere with the proper delivery of medical care. These QA procedures are designed to reduce simple human errors in medical uses of byproduct material. However, the pilot program is not designed to obtain a statistically significant quantitative cost benefit ratio because the frequency of occurrence of misadministration is very low. Participants may be selected from volunteers that responded to , the FR notices announcing a relevant Subcommittee meeting, the l proposed rulemaking, and the pilot program.
- 2. Selection of hospital (clinic) participants A. Factors to be considered in selecting participants
- a. Size of hospitals or clinics (in terms of No. of beds):
Large hospitals, small hospitals, or private clinics.3 ,
- b. Financial resources:
Private, or public hocpitals.
- c. Geographical locations:
East, central, or west coast
- d. Population characteristics:
Urban and suburban, or rural areas. B. Number of participants About 50 participants (see matrix on next page).
- 3. QA procedures to be tested QA procedures specified in the preliminary regulatory guide.
- 4. Test period Test period is 30 calendar days.
I e 2 $0RKING PAPER - MATRIX FOR DETERMINING NUMBER OF PARTICIPANTS PRIV. NO OF PARTICIPANTS SIZE /PUBLIC GEOGRAP. POPULATION IN THIS CATEGORY , L PR E U R
/h L PR E L PR C U L PR C R L PR H U L PR H R L PU E U L PU E R L PU C U L PU C R L PU W U L PU W R S PR E U g S PR E R TO BE DETERMIND U A --
S S PR PR C C R d. S PR W U
$ PR W R S PU E U S PU E R S PU C U S PU C R S PU W U S PU V, R C PR E U C PR E R C PR C U C PR C R C PR W U C PR W R C PU E U C PU E R ^
C PU C U C PU C R C PU W U 7 C PU W R / Estimate total participants: 50
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$0RKING PAPES
- 5. Information to be collected i For each QA procedure, record the following information A. Economic impacts:
, a. additional direct cost ~(S),
- b. additional manpower (man-hours for various types of personnel, such as physician, physicists, etc.)
- c. other costs
- - B. . Unavailability of qualified personnel:
- a. types of personrel needed
- b. how many do you need
- c. how many are available to you ,
- d. how did you obtain the additional-personnel during the pilot testing period.
- e. how would you obtain the persennel if this procedure would be required in the future C. Interference with medical practice:
- a. the circumstances under which a medical procedure is lh interfered with because of implementing a QA procedure
- b. how could the interference be avoided or reduced but still satisfy the intent of the QA procedure D. Benefit:
- a. types of human errors detected because of implementing a QA procedure
- b. types ofshuman errors you believe might be prevented because of a QA procedure
- c. other benefit
- 6. Alternatives to be considered based on test results I l
A. Interference with medical practice l
- a. provide other specific alternative QA procedures
. that could avoid or reduce the interference with medical practice
- b. if no other specific alternative exists, consider a more general QA procedure B. Unavailability of qualified personnel
- a. provide alternatives that may reduce the need for a special type of personnel b, consider special alternatives for certain types of hospitals or clinics
is . , 4
@RKING PAPER C. Economic. impacts
- a. Provide alternatives that may reduce the economic impacts
- b. consider special alternatives for small entities
- 7. Anticipated' problems ,
A. Severe impact or interference from a QA procedure If a licenree encounters a severe impact or interference with the delivery of medical care, the licensee should immediately notify the contractor's principal investigator or the.NRC project manager. Depending _upon l the seriousness of the problem, the.NRC project manager may take one of the following actions:
- a. discontinue the QA procedure, or
- b. provide alternatives. ([)
B. Implementation problems for testing QA prodcedures The contractor's principal investigator should periodically contact each licensee's principal investigator to ensure that the pilot If there are any testing at that i facility is fgnetioning properly. ~ problems, the NRC project manager should be immediately notified. Depending upon the seriousness of the problem, conference telephone calls or meetings among the licensee, the contractor, and the NRC project manager should be arranged to resolve the problem promptly. , e I 1 l 1
- - _ _ _ _ - - _ _ _ _ _ _ _ _ - - - A
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.. -,syncor' October 24, 1988 . Norman L. McElroy Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, D.C. 20555
Dear Mr. McElroy:
Thank you for taking time out of your schedule to discuss the apparent change in policy regarding misadministration. We (I) realize that it is the responsibility of the Nuclear Regulatory Commission to regulate the medical use of radioisotopes as necessary to provide for the radiation safety of workers and the general public (the patient is the general public). We also agree that it is the responsibil'ity of the Nuclear Pharmacy (Nuclear Pharmacist) to assure that prepared radiopharmaceuticals are labeled properly, since mislabeled ' products may result in multiple diagnostic misadministra-tions. In fact pharmacists, as part of the health care profession, take an oath which includes the statement "That I will hold the citizen's health and welf are paramouet in all considerations relative to the practice of my profession."
