ML20151E186

Transcript of 880407 Meeting W/Nrc Advisory Committee on Medical Uses of Isotopes & Industry Scientific Committees in Washington,Dc.Pp 1-84

ML20151E186
Person / Time
Issue date:	04/07/1988
From:	NRC COMMISSION (OCM)
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References
REF-10CFR9.7 NUDOCS 8804150113
Download: ML20151E186 (90)

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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION 1

Title:

BRIEFING ON PROPOSED BASIC QA RULE WITH REPRESENTATIVES OF NRC ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOP AND INDUSTRY SCIENTIFIC COMMITTEE Location:

Washington, DC t

Date: Thursday, April 7, 1988 Pages:

1 - 84 i

Ann Riley & Associates Court Reporters 1625 i Street, N.W., Suite 921 Washington, D.C. 20006 (202) 293-3950 I

6804150113 080407 4

PDR 10CFR PT9.7 PDR

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1 D I SC LA l MER 2

3 4

5 6

This is'an unofficial transcript of a meeting of thc 7

United States Nuclear Regulatory Ce~eelssion held on 8

April 7, 19&8 in the Commission's office at 1717 H Street, 9

~1. tJ.. (Ja s h i ng t on,

D.C.

The meeting waJ open to public 10 attendance and observation.

'this transcript has not been 11 reviewed, corrected, or edited, and it may contain 12 inaccuracies.

13 The transcript is intended solely for general 14 informational purposes.

As provided by 10 CFR 9.103, it is 15 not part of the formal or informal record of decision of the 16 matters discussed.

Expressions of opinion in this transcript 17 do not necessarily reflect final determination or beliefs.

No 18 pleading or other paper may be filed with the Commission in 19 any proceeding as the result of or addressed to any statement 20 or argument contained herein, except as the Commission may 21 authorire.

23 24 25 n

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1 1

UNITED STATES OF AMERICA 2

NUCLEAR REGULATORY COMMISSION 3

4 BRIEFING ON PROPOSED BASIC QA RULE WITH 5

REPRESENTATIVES OF NRC ADVISORY COMMITTEE 6

ON THE MEDICAL USES OF ISOTOPES AND 7

INDUSTRY SCIENTIFIC COMMITTEES 8

9 (PUBLIC MEETING) 10 11 Nuclear Regulatory Commission 12 Room 1130 f

i 13 1717 H Street, Northwest 14 Washington, D.C.

15 16 Thursday, April 7, 1988 17 18 The Commission met in open session, pursuant to 19 notice, at 2:02 p.m., the Honorable LANDO W.

ZECH, Chairman of 20 the Commission, presiding.

21 22 23 24 25 I

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COMMISSIONERS PRESENT:

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2 LANDO W.

ZECH, Chairman mf the Commission 3

THOMAS M. ROBERTS, Member of the Commission 4

FREDERICK M. BERNTHAL, Member of the Commission 5

KENNETH CARR, Member of the Commission 6

STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:

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S. Chilk 8

W.

Parler f

9 J. Taylor 10 R. Bernero 11 C. Marcus 12 G. Tonnesen f

1, 13 O. Linton 14 F.

Khan 15 R. Gross 16 V. Collins 17 M. Griem l

18 D. Woodbury

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19 9

Almond 20 AUDIENCE SPEAKERS:

i 21 N. McElroy i

22 D. Cunniugham 1

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i PROCEEDINGS l i

23 CHAIRMAN ZECH:

Good afternoon, ladies and gentlemen. ;

I 24 Commissioner Rogers will not be with us this afternoon.

He is 25 on foreign travel.

Commissioner Bernthal will be joining us i

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shortly.

2 Before we proceed with the meeting today, I would 3

like to point out that this is a historic occasion for more 4

than one reason, first of all, our important guests with us 5

today and they are all very welcome, but also it is an 6

important occasion because this is very likely the last meeting 7

that the Commission will have at "H" Street.

8 As most of you know, we on Monday move our 9

headquarters office, the commission offices, to the Rockville 10 area in White Flint and so unless we have something scheduled 11 tomorrow that is not scheduled now, this could well be the last 12 meeting that the Nuclear Regulatory Commission will hold here r

't 13 at the "H" Street Headquarters.

14 The purpose of today's meeting is to discuss the 15 rulemaking initiatives underway for quality assurance and the 16 medical use of byproduct material.

We will hear from the 17 Nuclear Regulatory Commission Advisory Committee on the Medical 18 Uses of Isotopes and representatives of the industry's 19 scientific communities.

20 This is an information briefing this afternoon and 21 the Commission is not expected to vote today on these issues.

22 Many of you know that the Nuclear Regulatory Commission is 23 proposing to amend its regulations concerning the medical use 24 of byproduct material.

25 The propoped amendments would require medical i

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licensees to implement certain quality assurance steps. The

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2 intent is to reduce the chance of misadministrations and the 3

Commission is also considering a more comprehensive program for 4

quality assurance in medical use of radioactive material and a 5

standard of care.

6 The Commission has great respect for the medical 7

profession and does not want to interfere with the practice of 8

medicine.

We are also keenly aware of the value of the use of 9

isotopes in both diagnosis and treatment.

10 However, the commission has an important 11 responsibility for public health and safety in the medical use 12 of isotopes and we take this matter seriously and although we 13 recognize that there are only a relatively small number of 14 misadministrations, we believe that a quality assurance program 15 would provide for improved patient safety by reducing the 16 potential for and severity of misadministrations.

17 I would like to welcome the members of the Nuclear 18 Regulatory Commission Advisory Committee and the 19 representatives from the industry's scientific communities to 20 the Nuclear Regulatory Commission.

I appreciate your time and 21 I want to thank you for being here especially on such short 22 notice.

1 23 Before we begin today, do any of my fellow

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24 Commissioners have any opening comments they would like to 25 make?

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(No response.)

2 CHAIRMAN ZECH:

If not, then Mr. Taylor, I would ask 3

you to proceed, please.

4 MR. TAYLOR:

Thank you, Mr. Chairman.

You recall on 5

the 22nd of March the staff briefed you on the proposed QA rule 6

and as part of that briefing listed several alternatives on an 7

approach to that rule but also recommended that the folks who 8

are here today representing the medical community have an 9

opportunity to present their views to the Commission.

10 So with that prelude, I will ask Mr. Bernero to 11 introduce those who are currently here at the table and then I 12 believe there will be a follow-up group, right?

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13 MR. BERNERO:

Yes.

Thank you, Jim.

Mr. Chairman and 14 Commissioners, the people at the table now starting at Jim 1

15 Taylor's left, first of all we have two physicians from 16 community hospitals, Dr. Carol Marcus from the Los Angeles 17 County Harbor-UCLA Medical Center and Dr. Glenn Tonnesen from 18 Fairfax Hospital.

I think you have met Dr. Tonnesen before 19 when you visited Fairfax.

20 CHAIRMAN ZECH:

Yes, I have.

21 MR. BERNERO:

They use byproduct material for patient 22 care and they will be able to speak authoritatively on these 23 regulatory initiatives in quality assurance.

Next to them are 1

24 people representing organizations involved in medical care.

i 25 Next to Dr. Tonnesen there is Otha Linton, the Executive

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Director of the American College of Radiology and Dr. Faiz Khan

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2 of the American Association of Physicists in Medicine.

These individuals should be able to speak on the voluntary quality 3

4 assurance initiatives in the field, in the practice, and 5

provide some useful comments on our rulemaking.

6 Lastly, over here in the federal enclave between Jim 7

Taylor and me is Captain Richard Gross of the Food and Drug 8

Administration, Center for Devices and Radiologic Health and he 9

should be able to describe our sister agencies' practices that 10 will be useful for this purpose.

So if I could turn the floor 11 over now to Dr. Marcus to start it off.

12 CHAIRMAN ZECH:

Welcome again, Dr. Marcus, and you

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13 may proceed.

14 DR. MARCUS:

Thank you, Mr. Chairman and Mr. Bernero.

15 My name is Carol Marcus and I am the physician in charge of the 16 nuclear medicine out patient clinic at Harbor-UCLA Medical 17 Center in Los Angeles.

18 I discussed these proposed regulations at the January 19 26th meeting with the assistants to the Commissioners and it is 20 a great pleasure for me to be here this afternoon to talk to 21 you gentlemen directly.

22 Today I represent both the Society of Nuclear 23 Medicine and the American College of Nuclear Physicians and

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24 that represents 12,000 people.

At the January meeting I 25 extensively discussed my attempts to implement the proposed

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regulation as it appeared in the Federal Register of October 2

2nd and described in detail my extensive problems with the 3

various prescriptive aspects of that regulation.

4 Those comments are on the record and I understand you 5

gentlemen have read them and so I am not going to talk about 6

that unless you want to ask me some questions.

7 Today instead I want to discuss briefly five and a 8

half months of experience with a key element in the proposed 9

regulations that did work that I didn't tell anybody about last 10 time that I found to be so helpful in my practice that I am 11 going to keep it in even if it ends up not being part of a 12 quality assurance plan and I would just share with you the t'

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13 experience.

14 Then I am going to talk about an approach to the 15 development of a nuclear medicine quality assurance program 16 which would serve as a basis for our support of performance 17 standards rather than prescriptive regulations.

1 18 For the past five and a half months, all t

19 administrations of sodium iodide in any form, I-123 or I-131, 20 for therapy or diagnosis have been preceded by a prescription.

21 Up until the time of the Federal Register article we only wrote 22 prescriptions for therapy doses.

23 I had the feeling initially that this would cause l

i 24 some problems with holding up studies but, in fact, that did i

25 not happen at all.

The endocrinologist knowing that I would be I

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reviewing all their cases before even a diagnostic dose was 2

administered tend to give me better and more complete 3

information and I think we actually improved slightly the 4

general level of medical care.

5 It certainly went generally smoother and although 6

some of them were miffed that they didn't have the power to 7

just order a test, they got used to it.

I told them it was 8

probably going to be the law.

They are just going to have to 9

accept it and they did.

10 I am going to retain that.

I think the lesson though 11 is that prior evaluation of patients for I-131 therapy 12 certainly is really a very helpful thing and as you have 7

1 13 pointed out in the discussions of misadministrations that 14 interposing the nuclear medicine physician between the patient 15 and the dose might have stopped some misadministrations, I

16 think probably there is some truth to that and I think that it 17 is not unreasonable to expect the nuclear medicine physician to 18 review cases ahead of time and that such a suggestion should be 19 in the parformance regulation.

