ML20140J449
| ML20140J449 | |
| Person / Time | |
|---|---|
| Issue date: | 05/08/1997 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NACMUI, NUDOCS 9705140091 | |
| Download: ML20140J449 (145) | |
Text
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
Title:
MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) - PUBLIC MEETING l
Location: Rockville, Maryland Date: Thursday, May 8,1997 Pages: 1 - 84 i
7, 140003 ANN RILEY & ASSOCIATES, LTD.
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DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on May 8, 1997 in the Commission's office at one White Flint North, Rockville, Maryland. The meeting was open to public attendance and observation. This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes. As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
. .< i 1
j 1 UNITED STATES OF AMERICA '
2 NUCLEAR REGULATORY COMMISSION 3 *****
l 4 MEETING WITH ADVISORY COMMITTEE 5 ON MEDICAL USES OF ISOTOPES (ACMUI) 6 *****
7 PUBLIC MEETING
- 8
! 9 Nuclear Regulatory Commission
- 10 Room 1F-16 1
11 White Flint Building 1 12 11555 Rockville Pike 13 Rockville, Maryland i 14 15 Thursday, May 8, 1997 16 4
] 17 The Commission met in open session, pursuant to 1
- 18 notice, at 9
- 01 a.m., Shirley A. Jackson, Chairman, l I
- 19 presiding.
20- COMMISSIONERS PRESENT:
21 SHIRLEY A. JACKSON, Chairman 22 KENNETH C. ROGERS, Commissioner l 23 GRETA J. DICUS, Commissioner 24 EDWARD McGAFFIGAN, JR., Commissioner 25 NILS J. DIAZ, Commissioner I
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1 STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
2 ANNETTA VIETTI-COOK, Assistant Secretary 3 -
NAOMI ALAZRAKI, M.D.
4 JUDITH I. BROWN 5 DANIEL F. FLYNN, M.D.
6 JOHN GRAHAM l
7 WIL B. NELP, M.D.
8 JUDITH ANNE STITT, M.D.
9 DENNIS P. SWANSON, M.S., B.C.N.P.
10 LOUIS K. WAGNER, Ph.D.
11 THERESA WALKUP ,
i 12 JEFFREY F. WILLIAMSON, Ph.D. I 13 ANDREW KANG, M.D.
14 15 16 17 18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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3 1 PROCEEDINGS 2 [9:01 a.m.]
3 CHAIRMAN JACKSON: Good morning, ladies and 4 gentlemen.
5 Today, the NRC's Advisory Committee on the Medical 6 Uses of Isotopes will provide the Commission with its annual 7 briefing.
8 The ACMUI, as its called, last met with the 9 Commission in May of 1996 to discuss the National Academy of' 10 Sciences report on the Medical Use Program.
11 In the intervening year, much has occurred that 12 relates to the medical use program.
13 Most recently, the Commission directed the staff, 14 in a March 20, 1997, Staff Requirements Memorandum, to -
15 develop a program for revising 10 CFR Part 35.
16 Also within that SRM, the Commission directed the 17 staff to continue to use the Advisory Committee on the 18 Medical Uses of Isotopes and other professional 19 organizations and societies in developing regulatory guides 20 and standards.
21 Today's presentation provides the Commission with 22 its first formal briefing since the SRM was issued. We look 23 forward to hearing from the advisory committee on its views 24 on achieving the goals of the SRM.
25 I understand that presentational material is ANN RILEY & ASSOCIATES, LTD.
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4 1 available at the entrances to the room.
2 So, unless my colleagues have any opening 3 comments, please begin.
4 Dr. Stitt, are you the lead?
5 DR. STITT: I think Don Cool is the lead.
6 CHAIRMAN JACKSON: Okay.
7 DR. COOL: Good morning.
8 The Advisory Committee on Medical Uses of Isotopes 9 is an advisory committee which has been established for a 10 large number of years, going way back to the time of the 11 Atomic Energy Commission.
12 Its function has changed over the course of time a 13 little bit, as the Commission's involvement in medical 14 regulation has increased, FDA involved that occurred in the 15 '70s occurred. So, it has undergone some transitions.
16 This group provides the staff with advice in a 17 number of areas in terms of the regulation and guidance j 18 documents that are being developed, some instances of 19 particular training and experience where some unique l
20 questions come up.
21 They provide us particular advice on individual 22 cases, provide us advice and a sounding board, if you will, )
23 for interactions with other Federal agencies, professional 24 societies, and various groups.
l 25 I personally find it very valuable to have these I ANN RILEY & ASSOCIATES, LTD.
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1 folks available to me and my staff in trying to' work through 2 the program.
3 The chairman for the committee now is Dr. Judith 4 Stitt from the University of Wisconsin.
5 The ACMUI met just about a month ago, on April 6 10th and lith, and devoted the entirety of that meeting to 7 the issues associated with the revision of Part 35 and the 8 questions and things which the Commission had put forward in 9 the SRM.
10 That SRM was available to the advisory committee 11 during that briefing.
12 And at this point, I'm going to turn it over to 13 Dr. Stitt to introduce the committee members and the 14 committee to provide you with their thoughts and views on 15 the subject.
16 Dr. Stitt?
17 DR. STITT: Thank you, Don, and good morning. The 18 ACMUI is very pleased to be here, to have this opportunity 19 to meet with the commissioners and to express our opinions 20 and our ideas regarding radiation medicine.
21 I'd like to introduce three of our members who are 22 seated behind me and are not at microphones but are 23 certainly available for questions.
24 Theresa Walkup, Certified Medical Dosimetrist and 25 Radiation Therapist. She's at Mercy Health Care in Oklahoma ANN RILEY & ASSOCIATES, LTD.
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6 1 City.
2 Andrew Kang, who represents the FDA as a member of 3 our committee.
4 And Will Nelp, to my far right, who is a Nuclear 5 Medicine Physician at the University of Washington in 6 Seattle.
7 I'd like to ask my committee members to introduce 8 themselves, starting with Jeff Williamson.
9 DR. WILLIAMSON: I'm Jeff WIlliamson, a Radiation 10 Oncology Physicist at Washington University-School of 11 Medicine in St. Louis.
12 DR. STITT: Dennis?
l 13 DR. WILLIAMSON: And good morning.
14 ,
MR.'SWANSON: Good morning. I'm Dennis Swanson, 15 Nuclear Pharmacist from the University of Pittsburgh, 16 MR. GRAHAM: John Graham, Director of St. Mary 17 Hospital, an affiliate of the Beaumont Hospital System.
18 DR. ALAZRAKI: Naomi Alazraki. I'm a Nuclear 19 Medicine Physician at Emery University School of Medicine in 20 Atlanta.
21 DR. FLYNN: Daniel Flynn, a Radiation Oncologist, 22 Holy Family Hospital in Massachusetts, also Mass General 23 Hospital and Harvard Medical School.
24 DR. STITT: Thank you, committee members.
25 We view ourselves as the voice of clinical ANN RILEY & ASSOCIATES, LTD.
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i
. a 3
7 1 medicine. The ACMUI members manage patients, we perform i
1 2 diagnostic tests, and treat cancer patients with radiation 1 3 procedures.
4 The ACMUI has been working together effectively 5 for several years and has developed a cohesive style but i 6 with plenty of room for different views.
l 7 We are now embarking on a new venture that for us l 8 started just three weeks ago, when we received direction
- 9 from the commissioners regarding the IOM report, the' !
10 elements of DSI-7, and Part 35 changes.
11 The ACMUI is here today to discuss an overview of
. \
i 12 these issues and to give the commissioners a sense of our j 13 clinical opinion.
i
, 14 I'd like to start with the first slide.
! 15 [ Slide.)
16 DR. STITT: Radiation medicine is a small part of 17 the NRC business. It's also a small part of medicine when 18 considered as a whole.
19 Radiation medicine is a safe process in
- 20 relationship to the practice of medicine.
4 21 We have taken our-definition of risk from the
, 22 documents that we have been reviewing from the NRC staff.
23 Risk is related to the probability of error and the severity 24 of consequences.
25 CHAIRMAN JACKSON: Let me just ask a question 4
W
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1 question. When yot speak of risk, are you referring to the .
2 worker, the patient, or the public?
3 DR. STITT: I'm referring to it in the sense of l 4 risk as a whole, when you're looking at medical events, i i
5 human factors in medicine. So, you could use risk in any of 6 those particular subcategories.
7 The risk is going to then change to some degree, !
8 depending on which group of procedures and whether you're i
9 -looking at workers, patients, or public, and I think those ;
10 all become important in some categories, and we're going to 11 try to address those as we go through our comments.
12 One can also think of risk in a little more 13 simpler term, but that is variation around an expectation, 14 and you can consider that variation, again, in all the 15 different walks of life of radiation medicine.
16 When I think about risk, it's something I do every 17 day.
18 I talk to patients about what is the risk of you 19 having a bowel injury if we proceed with this radiation and 20 what is the likelihood that radiation treatment to the 21 pelvis is going to keep cancer at bay versus your chance, 22 your risk of developing a bowel obstruction as a 23 consequence?
24 Next slide, please.
25 [ Slide.)
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9 1
- 1 DR. STITT
- Research in risk and event reporting j 2' for medicine is relatively new. It's been studied'for quite f 3 some time in transportation, aviation, and in other 4 industry, but when you look at the literature for medicine, l
5 it's really quite new.
l l 6 It's been said that risk or error just simply )
l l 7 doesn't occur in medicine, doctors don't make mistakes, and 8 so it's really not been the subject of much formal research. f 9 There is a growing body of literature about 10 medical events of all nature, and there are some small 11 pockets of research that are actually taking place now in I
12 radiation medicine.
l 13 In general, there's a very low incidence of error 14 in radiation medicine, and this is not even relating error 1 15 to consequence or to risk.
16 We feel that incidence of error is low in all of 17 the radiation modalities because of the elements listed here 18 on this slide.
19 They include voluntary practice patterns, practice 20 standards among the different groups, staff training :
21 standards for dosimetrists, physicians, physicians, and the .
l 22 broad quality improvement patterns, programs that exists in 23 all departments.
24 In addition, you can look at credentialing and 25 hospital privileges for those procedures that are. performed ANN RILEY & ASSOCIATES, LTD.
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10 l 1 in hospitals.
2 COMMISSIONER ROGERS: Excuse me. Just before we 3 leave that slide --
4 DR. STITT: Sure.
5 COMMISSIONER ROGERS: The number, 1 times 10 to l
l 6 the minus 4 -- where does that come from? We've had a lot t
7 of trouble trying to get numbers like that over the years, 8 and I wondered how you were successful in doing so.
9 DR. STITT: We did, too. We took it from NRC 10 materials that we were given.
11 [ Laughter.]
12 DR. STITT: Jeffrey, do you want to make any 13 comments?
14 DR. WILLIAMSON: Well, it's really hard to defend.
15 I looked at the numbers of misadministrations that 16 were reported in your evaluation of the QM program, and you ;
17 actually had the numbers of procedures there, so I looked at 18' that. I looked at the IOM report. I ball-parked the number 19 of procedures that occur over the country and kind of came 20 up with this number.
21 COMMISSIONER ROGERS: Well, it's always the j 22 denominator that gives us the problem, not the numerator. ,
23 DR. STITT: Correct.
24 Dan?
25 DR. FLYNN: I'll give you an example.
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c .0 11 1 Like maybe 5 or 10 years ago, we estimated the 2 number of brachytherapy procedures in the United States 3 between 30 and 50 thousand.
4 Now, with prostate seed implants, more than 5,000 5 a year, and HDR brachytherapy, individual procedures, it's 6 probably closer to 60 to 80 thousand a year.
7 If you have 8 misadministrations per year and the 8 denominator is 60 to 80 thousand, that would be 1 to the 10 9 to the minus 4th. That would be a reasonable estimate.
10 COMMISSIONER McGAFFIGAN: Could I ask a couple of 11 questions?
12 DR. STITT: Please.
13 COMMISSIONER McGAFFIGAN: Is it possible that NRC 14 regulation has had something to do with the 1 in 10 to the 15 minus 4th? I mean, you 1 mow, you have a list of --
16 DR. STITT: You notice we left that one out, but 17 it comes up every time we have this discussion, and 18 certainly, the NRC very definitely is of the opinion that 19 radiation -- that events are lower in radiation medicine 20 because of the NRC's presence.
21 CHAIRMAN JACKSON: Let me rephrase the question, 22 if I may. If NRC removed and replaced its prescriptive 23 regulatory requirements with performance-based, would the 24 low incidence of error remain so based upon these other 25 factors that you talked about?
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12 1 DR. STITT: I think that is putting it in a little 2 bit different context. I think it's one of the real issues.
3 We're going to try to at least address -- talk 4 around those issues as we go through our report to see if 5 there's some groundwork, some basis on which to try to 6 answer that question.
7 Naomi.
8 DR. ALAZRAKI: Yes.
9 I would just interject that I think the medical 10 community feels that the errors have been low more because 11 of the training and experience of those working in the field 12 than because of any prescriptive rules from NRC, and I think 13 that the experience -- there is some experience that --
14 that, in the absence of some of these -- and I can't quote 15 right off the top of my head -- that, in the absence of some 16 of the prescriptive-nature materials, that the error doesn't 17 change, that it's basically the bottom-line human error. l 18 COMMISSIONER McGAFFIGAN: Could I ask another I
19 question on voluntary standards? One problem -- the reason 20 your community -- medical community at large, not radiation 21 medicine -- ends up on "60 Minutes" with such regularity is I I
22 that the -- there are some people who clearly practice 23 medicine and don't practice it well, and you know, you get 24 the horror stories.