- Since the inception of the concept of the centralized radiopharmacy in 1971, pharmacists have refined data entry systenis, quality control, standardization of the specific activity of each radiopharmaceutical, etc. in an attempt to reduce the number of dose related errors. At the present ~
time, Syncor is responsible for approximately 100 diagnostic misadministration per year. At the same time, our pharmacists dispense over 3.9 million doses. (This works out to be one misadministration per 39,000 doses dispensed.) Ms
,-iinnovators in high-tech pharmacy services Ssncor international Corporation 20001 Prairie Street P.O. Box 2185 + Chatsworth, CA 91313 2185 (SIS) 886 7400 FAX 886 6028
- Telex MCI 6718642 Syncor CHATS
l I c. One of the reasons that centralized-nuclear pharmacies derived popularity during the late seventies and early eighties was the fact that they substantially reduced the rate of error in the hospitals. During the seventies, the diagnostic dosage error rate in nuclear medicine exceeded one per cent. This meant that a hospital doing 300 procedures per month could expect 36 misadministration per year. When a hospital contracted the services of a nuclear pharmacy the average error rate was reduced from-36 misadministration per year to one every 10.8 years. . During the past 18 months we have had three locations which have had misadministration rates which greatly exceeded the corporate average of one per thirty nine thousand. Upon examination we found that their rate approached one i misadministration per six thousand doses. While we do not I condone such a misadministration rate and we have done everything in our power to resolve the problem, it is still much lower that the hospital average. .For a hospital doing 300 procedures per month to approach this average, they could have only one misadministration every 1.7 years. We realize that there is a directive to reduce the number of medical misadministration and we, at Syncor, have continually experimented to improve existing and create new procedures which will reduce this number. In fact"during the 1988 fiscal year, Syncor developed a corporate bonus program which allows all employees to share in a percentage of the profits of the_ company. At the same time we decided to tie a portion of the bonus to the " quality of service" the location provides to the community. Since misadministration affect the quality of service, they will have a negative impact on the bonus. In this manner all of the employees of the . location will be impacted if a misadministration occurs. l (Hopefully this will have a peer pressure effect.) . Last but not least, it is generally accepted that diagnostic . ! x-ray _and nuclear medicine procedures carry an acceptable risk. The practice of medicine accepts that human error, equipment failure, and other factors can cause a diagnostic ' procedura to be repeated. A retake rate of 5-10% is not uncommon in radiology departments. Many radiology procedures (CT, Fluoro) have a higher radiation dose and often much higher absorbed dose to blood forming organs that do nuclear medicine procedures. i
We know that as long as we deal with human performance, we will never reach perfection. We believe that an error rate of one in thirty nine thousand is outstanding particularly. compared with the performance of other organizations working in the same area. Notwithstanding that we are attempting to decrease such error rate. However,-we ask what error rate is a an acceptable error rate for all nuclear medicine procedures. If, as we believe, it is much higher than our current error rate, then we question whether concentration of substantial effort by the Quality Assurance Subcommittee in the central nuclear pharmacy area is justified. Sincerely yours, h Monty Fu, CEO and Chairman of the Board h T i b . i
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4 6 d w. O
p.,-,-- , , - - - - -
, - - - - - , - - , - - - - , - - - - - - - - , - , - - ---, - , - - - -- - - , -----e, - - - - - ---- , - - - - - - ------ -,--- - ------- -- -- , - - --- - - -- -- - - - , - --- - - - - - - - - - , - - - -