20 After some six months now totally of considering 21 these proposed regulations and the circumstances that led to 22 them, I and the Society and the College am firmly convinced 23 that performance standards rather than prescriptive regulations 24 is the best approach to the misadministration issue.

25 Performance standards can be made practical and

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appropriate to any nuclear medicine practice environment and 2

many of them are really very different and this is so because 3

each nuclear medicine physician really has the burden of 4

defensible responsibility to do that.

He knows his practice 5

and he knows what he has to accomplish in the way of quality 6

assurance.

7 If acceptable performance standards are not conceived 8

by him or not adhered to, the NRC always has the power to 9

suspend the institution's license or institute fines.

At the 10

-present time, appropriate performance standards are required by 11 the Joint Commission on the Accreditation of Health 12 Organizations and their clout is hospital accreditation and

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13 reimbursement.

14 Performance standards can really work.

On the other 15 hand, as I have said before, I have found the suggested 16 prescriptive regulations to be very impractical and generally 17 unpromising as a generic approach to the solution of the 18 problem at hand.

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19 The Society of Nuclear Medicine and the American 20 College of Nuclear Physicians therefore propose that we work 21 with NRC to construct a guidance manual for nuclear medicine 22 performance standards.

23 This manual would then be used as a basis for the

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24 development of specific quality assurance programs in individual hospitals and other health organizations.

This 25

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should result in a rather uniform national standard, the 2

philosophy of which has been endorsed by NRC and hopefully a 3

decrease in-the already very low rate of misadministrations 4

caused by performance deficiencies subject to improvement.

5 For those Commissioners and members of NRC who are t

6 interested in specifics, I have assembled portions of our 7

nuclear medicine quality assurance program for you to read at 8

your leisure.

Some of you may not be aware of some of the 9

aspects of quality assurance that are on the horizon or that 10 are being incorporated by some of the larger institutions and i 11 thought you ought to at least have a chance to see what some of 12 the specific suggestions look like.

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13 Melissa Brown pointed out to me that the performance 1

14 standards manual that I was describing is very much like what 1

15 the National Institutes of Health does with experimental 4

16 animals.

i 17 They give you a manual of performance standards and 4

18 you have to come up with a quality assurance program at your l

19 institution that satisfies them.

So I brought a copy of that 20 not because we consider our patients to be experimental animals 21 but just as an example of a performance standard manual to look 22 at.

23 There are several computer programs that have j

24 recently become available that I think you might like to see 1

25 the printouts of.

One of them controls everything in nuclear l

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medicine, radio pharmaceutical quality control, patient

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2 identification, the dose that was given, the lot number, 3

everything you would want.

4 This is being sold at a decreased price or given away 5

by DuPont if you buy some of your radio pharmaceuticals from 6

them.

There is a similar program for radiation safety 7

officers that has been purchased by Medi+ Physics and they are 8

doing the same thing.

If you buy some of their products, they 9

will give it to you either cheap or free.

10 We had a recent inspection by the State of California 11 and when the inspector saw the radio pharmaceutical printouts, 12 he was most impressed with it and hoped that many orgm.izations f

13 would

• ve it.

14 The nice thing about it is that with a PC and a 15

$139.00 program called "Carbon Copy" you can access our data 16 from your office at the NRC directly and do your inspections 17 from Washington, in fact.

There are some very interesting 18 possibilities for keeping track of things with it.

So I am 19 going to leave this with Mr. McElroy and he will make it 20 available to any of you who would like to see it.

21 Thank you for the opportunity to speak and I thank 22 you for your attention and consideration.

23 CHAIRMAN ZECH:

Thank you very much.

We appreciate 24 it.

25 MR. BERNERO:

Dr. Tonnesen.

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DR. TONNESEN:

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Mr. Chairman and gentlemen, thank you 2

for inviting me to come.

As you heard, I am at a large 3

community hospital in this area, Fairfax Hospital.

My field is 4

mostly teletherapy which for NRC practices beams cobalt 5

machines although I do internal implants with encapsulated 6

sources but unlike Dr. Marcus I essentially never give free 7

radio pharmaceuticals to patients.

8 I have had the pleasure of giving Chairman Zech a 9

tour of our facility and I have assisted some of the NRC staff 10 in the early development of these rules and I, too, was at the 11 January briefing and I will try not to be too redundant in 12 repeating my comments there.

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13 I had a grave concern over one small portion of the 14 rule where it makes it the obligation of the licensed user to 15 be sure that the patient has been referred for a therapeutic 16 procedure.

I would like to just comment on that again.

17 There is already a duty of the physician to assure 18 that the benefits of a procedure out weigh the risks and the 19 duty of the physician to inform the patient of the natur<

of 20 the procedure and the risks and benefits and alternatives and 21 obtain the patient's consent.

22 The failure to perform that duty is already either a 23 criminal battery or a civil tort depending on the circumstances 24 and there is plenty of precedent for what happens to people who 25 don't perform that duty.

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In the introduction to your proposed rules, the NRC 2

policy is stated that the NRC will minimize intrusion into 3

medical judgments.

That portion is definitely an area of 4

medical practice that does not need further regulation and I 5

would like to see you drop that.

6 Moving on, the NRC has had a misadministration rule 7

in effect since, I believe, 1980 and has now a lot of data on 8

how frequent misadministrations are.

Because of the power you 9

have over licensure, I think you have a very good idea of how 10 many misadministrations there are.

I don't think you are 11 missing in your sampling procedure very much.

12 The numbers that wo have heard, about 27 l~(

13 misadministrations and so forth are already, I believe, down at 14 the noise level, at the human error level, where reducing them 15 further will be extremely difficult.

16 This is partly because of the clout that NRC has in 17 licensing, partly because of the inherent measurability of 18 radiation and partly because people who use radiation are 19 already trained to use radiation and they are not doing it part 20 time generally and also, through the ongoing quality assurance 21 programs that already exist through the Joint Commission on 22 Accreditation of Hospitals which as Dr. Marcus pointed out are 23 performance based rather than prescriptive and are generally 24 very effective.

25 Unlike your problems with nuclear power, for

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instance, I,

where the consequences of a mishap are so enormous 2

that enormous expenses are needed to prevent them, I think we 3

are at a level now where even very great expenses are not 4

likely to further reduce the rate of errors at least not in a 5

prescriptive sense.

6 The errors that are made may be minimized by better 7

education and by better qualifications but not by making a 8

more, what can I say, constrictive environment in which to use 9

the products.

10 CHAIRMAN ZECH:

But you are not saying, Doctor, that 11 there is no room for improvement, are you?

12 DR. TONNESEN:

There is very little room, sir.

I 13 think 27 misadministrations or a frequency of 0.01 percent is 14 incredible.

15 CHAIRMAN ZECH:

You don't think we can do any better 16 than that?

You think every misadministration was one that we 17 should expect?

18 DR. TONNESEN:

I am afraid that if you designed a 19 program to prevent all the misadministrations of the past two 20 years, we would find ways to make new misadministrations in the 21 next two years.

22 CHAIRMAN ZECH:

But that means, too, I mean, it is 23 saying what I think you are saying is that there is room for

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24 improvement.

25 DR. TONNESEN:

At a cost, yes, sir, but it would be

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an enormous cost compared to the benefit.

2 COMMISSIONER BERNTHAL:

I would just make the comment 3

for the record here that I believe it is still a fair statement 4

that in no case in the commercial use of nuclear power in 5

nuclear power plants have we seen injuries that are comparable 6

to the injuries that whether or not unavoidable, whether or not 7

down in the noise, that are comparable to the injuries that 8

have occurred because of certain misadministration events.

9 Now I am not speaking to frequency or any such 10 argument but that should be well understood.

We simply have i

11 had no comparable exposures.

4 12 DR. TONNESEN:

And we are all very glad of that, f

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13 COMMISSIONER BERNTHAL:

I am sure we are.

14 DR. TONNESEN:

It is just that the medical field is 15 different.

You haven't as much control.

I am sure you have 16 already been plagued with all these numbers about the real 17 accuracy of administering pharmaceuticals, aspirin tablets, and 18 how very frequent it is that a patient who is supposed to get 1

19 insulin really gets digitalis instead.

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20 It is very difficult to regulate in hospitals and the 21 fact that you have a very good idea of what is going on and 22 that it is very, very good already means that you are going to i

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23 have to spend a lot of money to make it a little bit better.

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24 There are always trade-offs.

1 25 There are.only so many dollars to spend on medicine 1

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and as a matter of fact, I have some ideas for how they might 1

2 be spent better.

3 COMMISSIONER BERNTHAL:

If I may, I don't want to i

4 interrupt too many times here, but we do have a requirement 5

here of which we are acutely aware these days because the court 6

has again made us acutely aware of it that we may not as a t

7 matter of our rules, we may not impose regulations that go 8

beyond adequacy without finding adequate cost benefit i

9 justification for those regulations.

10 That is called the Commission's Backfit rule, a name 11 obviously designed to fit with nuclear power plants but i

12 nevertheless applicable, l'

I think, throughout our regulatory 5.

13 structure.

14 The commission has not argued in this particular 15 case, I believe, that we do not have adequacy of protection in 16 this case nor have the staff argued that.

i The question is, as 17 the Chairman suggests, can we improve and then the second 18 question that we also have to answer for ourselves and the l

19 staff has to provide us with the justification is the issue you 20 raise, whether the cost benefit calculation and it is a 21 difficult one here because we are talking about human error.

I 22 It is very difficult to calculate but at least at some point 23 the staff will have to provide the Commission with an

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24 indication of whether we can make that justification.

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25 So we will consider that.

We have to consider that.

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We are now required as a matter of law to consider whether the P

2 benefits justify the cost.

I wanted you to understand that.

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think you are aware of that.

4 DR. TONNESEN:

Thank you.

Later on, particularly in 5

the advanced notice of the comprehensive rule you bring up a 6

valid point about the qualifications and certification of the 7

personnel who are dealing with these productions.

These

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8 involve technola,ists, physicists, physicians but especially 9

technologists.

10 Recently, the change in funding patterns has resulted 11 in a curtailment of the training programs for these 12 technologists.

Basically, hospitals can no longer write off k

j 13 their overhead for training programs and expect to get paid by 14 the federal government.

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15 Therefore, since they have to make ends meet, they 16 have curtailed the training programs and they no longer are i

17 qualified technologists coming out of training programs or not 18 nearly enough.