25 I was told last year by a fellow who does New York ANN RILEY & ASSOCIATES, LTD.
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13 1 City's radiation safety, not just for us but for the whole 2 city, of a person conducting mammographies who, when they 3 finally looked at him, almost everything was wrong about 4 what he was doing, over 100 procedures -- they're just 5 bogus.
6 Actions had been taken as a result of that. He 7 still hadn't been disciplined by the State medical board.
8 He had moved on to Pennsylvania or something. It was a real 9 horror story. That one hasn't made "60 Minutes" yet.
10 But how do you deal with the fact that you have -
11 - everybody on the other side of the table practices 12 medicine, practices medicine well, you know that there is an 13 outlier element of your community that doesn't, and you 14 know, does regulation or at least the possibility of 15 enforcement by us or a state body if it's not by-product 16 material keep those people somewhat honest or at least get 17 them off the streets?
18 DR. STITT: Well, a general response to that would 19 be more like the conments that Stephen Brier made in his 20 book, Breaking the Vicious Cycle. How can you regulate any 21 part of life down to the last 10 percent, 5 percent, 1 22 percent?
23 So, I mean I think we have to set standards, 24 whether they're NRC regulations, voluntary standards of 25 hospitals, or national practice groups, and then try to ANN RILEY & ASSOCIATES, LTD.
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- s l 14 1 bring practitioners to those standards.
2 Were you waving your hand?
3 DR. WILLIAMSON: Well, I guess I could make some 4 statement. I guess, in my own practice, which focuses ;
5 largely on brachytherapy, the Commission's rules and so on 1
6 are sort of an overlay that's imposed on top of already l 7 functioning quality assurance program. l I
8 You have to remember that brachytherapy in l l
9 virtually all departments is a relatively small part of the i 10 practice, and so, we have, in most institutions, a fairly 11 detailed quality improvement program that encompasses l l
12 brachytherapy.
i 13 So, we kind of have the NRC standards functioning, !
14 of course, and we have our quality improvement program 15 functioning, which I'll try and address in my part of the 16 comments.
17 It is my opinion that the incidence of errors is 18 kept low because of the adherence to voluntary standards 19 rather than compliance with the sort of overlay of 20 regulations, which I think are a fairly incomplete clinical 21 quality assurance program.
22 CHAIRMAN JACKSON: I think, as we go through --
23 and I think we should move on -- I think we do have to try 24 to make a distinction between two things.
25 One is, does the mere existence of regulation ANN RILEY & ASSOCIATES, LTD.
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15 1 encourage the creation and lay out some baselines for 2 effective quality assurance programs of the type you feel 3 that you have, and the second part has to do with the nature 4 of the regulations and what they can be or need be if we 5 assume that there's an affirmative answer to the first, 6 which is obviously where the Commission, in a certain sense,
' 7 is coming down, where one can accomplish and ensure that one ;
8 has the right elements in a program to protect patients, the 9 worker, and the public in a way that's different than the 10 way we've been doing it to this point.
11 DR. STITT: We'll continue on with slide three.
12 [ Slide.)
13 DR. STITT: I think the first comments that we 14 have made really lead us to the statement that the ACMUI 15 members have agreed upon, that the low-risk status does 16 justify and move away from prescriptive regulations and 17 toward the development of performance-based regulation of 18 radiation medicine.
19 So, I think the comments you just made, 20 Commissioner Jackson, put that side of the table and this 21 side of the table on a level where we have several things 22 that we agree upon.
23 Next slide, please.
24 CHAIRMAN JACKSON: I haven't made a statement. I 25 asked a question.
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16 1 DR. STITT: What's that?
2 CHAIRMAN JACKSON: I said I haven't made a 3 statement relative to prescriptive versus non-prescriptive.
4 DR. STITT: Okay, f
5 CHAIRMAN JACKSON: I've asked the question, which j 6 is what we'd like to hear from you about. {
i 7 DR. STITT: Next slide.
i
~
8 [ Slide.]
- 9 DR. STITT
- As we said initially, risk is related 10 to the probability of error and the potential for the 11 consequences of those errors. l l
3 12 We, as the ACMUI, have developed a spectrum of l 13 radiation procedures that we have begun to look at from one
- 14 end being high-dose-rate brachytherapy, which is a special 15 form of radioactive isotope therapy. to diagnostic nuclear
- 16 medicine, which we feel is at the opposite end of the l 17 spectrum.
18 CHAIRMAN JACKSON: Where does gamma teletherapy 19 fit in the spectrum?
20 DR. STITT: Gamma teletherapy is a specific type 21 of teletherapy, teletherapy referring to cobalt therapy, and 22 it should be on this list and is not.
23 We felt that it resided toward the bottom, around 24 the level of low-dose-rate brachytherapy and that the gamma 25 stereotactic really refers to very, very focused multiple ANN RILEY & ASSOCIATES, LTD.
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17 1 beams of. radioactive cobalt as the teletherapy unit that is 2 almost exclusively used for treating small brain cancers or 3 AVM malformations in the brain.
4 It has a risk that's on the higher end of the 5 spectrum because it has multiple fields, it's very high 6 doses, and treatment is given in a single visit.
7 Dan Flynn will continue with comments on the next 0 slide.
9 DR. FLYNN: Next slide, please.
10 (Slide.]
II DR. FLYNN: Again, continuing with the risks and 12 the potential, I should say, health consequences of 13 exposure, high-risk procedures. meaning high-risk for health 14 consequences, would be, for example, exposure to large 15 numbers -- I should say large numbers of members of the 16 public to greater than Part 20 limits, deterministic 17 injuries to staff possible or likely, probable serious 18 injury to the patient, and health consequences meaning a 19 low-risk event occurs and it results in a consequence such 20 as harm to the whole body, harm to a part of the body, like 21 an organ system, the kidney or the skin, produces symptoms 22 and injury.
23 Examples would be, for example, high-dose-rate 24 accident in Indiana, Pennsylvania, where a source is -- lost 25 control.
i l
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18 1
Not only is the patient severely injured by the 2
accident, but members of the public could be potentially 3 seriously injured as this source is out of control for 4 longer and longer periods of time.
5 Another example would be in Guyana, Brazil, an 6
uncontrolled teletherapy cesium-137 source, large numbers of 7 people, much bigger accident than even Indiana, 8 Pennsylvania, and with serious consequences.
9 Next slide.
10 COMMISSIONER McGAFFIGAN: Could I ask a question 11 on that slide before we go on? Which Part 20 limits are you 12 talking about?
13 Exposure to the public greater than Part 20 14 limits. Are you talking about the public release limit, the 15 100-millirem, the patient release, 500 millirem, the 16 occupational dose?
17 DR. FLYNN: It's more of a general statement, 18 meaning if -- large numbers of the public, meaning many 19 thousands of individuals -- that would be considered a high-20 risk procedure if thousands or -- large numbers of the 21 pop 21ation would be exposed to a dose that's greater than -
22 - much greater than the Part 20 limits, for example, such as 23 in those accidents.
24 CHAIRMAN JACKSON: Dr. Williamson has a comment.
25 DR. WILLIAMSON: Yes. This is attempting to i
l l
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O O 19 1 define risk separately for three separate sub-populations.
2 So, for general public, we meant large numbers of people 3 being exposed to even small doses that could have a, you 4 know, calculable epidemiological impact.
5 COMMISSIONER McGAFFIGAN: But that's 100 millirem.
6 DR. WILLIAMSON: That's 100 millirem, roughly. I 7 guess we took that as -- one could debate it, but --
8 COMMISSIONER McGAFFIGAN: Right.
9 DR. WILLIAMSON: -- for purposes of this 10 discussion, we accepted that.
11 For members of the staff working with the 12 radioactive sources, we took the end point to be the 13 possibility of some injury.
14 COMMISSIONER McGAFFIGAN: Greater than 5 rems?
15 DR. WILLIAMSON: No, much greater than that, an 16 injury, an actual injury, like putting the source _n your 17 pocket and getting a skin burn, a skin erythema, or 18 something of that nature, not -- I think we would say medium 19 risk might be for the public where only a relatively small 20 number of persons could be exposed to an epidemiologically 21 significant exposure.
22 COMMISSIONER McGAFFIGAN: So, for the staff, it's 23 much greater than 5 rems. 50 rems?
24 DR. WILLIAMSON: Possibly. It would depend on the 25 end point involved. 50 rem to the whole body, I think, ANN RILEY & ASSOCIATES, LTD.
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20 1 would probably be closer. :
2 DR. FLYNN: The staff is also being monitored, and i I
3 as radiation workers, of course, we would expect that the 4 limits on them would be different than the limits on the 5 public.
6 COMMISSIONER McGAFFIGAN: Right. The current ;
7 limit is 5 rems, isn't it? j 8 DR. WILLIAMSON: Yes. j i
9 DR. FLYNN: Yes. 1,250 a quarter, j 10 COMMISSIONER McGAFFIGAN: You're saying, in'this 11 case, it's much higher than 5 rems.
12 DR. WILLIAMSON: Yes, I'm talking about like an 13 actual injury, not the possibility of getting cancer 30 ;
14 years down the line.
15 CHAIRMAN JACKSON: Please go ahead.
l 16 DR. FLYNN: All right. Next slide, please.
17 [ Slide.)
18 DR. FLYNN: And then these are general statements 19 now in terms of risk.
20 Health consequences of exposure, let's say, 21 medium-risk procedures, members of the public and staff 22 exposed to less than Part 20 limits, but if we're talking 23 about very large numbers of the public -- and we'll discuss 24 the ALARA concept separately -- we certainly wouldn't want 25 to see unnecessary radiation exposure to large populations i
l ANN RILEY & ASSOCIATES, LTD. ,
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1 of people, even if it was below the limits, small numbers of '
2 individual staff or public exposed to greater than Part 20.
3 An example of medium risk might be teletherapy, 4 but not teletherapy in the sense of the Guyana, Brazil, 5 accident, teletherapy in the sense of medical practice.
6 I think when a source is decommissioned or a 7 radiation oncology facility is abandoned, like in Guyana, 8 Brazil, that that's a different issue, handling sources in 9 transport or sources that have been decommissioned, as 10 opposed to -- we're talking about medical practice, treating 11 patients on a daily basis.
12 Teletherapy would, in my opinion, be in the 13 medium-risk level.
14 Whereas in low-risk procedures, exposures to the j 15 public and all staff would be less than Part 20 limits, 16 would be, for example, diagnostic nuclear medicine, where if '
17 there is a technesium incident of some type, it is unlikely 18 to result in any harm to the public or staff and it only 19 involves one patient to which we would not expect any ;
20 medical consequence whatsoever and a very low-risk procedure i 21 in that particular isotope.
22 Next slide.
23 [ Slide.]
24 DR. FLYNN: Again, risk in radiation medicine --
25- high-risk procedures, the potential for risk based on the ANN RILEY & ASSOCIATES, LTD.
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- O 22 1 health consequence of errors -- that is, for individual 2 patients or individual staff, we're talking about harm to 3 the body or part of the body, especially when talking about 4 patients.
5 The probability of occurrence is low given the 1
6 current standards for both the physician, the physicist, the !
7 support _ staff in terms cf education and training, existing 8 quality improvement in practices, safety, regulations within
)
9 the community, and the delivery practices. j i
10 The overall risk is low given the current practice 11 standards, and practice standards normally means 12 professional societies like the American College of 13 Radiology, American College of Radiation Oncology, and other I l
14 societies, but the process that we're going through in terms 15 of state licensure, credentialing by the hospital, 16 privileging by specialists in the field to make sure that, !
17 even though physician is credentialed by the hospital, is 18 that person's background and education and training 19 sufficient to perform this procedure, and national 20 certification boards, which a lot of hospitals now, and 21 insurance companies, are requiring before they will 22 reimburse for that procedure, separate from the hospital :
l 23 privileging process. i 24 I think I'll turn this back to Judy now.
l 25 DR. STITT: I'd like to start with the next slide l
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o o l 23 j ,
1 and spend some time discussing the Medical Policy Statement.
l 2 [ Slide.)
j 3 DR. STITT: The ACMUI at its most recent meeting 4 just three weeks ago spent considerable time discussing the 5 Medical Policy Statement.
- j. 6 We felt this was a very important place to start f 7 our-comments regarding Part 35 and DSI-7, because the
! 8 Medical Policy Statement really is the foundation for those 9 other elements.
10 Number one, the NRC will continue to regulate 11 medical uses of isotopes as necessary to provide for the 12 radiation safety of workers and the general public.
13 Statement number two, which is the next slide --
14 (Slide.)
15 DR. STITT: -- and the slides have modifications 16 and they are named ACMUI modification in that it's in the
.17 lighter font -- the NRC will regulate the radiation safety 18 of patients only where justified by the risk to patients and 19 only where voluntary standards or compliance with standards 20 are inadequate.
21 Our second point is that assessment of the risks 22 justifying such regulations will reference comparable risks 23 and comparable modes of regulation for other types of 24 medical practice -- for example, anesthesia risk, drug
.25 administration error.
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-.._ - .~ - . - - - - - - .
s .
24 1 COMMISSIONER ROGERS: Before you leave it, do you 2 want to discuss these as we go or -- for example, the use of !
3 the word "only" --
4 DR. STITT: Uh-huh.
5 COMMISSIONER ROGERS: What is that intended to ?
6 exclude that's a problem right now? i 7 DR. STITT: I think it's intended to be -- to i
8 focus on what is included, potentially, more than what is 9 excluded.
i 10 I think that you could say that that relates back 11 to low risk of diagnostic procedures -- that is, that only 12 where justified by risk of patient could allow you then to 13 say risk from diagnostic procedures, the consequences are so 14 low that that might not need to be in the regulatory 15 framework.