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AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE Vf7 Office of the hesident Dect FAtz M. KHAN. PH D. University of Minnesota Hospital Department of Therapeutic Radiology I Dox 494. Harvard St. at East River Road 4 Mmneapolis, MN 35455 (612) 626-6445 NRC QA SUBCOMMITTEE MEETING Washington, D.C., November 7, 1988 Presentation by Faiz M. Khan, Ph.D. Representing the American Association of Physicists in Medicine (AAPM) Thank you for inviting the AAPM to attend this meeting. The AAPM is very much interested in participating in the development of a regulatory guide on quality assurance in the medical use of byproduct material. I have already provided the NRC, through a letter to Bill Morris, the naiaes of five indivi-duals who would be _available to provide the needed input in this endeavor on b; half of the AAPM. A task group of the AAPM has already been formed to dcVelop guidelines for a comprehensive quality assurance program in radi4 ation oncology. The AAPM will cooperate with the NRC whenever it is called upon to provide consultation or corninents. I should also pointout that an AAPM document on quality assurance in radiation therapy already exists but The Association's Soentsfc Joumais are MEDICAL PHYSICS and PHYSICS IN MEDsCINE AND BIOLOGY Member Socasty of the Amencan instrtute of Physics and the intemational Orgaruzation of Medical Physscs
will be updated by the now task Scoup. The NRC could use the finalized AAPM document in evaluating the Licensee's basic QA program which would be desig- ., ned in accordance with the NRC QA guidelines. Tne proposed NRC guidelines lay down a framework that could become the basis of a comprehensive QA program.
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In principle no institution should operate without minimizing the occurrance of errors identified in the propo- . sed guidelines. The only cautionary note that I have is that in its implementation the program must not become so burdensome or bureaucratic , that the institutions are forced to switch to nonabypruduct materials to avoid the hassle. I think the ideas presented here are all good but we must make sure that the reporting requirements are not unduly labor intensive and that _ the paperwork involved is minimal. I must confess that we, the licend sees, have an image of the NRC as "a little bit" bureaucratic. It often adopts a legalistic approach than a scientific or a practical one. However, we should strive to change this image to that of a regularitary body that is committed to public safety and welfare in the overall delivery of health care. This is quite possible if the rules are interpreted in a broad sense rather than the narrow, literal interpertations we often get from the NRC inspectors. We could avoid these problems if we keep this aspect of the regulatory process in mind during these meetings. Let me bring up another aspect of QA which is probably more basic than a set of QA procedures. This is the question of f acility structure. If the best equipment in a radiotherapy department is an obsolete cobalt unit or if no qualified (board certified) physicist is on the staff, the whole QA program becomes simply a ritual of checks with little relationship
with the quality of patient care. I think that the first order of business.
- 4 +
for the NRC should be to make.sure that the facility using the byproduct l material has qualified personnel on staff. Equipment and staffing guidelia nes already exist (" Blue Book" by the American College of Radiology ) to assist the NRC in this regard. le Human errors are committed by humans and I think that the qualified indi- , E viduals understand better both the scientific significance and the professional aspects of a QA program. For example, a technician or a dosi-metrist can be trained _to do the QA procedures step by step, but the physical QA must be designed, evaluated and supervised by a qualified physi-cist. Similarly, the clinical part of QA must be directed by the radiation onco' log ist/radiolog ist. If the NRC guidelines exist the institution should incibde them in the QA program but not limit itself only to those procedua res. In my view a comprehensive QA program should satisfy both the reguiatory agencies as well as other requirements that are essential in pro
- viding safe and effective treatment to patients.