There never have been enough in my field and 19 now there are even more not enough, i

20 There is a desperate need to increase the quality and i

21 especially the quantity of these trained technologists and I i

22 don't know how you can do it because those decisions are made 23 at very high levels about medicare.

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24 But if you can somehow spend money more on generating

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25 good qualified people to handle these products rather than 1

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making rules on how those who are already there are going to 2

handle the products, you will be doing all of us a much greater 3

favor.

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COMMISSIONER BERNTHAL:

Maybe we ought to do both.

5 CHAIRMAN ZECH:

There are other branches of the 6

government involved in this matter.

We don't claim to be the 7

only one but I woJld point out that our responsibilities are 8

for public health and safety as it involves the use of nuclear 9

materials and that is what we are trying to focus on, of 10 course.

11 Training, we recognize, in all aspects of nuclear 12 technology is crucial so we certainly would support that within f,(

13 the bounds that we have authority to do so but I do think that 14 even though and we all like more training, but it seems to me 15 that there is room for improvement in almost all aspects of 16 human endeavor.

17 I certainly respect the fact that the 18 misadministrations are very low.

I would like to think though 19 that perhaps they can be improved upon and what we are trying i

20 to do here is to ask for your assistance so we come up with 1

21 something that really makes sense to you as well as to us and ll 22 to the American public.

23 I appreciate Dr. Marcus' views as regards willingness 24 to work with the NRC in developing performance based standards 25 and so forth and Doctor, I know from visiting you and your

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facility your initiative and your professional contributions in 2

this area so what we are trying to do is to ask for your f

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support and your assistance to make sure that anything that we j

4 might put out would actually improve even to a very small t

5 degree but certainly within the bounds of possibility, but we i

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6 don't want to put out something that is going to intrude into 7

the field of medicine or intrude certainly on public health and i

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safety.

9 We are trying to improve it even if in a very small 1

10 amount but my personal observation of things that have taken

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1 11 place even in the short time that I have been involved on the i

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12 commission have led me to believe that there are occasionally f

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13 misadministrations although very, very few in number, I will 14 certainly admit, but there are a few that seem to me that i

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15 perhaps could have been prevented and I do think that if we can 16 even only save a life or two in all this that we are doing that 1

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it may be well worth while, a

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So what we are trying to do is make improvement in an

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i 19 area that we recognize is being very well handled but we do the 20 same thing in our other responsibilities as far as power plants 21 are concerned.

They also have a pretty good record of safety.

22 on the other hand, we keep trying to make them as 23 commissioner Bernthal points out above the adequacy level and

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24 that is what we are talking about here today, I think We are 25 not trying to say it is inadequate in any sense of the word but 4

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we are trying to say is there a way you can help us to improve N

2 in this field that you are really the experts in and we need 3

your assistance.

4 DR. TONNESEN:

I hate to even begin to sound 5

argumentative and please don't take it that way, it is just 6

when you say "to save a life or two," we all want to do that 7

and if you even say what is the value of a human life, we are 8

all willing to put a very large number on that but if you want 9

to save a life or two, you can do that in a lot of ways in the 10 medical business because nobody has enough resources.

11 You can buy a few more ambulances for Washington, 12 D.C.

You can buy us a helicopter.

You can fund a new 7..

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13 operating room.

In my own department I can come up with lots

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14 of ways that a million dollars a year could save a life or two.

15 CHAIRMAN ZECH:

But we are talking obout 16 administration either diagnosis or therapy usually, I suppose, 17 where it wasn't done right.

18 DR. TONNESEN:

But see, I have to decide how to spend 19 the money in my department and if you impose a rule that 20 requires me to spend the money to satisfy that rule, it means I i

21 can't spend the money on something else and I am saying that i

22 the bang for the buck can satisfy a more stringent rule.

23 CHAIRMAN ZECH:

We are only asking you, Doctor, as

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24 far as I can understand, we are only auking you in this narrow i

25 field that I am describing to you where misadministration did I

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take place,

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is there something that could have been done or 2

should have been done that would have prevented it.

3 I recognize you can spend muney for ambulances and i

4 all kinds of other things but in that particular instance, is 5

there something that could have been done or should have been 6

c0ne that would have within our authority or your authority or i

7 your professional judgment, is there something that could have 8

been done that would have prevented that from happening.

That 9

is all we are talking about, that very narrov field.

10 DR. TONNESEN:

In fact, my hospital has never had a 11 misadministration 'n my therapy department so no matter how 12 much money I spent I couldn't have improved my track record j

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13 any.

i 14 CHAIRMAN ZECH:

But not everyone can say that.

15 DR. TONNESEN:

That is true.

16 CHAIRMAN ZECH:

We are talking about those who have 17 had preblems.

18 DR. TOHNESEN:

But if you pass the rule, I have to 19 sp -

the money anyway.

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20 CHAIRMAN ZECH:

Well, not necessarily.

If we pass 21 the right kind of rule and you have a record of that kind of 22 performanco, if we write the performance standards like we are 23 trying to talk about that Dr. Marcus has emphasized that we 24 should do rather than be more prescriptive and we certainly 25 would want to do th9t.

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DR. TOHNESEN:

Exactly.

2 CHAIRMAN ZECH:

But we need your help to do that.

I 3

would hope that then perhaps we would be helping or assisting 4

perhaps those hospitals, those doctors, those physicians who 5

i have indeed had some kind of a pr'oblem and I think it is 6

commendable that you have not and I hope that the good Lord t

7 will continue to give you that kind of a record.

i 8

4 DR. TONNESEN:

Thank you.

9 CHAIRMAN ZECH:

And I know you do, too, but perhaps 1

10 there are others that have not been as fortunate and some of 11 these things happen, I honestly believe, through certainly no i

12 malicious intent, it is just through perhaps a lack of 13 training, perhaps a lack of understanding, perhaps some kind of i

14 carelessness that might have been preventable.

i 15 DR. TONNESEN:

How we are saying the same thing, that when performance is good, performance based standards will 16 t

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17 allow you to say, "Fine, we are doing a great job with the

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18 status quo."

The problem is that the standards before us are f

j 19 not performance based, they are prescriptive.

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20 CHAIRMAN ZECH:

Well, we have interrupted you enough, i

21 Doctor, please proceed.

4 22 DR. TONNESENt I am sorry, I have interrupted you,

\\

23 too, sir.

Basically, I think I have said enough and I thank i

j i

24 you for the opportunity to be here and I would be delighted to 1

1 25 I

answer any questions if I may.

1 4

23 1

k, CHAIRMAN ZECH:

Thank you.

t 2

COMMISSIONER BERNTHAL:

I would just make the comment j

3 that as far as I know it is not a done deal yet, the kind of 4

prescriptive rulemaking that staff has proposed.

I 5

COMMISSIONER CARR:

That is shy we are here.

I i

6 COMMISSIONER BERNTHAL:

Yes, I think somewhat at the 7

behest of the Commission, I cm not going to say that staff did i

8 all of this, the Commission observing the record and I have 1

9 been here now longer than anyone except Commissioner Roberts 10 who is two chairs over observing the record.

11 COMMISSIONER ROBERTS:

You don't have to emphasize 12 that, do you?

f

(.

13

( Laughter. )

14 1

2 l

COMMISSIONER BERNTHAL:

Where was I?

i 15 COMMISSIONER ROBERTS:

I don't know.

I 16 COMMISSIONER BERNTHAL:

{

Observing the record, we felt 17 that something could be done and I think staff responded to i

18 tnat sensitive need.

I do want to get back to the point though i

19 of cost benefit because you keep coming back at least I

a i

j 20 implicitly to that point and I am looking at the staff briefing i

j 21 which they gave the Commission before we hear from you today 22 where the staff jndicated that the incremental cost per i

23 misadministration averted was $20,000.00.

t 24 That is Lord knows a difficult estimate to make and I 25 am sure the error bars on that, the uncertainty bars rather are I

4

s 24 1

pubstantial but it would not be difficult then to tran l t sae 2

that $20,000.00 cost per misadministration averted into cost 3

per man rem or thousand man rem, person rem, excuse me, ave 4

which is a standard that unfortunately we do apply in this 5

agency.

6 We do attach a certain value to human life if you 7

vill and to health effects.

We have to do that.

We have to 8

have some standard.

I Quess I would ask staff at some point 9

and maybe not right now in the midst of your presentation to 10 remind us and respond again on the cost benefit question i

1 11 because it is a key point that you raise.

12 Would it really be better to spend the money in t*

I l

13 training?

Is this simply not cost beneficial enough even

(

14 within our regulatory authority?

We don't have that much 15 authority over the training that you are talking about but is 16 this $20,000.00 incremental cost per misadministration averted, 17 does that simply not justify the person rems avoided 18 DR. TOHNESEN:

At the risk of wearing out my welcome, 19 I am going to doubt that number.

20 COMMISSIONER BERNTHAL:

All right.

21 DR. TONNESEN:

If there are 27 misadministrations and 22

$20,000.00 per, that is only a half a million dollars I have 23 no idea how many licensed users you have but if there ar i

24 5,000 of them, you are only talking about a $100 00 p er utar.

25 It would cost a lot more than that to satisfy this rul e, a lot

^

t a

g 1

25 i

more.

t 2

COMMISSIONFR CARR:

Is your data bank the same as 3

mine?

4 DR. TONNESEN:

I don't know.

5 COMMISSIONER CARR:

Are you using our data bank?

6 DR. TONNESEN:

No, sir, I don't know.

7 COMMISSIONER CARR:

My brief sheet says that we have 8

more than 50 misadministrations from 1984 to 1987 but even more 9

worrisome is we don't even get all the reports before 1980 f 10 rom 1976 to 1980, there was one misadministration that involv 11 patients.

So I am not sure we are dealing with a good dat 12 a

bank that gives me a warm feeling that we know fi

(

13 rst how many are occurring and if we call one misadministration and it 14 affects 400 patients, we may have a whole lot of peopl e rather 15 than just 27 people.

16 DR. TONNESEN:

I am afraid I do not have your data 17 bank, sir.

18 COMMISSIONER CARR:

I am not sure it is worth having.

19 (Laughter.)

20 DR. TONNESEN:

The number we have been throwing 21 around at the January briefing was 27 misaC.ninistrations 22 over I don't know what period, perhaps one of the staffcould help me, 23 but that was the number we were using to come u t

p with the 0.01 1

24 percent misadministration rate.