16 Other comments from the committee on policy 17 statement two?
18 CHAIRMAN JACKSON: Dr. Williamson. !
l 19 DR. WILLIAMSON: Well, I think the underlying l 20 concern is that a criterion of risk, like 10 to the minus 6, ;
)
21 10 to the minus 7, or zero, might be imposed, and therefore, 22 even one incident could be cited to trigger, you know, the i
23 rulemaking process, and I think what we're trying to suggest '
24 is that the baseline for figuring out what an acceptable 25 risk is for threshold of regulation, you know, ought to be i
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o o i 25 1 somewhat comparable to what happens in other medical 2 specialties and not orders of magnitude below, you know, 3 what our colleagues deem acceptable.
4 COMMISSIONER ROGERS: But that could be the 5 interpretation of the statement without the "only," and you 6 know, what I'm trying to get at is there's something that 7 you felt was going to be accomplished by adding the "only,"
8 and I'm trying to get at what is that?
9 CHAIRMAN JACKSON: Mr. Graham? ;
10 COMMISSIONER ROGERS: You've already said we're 1
11 justifying it by the risk to the patients. !
12 MR. GRAHAM: Right.
13 And I think part of what the ACMUI has discussed ;
1 14 over the past several meetings is the concept that, as it's 15 originally defined, as it's originally developed, the 16 regulation may sound very reasonable, that the Medical 17 Policy Statement sounds perfectly adequate, but it's over 18 time, as incidents come up and then additional regulations 19 are applied and then you get into issues of interpretation 20 and enforcement in the field, that we want to assure that 21 the good programs, the majority of the programs out there, 22 have a system of performance-based initiatives in which 23 they're working with the NRC and the staff to get better and 24 yet there are prescriptive regulations that still permit the 25 winnowing-out of the bad players, who are small in number ANN RILEY & ASSOCIATES, LTD.
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> c ;
i 26 l l
1 but who, as'you say, garner a lot of the press. !
2 Adding the word "only," in the opinion of the >
3 committee, created a perspective of a threshold that you 4 don't write a regulation when it might help you write a i
5 regulation only where justified by the risk to the patient, j 6 and I think Dr.'Stitt's example of diagnostics is a concrete ;
7 example of, if there's very low risk to the patient, low ;
8 risk to-the public, then regulation related to those !
9 diagnostics under a revised policy that has added the word ]
10 "only" would probably be revised.
11 COMMISSIONER McGAFFIGAN: I'll tell you my I I
12 frustration with the focus on the Medical Policy Statement ;
13 before we redo Part 35 is-I think you can -- as Commissioner l
- 14 Rogers was just suggesting, under the current policy i l
15 statement and the staff's intention as expressed in various 16 papers to you and to us has been that they are going to look 17' in Part 35,'they've been wanting to look for three years in 18 Part 35 at.less prescriptive regulation on diagnostic 19 medicine, and that's within the spirit of the current policy 20 statement.
21 My sense is that what you're trying to do here is 22- constrain and work on -- you're really working on other 23 issues through the policy statement when probably the best 24 use of time is to work on Part 35 and see where you get, you 25 know, with the staff in addressing your specific issues on 4
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27 1 things like diagnostic medicine.
l 2 DR. STITT: I think the committee felt very 3 strongly about the Medical Policy Statement and that we as a 4 group reflect so many backgrounds of clinical medicine that 5 to come up with some sort of idea of where we wanted to 6 start working on this, we had to see if we even had the same 7 philosophy background-wise.
8 We're all clinicians here, we take the Medical 9 Policy Statement very seriously and feel that that's the 10 foundation upon which 35 needs to be addressed, and that's 11 the reason we spent most of our meeting discussing the 12 Medical Policy Statement.
13 CHAIRMAN JACKSON: Why don't we go on?
14 Commissioner Rogers, did you have another comment?
15 COMMISSIONER ROGERS: Well, I don't want to pursue i
16 it too much, but it does -- I tend to have the same response 17 that Commissioner McGaffigan had, namely it's really the 18 implementation of the policy statement that I think is where 19 you're finding problems, and I still haven't heard anything 20 that suggest that, with the addition of the word "only,"
21 there's a clear change in policy.
22 It's a question of how this policy is implemented 23 by the regulators, and so, I don't want to pursue it any 24 further, but so far I haven't heard anything that 25 illuminates that.
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28 1 DR. STITT: The word "only" appears in -- we 2 haven't made that as an addition, but the second bullet is !
3 also our commentary on statement two, and really the !
4 "only's" -- actuallyi there are two; one is missing -- only I I
5 where justified and only where voluntary standards are -
6 inadequate -- relate to the second bullet that tie this into 7 risks that are -- that reference comparable risks in other 8 parts of medicine.
9 COMMISSIONER RCGERS: So, you really would like to 10 add a second "only." Is that it?
11 DR. STITT: The second part of that slide is part 12 of our modification to statement two.
13 COMMISSIONER ROGERS: Well, no, but what you just 14 said now was a second "only" after --
15 DR. STITT: In the minutes of the ArMUI meeting, 16 there were two "only's," only where justified and only where i 1
17 involuntary standards are inadequate, followed by the second !
18 bullet.
1 19 COMMISSIONER ROGERS: You're adding a second 20 "only" to the first bullet. I'm just talking about the I
21 first bullet.
22 MR. GRAHAM: Yes. I think we're just trying to 23 clarify which set of slides you have there.
24 COMMISSIONER ROGERS: Oh, I don't know. I have 25 one that I got the other day.
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29 l 1 1 MR. GRAHAM: Okay.
f l 2 COMMISSIONER ROGERS: Has it changed?
3 DR. STITT: The minutes of the ACMUI meeting -- l l
4 COMMISSIONER ROGERS: Oh, yes , I'm sorry.
j 5 COMMISSIONER DIAZ: There's another "only" there.
l 6 COMMISSIONER ROGERS: Another "only." ;
t 1
7 DR- COOL: Commissioner Rogers, we apologize.
8 There was one that was sent up that had that typo, which we l l 9 tried to fix.
! i
, 10 DR. STITT: Statement three is the next slide. I L !
i 11 CRAIRMAN JACKSON: He wants to discuss the second '
l l 12 bullet
- 13 . COMMISSIONER ROGERS
- The second bullet also, I l 14 think, is a question, and could you just elsborate on that?
15 It sounds to me as if what you're suggesting here l
16 is that we look at what the risks are for anything else, any i 17 other practices of medicine, and see that what we do with 18 respect to -- what our expectations are for radiation, i 19 medical radiation areas, would be the same, we would have 20 about the same results. Is that what you're saying?
21 DR. STITT: I think what the committee is saying -
22 - and I'll let this unruly group speak for themselves --
23 COMMISSIONER ROGERS: In other words, that you 24 tolerate risks in radiation medicine that are comparable to l
j 25 the risks that occur in other practices of medicine.
I 0
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I 4 A 1 30 1 DR. STITT: Yes.
2 We think radiation medicine ought to be viewed as ,
I 3 part of a whole. It's a relatively small part of medicine. ,
4 Risks, events in medicine are now starting to be reported,
- 5 described, and assessed to complete the cycle to decrease 6 those events in all of medicine, and I think we feel that 7 radiation medicine shouldn't be kind of sitting out there on 8 the end of the limb by itself, it ought to be viewed as part 9 of the practice of medicine in the whole.
10 Does anyone else have a comment?
11 COMMISSIONER ROGERS: You know, my concern there l 12 is that our attention to this area is dictated by the Atomic l 13 Energy Act, and I think there is a question about whether 14 that, in fact, is a point of view that is justified under 15 that act. That's a question for OGC to look at. '
16 COMMISSIONER DIAZ: I actually share that concern.
17 It might be that --
the statement is very broad.
18 It might be that the intent is good, but if you look at the 19 statement, it says "as comparable." It's just very open, j 20 and it might not be compatible with the way that the we i 21 handle things. !
22 CHAIRMAN JACKSON: I think we need to move on.
23 [ Slide.]
24 DR. STITT: Let's move to the next slide, which is 25 the third statement under the Medical Policy Statement, and ANN RILEY & ASSOCIATES, LTD.
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31 1 the Medical Policy Statement three is the NRC, and we have 2 added "will not intrude into medical judgements affecting 3 patients and into other areas traditionally considered to be 4 part of the practice of medicine." l 5 CEAIRMAN JACKSON: Do you have a working l 1
I 6 definition of what those areas are?
7 DR. STITT: Certainly, patient-physician 8 interaction. I think this has specifically come up, and 9 Jeffrey will probably address this in his section, the 10 obligation to send a written letter to a patient about an 11 event that's occurred, most people would feel is an 12 intrusion into the practice of medicine, and that tends to 13 come up on a regular basis at ACMUI meetings.
14 COMMISSIONER McGAFFIGAN: Could I --
15 DR. STITT: We feel that the risk to the patient 16 in radiation medicine is probably lower than other areas of 17 medicine.
18 This is what you have addressed in statement two 19 as an area of question, and we feel that there are a variety 20 of reasons that the risk is quite low, including the many 21 factors that we've discussed this morning.
22 COMMISSIONER McGAFFIGAN: Again, I'll just suggest 23 that the current words are " minimize its intrusion irato the 24 medical judgements," etcetera, and " minimize its intrusion,"
25 I think, recognizes that there's, you know, always going to ANN RILEY & ASSOCIATES, LTD.
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32 1 be a balance that has to'be struck, we're going to try to 2 minimize, but "not intrude" is such a blanket statement that 3 it is surely intended to be used as a stick against us in 4 any case where any doctor perceives any' intrusion into what 5 their definition is of the normal practice of medicine. l 6 So, I think you're taking a balanced statement 1
7 from 1979 and trying to turn it into a stick that the 1
8 medical community can use against us. !
9 DR. STITT: Well, it probably reflects the fact 10 that we're clinicians and practice medicine and think pretty 11 strongly about these issues.
12 COMMISSIONER McGAFFIGAN: Okay.
13' DR. STITT: Let's move on.
l 14 I have a series of slides that try to focus in a i 15 little bit more detail on the issues of prescriptive and .
1 16 performance-based, and this has to do with the issue of i 17 quality improvement and quality assurance.
18 (Slide.]
19 DR. STITT: This slide describes quality assurance 20 which, for any procedure, action is taken only when the 21 process average exceeds a pre-determined threshold. This 22 would be very -- this would be a definition of a 23 prescriptive-based process as we know it.
24 So, when the process average is under the '
25 threshold, no questions are asked; when the threshold is ANN RILEY & ASSOCIATES, LTD.
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l 33 1 exceeded, there's commonly panic and finger-pointing.
2 This is not exclusive to our area of medicine at 3 all. Common examples of traditional QA include the number 4 of C-sections performed at an institution per month, 5 medication errors, and certainly, radioactive isotope 6 events.
7 Next slide.
8 [ Slide.)
9 DR. STITT: When you look at quality improvement, 10 the entire output of the process provides a basis for 11 action, not just occurrences that are deemed unacceptable 12 because they exceed a certain threshold or specification.
13 I'd like to move to the next slide, which is a 14 graphic.
15 (Slide.]
16 DR. STITT: So, in the top graph, in the QA 17 process, there are a number of cases -- and you can see that 18 on the vertical axis -- th:t are evaluated by some sort of a 19 quality measure -- that's on the horizontal axis -- and then 20 when that threshold is exceeded, some sort of action occurs, 21 and that's a fairly common description that's used in 22 manufacturing, business, and in medicine and does describe a 23 prescriptive-based type of process.
24 If you look at the second diagram, which describes 25 the OI approach and a more performance-based approach, cases ANN RILEY & ASSOCIATES, LTD. ,
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34 1 are evaluated also according to a measure, but as you can 2 .see, there are more cases that are being evaluated and acted i 3 upon, and therefore, you're narrowing that curve.
4 So, there is a shift in the process and a shift 5 toward the desired direction of quality.
6 COMMISSIONER McGAFFIGAN: Could I ask, how is that !
7 achieved?
8 I mean how -- if this approach has been used, how 9 do you enforce or -~ you know, as a - - if you're the head of 10 the hospital and you want -- you want the whole curve 11 narrowed, you know, do they get a -- if you're the head of 12 the hospital, do you get a monthly report as to whether --
13 whether things are narrowing and then hold the department 14 head responsible if they aren't and, you know, ultimately 15 fire them or -- I mean how do you -- how do you --
16 DR. STITT: One issue -- and we'll be getting to 17 enforcement, and I think that is a key, and it's -- this is 18 not a knee-jerk. This is a continuum. It goes on and on 19 and on. And I was hoping our hospital administrator might 20 perk up and contribute.
21 This is actually a process that JCHO has 22 encouraged for some time and that you find most institutions 23 applying on a broad hospital or out -- now out-patient i 24 clinics are starting to come under this JCHO type of 25 process.
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35 1 So, John, why don't you make some comments?
2 MR. GRAHAM: Let me give one -- one simple example l l
3 of how we've converted over the past 10 years from quality 1 4 assurance to quality improvement, going back to that real 5 simple example of Caesarean-section rate, and then the 6 related event is the attempt, the goal to have a vaginal 7 delivery for later births wherever possible, and under 8 quality assurance, we would track the Caesarean-section rate 9 of a physician. )
i
- 10 Those that truly were outliers, we would send a l i
11 letter to; the chairman would talk to them. It had very 4
)
i 12 little potential affect on practice in a lot of cases. f i
13 It was only where it was a very large dramatic
\
- 14 variance from the entire group that it became so obvious
- 15 that we could take some sanctioned action against that i
{ 16 individual. t 4
17 Under quality improvement, we developed a review a
j 18 of the process of how you would take care of that patient in l
- 19 their second delivery, where you're trying to encourage a l 20 vaginal delivery, and identify the concerns that had kept l
21 practitioners from using the approach -- the time it took to 22 try to educate the mother on getting ready for that attempt 23 --
set up a process with the nursing staff and others that
- 24 would collaborate so that it became much easier in the 25 overall process to achieve the goal of that vaginal delivery I
i 1
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\
36 1 in the second birth, and all of the statistics moved in the 2 right direction, the C-section rate went down, the V-vac 3 rate went up, because we focused on the process, we l 1
4 identified where the problems were in the system, defined 5 the resources that could improve that process, and without 6 ever going after anyone, all of the numbers simply moved in 7 the right direction.