(hope the NRC will take the view that the regulatory guidelines are no substitute to a proper facility organization in which the medical applied stion of a byproduct material is under the control of qualified personnel (see Fig. 1). For example, requiring a facility to do a certain number of QA precedures is not as important to me as requiring that qualified staff be I available to do or direct a QA program that is comprehensive and is integr-sted with the quality of patient care. Unfortunately, the NRC cannot go all the way in assuring a quality treatment to patients without interfering in the conduct of therapeutic procedures. However, the NRC could require
appropriate personnel support for the GA program, considering the equipment
- and the patient load the facility has.
In summary the expertise exists within the professional organizations such as the AAPM, the ACMP and the ACR to assist the NRC in drafting QA gui-d211tes. The proposed guidelines are expected to minimize simple errors and, therefore, improve the quality of medical practice provided the atten-dont bureaucracy in program evaluation and reporting is minimized. In
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addition to these guidelines, the NRC should examine the facility structure of the licensees with regard to equipment and staffing in the light of the
" Blue Book" recommendations.
I will be glad to respond to specific QA issues as they are brought up for discussion during the QA Subcommittee meeting. 1
- 1) AAPM Report No. 13:" Physical Aspects of Quality Assurance in Radiation Therapy", 1984
- 2) Intersociety Rederences Council for Radiation Oncology (ISCRO): "Radia atton Oncology in Integrated Cancer Management", 1986.
L L ,, l: FACILITY STRUCTURE FOR QUALITY ASSURANCE y' , OVERALL QA Department Head t
- PHYSICAL QA CLINICAL QA Medical Physicist Radiation Oncologist/
Radiologist 4 IMPLEMENTATION - Y Assisted by y Dosimetrists, Techs and Nurses
. Overall QA: Administrative responsibility for the QA program
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Clinical QA: Diagnostic workup, protocols, treatment verification, etc. Physical QA: Equipment checks, dosimetry checks, radiation protection, etc.
, #Cl#7 American College of Medical Physics Execudve Committee: Mr. Chairman, members of the sub-committee and Nagalingam Suntharalingam Ph.D.
Chairman U.S. NRC Staff: Lawrence N. Rothenberg, Ph.D. I C nna" Thank you very much for inviting the American
- Se D.
Chairman Elect Jimmy O. Fenn Ph.D. College of Medical Physics (ACMP) to have a representive Secretary David P. Spearman, M.E. participate in this meeting. I am here as the current Treasurer Board of Chancellors: Chairman of the Board of Chancellors of the American Kenneth Kase, Ph.D. ob rt r M S. College of Medical Physics. The ACMP is a relatively Paul Feller. Ph.D. Walter Grant, Ph.D. young organization, formed in 1983, to address lames Purdy. Ph.D. ben hu. D. professional concerns of the practicing clinical medical gp James Smathers. Ph.D.
%% %,,, physicist. We have been active in several areas of
- 1. aura Fleming Jones importance including establishing a close interaction with regulatory agencies, both Federal and State, and the Joint Commission on the Accreditation of Health Organizations (JCAHO). In this respect we welcome the opportunity offered us today.
The ACMP and its membership are dedicated towards providing and maintaining a high level of clinical l , physics participation towards optimal patient care. We 4 ' l recognized the need for written documents and issued three separate protocols, in January 1986, covering Radiation Control and Quality Assurance Procedures in Diagnostic Radiology, Radiation Oncology and Nuclear Medicine (ACMP Reports 1-3, attached). The purpose of these documents was to provide to hospitals and the 1891 Preston White Drive, Reston, Virginia 22091 j (703) 648-8966
2 JCAHO a guide prepared by medical physicists suggesting procedures which should be performed by or under the supervision of a " qualified" medical physicist. Our organization has, after much deliberation issued an unambiguous definition of a " qualified" medical physicist for use by regulatory agencies, hospitals and related organizations (copy attached). . The ACMP is fully supportive of establishing, if one does not
- already exist, a performance based minimum effective quality assurance program for all facilities using radiation in medicine. The program should include both the physical and clinical aspects of delivery of patient care. The program should be established as a team effort with input from all relevant groups of supporting staff with the physician (licensee) assuming overall responsibility for its implementation. We do feel most facilities have some QA program in existence though they might not be adequately documented or followed. Thus, there should be na undue burden in formalizing an effective program.