25 MR. TAYLOR:

I think we ought to share our data with

{

J

a 26 1

him.

(s 2

COMMISSIONER CARR:

It seems like we should, yes.

3 MR. TAYLOR:

It is a first start anyhow.

4 COMMISSIONER BERNTHAL:

Do you have some level, if I 5

may turn to the staff for a moment, do you have some level of 6

confidence in this $20,000.00 number and Jim, how did that 7

translate into cost per thousand person rem or whatever 8

MR. TAYLOR:

I think a gentleman is here who has 9

worked on it.

10 MR. BERNERO:

Yes, Norm is here.

11 CHAIRMAN ZECH:

Would you identify yourself for the 12 reporter, please?

r(

13 MR. McELROY:

I am Norman McElroy from the Medical 14 and Academic Section.

15 CHAIRMAN ZECH:

Thank you.

16 MR. McELROY:

Various individuals on the staff have a 17 various degree of confidence in that calculation.

I would have 18 added another zero on the tail end and come up with about 19

$200,000.00 per event averted.

20 I would also note that we typically do calculations 21 with a healthy population when we look at cost per life saved 22 and that is not the population that you are dealing with in a 23 hospital.

So the calculations very quickly become laden with 24 very important societal considerations from policy 25 considerations that I think are a little bit different tha

o 27 1

environment that you folks are used to working in.

('

2 COMMISSIONER BERNTHAL:

Lest I be accused of being a 3

physicist or something, I don't want to make too much a 4

numerical exercise out of this but let's say it is $200 000 00 5

per misadministration, what is the average dose per 6

misadministration?

Does anybody know?

7 MR. McELROY:

I hesitate to respond to that because 8

is not typically a whole body dose which again is I think, the 9

kind of calculation you are used to working with in power 10 plants.

It is typically a very large dose to a very small 11 portion of the body and the science is a little bit more 12 difficult to use to predict the effect on the patient

,~(,

13 COMMISSIONER BERNTHAL:

Mayht; somebody can think 14 about a reasonable guesstimate just to see if we are in the 15 ballpark here but maybe we should go on.

16 CHAIRMAN ZECH:

All right.

Let's proceed.

Did you 17 finish, Doctor?

18 DR. TONNESEN:

Yes.

19 MR. BERNERO:

Otha Linton, would you make your 20 remarks now?

21 MR. LINTON:

Thank you, sir.

Mr. Chairman, 22 gentlemen, ladies and gentlemen, I feel like I am coming in the 23 middle of this discussion but perhaps I will carry on I am 24 the Associate Executive Director of the American Colleg e of 25 Radiology and about,8,500 of our 20,000 members are li censed i

28 1

either by you or by a state to use byproduct material I '

2 I also represent the American Society of Therapeutic 1

3 Radiologists and Oncologists most of whose 3 000 member s also 4

belong to the College so I have Dr. Tonnesen twice for 5

example.

6 As a generalization the ACR has complimented the NRC 7

and the Atomic Energy Commission on enlightened regulato 8

approaches cver the years which have emphasized safety and ha e

9 avoided intrusions into medical judgment and practice 10 On the whole, your regulations have been practical 11 and cost effective.

In the opinion of our expert committees, 12 the ones before us now don't meet your standards Thus, our

(

13 comments are not supportive of further regulations as a ba i ss 14 for improving safety and quality.

15 ACR, for example, has a long history of its own 16 quality assurance programs applicable to the use of isotop s

17 and those, too, have had a significant. impact on the quality of 18 practice that we now enjoy.

19 Those approaches include, of course, education, 20 standard sotting and credentialing those who can regulate 21 those who nave to educate.

So we are all coming from our 22 points of view.,

i 23 We have three points, sir, and essentially we are i

24 agreeing with what has been said here.

The quality is 25 amazingly good and certainly the Commission and its activiti es

~

29 1

deserve a very large share of the credit for achieving and t

2 maintaining that quality.

3 We fear in the sense of prescriptive regulations that 4

we hcVe passed de minimis and are approaching reductio ad 5

absurdum ar.$ the best and tightest regulations won't keep 6

somebody from making a mistake and hurting somebody.Maybe it 7

will decrease this aiready small number but perfection is 8

beyond all of us.

9 CHAIRMAN ZECH:

If I may interrupt very briefly, we 10 know the risk is not zero.

11 MR. LINTON:

Right.

12 CHAIRMAN ZECH:

We appreciate that.

We are not f'

i 1.3 asking for zero risk.

We are just asking in your professional 14

opinions, is there any way we can improve and if so, we want to 15 listen to those.

16 MR. LINTON:

I will come to that, sir.

17 CHAIRMAN ZECH:

Thank you very much.

18 HR. LINTON:

The second problem that we have had with 19 this is the misadministration rule itself and I think th e

20 discussions that have just preceded us almost reflect that ki nd 21 of problem.

22 As it was written several years ago, your answers are 23 drafted by the institution's lawyers unose purpose is to avoid 24 obligations and not as was the case prior to that to share with 25 you the observations of physicians and physicists about chat

30 1

went wrong and how can we keep it from happening anywher 2

again.

else 3

The other thing, of course, is that the definition of 4

a misadministration is such that while one misad n

5 harmed 400 people, many of those reported harmed no one.

You 6

ask about the average amount of misadministration.

It could be 7

a fraction of a rad in a diagnostic misadministration It 8

could be as little as 100 rads in a therapeutic administr ti a

on 9

because of the way the rule was not very well cou h d ce 10 So we have urged you on many occasions and let me d 11 o

it again in the context of this to define misadmini t s ration so 12 that whatever efforts you devote to them are re ll r

1:.

13 a

y getting at the actual problems and not making more work for the attorneys 14 of the world.

15 If you were an attorney, I would not want to do you 16 out of work otherwise, but here would be fine.

17

[ Laughter. )

18 COMMISSIONER BERNTHAL: That's all right.

You are 19 welcome to advocate that.

20 MR. LIMTON:

My daughter the law student tells me to 21 quit doing that.

22 CH?.IRMAN ZECH:

Well, let me defend our attorneys 23 1

just very briefly.

\\

24

[ Laughter.)

l 25 CHAIRMAN ZECH:

Because we make up the rules, we aro

31 a,

1 the policy makers are at the Commission level

\\'

2 and we rely on the attorneys to assist us.

On the other hand, when we make 3

the rule, they have to interpret them and apply them, too.

So 4

we at the Commission, I think, accept the responsibility We 5

try to make the best tactical decisions we have relyingon our 6

technical staff who I think are superb.

We also rely on our 7

legal people who I also think are superb.

We are well served.

B But if the mistakes are made, it is made by the 9

Commission.

It is our judgment and we accept that 10 responsibility but we do think that we have some pretty fine 11 legal people as well as some pretty fine technical peopl e and I 12 just want to make that point that this Commissi

$~

on is well 13 served by our staff, legal and technical.

14 MR. LINTON:

We have admired all of those levels over 15 the years, sir, and think the problem is a difficult one.

16

Actually, I was attacking the other lawyers who are trying to 17 fight you back but still they may all be kin to one another for 18 all I know.

19 CHAIRMAN ZECH:

There are all kinds of lawyers all 20 right, but we have some awful good ones is my point here a 21 they do serve us well.

22 MR. LINTON:

Let me try to recover from all of that 23 then.

i

\\

[

24

[ Laughter.)

i

\\

25 MR. LINTON:

The third of our points before we get to

32 1

the good side of all of this is that you are a very vital part

(

2 of a web of public and professional responsibility which goes 3

into the creation and support of the standards that Dr 4

Tonnesen referred to and you will hear from Captain Gross and 5

we might mention the Joint commission on Accreditation of 6

Health Care organizations, the American Board of Radiology, the 7

American Registry of Radiologic Technologists, the College, the 8

Association of Physicists in Medicine and on and on.

9 The patterns of care study which the American College 10 of Radiology has carried out for the National Cancer Institute 11 has done more to define the state-of-the-art practice in cancer 12 treatment than any other single activity and Dr. Tonnesen's 13 organization participates in that, for example.

14 What it is to say is that there are a lot of people 15 working toward the same aim and that certainly your 16 responsibility is a very real and direct one but it is by no 17 means the only thing going for what we are at.

We, too, are 18 concerned about costs.

19 We are particularly concerned right now in that the 20 Medicare program will very shortly take about 20-cents of the 21 hospital's dollar out of the way it ways for any radiology 22 service including all of those in isotopic medicine too.

So 23 that even a little more expenditure comes at a very painful 24 moment unless there is a terribly good reason for it 25 Now having rained on the parade up to now, sir, may I

33 1

b offer some suggestions of where to go, 2

CHAIRMAN ZECH:

We would appreciate that very much.

3 MR. LINTON:

Well, the staff warned me, sir.

4 CHAIRMAN ZECH:

Good.

5 (Laughter.)

6 CHAIRMAN ZECH:

We are asking for help.

We know we 7

have problems.

That is why we are all here.

8 COMMISSIONER CARR:

If you help us, you help 9

yourself.

10 MR. LINTON:

Absclutely. sir.

11 CHAIRMAN ZECH:

We are looking for assistance and we 12 are grateful for your being here today and we are very anxious p

1 13 to hear your comments.

Please, proceed.

14 MR. LINTON:

I can hardly wait myself, sir.

15 CHAIRMAN ZECH:

Good.

16 (Laughter.]

17 MR. LINTON:

The first would be for the NRC to 18 reaffirm its interest in safety and stay in that area.

The 19 intrusion into medicine is something that people bristle at 20 CHAIRMAN ZECH:

Don't let us do that.

We don't want 21 to do that.

22 MR. LINTON:

All right, sir.

23 MR. PARLER:

You can't do that.

24 CHAIRMAN ZECH:

That's right.

There is my lawyer 25 speaking up, see.

l

i, 1

34 (Laughter.)

N 2

MR. LINTON:

He is one of the good ones.

3 CHAIRMAN ZECH:

He is o:., of the good ones, that is 4

right.

5

[ Laughter. )

6 MR. LINTON:

The second is as our committee talked 7

over this thing and we listed all of the things I have cit d e

8 and you have heard here, it occurs to us that perhaps all of 9

together haven't really put it together to see if in fact, 10 there is a gap somewhere that either you or the FDA or somebody 11 else might pick up on.