8 It became easier from a system and a process !
9 standpoint to try to achieve the right outcome than to do it 10 the old way.
11 CHAIRMAN JACKSON: I think Dr. Flynn wanted to ]
12 make a comment.
l 13 DR. FLYNN: A radiation medicine example would be 14 -- and this is also an example of compliance with voluntary i i
15 standards by professional societies -- you know, weekly l 16 chart rounds where the radiation physicians get together and ;
i 17 present cases and show up the films, weekly checks of the ;
18 patients under treatment, weekly checks of the dose 19 calculations by the physicist, usually a second physicist or )
20 a second dosimetrist other than the one who initially did 21 the calculation.
22 But for example, in port filming -- port filming 23 is whereby a patient is under treatment and we actually take 24 a film of the treatment beam to make sure the patient hasn't I 25 -- see how compliant the patient is in not moving, how good ANN RILEY & ASSOCIATES, LTD.
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)
37
]
1 the technologists are in setting up the fields and 2 everything.
3 Now, if we do port films, let's say -- let's say a 4 practice may choose to do port films once a week. They see ,
5 that the prostate cancer patients with very stable setups 6 are not moving.
7 So, the outcome would be that, with all these j 8 films that we're looking at, there is no real deviation 9 seen, but with the -- so, instead of doing the port films on 10 those patients every week, it might be every other week.
11 But on the other hand, the Hodgkin's disease 12 patient, the setup in complex. There a patient may move or 13 cough, and so, those port films, instead of being done once l 14 a week, they may be done twice a week.
15- So, therefore, you are focusing medicine in a 16 cost-effective means on the more error-prone measures of 17 outcome and less focus on the less error-prone procedures.
18 That would be an example of what we actually do today and 19 what most practices do. That's just one example.
20 DR. STITT: I think one of the points that we 21 would like to make is that this -- these two graphics do 22 describe the QA versus QI type of performance.
23 The QI is performance-based type of process. It's 24 something that actually goes on in hospitals on a routine 25 basis; this is not research that we've pulled from I
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l 38 l
l 1 something.
l l 2 So, I just want to make it known that this is 3 something that we're already doing. This may be a way to 4 shift radiation medicine into a process that we're already 5 familiar with.
6 COMMISSIONER McGAFFIGAN: You said you're going to 7 get back to enforcement?
8 DR. STITT: Yes. That's coming up.
9 COMMISSIONER McGAFFIGAN: So, is this enforceable?
10 I mean the statistics that were talked about earlier.
11 Instead of enforcing against the outlier, can you enforce 12 against the whole licensee improving practice, and if that's 13 --
14 DR. STITT: I think so. Most of us are hospital-15 based, some or all of our practices.
16 In order to maintain accreditation for our staff 17 privileges, for the hospitals that we work in to maintain 18 accreditation with JCHO, we're obligated to be able to show 19 that we can work within these boundaries.
20 Well, I'm going to turn it over to Jeff 21 Williamson, who's going to address more of those issues, and 22 we'll start with our favorite slide of all.
23 Next slide, please.
24 [ Slide.]
25 DR. WILLIAMSON: Well, we thought this would be a ANN RILEY & ASSOCIATES, LTD.
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39 1 good lead-in to the two topics that I want to address.
2 One is just to review our committee's concerns 3 with what we understand to be tt;e current regulatory 4 approach, especially as it pertains to patient safety as an 5 end point and especially in those areas where continuing 6 regulation -- i.e., the high-risk procedures -- seems 7 likely.
8 The government-by-yo-yo is kind of -- is an 9 amusing analogy, of course, coined by our previous chairman, 10 Dr. Siegel, and what he's getting at is the consequences of 11 letting the course of rulemaking be charted by single very 12 low-likelihood events.
13 The consequences I've sort of listed on this next 14 slide.
15 I think the -- you know, one major result is that 16 you wind up, when you look at the totality of regulations 17 formed in this way, without regard to principles of 18 coherence and completeness and without looking at the place 19 of these events that drive the process in the whole spectrum 20 of potential risks, one winds up with a kind of a quality-21 improvement fragment that's a very sort of unbalanced and 22 distorted sort of mirror image of what we do every day in 23 clinical practice.
24 I think two characteristics that it has is that 25 there are a lot of detailed prescriptive rules on some ANN RILEY & ASSOCIATES, LTD.
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40 j i
1 things that are not very important, and other things that 2 are very important are left unmentioned by the regulations.
3 A good example might be the excruciatingly 4 -detailed regulations regarding quality assurance of dose 5 calibrators used to measure source strength of diagnostic 6 radiopharmaceuticals, whereas the calibration of low dose-7 rate brachytherapy sources, to my knowledge, is not 8 mentioned anywhere in the regulations or even in the 9 guidance, and brachytherapy is an area where trying to ;
10 deliver the dose accurately to the patient is, you know, 1 11 much more important to clinical outcome, I believe you could 12 argue, than it is in diagnostic nuclear medicine.
13 I think not only in terms of content but style, 14 too -- this is really maybe the -- a major point we're 15 trying to get across is -- is that what we have is basically 16 a set of relatively rigid rule-governed prescriptive things 17 we're supposed to do that are supposed to be applied no 18 matter what the circumstances are, and that's just not how 19 effective functioning quality improvement works in radiation 20 oncology.
21 Most of our -- the guidance provided by, for 22 example, the AAPM emphasizes the process of adopting and 23 adapting general guidelines to the specific needs of each 24 individual clinical practice.
25 I think another example I could give -- one might ANN RILEY & ASSOCIATES, LTD.
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41 1 consider requirements in our license that we have vendor-2 supplied training for our HDR unit every year. Well, how 3 useful is this, one could ask.
4 I think for a facility that has a very high 5 frequency of procedures, has a lot of experience using the 6 unit, frequently it's probably a waste of time.
7 In a practice that has a very low frequency of 8 procedures, the annual training is probably woefully 9 inadequate, and some sort of program, ideally, needs to be 10 set up in order to maintain the competence of the care-11 givers.
12 Where exactly this line should be drawn is very 13 difficult. It really boils down to a clinical judgement on 14 somebody's part.
15 In this particular instance, which is a technical 16 question, it would have to be answered by the physicist; he 17 would be the responsible person for determining this.
18 I think another example of QI versus QA is, if 19 there is some sort of an event, maybe not even a 20 misadministration but just some concern about the overall 21 delivery process, I think just simply slapping another rule 22 like, uh-oh, better have a second person now come and check 23 the treatment plan if you're concerned about the accuracy of 24 computer treatment planning -- I think, in fact, what we 25 would do is look over the whole process and decide among a ANN RILEY & ASSOCIATES, LTD.
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l 42 1 number of different alternatives to try and improve the 2 overall quality of treatment planning.
3 Some possibilities that we would consider would be 4 more intensive training, perhaps, increased physicist 5 supervision of the dosimetrist in certain types of cases, 6 maybe improved forms for capturing the data that's needed to 7 drive the treatment planning process in a clearer and more 8 accurate form.
9 So, it's not necessarily adding another sort of 10 formal feedback loop. It's not like we're workers at some 11 machine where we do the same actions all the time. i 12 A great deal of clinical judgement is needed to 1
13 keep this system going, and as a clinical physicist, much of 14 my time is spent, really, in designing and overseeing a 1 l
15 process and trying to make the standard deviation be as l 16 small as possible.
17 I think another really major concern is the way 18 enforcement is done.
19 I think most of us would agree that the end points 20 mentioned in the regulations are good common sense things 21 and they're incorporated in virtually all voluntary l 22 standards, but what really is upsetting and, I think, 23 somewhat counterproductive is the adversarial and punitive 24 enforcement attitude.
25 The emphasis is on -- during inspections, to this ANN RILEY & ASSOCIATES, LTD.
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43 1 day, at least in our institution, at least remains on 2 isolated errors and paperwork violations, really, whether or i
3 not they are truly representative or descriptive of the
)
4 overall quality of our program and whether or not these i 5 particular paperwork violations, which they are, often, have 6 any real clinical significance.
^
7 So, it's sort -- when you make a very rigid rule-8 based system that relies on sort of automatic fixed
- j. -9 punishments, you know, that does not rely -- or leaves out i 10 clinical judgement, I think you maybe, we would submit, wind 11 up with something that is not a productive use of either the l 12 agency's resources or our time either, 13 CHAIRMAN JACKSON: Let me ask you a question about 14 this.
15 DR. WILLIAMSON: Sure.
16 CHAIRMAN JACKSON: You talk about future patient 17 safety regulations, and your second bullet suggests that --
18 encourage the acceptance of voluntary practice standards, 19 and with many voluntary standards available to 20 practitioners, how should the NRC determine which ones are 21 acceptable?
22 DR., WILLIAMSON: Well, I was going to try and l 23 address that.
24 CHAIRMAN JACKSON: Okay. Well, when you do that -
25 -
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44 !
1 1 DR. WILLIAMSON: Okay. Yes. I will --
l l l 2 CHAIRMAN JACKSON: --
address the following, also. 1 3 DR. WILLIAMSON: Yes. I will try to do that.
l 4 It's not a simple answer.
I l 5 CHAIRMAN JACKSON: That's right.
)
6 DR. WILLIAMSON: Yes. l 7 CHAIRMAN JACKSON: And there are many industry 8 standards that are actually broad guidelines, that, in fact, 9 require the user or allow the user to modify or tailor those j i 10 guidelines to his or her economic or staffing situation, and 11 so, to what extent should NRC allow flexibility in 12 -interpreting or making a choice?
13 DR. WILLIAMSON: I'll try to give an answer. I 14 guess, at this point, I would say there are, you know, 15 really three directions maybe the Commission could go in
.16 terms of what to do about patient safety in so-called high-17 risk procedure areas.
l 18 One would be to maybe accept the modification 19 we've suggested or accept the implications of our modified 20 Medical Policy Statement, which suggests that things really ;
21 work quite well by themselves, that the community really has !
22 an intensive significant commitment to this type' of quality 23 improvement program, as evidenced by our overall good record 24 in unregulated parts of radiation, or at least unevenly 25 regulated parts of radiation medicine.
j l
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45 1 I-think a second option would be to persist with a 2 similar sort of model, which is the threshold-driven, rule-3 based, punishment-based type of system.
4 CHAIRMAN JACKSON: Better get to the third.
5 DR. WILLIAMSON: Okay.
6 Well, the third -- okay -- I think would be to put 7 aside this whole model of rigid rule-based prescriptions and 8 -- and accept, I think, that clinical judgement and ,
l 9 flexibility really are critical elements of a functioning )
10 quality improvement process, and if you could come up with a 11 system of writing regulations and enforcing them that was 12 consistent with the actual way most of the community 13 practices quality improvement, I think a lot of the sort of 14 dissonance would go away.
15 CHAIRMAN JACKSON: But that still begs the 16 question of how does one decide which voluntary standards 17 .
are acceptable, and how does one decide how to bound 18 flexibility, and what does flexibility mean?
19 DR. WILLIAMSON: Okay.
20 CHAIRMAN JACKSON: Then I'm going to defer to 21 Commissioner Dicus.
22 DR. WILLIAMSON: All right. Okay. ;
23 Well, I will -- our suggestion is to go to some 24 type of a system that's more of an overall score-card, like 25 an accreditation process of each practice, that that should 4
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46 j 1 be the enforcement mechanism, rather than punishment related 2 to detailed infractions of prescriptive regulations or even l 3 detailed -- even individual treatment errors, there should !
4 be a credentialing or accreditation process to which each {
5 practice is subjected to periodically, and I think it would i
6 be helpful if we had slide 17. l 7 CHAIRMAN JACKSON: Let me let Commissioner Dieus - l 1
8 -
I think she had a question.
9 DR. WILLIAMSON: Okay. I'm sorry.
10 COMMISSIONER DICUS: Let me pursue the enforcement ;
11 policy a little bit with you, and I'll be as brief as 12 possible, just a little bit of discussion.
l 13 I think you're going to touch on a couple of 14 things I'm bringing up, but -- and I am familiar with l 15 accreditation processes from my previous life in the State f 16 of Arkansas, and they have a different goal than perhaps the 17 regulatory process, and so, we have-to be a little careful )
18 there when we try to make these kinds of comparisons, but i 19 one of my theories about enforcement policy is basically, in )
20 a perfect world or a better world, an enforcement policy l
21 should be a very positive process, one that, in effect, !
22 encourages, even promotes better performance, a better way 23 of doing business, but also has an element of it that will '
24 address the outliers, the 10, 5, 1 percent that you l 25 mentioned that don't --
that f all outside the f ramewc7.k.
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47 1 Given that, given some of the things that you're I i
2 talking about here and, I think, a couple of things you're i 3 going to go into, what I see missing -- I like the idea of q 4 QI. That's a positive process. You have that, you have 1 5 accreditation.
I \
l 6 But what is missing, in my view, is the transition I i
7 and the metrics to really show how we make a positive l 8 enforcement policy work, and my question, then, to the )
9 advisory committee is, are you prepared to be able to give 10 us some very definitive advice on how we make that )
i 11 transition and what those transition steps are?
l 12 It's not an easy thing to do, and we have to go l l
13 from the words to the reality, and so, I'm asking -- give us l 14 a little bit of feedback on that. I 1
15 CHAIRMAN JACKSON: Don't everyone speak at once. '
16 (Laughter.]