Initial Comments on Draft Documents A. Draf t Reporting and QA Rule , 1 .. Reco' amend separating Diagnostic and Therapeutic incidents with clearly defined reporting requirements - l 2. Endorse the concept written in Alternative III regarding patient notification to be left in the hands of the physicians. l L-___--.________-_.
.e.
3
**' 3. Listing of the reportable events as in Alternative III appears to be too exhaustive.
- 4. Errors in brachytherapy procedures need to be clearly defined. The current statements appear difficult and cumbersome.
5 It is not clear why incidents / errors in an individual treatment or 0 L fesetion need to be reported.
- 6. What is the significance of dose errors totalling more than 150 rads?
B. Draf t of Basic QA Regulatory Guide
- 1. The preliminary guide as written seems reasonable.
- 2. Is it really necessary to identify and spell out in detail all the required QA steps / procedures?
- 3. Why not require all facilities to implement a QA program and make it available either for inspection or at time of application / renewal.
e
- 4. Redundant checks by a second individual are useful if carried out by
+
' qualified individuals'. This requirement might be a burden on most 4
facilities. C. Draf t Protocols for Pilot Program
- 1. Is this program really necessary?
- 2. Will one really gather any more information thaq what we already know?
- nh -
. Suntharalingas, P . D.
Chairman November 7, 1988
QUALIFIED MEDICAL PHYSICIST (Definition) DEFINITION OF A OUALIFIED MEDICAL PHYSICIST A qualified medical physicist is an Individual who is competent to practice independently one or more of the subfields of medical physics. Explanatory Foot Notes:
- 1. At the present time, the subfields of medical physics am:
- a. Therapeutic Radiological Physics is that branch of medical physics that deals with (1) the therapeutic applications of roentgen rays, of gamma rays, of electron and other charged particle beams, of neutrons, and of radiation from sealed radionuclides sources, and (2) the equipment associated with their production and use.
- b. Diagnostic Radiological Physics is that branch of medical physics which deals with (1) the diagnostic applications of roentgen rays, of gamma rays, rays from sealed sources, of ultrasonic radiation, of radiofrequency radiation, and (2) the equipment associated with their production and use.
- c. Medical Nuclear Physics is that branch of medical physics which deals with (1) the therapeutic and diagnostic applications of radionuclides (except those used in sealed sources for therapeutic purposes), and (2) the equipment associated with their production and use.
. d. Medical Health Physics is that branch of medical physics which deals with the safe use of roentgen rays, of gamma rays, of electron and other charged particle beams, of neutrons, of radionuclides, and of radiation from sealed radionuclides sources for both diagnostic and therapeu tic purposes, and (2) the instrumentation required to perform appropriate radiation surveys.
Additional subfields may be added as required.
- 2. An individual will be considered competent to practice one or more of the subfields of medical physics if he/she is certified in that subfield by any of the following:
- a. The American Board of Medical Physics l
- b. The American Board of Radiology
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- c. The American Board of Health Physics March 1988 13
- d. The American Board of Science in Nuclear Medicine
- e. The Canadian College of Physicists in Medicine Additional cerufying organizations may be added as they are recognized.
- 3. During a transition period not to exceed five years from the time of adoption of this definition by a regulatory agency, an individual may, in lieu of a certificate, be deemed by that agency competent to practice one or more of the subfields of medical physics provided that he/she:
- a. Holds a degree of Master of Science, Master of Arts, or a higher degree in an appropriate field. Appropriate major fields include radiological physics, biophysics, physics, health physics, engmeering, and public health when a Bachelor's degree is in a physical field, and
- b. Has had some training in the biological sciences - preferably formal coursework, and .