12 We think that correlating all of this f

1 13

, not just is the Commission doing its job, but together volunteers, other 14 agencies and so forth, is there, in fact, a gap and we wou 15 urge you to take the lead in a correlative effort and in that 16 respect discussions not only with you but meetings c ll d a

e for 17 your staff, the other agencies, groups like the College, I

18 think in a fairly short time could turn that up and tell us all 19 the constructive ways to go.

20 We would like to urge that on you and we would lik 21 e

to offer on behalf of the College and I suspe t th c

e other 22 groups to be part of that if we can go that route So that is 23 our pitch, sir.

Thank you.

24 CHAIRMAN ZECH:

Thank you very much.

We appreciate 25 it.

I

1 35 1

MR. BERNERO:

Dr. Khan.

2 DR. KHAN:

Mr. Chairman, ladies and gentlemen, I am 3

professor of medical physics at the University of Minnesota and 4

I am representing the American Association of Physicists in 5

Medicine.

6 I thank the Commission for inviting the AAPM to 7

present their views in this meeting.

A formal item by item 8

response to the proposed rules has already been submitted.

At 9

this meeting I would like to address the general issue of 10 quality assurance and present my views on how a regulatory 11 agency like the NRC should approach this problem.

12 It is well known that the standards of radiotherapy g*

k..

13 practice are not uniform across the country and that some

\\

i 14 facilities do provide sub-standard care to their patient s.

15 Patterns of Care Study under the American College of Radiol i

ogy 16 has demonstrated that standards of care do vary and that th i

e 17 quality of radiotherapy practice is definitely linked to the outcome of treatments.

18 I

19 Facilities that are ill-equipped and ill-staffed are 20 the ones that operate without adequate quality assurance

and, 21 therefore, pose a threat not only to their patients' health b t u

22 also to their employees and the general public.

23 It is obvious that the NRC is trying to upgrade the

{

24 standards of practice by introducing regulations that cover 25 some selected aspects of quality assurance.

The idea is a

36 1

nobel one but the problem is that by identifying a few qualit 2

assurance procedures based on some isolated accidents is not, 3

in my judgment, going to eliminate the possibility of more 4

accidents or, more importantly, improve the standards of 5

community practice.

6 On the other hand, it may encourage users to follow a i

7 few regulations simply to satisfy the NRC but still not improve 8

their standards of practice.

For example, there is no law that 9

prohibits facilities to operate with inadequate equipment.

l 10 A cobalt unit that has poor beam geometry and poor 11 depth dose can compromise the treatment of a cancer patient who 12 needs better beam characteristics, accurate beam delivery,

(

13 higher photon energy or electron beam.

14 A facility that treats all different types of cancer 15 patients with an obsolete cobalt unit is symptomatic of a real 16 lack of desire to upgrade its standards of practice and

\\

17 therefore is more likely to cut corners in quality assurance 18 I strongly feel that the NRC instead of making rules 19 based on isolated incidents should make it mandatory for the 20 licensees to follow: (a) the staffing and equipment guidelines 21 as recommended by an organization called ISCRO, and I would not 22 like to spell it out because it is very difficult, but anyway, 23 (b), the quality assurance guidelines published by the AAPM, my

[

24 own organization.

Actually, that document exists.

Now it 25 needs to be updated and I think we would like to work with the

f..

1 37

(

NRC to update it and include some of the g ood points which weg 2

proposed in the rulemaking.

3 NRC inspectors could review institutions qualit 4

y assurance procedures, for example, procedures and their 5

frequency, log books, staffing, et cetera, in the light of the 6

above reports.

My point is that instead of legislating in 7

response to accidents when or if they happen, the approach 8

should be to have the QA programs in place in writi ng and the 9

NRC review them and oversee implementation as well as minimize 10 the type of accidents that the NRC is concerned about.

11 Another point I would like to make is that th 12 e NRC

(

should not interfere in the conduct of therapeuti c procedures, 13 medical prescription or other decisions related to patient care 14 and that is obvious that this meeting nobody disag 15 rees with.

However, the NRC has every right to demand that th 16 byproduct material is used safely and that e

17 proper quality assurance procedures are in place.

The required quality 18 assurance procedures for the radiott irapy equip ment are 19 available in the current AAPM document as I mentio ned and the 20 NRC can adopt this or an updated model of it 21 These recommendations are based on well r 22 esearched opinions of a task group on quality assurance of th 23 e AAPM and not a collection of rules and regulations whichoften hinder 24 rather than facilitate optimal health care deliv 25 ery.

Now I would like to summarize all of thi s by three

O 38 1

points that I have.

First, the NRC should adopt a model

(

2 quality assurance' program in cooperation or in collaboration 3

with the AAPM and the American College of Radiology and the 4

licensees should be required to have this program in place and 5

NRC inspectors should verify that it is being implemented.

6 Second point, the NRC should demand proper staffing 7

to implement the program.

Staffing means that the staff that 8

takes care of the quality assurance is well trained, is, for 9

example, board certification is one requirement that could be 10 considered and they should have qualified. physicians, qualified 11 physicists and qualified technicians to do the quality 12 assurance.

The Blue Book by the ISCRO, it is called Blue Book 1

g 1

13 because the color is blue, has staffing recommendations and 14 that should also be considered when making recommendations on i

{

15 this issue.

16 Three, the NRC should leave the details of medical 17 practice to the professionals involved.

Organizations such as 18 the Joint Commission on Hospital Accreditation can attend to 19 more of these details than the NRC inspectors can.

So thesa 20 are my three points.

21 CHAIRMAN ZECH:

Thank you very much.

We appreciate 22 it.

Thank you.

l 23 MR. BERNERO:

I would like to call on Captain Gross 24 now, please.

25 CHAIRMAN ZECH:

All right, thank you.

You may

39 1

proceed.

t.

2 MR. GROSS:

Thank you, Mr. Chairman and 3

Commissioners.

I appreciate the opportunity to come here today:

4 and describe a medical quality assurance program that the S

Center for Devices and Radiologic Health has had in place for 6

some time.

7 I am speaking today from the perspective of an 8

organization with nearly 30 years of experience in the 9

development and implementation of voluntary educational 10 programs in cooperation with the states, manufacturers and 11 medical professionals.

Our more recent regulatory activities 12 are directed primarily at manufacturers.

(.

13 I would like to mention a few of the more recent i

14 examples of the impact of these efforts beginning with our i

t 15 efforts to encourage quality assurance programs in diagnostic 16 radiology facilities.

i 17 While I will restrict my comments here to fit within i

18 the time allotted, I would encourage the NRC to conduct a 19 separate meeting to discuss specifics in more detail.

i When our

{

20 program was initiated, quality assurance programs were 21 essentially unknown in medical facilities and measures of 22 quality were basically left to the eye of the beholder.

23 The first step in changing this was to identify

{

24 specific problems resul*.ing in unproductive radiation exposure 25 Quality assurance solutions were then developed to correct

40 1

these specific problems.

st 2

Demonstration projects were conducted in medical 3

facilities which showed the effectiveness of the solution 4

strategies and helpful written manuals were published by the 5

agency.

6 A comprehensive formal recommendation describing the 7

organization of a quality assurance program was published in 8

the Federal Register in 1979.

Although the ten elements of the ;

9 recommendation were discussed in relationship to a diagnostic 1

10 radiology facility, the principles they outlined would be 11 applicable in any medical area.

12 These recommendations and manuals continue to se g-1.

13 as a guide to individual facilities and the industry in the 14 development of quality assurance programs.

Our efforts to 15 encourage the spread of good QA programs have been reinforced 16 by cooperative projects with respective medical professions and 17 appropriate segments of industry and the state radiation 18 control programs.

19 The initial focus of these programs were the 20 hospitals because of their high patient workload.

Today nearly 21 all hospitals and many non-hospital medical facilities have 22 implemented quality assurance programs for diagnostic 23 radiology.

This does not mean that all of the technical 24 problems that result in unproductive patient exposure are 25 solved but the basis for their solutions are in place.

l t

41 k,.

1 The situation with mammographic examinations provides 2

a recent example of the process and the involvement of 3

industry, the medical professionals and state radiat19n control 4

program personnel.

When NCI began its program to encourage the 5

expansion of mammography capacity in the United States, FDA was 6

concerned about the rather high exposures in that examinations 7

Working with the radiology community we were able to determine 8

what parameters were essential to proper mammography, good 9

images with reasonable exposures.

10 In time, manufacturers were able to improve the 11 equipment available for mammography and the essential exposure 12 levels were reduced.

r*

The states were also provided with a i.

13 program that was effective in identifying the problem areas and 14 were able to demonstrate to the medical personnel how they 15 could improve quality and reduce unnecessary exposure.

16 Recent studies in cooperation with the Conference of 17 Radiation Control Program Directors have demonstrated that 18 these voluntary programs have reduced mammography exposures 19 about 50 percent over the last ten years.

Recent cooperative 20 efforts of FDA, the radiology community and the states have 21 concentrated on further improvements in image quality.

22 In 1984, the FDA published separate quality assurance 23 recommendations for nuclear medicine.

While we have less 24 information about the extent of their implementation, there has 25 been strong professional organizational support for voluntary

42 1

(

quality assurance programs in nuclear medicine.

2 Even more recently and in a fairly short period of 3

time, we have had similar impact in other areas of medicine, 4

specifically, in anesthesiology and hemodialysis.

In the cas%

5 of anesthesia with no regulatory action a cooperative project 6

with the anesthesia community has successfully reduced user 7

errors that result in misadventures.

\\

This has resulted in the) 8 reduction of medical liability claims and this has in turn 9

reflected in reduced premiums.

10 j

This past Sunday the minister in our church made the 11 observation that if the only tool we have is a hammer, then all 12 our problems look like nails.

Based on our experience, we g.

13 would encourage the~NRC to look for different tools especia 14 educational tools that may be more appropriate for this

{

15 particular set of problems than is the regulatory hammer.

16 Like regulatory solutions, educational solutions must 17 be maintained.

With educational solutions, however, much of 18 the maintenance is provided by the professions involved For 19

example, FDA started workshops to encourage good QA pro 20 nuclear medicine.

In a short time those workshops were taken 21 over by the professional groups.

The result, of course, is a 22 reduced overall cost to the government.

23 The involvement of the professions in the problem 24 definition and the solution strategy also tends to insure that 25 the issues are clearly and fairly defined.

The resulting

43 1

(

solutions are reasonable for medical facilities that are th 2

target audience for these programs.