17 DR. STITT: We love to give you advice. That's 18 one thing we're good at, and certainly, that would be --
19 COMMISSIONER DICUS: I mean something very 20 definitive.
21 DR. STITT: That would be part of our continuing 22 discussions as a committee. We have tremendous work that 23 has to be done, and I think what we need is what you're 24 saying.
25 You're telling us what you would like to hear from ANN RILEY & ASSOCIATES, LTD.
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1
48 1 us, and so, that -- what we're putting forth here are some 2 ideas, and you're responding back, and I don't happen to 3 have a list in my pocket, but certainly we can move toward 4 that.
5 DR. WILLIAMSON: I'll try to give some examples as 6 I go through my last slide.
7 CHAIRMAN JACKSON: Commissioner McGaffigan.
8 COMMISSIONER McGAFFIGAN: I want to go back --
9 actually, this may help, it may not -- to the example you 10 gave.
11 Your license at the moment requires you to provide 12 vendor-supplied training for an HDR unit annually. If we 13 went performance-based, say, and your license instead said, !
14 you know, in your case, you believe you don't need it at j 15 all, because your unit uses the device.
16 How does an NRC staffer -- and other units, you i 17 said, might -- you know, that use them infrequently -- might 18 need it much more frequently.
19 Do you want us, in writing licenses, instead of to 20 say annually, to say, in your case, not at all, and in 21 another case, you know, three times a year, or do you want 22 us to say you will get vendor-supplied training on an 1
23 adequate basis in your clinical judgament, and then how do '
24 we enforce against --
25 One exercise you might go through in terms of ANN RILEY & ASSOCIATES, LTD.
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49 1 bringing this down to details is each of you look at your 2 licenses and tell us what -- tell Don Cool what your license 3 really should look like and what -- and what it is that --
l 4 that he could do, then, to enforce that new license you --
- 5 you propose.
, 6 But in this particular case, you know -- because 7 if we start doing it, you know, we'll be into clinical 8 judgement all the time as to whether adequately, you know, 9 you took advantage of vendor-supplied-training.
10 DR. WILLIAMSON: Well, you raise a really good 11 general question. If you're going to get into the swamp and 12 swim with us, you have to learn to swim with us, I guess.
13 CHAIRMAN JACKSON: I think what the commissioner
- 14. is suggesting is an exercise, which you say you're going to 15 be taking this up in ensuing meetings, is that, you know, at 16 some point the rubber has to meet the road.
17 DR. WILLIAMSON: Yes, exactly.
18 CHAIRMAN JACKSON: And you could do this exercise, 19 not a Gdanken experiment, to look at a license and how it 20 would be --
21 DR. WILLIAMSON: Yes.
22 CHAIRMAN JACKSON: -- modified and how it would be 23- enforced against -- okay -- because if the enforcement is 24 against a given doctor's judgement as to what is adequate, 25 then you're basically sc.ying we predicate our regulatory ANN RILEY & ASSOCIATES, LTD.
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50 1 action on the judgement of that person to whom -- you know -
2 - or the institution that hires that person, to whom we're 3 giving the license, and so, that's an interesting concept.
4 DR. WILLIAMSON: Okay.
5 CHAIRMAN JACKSON: So, I think it's more than a 6 Gdanken experiment that he's talking about. ;
7 So, why don't we move along? ,
8 DR. WILLIAN. SON: Okay. Okay.
9 Now, the -- could I have the next slide, please, i 10 the next one?
11 [ Slide.]
12 DR. WILLIAMSON: Well, to continue -- and maybe ;
13 this is a really good example -- I think, to have a 14 accreditation-based system, you first have to decide what 15 the end points of it are, what indicators are going to be 16 looked at, what sorts of things is this process going to 17 attempt to see that are available in every practice.
18 l As a mechanism, I would suggest close ;
1 19 collaboration with the professional organizations that are 20 in the business of attempting to set and codify voluntary 21 standards of practice.
22 I think the practices that have to be developed 23 maybe fall into three categories.
24 I think that there are safety standards for --
25 similar to -- perhaps qualitatively similar to those in the i ANN RILEY & ASSOCIATES, LTD.
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51 1 present regulations for handling and storing and i 2 inventorying sources and so on, designed to promote safety 3 of staff and public.
t 4 There are essential resources that must be l .
5 available for any staff or practice to be up to standards. !
6 These include not only equipment, such as quality assurance )
7 equipment, but appropriately-trained and credentialed staff 8 for handling the kinds of procedures that are done.
9 This is sort of the really sticky end point, which I 10 is these specific quality improvement elements, which are 11 agreed upon are appropriate to be in a accreditation-based ,
1 12 regulatory system -- I guess we'd take Commissioner 13 McGaffigan's example -- probably a good end point it would 14 be reasonable to consider would be there has to be some sort 15 of a program which is deemed adequate for ensuring the 16 competency of all staff members using critical treatment 17 delivery equipment -- the treatment planning system, the 18 treatment delivery unit -- and how do you compensate in your 19 individual practice if you have only a few procedures each 20 year to ensure that you maintain competence in that?
21 The site visit would be, basically, is that a good 22 answer?
23 Do professionals in the field agree that this is a 24 reasonable approach that this institution has put together 25 in order to assure a minimum -- minimal state of competence ANN RILEY & ASSOCIATES, LTD.
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52 -
1 in using the devices which are essential to doing treatment 2 accurately.
3 So, this is kind of the example.
i :
4 If I could go to the next slide. t 5 [ Slide.]
c 6 DR. WILLIAMSON: It's qualitative. It relies on i
7 '
the judgement of some kind of a team -- cutside team of 8 experts that comes and visits each institution.
j 9 So, this is what this slide attempts to do, is 10 inspections would function like an accreditation site visit.
- 11 It might helpful to incorporate some clinical professionals 12 as outside reviewers in.this periodic process. 1
^
I 13 Next slide, please. !
14 (Slide.] l
- 15 DR. WILLIAMSON
- I think it would be helpful to 16 study other models of accreditation. 1 i
i 17 There's the American College of Radiology 18 Accreditation program, which is functioning for radiation 19 oncology.
20 There's the Mammography Quality Standards Act, 21 which functions somewhat as sort of score-card of overall
, 22 institutional performance in providing mammography services 23 and, at least ideally, doesn't hit on people for isolated i
24 infractions but, you know, presumably, is designed to bring 25 that group of outliers, that 10 or 15 percent, try to I
d
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53 1 encourage them to stay closer to the mean.
2 It looks at the end point being, you know, overall 3 conformance with the appropriate quality improvement 4 standards.
5 I think maybe calibrating this process against a 6 random sample of institutions might be a good way to garner 7 experience and decide the details of where cutoffs should 8 be. '
9 Thank you.
10 DR. STITT: Dennis Swanson will continue.
11 MR. SWANSON: Yes. I've been asked to address 12 misadministration medical event reporting.
13 Next slide, please.
14 (Slide.)
15 MR, SWANSON: At the outset, let me state that the j 16 commissioners did ask the ACMUI to provide input on the use .
17 of terminology " misadministration" versus " medical event,"
18 and you'll see that this slide has listed " isotope event."
19 The ACMUI has not come to any agreement on what 20 terminology should be used, and certainly, " isotope event" 21 is not the final ACMUI terminology. i 22 My personal thoughts on it is that the actual 23 terminology used is probably not nearly as important as the 24 mechanism by which we go about doing event reporting. So, 25 I'm just going to refer to these as events at this point in ANN RILEY & ASSOCIATES, LTD. .
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54 1 time.
2 The ACMUI has come to some agreement, though, on >
3 key points related to event reporting.
4 The first of these is that there is a need to 5 dissociate the reporting of isolated events from actual or ,
- 6. perceived punitive actions, and we feel that one mechanism 7 to approach this -- and I'll come back to this a little bit 8 later on -- is to address reporting at a local level, for 9 example, have regulations that' require reporting to the RSO 10 or to the licensee rather than reporting on a national 11 level.
12 That will take some of the perception of punitive [
13 action away from it, I think.
14 CHAIRMAN JACKSON: Let me ask you a question about I 15 that.
16 MR. SWANSON: Sure. t 17 CHAIRMAN JACKSON: With this focus at the local 18 rather than the NRC level, then to whom should an NRC 19 licensee report, and how will the NRC be made aware of 20 events that affect its overall mandate to protect public i 21 health and safety? l 22 MR. SWANSON: Well, certainly, the reporting at 23 the local level is not necessarily in lieu of a central i 24 reporting program, and I'll come back to that later on.
25 When the NRC, in the agreement states, conducted ANN RILEY & ASSOCIATES, LTD. l Court Reporters '
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55 1 1 inspection processes, they certainly have the right to look ,
1 2 at the adverse events reporting at the local level and can l
( 3 make judgements at that local level as to were these events l 4 appropriately responded to.
5 They also, I think, would have the opportunity to 1
l 6 identify what are potential problem programs and then, with I i I 7 the assistance of consultants, can actually make the final i i
8 determination of are these or are these not problem l 9 programs.
10 Reporting at the local level -- I mean you still 11 have your inspection processes in place -- doesn't preclude 12 the NRC from ascertaining that that process is taking place.
13 I'll come back to central reporting program in my 14 next slide.
I 15 CHAIRMAN JACKSON: I'm also interested in how the i 16 NRC would be made available of events that have generic 17 implications.
18 MR. SWANSON: Let me come back to that one in the 19 central reporting program, which is in the slide down the 20 road here, okay?
21 Other key points.
22 There's certainly a need to dissociate the 23 reporting of events from the patient notification 24 requirements. This gets a little bit into the quality 25 management rule.
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l 1 As Dr. Stitt said earlier, while the ACMUI 2 recognizes the concerns related to patient notification, 3 patient notification falls into practice of medicine, and i
4 really, I think this is beginning to intrude into the l 5 practice of medicine.
1 .
6 '
COMMISSIONER McGAFFIGAN: So, you would have no l 7 requirements on patient notification?
8 MR. SWANSON: Patient notification is taking place 9 at the institutional level. It's part of the patient-10 physician interaction.
11 I think that that's an area that the NRC has 12 gotten itself in particular trouble with with the quality 13 management. rule in general, if you read the comments of the 14 community.
15 Third point. There is a need to simplify and 16 harmonize the definitions of isotope events. The current 17 definitions of events, medical misadministration events, are 18 far too complex, far too confusing.
19 I as a practitioner, when I'm giving presentations 20 on this or discussing this, I have to go back and review the 21 rules every time.
22 They're very complex definitions, far too complex, 23 and I would personally feel that many of the violations of 24 the quality management rule that have been documented are ,
25 probably due to just simply the complexity and the confusion
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57 1 surrounding the definitions.
2 There is also a need to harmonize the definition.
3 Another factor contributing to the complexity is the 4 difference between state definitions and NRC definitions.
5 I come from Pennsylvania, which is an NRC state.
6 Our state regulations governing accelerator-produced !
7 materials have a totally different set of definitions for j 8 misadministrations.
9 It's already confusing to begin with, and then add 10 a different set of confusion on top of it, it's almost 11 unwieldy to deal with. l l
l 12 Also, when we're talking about harmonizaticn, I l 13 think you need to look at, you know, how does the rest of 14 medicine define misadministration medical event reporting, 15 and it's something that we need to take a look at as we 16 evolve these definitions.
17 Next slide, please.
18 [ Slide.]
19 MR. SWANSON: As a possible approach in defining 20 the definitions, a couple of points that we need to consider 21 -- if technical data is desired, if that's what we're going 22 after, then we need to define the technical criteria 23 independent of clinical effects.
24 If what we're trying to go after are patient 25 sequelae data, .nen we need to define our terminology in ANN RILEY & ASSOCIATES, LTD.
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58 1 terms of clinical findings and come to some decision on l 2 that.
3 Next slide, please.
4 [ Slide.]
l 5 MR. SWANSON: Some possible approaches to this --
6 as I mentioned earlier, I think we need to look at the t l
l 7 development of a performance-based regulation that addresses 8 reporting at the local level, required reporting to the 9 licensee, to the RSOs.
10 As I said earlier, I still think that this will 11 allow the NRC in agreement states to review medical event 12 reports, the fact that they're taking place. It will allow 13 the NRC and agreement states to identify potentially problem 14 programs.
15 With regard to centralized reporting, I think --
16 it's a personal comment; I don't think the ACMUI has come to 17 total agreement on this -- 1 think there is a need for 18 centralized reporting of misadministration, because if we're 19 ever going to be looking for trends or causes of these 20 events, we need more data that what we'd see at a given 21 institution.
22 This has actually been a problem with event 23 reporting in medicine in general, is that this information 24 has tended to remain sequestered within the individual 25 institutions, a$d thereby, the word doesn't get out, and ANN RILEY & ASSOCIATES, LTD.
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1 I
l
j 59 j 1 people aren't aware of problems that other institutions are
- 2 having.
3 CHAIRMAN JACKSON: I just wish to point out that, i 4 you know, in addition to what you just said -- you were 5 talking a minute ago about harmonizing the definitions of i
i 6 " isotope event" and you talked about.the difficulties within i 7 a statement between what the agreement state program
) 8 required versus -- you know, for what.it covers versus NRC, j 9 but yet, you know, you stress, you know, having local j
10 reporting, and you know, is that an oxymoron, that somehow !
] 11 you want harmonization and consistent definitions and so 1
l 12 forth, but you want very tailored ways, localized ways of 4 l
- 13 reporting events. !
k 14 I mean it seems to me that, therein, you offer the i 15 opportunity for different definitions to propagate into the l 16 mix. !