- c. Has had at least two years fuU-time active association with a qualified medical physicist practicing the subfield of in:erest. If qualification in more than one subfield is desired, an additional year of experience must be obtamed for each additional subfield.
Following this transition priod, any individual will be considered qualified only if he/she is certified by one of the organizations isted in paragraph 2 above. This implies that an individual who was deemed qualified under the provisions of paragraph 3 above will remain qualified only if he/she becomes certified before the end of the transinon period. It is expected that an individual will not hold him/herself out to be qualified in a subfield for which he/she has not established competency accordmg to the requirements of either paragraph 2 or paragraph 3 above. 14 ACMP Bulletin
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, yg( 1101 connecticut Avenue, N.W.
- Suite 700
- Washington, D.C. 20036 202429 5120 American The Society College of of Nuclear Nuclear Medicine Phys! clans s
STATEMENT of AMERICAN COLLEGE OF NUCLEAR WlYSICIANS/ SOCIETY OF NUCLEAR MEDICI'NE a before the ACRll SU8COMITTEE ON QUALITY ASSURANCE November 7, 1988 8
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[ w. Mr. Cunningham and Members of the Subcommittee: My name is Dr. John Laude. I am Director of the Department of Nuclear Medicine at the Elmhurst Memorial Hospital in Elmhurst, Illinois. ' I am here today on-behalf of the American College of Nuclear physicians and
, the Society of Nuclear Medicine, and as a member of the joint ACNP/SNM Task Force that developed our formal comments to the NRC on both the basic and comprehensive quality assurance proposals. Additionally, I serve as chairman of the ACNP Quality Assurance and Practice Certification Committee. This Committee is responsible for reviewing the practice of Nuclear Medicine and recommending mechanisms and procedures to ensure'the maintenance of high quality in Nuclear Medicine, and for conducting voluntary inspections and practice audits of Nuclear Medicine practices to certify the degree of compliance with the Guidelines for Quality Assurance in Nuclear Medicine Practice as published by the ACNP. These guidelines overlap the requirements of other accrediting and licensing agencies. The College and Society are extremely proud of our commitment to quality, and believe that the record of Nuclear Medicine demonstrates this quality.
1 1 I am- here today to provide this Subcommittee with organized Nuclear Medicine's views on the NRC's role in assuring quality in the medical use I of byproduct material, and to comment on the NRC's misadministration reporting rule.
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Quality Assufance
- i The College and Society jointly submitted comprehensive comments on the'NRC's proposed basic and. comprehensive quality assurance requirements for medical use. Together with oral presentations before the Advisory.
( Committee and'the Commissioners, these comments stressed that the NRC should avoid adopting burdensome, costly prescriptive regulations in an effort to reduce-the already extraordinarily low rate of diagnostic and therapeutic misadministration. We argued that the NRC's proposed QA regulations are unnecessary and would constitute unprecedented NRC
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intrusion into the practice of medicine. Dr. Carol Marcus, who appeared betare the Advisory Committee last January, told you that in her voluntary pilot test of the NRC's proposed basic QA regulation, she found that it would adversely affect the timeliness, appropriateness, quality and cost of medical care, and that contrary to its intent, the proposal would not decrease the already low incidence of misadministration. The Advisory Committee heeded the recommendations of the College and
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Society, and suggested to the Commissioners that the Nuclear Medicine community is doing a good job in the area of quality assurance, and that if . anything, the NRC should adopt performance standards rather than prescriptive regulations. I must reiterate our major concern at this point: we believe that 2 t
? ,o the NRC has a mandate to regulate the radiation safety of workers, patients and the general public, but it does not have a mandate to dictate how medicine is to be practiced. Recent activities we have learned about within the NRC have led us to believe that the NRC is knbarking down the road of medical intrusion, contrary to its own medical policy statement.
- While we have the highest commitment to quality assurance, we will not tolerate further unnecessary and unwarranted NRC intrusion into Nuclear Medicine practice.