3 Doctors don't want to practice bad medicine and once 4

problems are pointed out in a way that makes sense to them, out 5

experience indicates that they will work hard to correct those 6

problems.

That is my five minutes.

Thank you, sir.

7 CHAIRMAN ZECH:

Thank you very much.

We appreciate 8

it.

Does that complete the presentation?

9 MR. BERNERO:

Yes.

I would like to thank our guests 10 here at the table and ask if we can change places here.

11 MR. PARLER:

Mr. Chairman, while the folks are 12 changing places, may I make a brief comment for clarify of the t'

i, 13 record?

14 CHAIRMAN ZECH:

Certainly.

15 MR. PARLER:

Some of the earlier discussion may have 16 left the reader of the transcript with the impression that the 17 Commission's Backfit rule applies legally in this area of 18 course, the Commission's Backfit rule only applies to 10 CFR 19 Part 50, nuclear reactors production and utilization 20 facilities.

However, generally speaking across-the-board in 21 any of this agency's regulatory rulemaking endeavors, we do 22 look at the thing from the standpoint of the cost effectiveness 23 of the rule.

i' 24 CHAIRMAN ZECH:

Thank you very much.

I appreciate 25 that.

44 g

1 MR. BERNERO:

Gentlemen, if you could join us, L

2 please.

3 CHAIRMAN ZECH:

All right.

Mr. Bernero, will you.

4 introduce our other guests, please?

5 MR. BERNERO:

Yes.

The gentlemen who have joined yo(

6 l

now are all members of the formal committee, the Advisory 7

Committee on the Medical Uses of Isotopes, and starting on the, 8

immediate left of Jim Taylor here we have Dr. Vincent Collins 9

who is a radiation oncologist in private practice in Houston, 10 Texas.

11 The next gentlemen is Dr. Melvin Griem, also a 1

12 radiation oncologist at the University of Chicago.

Next down 13 the line is Dr. David Woodbury, a practitioner in nuclear 14 medicine at the Westland Medical Center in Westland, Michigan 15 and on the far end of the table is Dr. Peter Almond, a medical !

16 physicist at the University of Louisville.

17 As I said, these are all members of the Advisory 18 Committee on the Medical Uses of Isotopes.

They participated 19 in the January meeting and they are available to discuss their 20 comments with you.

Perhaps I can turn to Dr. Collins first.

21 DR. COLLINS:

My background is as a faculty member at 22 Columbia University and then chairman at Baylor but for 15 23 years I have been in practice in a 200-bed hospital so I speak 1

24 for the minor facility.

25 Now whether dealing with a breathing session or a

45 i

quality assurance program or that familiar classic course of s

2 mules, it is necessary to catch attention to start with We 3

have here a rule and there can be objection whatsoever to 4

of these.

We can all be in favor of it, in favor of safety aC 5

quality assurance.

The question is, is there any excuse 6

whatsoever for a limitation to'be placed upon this.

?

All of you here travel from home to get to the placG 8

today.

You are fully aware that across the country there will 9

be thousands of accidents and dozens of deaths on the publi t

10 highway.

We are not in favor of this.

We are in favor of 11 prevention.

How many of you travel in a car equipped with a 12 roll cage?

p I.

13

[No response.]

14 DR. COLLINS:

Nobody?

15 CHAIRMAN ZECH:

What kind of a cage?

16 DR. COLLINS:

A roll cage.

There may be some reason 17 to restrict safety as for as driving a car is concerned 18 perhaps we are all not required to do that.

19 However, we come to our smaller institutions.

These 20 probably should be studied not so much for the purpose of 21 policing as for assisting.

Consider, for instance, Mrs. Billie) 22 Jo Brown, the double name is rather common throughout th e

23 South, and he is a truck driver is some remote place, say, 200 i

24 miles from Houston and mom has Hodgkin's disease, she has a 25 carcinoma of the cervix, we are going to require treatment It

46

(,

1 is 200 miles to Houston, she won't be hospitalized for this, 2

board, room, who is going to look after the kids, dad has to l 3

drive that truck to pay the bill, maybe we really ought to haq 4

a local facility _for treating such things.

5 Now how do we do this?

Well, for quite a few years '

6 my Department did operate a network, a treatment planning 7

network, across the South from New Mexico through Texas to l

i 8

Louisiana where institutions, not institutions, but set-ups in i

9 small towns usually with a cobalt unit were performing the 10 function of saving Mrs. Billie Jo from having to trat'el 200 11 miles, an impossible economic handicap.

12 Well, by telephone, by telecopier, by transportation

,~(

13 the patient for consultation, by visits from our physicists, i

wo 14 did manage to operate these things.

15 Each of us have an opinion.

We speak in light of ouri 16 education, background or bias and we listen in a similar l

17 fashion.

I am speaking from experience in this kind of thing 18 and I don't think I share that with members of the commissio 19 Now in these organizations out there we must consider 20 what is the need for cancer care in a small community.

Is that 21 necessary?

Well, my experience is one thing, yours may be 22 another, the others in the audience may be still different.

23 What is the need of such a small cancer clinic?

What does it 24 need to operate?

25 certainly an appropriate quality assurance program

o 47

k. -

1 for each would be desirable and what they really need is a 2

program of assistance to achieve an appropriate level of 3

excellence and I might have started it by saying that 4

everything I have to say has already been said.

I am not 5

saying something different.

I am saying it differently 6

perhaps.

7 Such programs should be encouraged and developed with 8

a performance based quality assurance rule more appropriately 9

and effectively than prescription based rule.

We had the 10 representatives here of the College of Radiology, the American 11 Association of Physicists in Medicine, the American College of 12 Medical Physics, the Health Physics Society, the Joint r

k 13 Commission on Accreditation of Hospitals, the Association of 14 Community Cancer Centers, all are concerned with this.

All 15 have something to contribute.

It is possible we could begin a 16 collaboration.

17 So in line with what has been said, my suggestion is 18 that we have talent avullable, we have programs in course.

19 Have in mind that community facility out there that would 20 really like to do better because the man who is relying upon a 21 referral practice must have the approval of both the patient 22 and the referring physician if he is going to survive.

He 23 wants excellence.

He will assist, he will collaborate if we 24 can provide a program for him, such things as the Blue Book, 25 the other suggestions that have been made is what I am talking

48 l 1

about.

k 2

So in that case, I think that really sums up what i

3 have to say and I can only add that my personal car does hav 4

roll eage in it and if there is anyone here who feels tnat 5

quality arsurance should be subject to no limitation whatsoe 6

and that they, therefore, would like to have a roll cage, I

7 would be pleased and happy to provide a prescription for such 8

ro) cage after this meeting is over.

9 (Laughter.)

10 CHAIRMAN ZECH:

Thank you, Doctor.

11 COMMISSIONER CARR:

Do you have an air bag, too?

12 (Laughter.)

r Iv 13 DR. COLLINS:

I don't need one with a roll cage!

14 CHAIRMAN ZECH:

Dr. Grien, pleaue proceed.

15 MR. BERNERO:

Dr. Griem.

16 DR. GRIEM:

I wish to thank you for inviting me to 17

coms, Let me introduce myself.

I am Professor of Radiation 18 oncology at the University of Chicago and I started my career 19 at the Atomic Energy Commission Hospital there, theo 20 Hospital, in 1954 and you people bent a twig in the direction 21 i

of working in this field.

Then I received a research career 22 development award from the NIH and I have served on the 23 Radiation Study Section for over eight years.

24 IhavewrittenanumberofarticlesandIco-autho 25 a text in this general area about two years ago in which we

49 1

invited about 30 people, Dr. Paliwal and I, to participate in

(

2 week long session on treatment planning.

3 Now none of the authors nor the editors receive any; 4

money from this and this is really although it is $20.00, the 5

Radiological Society of North America subsidizes this as an

{

6 educational effort.

We sold over 2,000 copies of this.

7 In this book there are two chapters dealing with 8

quality assurance, one from the physicist's point of view and 9

one from the physician's point of view.

There is also a 10 chapter very relevant to brachytherapy written by Jim McGee 11 from Decatur, Illinois, down where they grow corn and beans and l

12 he used brachytherapy la management of breast cancer and women t*(

13 from all over the southern part of Illinois come to him for 14 that treatment.

15 He uses the Paris System, a manual system, of 16 evaluating the dose and how this is to be done and he has an 17 excellent outcome.

18 There is another chapter in here dealing with 19 gynecologic treatment in which brachytherapy is essential and 20 here again we attempted to educate on the appropriate use of 21 sealed sources.

This type of thing is available.

22 The second type of thing can be found in the Blue 23 Book and I will leave that with you and this is a group of

[

24 societies that have gotten together to specify what they think l

25 is essential for good care.

50 1

i.

Now DeVita states in the book, "the radiation 2

oncology community, succinctly presents the standards for 3

clinical practice and the objectives for radiation oncology 4

during the remainder of the 1980's."

5 Now in addition, there are a number of studies 6

supported by the U.S. government which have reviewed the 7

practice of Radiation Oncology, the methods used, the locatios 8

of facilities, types of hospitals, training experience, 9

staffing and the many factors which affect outcome and that 1:

10 the outcome in curing the patient and in avoiding 11 complications.

12 TP S Patterns of Care and Outcome Analysis studies a

13 have been considered an outstanding example of how this proces 14 can serve and improve the quality of care in the United States 15 Now in fact, the say after the January 25 meeting of our 16 advisory committee, I served as the chairman or a panel which 17 i

approved a contract for continued support of the Patterns of 18 Care and Outcome Analysis which deals with the broad scope of 19 quality assurance as it impacts on cancer treatment in the 20 United States.

21 Now they singled out three cancers, colon, prostate i

22 and breast; l

two of those use brachytherapy.

The other thing 23 they considered was fractionation and the last was quality 24 assurance and how by improving quality assurance programs could!

25 they improve the quality of care.

i

51 1

Now it would seem to me that the U.S. Nuclear k~

2 Regulatory Commission could more effectively improve the 3

quality of radiation oncology in the United States and that is 4

the use of teletherapy and brachytherapy by joining some of the 5

excellent programs that are now in plr.ce.

6 In particular, I certainly would think that you might 7

be wise to join together with a broad based government 8

sponsored program on the Patterns of Care Study and its 9

contirued implementation which has a proven track record and 10 then support this inter-society "Blue Book" which is referred 11 to regularly by various administrations and it would be nice to 12 have the Nuclear Regulatory Commission's name across the t'

(

13 bottom.