2 17 MR. SWANSON: Well, I think what I'm talking about
- 18 about simplification and harmonization of the definitions -
I 19 - there probably needs to be somewhere within the new i
' l 20 regulations a simplified definition of events with reporting !
21 at the local level based upon those regulatory definitions.
22 At least that's my perception of how -- my personal ,
23 perception of how that would happen.
d 24 I don't think it would be wise to allow each i
. 25 institution to define its own definitions of 4
i !
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60 1 misadministrations or events, because then you would end up 2 with the scenario that you're describing, a very niixed bag 3 of reporting.
4 CHAIRMAN JACKSON: I think Commissioner McGaffigan 5 has a comment.
6 COMMISSIONER McGAFFIGAN: I'll just tell you that 7 the word " voluntary" under voluntary central reporting --
8 I'm not sure I even buy the notion that you wouldn't -- the 9 reporting at the local level, but voluntary central 10 reporting just strikes me that we're going to end up --
11 people with good records may voluntarily share their --
12 share their data, and people with bad records can 13 voluntarily not share their data, and you just said the 14 medical community as a whole has had a problem, not just in 15 this area, knowing what's going on, you don't have good 16 databases.
17 Are your insurance companies sort of forcing non-18 voluntary reporting and better databases for their own uses 19 to decide what insurance rates to charge you, or how does 20 all that work?
21 MR. SWANSON: Well, first of all, I haven't gotten 22 to that yet, and I think the introduction to that will 23 probably address some of your concerns.
24 I think that, when it comes to centralized 25 reporting, one of the things that's missing now is that ANN RILEY & ASSOCIATES, LTD.
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1 8 61 1 there has to be a clearly defined purpose for the central 2 reporting of medical events, and you know, I might be so 3 radical as to suggest that that purpose may be a cooperative 4 effort of the medical community and the NRC to identify 5 possible causes of events and to document their prevalence. ]
6 That ought to be the approach that we're taking if we're 7 working together on this.
l 8 COMMISSIONER McGAFFIGAN: Right. J
\
9 MR. SWANSON: Okay? That's not happening. Right i 10 now, it's viewed as punitive -- okay? -- and it's based upon i
11 isolated events. You have a requirement for reporting only 12 high-consequence events. You've collected minimal amounts 13 of data. It's absolutely serving no purpose, period.
14 Now, I'm all for central reporting personally --
15 and I'm speaking personally -- if that's the purpose of the 16 central reporting. I'm 100-percent in favor of it. Okay?
17 To get to that, though, you've got to take the 18 punitive -- the perceived punitive actions out of this, and 19 that means it needs to be a voluntary, anonymous reporting 20 system, and I can give you some models that work very well.
21 You can look at the pilot event reporting of the 22 Federal aviation people, the FAA. It works very nicely.
23 It's a voluntary, anonymous reporting system.
24 If you want to know what happens in traditional 25 medicine now, there's a voluntary reporting system. It's ANN RILEY & ASSOCIATES, LTD.
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e t
62 1 called the Medical Errors Reporting Program, takes place
- 2. through the United States Pharmacopeia Convention, 3 Incorporated.
4 It's a voluntary, anonymous reporting program.
5 The USP is an independent agency. For your information, ;
6 it's an agency responsible for setting drug standards and '
7 has been and is the only agency -- it's one of the oldest 8 agencies in the country.
I 9 It's a voluntary, anonymous reporting program for 10 the central collection of information on medical errors for i i
11 the purpose, as I stated, to identify the possible causes of 1
a 12' those errors and to document their prevalence. That's what 13 we need to get to if we're truly going -- I 1
14 COMMISSIONER McGAFFIGAN: How does this deal with j 15 the 10 to 15 percent or 1 percent--- why would somebody who 16 is not practicing medicine well submit this information 17 anonymously? Is this another doctor turning in a doctor who 18 they think is not --
19 MR. SWANSON: No. It's a voluntary reporting 20 program.
21 Again, you know, I think you're going to have to 22 seek the endorsement of the professional' organizations, the 23 practice standards to participate in this program, very 24 important that you get a buy-in of the professional 25 community in doing it, and I think that's easy to do if you ANN RILEY & ASSOCIATES, LTD.
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- 63 1 have that stated purpose up front.
2 Let me ask you the question. What makes you think 3 a regulation is going to make somebody report it? Why do 4 you think a bad person -- isolate a bad person -- will 5 report an event just because'a regulation requires it?
6 COMMISSIONER McGAFFIGAN: I suspect that isolated 7 bad person will get --
I hope get caught and enforced 8 against, having not done it.
9 CHAIRMAN JACKSON: And if it affects the license 10 of the facility, others have a shared interest.
11 COMMISSIONER McGAFFIGAN: Right.
12 CHAIRMAN JACKSON: But I don't think we're here to 13 debate that issue here.
14 MR. SWANSON: You asked for specific issues and i 15 how you might go about doing this. You can have a I 16 performance-based regulation that basically addresses people 17 participating in this voluntary reporting program. l 18 Go on to the next slide, please.
19 (Slide.)
20 MR. SWANSON: We're talking about philosophies 21 here, a little bit about ALARA. ALARA started out as a ,
22 philosophy and has gradually evolved into a requirement, and 23 the ACMUI believes that ALARA needs to be a philosophy. l 24 I think here is another area that the NRC can l 25 actually become actively involved in this philosophy.
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64 1 At the last meeting we had with the commissioners, 2 one of the statements I made was I can never understand --
3 the NRC goes out and sees a lot of these practices and you 4 report the bad things, but we don't see the good things 5 reported.
6 Here-is where the NRC could actually become 7 involved-in the ALARA program and letting other people know 8 good things that are happening out there, as a philosophy.
9 Next slide, please.
10 [ Slide.]
11 MR. SWANSON: Quality management program.
12 As per the commissioner's directive that appears 13 in the SRM through the NRC medical program staff, the ACMUI 14 concurs that the useful regulatory end points of the quality 15 management rule are written treatment prescription, review 16 of dose calculations, identification of the patient.
17 We feel that the quality management regulatory end 18 point should be performance-based and not prescriptive. !
19 I' don't care to be cited, for example, if my 20 physicians initial the written prescription rather than sign 21 it, doesn't make a whole lot of sense -- okay? -- and !
22 certainly the quality management rule with these end points 23 should focus on the higher-risk procedures, which they do 24 not.
25 DR. STITT: We have two final speakers.
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- 65 1 Dr. Alazraki?
2 DR. ALAZRAKI: Could I have the next slide, t
3 please?
l l 4 [ Slide.]
5 DR. ALAZRAKI: I'm going to address the NRC and l
6 medical expertise.
7 I've been a practicing physician in nuclear 8 medicine for the past 25, 26 years, and over that period of 9 time, I've witnessed a very painful and sometimes tumultuous 10 relationship between the NRC and the medical community.
11 Many of the problems can be distilled down to a
~
12 lack of involvement of the medical community, medical 13 practitioners, in the regulatory process over the years and 14 also a mind-set of punitive consequences for transgressions 15 which are frequently the result of the human element in 16 practicing medicine, and therefore, the ACMUI encourages an 17 enhanced level of medical and clinical input into the i 18 regulatory process.
19 Several years ago, about seven or so years ago, 20 the NRC initiated the Medical Fellows Program. Currently, 21 although there are two slots, only one is filled by Dr.
22 Myron Pollycove, a nuclear. medicine physician. >
23 Now, we think it's very important that medical 24 personnel be incorporated into the rulemaking process at the 25 NRC level and that the role of the medical fellows perhaps l
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l 66 1 be enhanced.
l 2 We feel that not only nuclear medicine physicians l 3 but radiation oncology physicians, clinical physicists, and i
nuclear pharmacists should all somehow be incorporated as 4
5 medical fellows and active in the fundamental process which 6 NRC is now about to embark upon of the revision of !
1 7 regulations.
8 Further, perhaps a jump, but even further, even 9 though the ACMUI appreciates and is aware that the 10 commissioners take in account the advice of the ACMUI, the 11 medical community is probably not going to be truly 12 satisfied until one of its own, someone involved, who has 13 been involved in the daily medical decision-making process 14 and the care of patients, is on the Commission, even though 15 the activity of the Commission, we understand, only a very 16 small --
17 CHAIRMAN JACKSON: On the Commission or on the NRC 18 staff?
19 DR. ALAZRAKI: No , on the Commission.
20 CHAIRMAN JACKSON: Then you should go to the White 21 House.
22 [ Laughter.] ,
23 DR. ALAZRAKI: I'd be very happy to.
24 But you know, even though the activities of the 25 Commission, probably only a very small part relate to ANN RILEY & ASSOCIATES, LTD.
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- 67 1 medical issues, what the Commission does greatly affects the 2 activities in the clinical areas of nuclear medicine and 3 radiation oncology, particularly, and so, we feel that there
, 4 is perhaps an appropriate rationale for that stand.
5 Could I have the next slide, please?
6 [ Slide.)
7 COMMISSIONER McGAFFIGAN: Could I ask a question?
8 CHAIRMAN JACKSON: Please.
9 COMMISSICNER McGAFFIGAN: On that last slide, the i I
10 fellows program, you understand the conflict of interest and l l
4 11 salary problems that we get into in trying to recruit 12 fellows from your community.
13 The highest salary I think that can be offered is 14 $123,000, which oftentimes isn't very attractive, unless 15 somebody comes in under the inter-governmental personnel 16 act, which means people working at state university medical
- 17 centers or universities, you know, can come in and get paid 18 whatever they're currently getting paid, but then you still 19 have conflict-of-interest issues that arise. Have you 20 thought those through?
21 DR. ALAZRAKI: This is problematic, we're aware of 22 that, and every other agency which tries to do the same sort
< 23 of thing -- the FDA and at NIH, in particular -- faces those 24 problems.
25 There are ways around that or there are ways, I ANN RILEY & ASSOCIATES, LTD.
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i 68 1 think, particularly if you deal with people on sabbatical !
2 leaves, where these things can be dealt with, and we would-3 encourage that the people who come in under this program be 4 people who are really actively involved in medical practice ;
5 or medical care, and so, they can't be removed for many 6 years; they have to be current people who really understand 7 what's going on in the current environment in the medical 8 community, i 9 The medical program in Part 35, as you're all 10 aware, the changes are going to be considerable, the 11' deliberations and discussions and the consensus building, 12 and the staff is, I think, embarking on a -- or planning to 13 embark on a program which would involve consensus building 14 through sessions that they would -- briefings they would 15 hold around the country and solicit commentary.
t 16 However, when they go back to their room to write ;
17 the regulations, those are -- somehow become distant and, 18 therefore, very important that not only the Medical Fellows l 19 Program but perhaps even the ACMUI be involved at the level '
20 of the writing of regulations. -
21 ACMUI will be problematic, we're aware of that, 22 but I think that we probably would be willing to make some 23 sacrifices to help as much as we can, time permitting '
24 because of our -- getting harder and harder in the medical !
25 world to find time to do voluntary work such as this because ANN RILEY & ASSOCIATES, LTD.
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69 1 of the pressures'of reimbursement and the pressures that are 2 on us.
3 CHAIRMAN JACKSON: We're doing voluntary work, 4 too.
5 [ Laughter.]
6 DR. ALAZRAKI: Okay.
7 So, encourage active input from the regulated 8 medical users - -that's what we've been talking about with 9 the fellows program, with the ACMUI, with the -- also, the 10 professional societies.
11 Just as we've been talking -- both Dennis and 12 Jeffrey were talking in the past about the programs of the 13 professional societies. They're also volunteers.
14 But there you have groups who want to contribute 15 meaningfully in the types of programs that you reed to have, 16 and frankly, I.think that's your best way right now, in the 17 absence of one of you who's really been in the medical 18 practitional world.
19 That's your best way of effectively instituting 20 good programs which will be satisfactory to the users and 21 also do what you need to do in your regulatory mission.
22 .The Soci*ety of Nuclear Medicine, the American 23 College of Nuclear Physicians, the Radiation Oncology
! 24 Groups, and the American College of Radiology all can help 1
25 in putting together those types of programs for you, and ANN RILEY & ASSOCIATES, LTD.
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70 l'
then there will not be the same question of intrusion into 2 the practice of medicine, and any quality improvement !
3 program can be viewed as an intrusion into the practice of 4 medicine.
5 DR. STITT: John Graham is our final speaker, to V 6 summarize.
7 MR. GRAHAM: On a bright note, we're done with the i
8 slides, so I'll try to keep this brief. j l
9 In summary, the Advisory Committee on the Medical I 10 Use of Isotopes concurs with the Nuclear Regulatory 1 11 Commission's preliminary position supporting a combination 12 of two options -- to continue the ongoing program with 13 improvements, which is option two, and to decrease oversight 14 of low-risk activities with continued emphe is on high-risk 15 activities, which was option three.
16 The advisory committee supports the definition of 17 risk as presented by the International Commission on I 18 Radiological Protection in Publication 60.
19 Risk is the product of the probability that an 20 event occurs and some measure of the potential loss or 21 consequences associated with that event. I 22 Within the context of this definition and based on 23 the NRC's documentation of abnormal events and )
24 misadministrations, the actual history of risk from the 25 medical use of isotopes has been very low. ]
i !
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71 1 Radiation medicine, in a relationship to the 2 entire practice of medicine, is low risk. The actual 1 3 history of low risk has been a result of standards, i l
4 policies, and procedures that have been voluntarily 5 developed by medical practitioners.
6 The advisory committee believes the most efficient 7 and effective control of risk will be achieved from working 8 with the provider community to further refine those 9 standards, policies, and procedures.
10 The actual history of low risk also is a result of 11 a portion of the regulations that have been established by 12 the Nuclear Regulatory Commission.