The NRC has asked the Quality Assurance Subcommittee to consider the types of performance-based QA criteria that should be specified in the regulations to avoid, detect and correct simple human errors in medical use. While perfection is unattainable, we would suggest that the NRC look to the 7 principles outlined in the ACNP Practice Audit manual: o Nuclear Medicine consultations shall be performed by a qualified Nuclear Medicine physician, who is responsible for performing procedures in the best interest of the patient. o Patient records shall be accurate and complete, and the responsi-
- bility for each significant comoonent of the patient consultation
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eeport traceable. o All Nuclear Medicine procedures shall be identified and described in the technical procedure manual. 3
o The physical fccilities' and practices in the department shall be ., sufficient to maintain the dignity and safety of both patients 3 and personnel. Adequate , space and equipment shall be provided. o Procedures ensuring control and recording of the components of the nuclear medicine imaging process shall be followed to assure
- image quality sufficient for diagnosis.
o The quality of radiopharmaceuticals shall be controlled. o The quality control systems of the Nuclear Medicine radioassay laboratory shall be designed to assure the medical and analytic reliability of test data. All of these principles are supplemented with further guidelines and recommendations. We would recommend that the NRC simply adopt a requirement that each byproduct licensee implement and maintain a quality assurance program that espouses the 7 principles identified above. The NRC should not, however, prescribe how that program should be fulfilled; such decisions must be lef t - to the disc'retion of the director of the Nuclear Medicine Department who
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must have the flexibility to achieve quality assurance standards that meet the needs of his/her department and patients. It is difficult to address, within this oral presentation, the com-plex balance between NRC's appropriate radiation protection mandate, and 4
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, e the inappropriate intrusion into medical practice. Further NRC action, other than the simple requirement that each licensee have and follow a QA program, is unnecessary. The NRC should NOT adopt prescriptive basic QA steps for the licensee to fc111ow.
t e. pilot program The NRC has asked for coments on the number and type of hospitals or clinics that should participate in the pilot program, and what information should be collected during the pilot study. The College and Society believe that the NRC should strive to obtain at least 5 pilot participants from each of the following types of hospitals: a
- 1. academic medical centers - stra.tified by region, private v.
public, and urban v. rural.
- 2. Large community hospitals (over 500 beds) - stratified by region, urban v. rural, profit v. non-profit.
. 3. Medium comunity hospitals (250-500 beds) - stratified by region, urban v. rural, profit v. non-profit.
- 4. Small community hospitals (under 250 beds) - same stratification.
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- 5. VA and other government hospitals - stratified by region, urban
- v. rural, bed size.
l The types of information collected by these pilot participants should be'. =Lether the QA standards enhanced quality and safety; the impact of the standards on the timeliness and cost of services; whether the standards are workable or burdensome; cost / benefit analysis; and , alternatives. Misadministration Reporting Requirement As you know, the College and Society oppose the NRC's reporting requirement for diagnostic misadministration. We believe these errors occur so infrequently (1 in 10,000 per year) that the NRC's administrative expenses needed to run this program are not justified. As the NRC has correctly noted, diagnostic misadministration do not pose a clear hazard to the patient. Requirements for reporting of diagnostic misadministra-tions serve only to diffuse the focus and deflect the impact from the more important problem of therapeutic misadministration. In view of the documented exemplary record of Nuclear Medicine, we believe the diagnostic reporting rule is discriminatory and should be , deleted. With regard to therapeutic misadministration, we believe the patient notification requirement should be deleted. The decision to notify 6
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' the patient of a therapeutic misadministration cad its effects should be left to the referring physician.
CONCLUSION r. b In conclusien, the College and Society urge the NRC to exercise
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v caution in the development of QA standards. Any standards adopted should be generic, flexible, cost-effective and amenable to change and updating. Finally, licensees should be allowed the flexibility to implement QA programs according to their own needs and resources, without heavy-handed-prescriptive steps dictated by the NRC. Thank you for the opportunity to present our views. h O}}