14 CHAIRMAN ZECH:

l Thank you very much, Dr. Griem, we 15 appreciate it.

16 MR. BERNERO:

Dr. Woodbury.

17 DR. WOODBURY:

Thank you, Mr. Chairmar.

I am David 18 Woodbury, I am assistant professor of internal medicino at the t

i 19 University of Michigan, chairman of the department of nuclear i

20 i

medicine at the Westland medical Center, former employee of the 21 Atomic Energy Commission at Oak Ridge, Tennessee.

22 I have been privileged to serve on the advisory 23 committee for the NRC and when called to give comment relative 24 to our January meeting, I was very pleased to do so until I was 25 told that I only haq five minutes.

i

t 52 1

So in order to try to get across the points T wanted

/\\

2 to, I have taken the liberty of trying to outline what I have 3

to say perhaps in a very cryptic and not very expansive form 4

but certainly would be willing to answer any questions that you 5

may have.

6 In a very simplistic mode, I have tried to outline 7

three areas I would like to attend to, just a few seconds as I 8

perceive the Commission's concerne, a minute or so on what I 9

perceive as the concerna in nuclear medicine and I would like 10 to spend most time on alternate proposals on how the NRC might i

11 be more effective in helping us determine quality assurance.

12 Ever since the Three Mile Island accident and t'(

13

\\

Chernobyl the public has been increasingly concerned about 14 radiation exposure and I am sure that this has heightened the i

i 15 concerns in the political arena and has raised concern about i

i 16 the commissioners.

l 17 During this period of time, in fact, in 1979 and 1980 18 we had taken a look at quality assurance and misadministration 19 and we thought that the incidence was sufficiently low that we 4

20 need not deal with it no more but since that time, it has come i

21 up again.

l 22 In a four year survey, on the order of 27 23 misadministrations were found.

So the commistioners concern is 24 can we do better.

One of the three things the commissioners 25 thought were out. lined in the misadministration reported, d

f.

U 53

(.

1 problems might be inadequacy of training, lack of attention to j

2 detail and lack of redundancy.

3 I would like to digress 15 seconds to say something 4

about the inadequacy of training cecause this is one area in l

5 which the NRC gives the medical community double information, j

6 For instance, during the same time the NRC is requiring greater l 7

detail in quality assurance, during the same period of time 8

that there was some concern about decreasing the length of 9

training for licensees.

It gives a double message.

10 As a result of the problems of misadministration, the 11 NRC has proposed ten separate new regulations to correct the i

12 problems.

The nuclear medicine concerns relative to these f

13 proposed regulations, the nuclear medicine community in general 14 approves of and has taken part in quality assurance.

We have 15 adopted the ALARA concept by subjecting patients, personnel and 16 ourselves to as little radiation as is humanly possible.

17 We have attempted to abide by all the quality 18 assurance guidelines by the Joint Commission as also by the 19 state public health guidelines and we meet quarterly with our 20 radiation safety committee who can review our activities on a 21 quarterly basis to assure that we are in compliance.

22 The proposed regulation of 35-39B comes as close to 23 the NRC intrusion into the actual practive of medical care as 24 it ever has sinco changing from the AEC.

This is a real 25 concern to the medical community.

e 54 1

(

The community questions the rules as proposed as 2

having any real effect on decreasing _ human error.

The question 3

is can we really legislate human error.

There is a feeling 4

that the rules were promulgated with limited impact on those 5

specialists and organizations who are daily involved in the 6

practice of nuclear medicine.

7 The cost effectiveness of the rules clearly have not 8

been evaluated.

One estimate is that it would cost the 9

hospitals approximately five million dollars per year to 10 decrease misadministrations and if that were half the record, 4

11 the figures that we had ist that it would cost $360,000.00 per 12 misadministration, or $260,000.00 or $250,000.00, in that i

13 ballpark.

14 The feeling is that if the rules are placed in fact 15 in force they may cause conflict with cost reduction 16 regulations promulgated by HCFA and HHS by increasing, probably l 17 increasing the length of hospital stay.

18 As far as we now know, no studies to date have 19 demonstrated deleterious clinical effects of radionuclide doses 20 used for diagneatic purposes in animal studies or human 21 studies.

The lethal potential seems minuscule.

22 Lastly, resources that could be used for training or 23 acquisition of better equipment and material might have to be g

24 used to keep up with the proposed rules, a

25 How can we help NRC help us improve quality 4

55 1

assurance?

If rules have to be made, any rule should be s '

2 performance based rather than prescription based so as to best 3

encompass the variety of practices that we have in nuclear 4

medicine.

5 For instance, I doubt that the complexity of trying 6

to review every chart, examine every patient sent for diagnosis 7

was thought out.

Ten years ago, 70 percent of nuclear medicine 8

diagnostic procedures were done on in-house patients.

That has 9

reversed in the last three to four years and now 60 percent, in 10 some practices, 60 percent of our p res are done on an 11 out-patient basis.

12 It would be very difficult to get all the charts from 13 all these patients sent in from referring physicians and to 14 examine each one after they have been examined by their own 15 physician.

There is a lack of practicality there.

16 If rules have to be made, we fully support the 17 approach to doing pilot studies in these areas before the rule 18 is made so that the financial, personal and administrative impact of the rules can be assessed before the study is done.

19 20 Dr. Marcus has already alluded to the problems that 21 she had as she tried to do a pilot study on her own.

Some 22 benefit came out but there were a lot of headaches, some 23 aspects that she just had to disband.

24 If this pilot study had been done before the 25 regulations were promulgated, these effects, financial,

56 1

(

personal and administration, may have been forthcoming before 2

the rule was proposed in the Register.

3 If rules.have to be made, thnre should be a 4

coordination of efforts with existing roups to have a 5

synergistic effect on quality assurance.

The American College 6

of Nuclaar Physicians has its fourth printing on its inspecting 7

manual and there are 25 pages that are dedicated to quality 8

assurance, the back of which are about 15 pages on questions 9

and answers so that when we inspect our nuclear medicine 10 institutions, the institutions know what to look for.

There le 11 a check-off sheet plus there is a manual that tells them what 12 we expect in quality assurance in nuclear medicine.

e-g 13 Lastly, I very strongly propose that the NRC and 14 commissioners improve communication with the nuclear medicine 15 community and the medical community.

Few physicians read the 16 Federal Register.

Many of us who get the Federal Register 17 because the language is so obtuse will put it aside and cay

{

18 i

that we will get to it this weekend and sometimes we don't get 19 to it.

20 other organizations, the FDA and the Joint commission 21 have flyers on a quarterly basis that may highlight some aspect 22 of quality assurance or some aspect of improver.ent in service.

23 other organizations have regional heetings, JCAH has regional

{

24 meetings where they discuss some aspect of rules and 25 regulation.

57 1

We propose the same type of thing might be generated

(.

2 through the NRC so that those practitioners who might not make 3

the specialty meetings, who don't read the Federal Register, 4

may have thu opportunity to discuss the regulations as they 5

impact on the practice of medicine.

6 We have also suggested that perhaps a national 7

meeting could be held and this could be at little financial impact to the NRC because registration or tuition could be 8

9 chargad and I am sure that the hospitals would support ser. ding 10 their radiation safety officer to Washin,Jton or to a regional 11 meeting where the quality assurance aspects and other aspects

~

12 of deliver'l of medical care as it relates to radioisotopes

(

13 could be discussed and the decisions could be implemented or at 14 least explained and expanded.

15 These are areas that we think, the educational areas, 16 would be very helpful so that the NRC comes across not as an 17 adversary but as a colleague in assuring quality assurance.

As 18 we compare other organizations, other organizations say "This 19 is what vi expect" and when they inspect us at the end they sit 20 down with us and say, "This is what we found right and this is 21 what we foo d wrens and here are ways that we think you might 22 improve.

We will cite you in this area but we will give you 23 time to correct what you are doing."

i 24 The NRC on the other hand says, "We are going to slip s

25 in unannounced, finq out what you are doing wrong and they we

58 1

are going to fine you for it."

So an adversarial relationship

,(

2 is set up that should not be.

It should be an educational, a

3 collegial experience where we are all going in the same 4

direction for the improvement of quality assurance.

Thank you, 5

Mr. Chairman.

6 CHAIRMAN-ZECH:

Just one quick question, Doctor.

I think you mentioned and if you could just tell us briefly, 7

I 8

think you mentioned that you thought that perhaps we were 9

intruding into medicine.

10 DR. WOODBURY:

Yes.

11 CHAIRMAN ZECH:

Could you elaborate briefly on that, i

12 please?

We don't want to do that, as I am sure you know.

13 DR. WOODBURY:

The proposed rule 35-39B suggests that 14 the user should examine every patient sent for a diagnostic 15 procedura, should then contact every referring physician and 16 this is a direct imposition into the practice of medicine 17 because there are many ways that quality assurance can be 18 promulgated without examining every patient particularly in a 19 large institution where the patient has already been examined 20 ten times by students, residents and interns.

21 CHAIRMAN ZECH:

Is this the same point that Dr.

i 22 Tonnesen was making?

23 DR. WOODBURY:

Yes.

f 24 CHAIRMAN ZECH:

Is he still here?

Is that the sawe 25 point, Doctor?

,1

59 1

DR. TONNESEN:

Yes, it is the same part of the r

2 regulation.

3 CHAIRMAN ZECH:

Thank you.

Thank you very much, 4

Doctor.

5 COMMISSIONER BERNTHAL:

I just want to make a 6

comment.

I am devastated to learn that along side the Gideon 7

Bible there is not on every night stand a copy of the Federal 8

Register.

9 (Laughter.)

10 COMMISSIONER BERNTHAL:

You have made a very good 11 point and it certainly fits in with my own long standing belief 12 that we need to do a better job here in communications and that f

1, 13 is a very useful suggestion you have made.

14 E,<actly how that sort of in plain language communique 15 could be distribute.d and should be distributed, I am not sure i

16 but perhaps our government and public affairs office could take 17 a hard look at that suggestion.

It is a good one and you have 18 raised some other good points but I think maybe we should go 19 on.

Thank you very much.

20 CHAIRMAN ZECH:

All right.

Thank you very much.

21 Please proceed.

22 MR. BERNERO:

Dr. Almond.

23 DR. ALMOND:

Mr. Chairman and Commissioners, thank 2 ',

you for this opportunity to speak to you.

Mr. Chairman, yJu 25 will appreciate that I believe that peoples whose last names

60 begin with "A" and "Z occupy a special place in this world.