13 There are areas of radiation medicine that need 14 more surveillance than others for the protection of public 15 safety. The advisory committee is committed to working with 16 the NRC to establish these required regulations.
17 The advisory committee recommends reconsideration 18 of the Medical Policy Statement of 1979. Every action taken 19 by the NRC on the medical side and every discussion that we 20 have at the ACMUI should be influenced and guided by the 21 Medical Policy Statement.
22 The advisory committee is encouraged by the 23 Commission's commitment as stated in the Staff Requirements 24 Memorandum for the Materials Medical Oversight to support 25 the use of the ACMUI and professional medical organizations ANN RILEY & ASSOCIATES, LTD.
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__ . ~
72 1 and societies in developing regulatory guidelines and 2 standards.
3 The ACMUI represents a focused clinical background 4 and a medical perspective that can support the Commission's 5 responsibility for the public health and safety.
6 The ACMUI encourages an increased medical 7 perspective through addition of a radiation medicine 8 practitioner to the NRC staff and increased utilization of 9 medical fellows within all of the practical constraints that 10 you identified, Commissioner McGaffigan.
11 Medical representation within the NRC also could 12 evaluate minor incidents and medically rationalize the 13 enforcement process to avoid some of the reactionary 14 response that is so vocally presented at some of the 15 meetings that we attend.
16 The advisory committee looks forward to having an 17 opportunity to work with the commissioners, the staff of the 18 NRC, medical professionals, and the general public to revise 19 10 CFR Part 35.
20 As discussed in the Staff Requirements Memorandum 21 for Materials Medical Oversight, we agree that revision of i
22 Part 35 should emphasize high-risk activities, which was i 23 item one in the summary of that memorandum.
24 We support the development of performance-based 25 initiatives for activities where failure to meet the 1
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I 73 1 performance criteria results in tolerable conditions for 2 which appropriate ccrrective action will be taken in 3 referenced items two, three, and four of that memorandum.
4 We support revision of Part 35 to safely introduce 5 new treatment modalities to the American public as quickly i
6 as possible while considering the public safety, which was 7 listed in item five.
8 We recommend that the Quality Management Program ]
9 should be revised or revoked as a rule since we have not j 10 efficacy from the program.
11 We recommend an emphasis on quality improvement of 12 the processes in the systems, with prescriptive regulations 13 only applied when absolutely necessary, in addressing item 14 six.
)
15 We concur with the concept of collaborating with 16 professional organizations to develop practice standards l
17 within Part 35. We want to emphasize the role of training i 1
18 and experien,ce in referencing available industrial guidance 19 and standards, as stated in item seven. l 20 We support the concept of a rulemaking process I 21 that creates more opportunity for input from potentially 22 affected parties but that is more efficient for timely 23 completion of the process, as outlined in item number eight.
24 In conclusion, the ACMUI is prepared to work with 25 the Commission and the staff of the NRC to review 10 CFR ANN RILEY & ASSOCIATES, LTD.
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74 !
1 Part 35.
2 You have deliberated on this issue for a few 3 years. There has been a strategic assessment initiative, '
4 public comments, the IOM report, and recommendations from ;
5 the ACMUI.
t 6 We believe that, with open communication and 7 feedback from the Commission and staff, the ACMUI can 8 contribute to the public safety and improve the environment t 9 for the practice of radiation medicine.
10 CHAIRMAN JACKSON: Thank you. ;
11 DR. STITT: I just wanted to thank my committee, '
12 who has put in all sorts of time, late at night, during- l 1
13 weekends, and to a man and woman, every single individual 14 has contributed.
15 So, thank you very much for everything that you 16 have done.
17 And thank ycu. the commissioners, for the 18 opportunity for us to be here today.
10 CHAIRMAN JACKSON: Dr. Cool, I have one question 20 for you. Do you have a patients' rights advocate on the 21 committee?
22 DR. COOL: Yes, there is, at this time, a 23 patients' rights advocate. Ms. Judith Brown was not able to 24 be in attendance today. l 25 That is one of the positions which will be coming l
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75 1 open come this October. Ms. Brown will have been on the 2 committee for six years, which is the maximum length, and 3 that is one of the positions which has currently been 4 advertised in the Federal Register for replacement.
5 CHAIRMAN JACKSON: Okay.
6 Any final comments?
7 Commissioner Rogers?
8 COMMISSIONER ROGERS: Yes. There's two points 9 that -- I don't know how far we can get into them today, but 10 I'm just going to raise them with you.
11 The first is, how is NRC to determine when an 12 isolated event is truly an isolated event? That's a matter 13 of concern to us.
14 You have emphasized very much in your presentation 15 that there's been too much focus on isolated events.
16 That's probably true, but how, from the standpoint 17 of a -- of responsible stewardship point of view, is NRC to 18 be able to determine objectively or find out on some 19 objective basis when an isolated event is truly an isolated 20 event and not evidence of something broader?
21 The second one is really the question that's 22 somewhat connected to this, and that is, should there be a 23 threshold for required corrective actions?
24 In reading your -- looking over your slide 25 material and trying to understand, you know, what you were ANN RILEY & ASSOCIATES, LTD.
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76 1 thinking about, it seemed to me that basically you were 2 rejecting the idea that there should be a threshold for any 3 kind of required corrective actions, and I think that's a 4 very fundamental point that somehow is going to have to get 5 thrashed out, because if there is no threshold, then I think 6 --
and a well-defined threshold for required corrective 1
7 actions -- how do you deal with the situation which is j
1 8 really -- has a significant root cause that just never gets )
9 dealt with?
10 So, those are the two points which I'd like to 11 throw out at you. I don't expect answers right now, but it 12 does seem to me that these are points that you really have 13 to think about, because they're very fundamental to the 14 whole thing. j 15 The other point I'll just touch on, and that is 16 terminology. I would ask you and the NRC staff to try to be 17 as clear as possible on terminology.
18 When you talk about quality assurance in your 19 slides, you're really talking about what we would call 20 quality control, not quality assurance, and I know that 21 these terms sound and seem as if they mean the same thing.
22 To us , they do not mean the same thing. There's a 23 significant difference between quality control and quality 24 assurance. ,
25 In brief, quality assurance relates to the ANN RILEY & ASSOCIATES, LTD.
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77 1 demonstration that you have done everything that is 2 reasonable, when challenged, after you've, in fact, done the 3 right thing, and quality control relates to the processes 4 that lead you to determine what is the right thing to do.
5 So, there's a distinct difference there, and when l
6 yo>. talk about quality assurance and we talk about quality 7 assurance, maybe we ought to make sure we are talking about 8 the same thing, because you know, it's very, very easy t'o 9 carry on endless discussions and debates when, in fact, you 10 mean something different by the same words.
11 So, I would just simply point out to you that 12 there may be a little problem here of terminology and an 13 understanding of what we mean when we're talking about 14 quality assurance. Certainly, in the reactor area, it's 15 very clearly different from what you've outlined here as QA. !
16 So, I would just say, try to make sure that s
17 terminology is not an impediment to -- a misinterpretation 18 of terminology is not an impediment to progress. ,
3 19 CHAIRMAN JACKSON: Commissioner Dicus.
20 COMMISSIONER DICUS: I have a question just for 21 information purposes. ;
22 To your knowledge -- and it's on patient ,
23 notification -- is our rule on patient notification, to your 24 knowledge, the only rule related to medicine by a Federal 25 agency or a state agency or government or law, for that ANN RILEY & ASSOCIATES, LTD.
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l 78 1 1 matter, requiring patient notification? Does anyone know?
i 2 DR. STITT: I'll answer for myself. To my j
\
-3 knowledge, that is correct. !
i 4 I think that some of the basic problems are those !
1
- 5. of communications. The QA would be a standard medical '
6 process, and we're not reactor people, and I think that's 7 why there is a lot of difficulty in trying to communicate. ,
8 If an individual received the wrong medication, 1
9 the standard process of dealing with that is formal, it's j c
10 institutional, it's written, but there's no Federal 11 regulation that requires you to write a letter to the i 12 patient.
13 The patient has to be discussed. You have to fill I 14 out the appropriate hospital form. It's reviewed by the QA 15 committee and becomes-part of the hospital or clinic's !
16 annual report in that particular area.
17 CHAIRMAN JACKSON: But it doesn't necessarily 18 trigger an automatic notification of the patient. :
19 DR. STITT: No. The patients may have that 20 discussed, but there's nothing that's in the form of --
21 CHAIRMAN JACKSON: It may or it may not be 22 discussed.
23 COMMISSIONER McGAFFIGAN: Is this true for the 24 mammography act? I thought that, in the mammography act, 25 there was some requirement for patient notification.
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79 1 DR. STITT: That's the notification of results of 2 the mammograms.
3 ' CHAIRMAN JACKSON: Commissioner Diaz.
4 COMMISSIONER DIAZ: I personally agree that, you 5 know, we need to look at this on a risk basis. I think we 6 realize that the low risk -- it should be relatively clear.
7 I do have a concern when we're talking about 8 assessments of risk and trying to make assessments of risk 9 in nuclear medicine comparable to other areas in medicine.
10 Although it was a long time ago, I did work for 11 hospitals and I did perform as a physicist, and I saw so 12 many differences between these places that I've always kept 13 the concern that what we are trying to do is to minimize the 14 risk to the public. I'm sure you want to do the same thing.
15 However, to compare to the risk in medicine -- I 16 have a serious concern that that is probably not definable, 17 because there are many procedures in medicine that are very 18 high-risk, and we certainly don't want to elevate the risk 19 from nuclear medicine, especially diagnostics, although, you 20 know, therapeutical procedures are different, to some of the 21 same kind of risk that are associated with some of the 22 medical procedures, and I'm a little bit concerned that 23 we're trying to say we are taking this risk field in nuclear 24 medicine and comparing it to other fields in medicine, and I 25 don't think that that will fly very far. I'm sorry.
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80 1 I see that as a di'stinct, you know, for me, a i
2 philosophical difference. I would like to keep them in a 3 playing field that is more quantitative, because we have a l l
4 way of quantifying it and maintain it in a more controllable 5 manner than many other processes in medicine.
1 6 CHAIRMAN JACKSON: Commissioner McGaffigan.
7 COMMISSIONER McGAFFIGAN: I'd again like to ask a 8 point of information.
9 The rule on patient notification says that you 10 have to notify the patient unless the referring physician 11 personally informs the licensee either that he will inform 12 the individual or that, based on medical judgement, telling I 13 the individual would be harmful.
I 14 Does that occur, where people use clinical 15 judgement and say no, we won't, and is that enough of an 16 effort to allow clinical judgement to get into the 17 notification process?
18 DR. STITT: Yes, it does occur where clinicians i 19 make a decision.
20 DR. FLYNN: I've had a number of instances, i
21 looking at about 50 or 60 misadministrations as a medical i 22 consultant for the NRC, whereby the radiation oncologist 23 notifies the referring physician, the referring physician 24 says I don't want my patient notified.
25 The referring physician has no idea what NRC !
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o -
81 t 1 _ regulations are. They have no idea.
- 2 And oftentimes, then, the radiation oncologist 3 reminds the referring physician that they have this 4 regulation, and then it may be that the patient is -- harm 5 , won't be brought to the patient, but the patient may be 6 elderly, and whatever you tell them in the nursing home 7 would be confusing to them, you tell their next of kin that 8 some minor event occurred, and some of the referring 9 physicians believe it brings on a psychosis and a radiation 10 phobia, a psychosis of some minor event that they're 6
11 required to report. l 1
12 So, it comes into problems with how do you deal 13 with the referring physician if the referring physician is
' I 14 adamant about the patient not knowing.
15 So, there's some --
l 16 CHAIRMAN JACKSON: It strikes me that the 17 regulation has that escape hatch.
18 DR. WILLIAMSON: It does not have that escape 19 hatch.
20 We had a case where a 10th of a centigrade was 21 given to the wrong site because of a minor machine 22 malfunction, which, since there's no lower threshold for 23 wrong site, this minor technical error was required to be 24 reported to the patient. .
1 25 The physician and referring physician did not want ANN RILEY & ASSOCIATES, LTD.
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82 1 to repsrt it to the physician and we had extensive 2 discussions with your ceneral counsel, and we were forced to 3 report it, to sort i fck out one of the patient's 4 relatives or friends.
5 So, as the law reads now, you have to report it to 6 somebody.
7 If you, on medical judgement, decline to report it 8 to the patient, you must then put yourself in the position, 9 as physician, of violating the patient's confidentiality and ,
10 sort of picking out some friend, associate, or relative. I 11 think the word in the law is " guardian," but it's very 12 broadly interpreted.
13 COMMISSIONER McGAFFIGAN: This gets down to my 14 earlier point. I think you all have to deal with the words '
15 in the regulations and your words in your licenses, and we 16 have to get beyond philosophy in the next year -- 1 17 CHAIRMAN JACKSON: That's right.
18 COMMISSIONER McGAFFIGAN: -- to rulemaking, and I 19 appreciate the last speaker's commitment to do'that, but 20 that's --
21 CHAIRMAN JACKSON: That's where the rubber meets 22 the road.
23 COMMISSIONER McGAFFIGAN: -- where the rubber 24 meets the road, right.
25 CHAIRMAN JACKSON: And on that note, I'd like to ANN RILEY & ASSOCIATES, LTD.
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d 83
, 1 thank each member of the committee for today's briefing.
2 It's clear that you've devoted many long hours of 3 thought and consideration to this matter, obviously, in and 4 out of the committee meetings.
5 And the issue of NRC's regulatory role in the 6 medical use of by-product material is not a simple or a 7 trivial one, and the Commission didn't arrive at its recent 8 decision lightly on this matter.
9 And the advisory committee's views will be of 10 tremendous benefit to the Commission and the staff as we 11 work to revise the program.
12 And we'll, of course, always give serious 13 consideration to the views expressed here today, as the 14 staff reviews the program -- its program for completing the 15 revision of 10 CFR Part 35. j l
16 And building on what Commissioner McGaffigan said, 17 the Commission would appreJiate a more direct and focused i
18 look at possible revisions to 10 CFR Part 35, including test ;
1 19 cases -- I mean you can take any suggestion or think of your !
l 20 own -- in order to advance the decision-making on this 21 issue.
22 And as you do that, it's important to address a l
23 number of the questions that you've heard put to you today '
24 by the Commission, because it's what we are thinking about, 25 and it's going to inform our decision-making. i ANN RILEY & ASSOCIATES, LTD.
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84 1 And so, those two elements of giving a more direct 2 and focused look at possible revisions to Part 35 and, in 3 the process, addressing the questions or types of questions 4 that you have heard put to you today are how you can be of 5 the best help to us as we review the staff's activities on 6 revising Part 35, because that's where we're going.
7 We're a regulatory agency, and we're focusing on 8 that, and so, unless there are further comments, we're 9 adjourned.
10 Thank you.
11 [Whereupon, at 10:51 a.m., the meeting was 12 adjourned.)
13 4
14 15 16 17 18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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i CERTIFICATE This is to certify that the attached description of a meeting of the U.S. Nuclear Regulatory Commission entitled:
TITLE OF MEETING: MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) -
PUBLIC MEETING PIACE OF MEETING: Rockville, Maryland DATE OF MEETING: Thursday, May 8, 1997 was held as herein appears, is a true and accurate record of the meeting, and that this is the original transcript thereof taken-stenographically by me, thereafter reduced to typewriting by me or under the direction of the court reperting company Transcriber: N h/) m rt m S n, n.
Reporter:
Mark'Mahoney
j -
l ACMUI Commission Briefing t
May 8,1997 Judith Stitt, M.D.
John Graham Dennis Swanson, M.S., B.C.N.P.
Jeffrey Williamson, Ph.D.
Risk and Radiation Medicine o Radiation Medicine is a safe process in relation to the practice of medicine as a whole o Risk is related to the probability of error and the severity of consequences
Risk and Radiation Medicine l o Low incidence of errors (1 x 10d) in all modalities .
because of:
Voluntary practice standards Staff training standards Broad Quality Improvement (QI) programs s
Risk and Radiation Medicine o The low risk status justifies a move away from prescriptive regulations.
i o The low risk status justifies the development of performance based regulation of radiation medicine.
I i
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i Risk in Radiation Medicine
, Potential Consequences of Exposure l
l o Spectrum of radiation procedures HDR brachytherapy Gamma stereotactic therapy Radionuclide therapy LDR brachytherapy Diagnostic nuclear medicine 4
Risk in Radiation Medicine i Potential Consequences of Exposure i'
o Higher risk procedures Exposure to pu alic greater than Part 20 limits Deterministic injuries to staff possible Probable serious injury to the patient .
l 5 i f
Risk in Radiation Medicine Potential Consequences of Exposure o Medium risk procedures Public and staff exposures less than Part 20 limits Small numbers of staff & public exposed to greater than Part 20 o LoTver risk procedures l -
Public and staff exposures less than Part 20 limits
l Risk in Radiation Medicine o High risk procedure has the potential for risk based on consequences of errors o Probability of occurrence is low given current standards of .
Physician, physicist, support staff education and training QI, safety, physics, and delivery practices o Overall risk is low given current practice standard compliance ,
7
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s c g; o IS igtement $:f;Th ' 'RC will regulate the radiation [
'(p.. Nfef$ of P afi~ents3 nly where justified by the risk i flhl)e patients, a only w.here voluntary . ;.
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o Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical ,
practice.
9
O Medical Policy Statement AC MUI Modification o Statement 3: The NRC will not intrud.e into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicme.
i 10 !
Radiation Medicine and Quality Improvement
< o Quality Assurance: For any procedure, action is taken only when the process average exceeds a predetermined threshold.
i o When the process average is under the threshold, no questions are asked. When the threshold is exceeded, there is panic and finger pointing. .
t 11 1
i Radiation Medicine and Quality Improvement o Quality improvement: The entire output of the process provides the basis for actions, not just those occurrences that are deemed unacceptable because they exceed a specification limit.
o When a QI approach is taken there are two options for improvement.
Reduce the variability in the process &/or Shift the process in the desired direction 12
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Current Patient Safety Regulations o QI program is incomplete and unbalanced Driven by low-probability single events at expense of higher-likelihood processes
- (Yo-Yo effect)
Focuses on excessive documentation Relies on prescriptive rules and threshold events t
14
t Current Patient Safety Regulations t
o Adversarial with punitive enforcement Emphasis on isolated errors and paper work violations rather than overall QI program Errors result in punishment rather than constructive assistance I
15 l l
1 Future Patient Safety Regulations o Do not intrude into medical & physics practice l o Encourage acceptance of voluntary practice standards .
o Focus enforcement on substandard practices rather than isolated errors & paperwork ~
infractions by good practices o Enforcement should be constructive not punitive ,
16
Regulatory Program-Practice Standards o Collaborate with professional organizations (ACR, AAPM, SNM). Develop practice standards for specific areas of radiation medicine Safety standards for public and staff Essential resources - equipment staff ,
QI program elements for patient safety 17
. . _ _ - - - _ . . - - . _ _ _ )
Regulatory Program-Enforcement o Enforcement process guidelines Inspections - function like an accreditation site visit E se clinical professionals as reviewers Emphasize staff credentialing and adherence to l practice standards vs. isolated errors 1
18
Accreditation Standards .
t o Goal - Bring sub-standard practices into mainstream without burdening others i
o Calibrate inspection process against random sample of practices to ensure reasonableness o Models to study:
ACR accreditation programs Mammography Quality Standards Act i -
JCAH l
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Isotope Event Reporting o Dissociate the reporting ofisolated events from actual or perceived punitive actions o Address reporting at the local rather that NRC level 20
Isotope Event Reporting o Dissociate the reporting of events from patient notification requirements o Simplify and harmonize the definitions ofisotope events 21
Isotope Event Reporting -
Possible Approaches o Performance-based regulation that addresses reporting at the local level RSO, licensee, Agreemen1: States ,
NRC review problem programs o Change the mechanism of centralized reporting Clearly define purpose Voluntary central reporting 22
Adverse Event Reporting -
Possible Approaches I
o If technical error data is desired - define technical criteria independent of clinical effects ;
o If patient sequelae data are sought - define in terms of clinical findings i
i 23
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i Quality Management Program t
o ACMCI concurs that useful regulatory endpoints include:
- Written treatment prescription Review of dose calculations
- Identification of patient i i
o Regulatory endpoints should be performance-based not prescriptive Focus on procedures with higher risk 24 i
ALARA o Current program imposes 500 mR annual staff exposure limit on procedure and facility design o Require only compliance with Part.20 limits o Encourage ALARA as a program philosophy but not a requirement 25
m NRC & Medical Expertise o AC MUI encourages an enhanced level of medical and clinical input into the regulatory process.
Consider medical personnel for NRC staff Increased role of Medical Fellow 26
Medical Program & Part 35 o Changes will require considerable deliberation, discussion, and consensus building.
o Encourage active input from the regulated medical users .
o L se ACMLI as part of the process
- - - - - - - - - - - - - - - - - - - - - - - _ - _ _ _ - - - _ - - _ - - -_ - a
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l Quality Measure FIGURE 1.1. The difference between quality assurance and quality improvement.
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ACMUI Commission Briefing May 8,1997 Judith Stitt, M.D.
John Graham Dennis Swanson, M.S., B.C.N.P.
Jeffrey Williamson, Ph.D.
Risk and Radiation Medicine o Radiation Medicine is a safe process in relation to the practice of medicine as a whole ,
a o Risk is related to the probability of error anc the i
severity of consequences i
1
Risk and Radiation Medicine o Low incidence of errors (1 x 10-4) in all modalities because of:
Voluntary practice standards Staff training standards Broad Quality Improvement (QI) programs
II Risk and Radiation Medicine o The low risk status justifies a move away from prescriptive regulations.
o The low risk status justifies the development of performance based regulation of radiation medicine.
3
i Risk in Radiation Medicine Potential Consequences of Exposure o Spectrum of radiation procedures l
HDR brachytherapy Gamma stereotactic therapy Radionuclide therapy LDR brachytherapy Diagnostic nuclear medicine 4
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Risk in Radiation Medicine Potential Consequences of Exposure o Higher risk procedures l
Exposure to public greater than Part 20 limits Deterministic injuries to staff possible Probable serious injury to the patient 4 s
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Risk in Radiation Medicine Potential Consequences of Exposure o Medium risk procedures Public and staff exposures less than Part 20 limits Small numbers of staff & public exposed to .
greater than Part 20 o Lower risk procedures
. Public and staff exposures less than Part 20 limits 6
. -. . . -_\
Risk in Radiation Medicine o High risk procedure has the potential for risk based on consequences of errors 4
o Probability of occurrence is low given current standards of .
Physician, physicist, support staff education and training l
QI, safety, physics, and delivery practices l
o Overall risk is low given current practice standard l
compliance l -
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-l Medical Policy Statement o . Statement 1: The NRC will continue to regulate i; the medical uses of radioisotopes as necessary to provide for the rac iation safety of workers and the general public.
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Medical Policy Statement ACMUI Modification o Statement 2: The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary l
standards or compliance with the standards are l
, inadequate.
o Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
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Medical Policy Statement ACMUI Modification .
o Statement 3: The NRC will not intrude into i medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
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Radiation Medicine and Quality Improvement o
Qua:Lity Assurance: For any procedure, action is taken only when the process average exceeds a
. predetermined threshold.
o When the process average is under the threshold, no questions are asked. When the threshold is exceeded, there is panic and finger pointing.
I 11
Radiation Medicine and Quality Improvement
- o Quality improvement
- The entire output of the process provides the basis for actions, not just those occurrences that are deemed unacceptable because they exceed a specification limit.
o When a QI approach is taken there are two options for improvement:
Reduce the variability in the process &/or m Shift the process in the desired direction n
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e Current Patient Safety Regulations o QI program is incomplete and unbalanced Driven by low-probability single events at expense of higher-likelihood processes
- (Yo-Yo effect)
Focuses on excessive documentation Relies on prescriptive rules and threshold events l
14
t Current Patient Safety Regulations I
o Adversarial with punitive enforcement Emphasis on isolated errors and paper work violations rather than overall QI program Errors result in punishment rather than .
constructive assistance I
15
e Future Patient Safety Regulations o Do not intrude into medical & physics practice o Encourage acceptance of voluntary practice standards o Focus enforcement on substandard practices rather than isolated errors & paperwork -
infractions by good practices o Enforcement shoulc be constructive not punitive 16
_ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ . , _ _ _ _ _ _ _- - - - _ _ _ _ _ ______e - r --- _- _ _ _ , _ _ _ - - - - - - - - - .
Regulatory Program-Practice Standards o Collaborate with professional organizations (ACR, AAPM, SNM). Develop practice standards for specific areas of radiation medicine Safety standards for public and staff i -
Essential resources - equipment staff ,
QI program elements for patient safety 17
Regulatory Program-Enforcement o Enforcement process guidelines .
Inspections - function like an accreditation site visit Use clinical professionals as reviewers Emphasize staff credentialing and adherence to practice standards vs. isolated errors I
18
i Accreditation Standards o Goal.- Bring sub-standard practices into mainstream without burdening others o Calibrate inspection process against random sample of practices to ensure reasonableness
- o. Models to study:
ACR accreditation programs Mammography Quality Standards Act JCAH .
19 ,
1 i l
Isotope Event Reporting o Dissociate the reporting ofisolated events from j actual or perceived punitive actions o Address reporting at the local rather that NRC level
)
20
Isotope Event Reporting o Dissociate the reporting of events from patient notification requirements ,
o Simplify and harmonize the definitions ofisotope events 21 1
Isotope Event Reporting -
Possible Approaches o Performance-based regulation that addresses reporting at the local level .
RSO, licensee, Agreement States NRC review problem programs o Change the mechanism of centralized reporting Clearly define purpose Voluntary central reporting 22 e e w -- r a _ _ ---_ ___ _. -_. _ _ . _ _ _ ____ _ _ _m -_ ____.__ _ _ _ _ _ . - _ _ _ _ _
1 Adverse Event Reporting -
Possible Approaches o If technical error data is desired - define technical criteria independent of clinical effects o If patient sequelae data are sought - define in terms of clinical findings 23
l Quality Management Program l
o ACMUI concurs that useful regulatory endpoints include-Written ':reatment prescription Review of dose calculations Identification of patient o Regulatory endpoints should be performance-based not prescriptive Focus on procedures with higher risk 24
ALARA o Current program imposes 500 mR annual staff i exposure limit on procedure and facility design :
o Require only compliance with Part 20 limits o Encourage ALARA as a program philosophy but not a requirement h
4 25 k
NRC & Medical Expertise o AC MUI encourages an enhanced level of medical and clinical input ini:o the regulatory process.
Consider medical personnel for NRC staff Increased role of Medical Fellow i
l i
26
Medical Program & Part 35 o Changes will require considerable deliberation, discussion, and consensus building.
1 o Encourage active input from the regulated medical users o L se ACMLI as part of the process i
i f
27 i
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d OA Approach 4
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Number action is taken l cases i l
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Ol Approach Resulting improvemer.t in process variability i
i Number OI 4
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Quality Measure IfGURE 1.1. The difference between quality assurance and quality improvement.
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