(.

L 2

CHAIRMAN ZECH:

Very speciall 3

(Laughter.)

4 DR. ALMOND:

The A's generally are asked to start off 5

and the Z's generally to bring up the rear.

6 CHAIRMAN ZECH:

That is the way it works.

7

( Laughter. )

8 DR. ALMOND:

This is therefore an unusual position 9

for me today being the last speaker.

10 CHAIRMAN ZECH:

We trade places today.

11 DR. ALMOND:

Thank you.

I am a medical physicist with 30 years of experience with Cobalt-60 and brachytherapy in 12

-r i_

13 nuclear medicine.

I have served as president of the American 14 Association of Physicists in Medicine and as chairman of the 15 Board of Chancellors of the American College of Medical Physics 16 and I am vice chairman of ISCRO, the Inter-Society Council that 17 produced this book so I have some experience in working with 18 these.

19 All of these groups and others as you have heard are 20 very actively involved in quality assurance programs.

I do 21 know that you were concerned somewhat that this committee 4

22 seemed to be somewhat opposed to this rule when only 20 percent 23 of the public respondees seemed to be opposed.

3 24 I can say having looked at a fair number of those 25 organizations that did reply to you and those in particular

61 1

that I have mentioned and some of those I work with, we were

('

2 rather like the man who was asked whether he had stopped 3

beating his wife.

4 We obviously are for quality assurance and all stated 5

that, however, if you look at the detailed comments by each of 6

these organizations, I think they left no doubt in my mind that 7

to be workable this rule would have to be dras,tically changed 8

at least.

There were just things that were not workable about 9

it.

10 We are as you all heard very much concerned about 11 quality assurance and the commissioners, I think, are aware 12 that the above mentioned organizations because it has been said

[

tm 13 many times today and many others have been from the very 14 beginning active in setting standards and in developing quality 15 assurance programs to ensure the safe use of radioisotopes in 16 medicine.

That has been one of their main concerns.

17 In fact, these, I think, everyone would agree have 18 been very successful and as has been mentioned here today the 19 extremely low misadministration rates for Cobalt-60 20 radiotherapy and brachytherapy, for example, with approximately 21 one to two misadministrations in 10,000 treatments.

So it is a i

22 very low number.

23 The Advisory Committee in its deliberations of

[

24 January 26th of this year questioned whether it would be 25 possible or cost effective to reduce this number any lower and

62 1

i would like to address that because it has come up today.

2 By the way anq 1et me say about misadministration, I 3

think to answer one question that came up, misadministration in 4

this context means a dose different than ten percent from that 5

prescribed and can be lower as well as higher.

6 So we may well be underdosing as well as overdosing 7

the patient and, in fact, it is likely that the overall dose 8

load to the population may be averaged out to very low but 9

understand, it is just as bad in our situation to give a low 10 dose as it is to give a high dose and thero are 11 misadministrations of those kinds reported.

12 You are all aware that radiotherapy is a complex form' 13 of treatment requiring an integrated team approach.

There is 14 the radiotherapist, the medial physicist, the radiotherapy 15 technologist and very often a dosimetrist and this requires 16 many links in the chain from the prescriptie-o the treatment 17 plat.71ng to the application and to record keeping.

18 How many links in the chain will depend very much 19 upon the institution er the case being treated but there may be 20 ten, 20 or 30 links in the chain.

If only one of the links is 21 broken, a misadministration may occur.

22 This actually is very clearly illustrated by the 23 HRC's misadministration report in radiotherapy and here, I i

24 believe, we do have the same data bank.

This report that was 25 published in December of 1985, the case study report on the

63

(

1 therapy misadministration report to the NRC, is an excellent I

2 document and is really the only detailed account that we have 3

of the types of misadministrations that occur.

r 4

During the three and a half years covered by that 5

report there were some 300,000 patients or so treated on Cobalt 6

units that entered into this report.

It is interesting to note 7

and I just deal with the radiotherapy external beam of which I 8

think there were 16 reports, there were 11 different types of 9

errors which occurred only once and that means on that chain, 10 very randomly from wherever, from the prescription, the 11 treatment planning or application, one chain broke here and one

~

12 link another chain, it might have been another link and so on r(

13 but they were not duplicated which indicates a very random 14 distribution.

15 Only one error occurred twice, that is, the same link 16 broke in both cases.

There were three mathematical mistakes 17 but that we do not know, it probably occurred somewhere within 18 the whole total so there is, in fact, a very random nature 19 here.

J l

20 When you consider the hundreds of thousands or 21 actually millions of parameters that were calculated, measured, 22 set and recorded, this is a very remarkable record.

I don't 23 think it can be reduced and it is quite likely that if we

{

24 repeated the study today, we would get a different set of I

25 errors.

Different 9hains would be broken.

1

64 1

That is due to the very random nature of the errors s

2 and the very low frequency with which they occur.

So it would 3

not be possible in my opinion to base quality assurance upon a 4

study like that trying to strengthen those links that did break 5

because next time, another link might break.

6 So to try and write a comprehensive prescription 7

quality assurance rule would result in a very big and largely 8

unworkable document.

If you tried and included all the links, 9

the document gets very big.

10 The committee sort of having considered this felt the 11 approach to quality assurance as you have heard today should be 12 to require the licensee to submit their own quality assurance f'

t..

13 program as part of their license application for review by the 14 HRC and which could be used as the basis for enforcement if 15 they were not followed.

16 Now a large amount of assistance exists for the 17 setting up and you have heard today about AAPM, this is their 18 physical aspects of quality assurance in radiation therapy.

It 19 is a brief guideline, proceedings of a symposium on quality 20 assurance of radiotherapy equipment, a symposium by the AAPM, 21 The American College of Medical Physics has and this is one on 22 quality assurance in radiation oncology and another in nuclear 23 medicine.

There are many of these such documents available.

24 COMMISSIONER CARR:

If it is such a minor problem, 25 why do you study it so much?

4

65 1

[ Laughter.)

2 DR. ALMOND:

Let me say the fact that these 3

organizations have from the beginning studied and been involved 4

in this has resulted in the very low misadministration rate.

5 COMMISSIONER CARR:

We are coming in behind the 6

problem.

7 DR. ALMOND:

I would believe so.

As you have heard, 8

i the NRC should consider working more closely with these 9

scientific and professional organizations and assist in their 10 educational programs where quality assurance is involved.

If 11 necessary, we need to get the word out there.

12 We have heard about the cost involved and that is a l'

lx 13 very dif ficult subject but we did hear testimony that between 14 five million and ten million annually to implement this rule 15 for an institution that has a single Cobalt unit but with good 16 quality assurance elready in place and physics support, the 17 cost to that department might be $4,000.00 to $5,000.00.

I 18 can't disagree with these numbers.

19 They may be somewhat different but the numbers are 20 fairly large and as pointed out, if that money is taken to do 21 quality assurance, increased quality assurance, it has to come 22 from somewhere and I do not see any recurring benefit to the 23 patient.

f 24 We all, and I strongly believe that quality assurance 25 in radiation oncology is a very important subject but that

e 66 1

adequate protocols and assistance exist through the various i

2 professional and scientific organizations as we have said and 3

that the NRC should work with these groups to develop a 4

performance based approach and you have heard that word from, I

5 think, all of us rather than a prescriptive based approach to 6

continue to ensure that radiation therapy is one of the safest 7

forms of therapy.

8 Thank you very much.

9 CHAIRMAN ZECH:

Thank you very much.

We appreciate 10 it.

11 MR. BERNERO:

We have nothing else, Mr. Chairman.

12 Thank you.

Before we close the meeting i would like to remind 13 the Commission in our briefing to you just a few weeks ago, wo 14 spoke of regulatory alternatives and one of them, alternative 15 number two, was a performance based rule, t

16 You have heard a number of exhortations and a number 17 of offers of help today and the staff will dedicate substantial 18 effort to developing a real performance based alternative for 19 you to consider and in selecting the performance bases we will 20 seek ar.d I hope get the help of those who offered it.

1 21 I also would say that the staff will give special 22 attention to the issue of the cost, the data base and the cost 23 benefit analysis.

It is a knotty one.

I think we need to i

24 develop it better as a basis of decision.

25 CHAIRMAN ZECH:

All right.

Thank you very much.

l

. -. - =..

e s

67' 1

Questions from my fellow Commissioners.

Commissioner Roberts.

k 2

COMMISSIONER ROBERTS:

No questions.

t 3

CHAIRMAN ZECH:

Commissioner Bernthal.

4 COMMISSIONER BERNTHAL:

Yes.

I trust this point 5

wasn't brought up early in the meeting.

I was a bit late 6

getting here but let me ask it if it was and maybe someone can 7

repeat it.

8 In the staff's summary of public comments on the 9

proposed rule, I noticed that among those supporting the 10 proposed rule was the Commission on Radiation Therapy of the 11 American College of Radiology which I understand is a subgroup 1

12 or subset of the American College of Radiology as the name r

1 13 implies which opposed the rule and there was actually a middle 4'

o 14 ground which one could have taken.

t 15 Fifty-five percent suggested changes in the rule.

It 16 struck me as odd that in a subgroup of the American College of t

17 Radiology you would get support whereas the College itself 18 opposed.

Can somebody explain that to me?

19 CHAIRMAN ZECH:

Yes, please, i

20 COMMISSIONER BERNTHAL:

Maybe the representative of 1

21 the American College of Radiology would like to comment on that 22 as well as the person who has been working with our staff, but 23 go ahead.

24 MR. LINTON:

Over a year ago some draft documents 25 were circulated very informally and the Chairman of our i

=

68 1

commission in writing what he admits is a personal letter to 2

Mr. Miler of' your staff agreed in part with some proposed 3

changes relative only to misadministrations.

4 This letter somehow got entered into your record as 5

supporting the whole current set of regulations and I believe 6

that was an error, sir.

7 CHAIRMAN ZECH:

Thank you very much.

8 COMMISSIONER BERNTHAL:

Thank you.

9 CHAIRMAN ZECH:

Norm, did you want add anything else?

10 COMMISSIONER BERNTHAL:

Does that comport with your 11 impression?

12 MR. McELROY:

That is what I wanted to report.

The r

1.

13 committee had gotten hold of an early copy of the draft 14 regulation, I believe, before it was formally submitted to the 15 commission and they were responding to technical detail in that 16 early draft.

I don't believe they were supporting the entire 17 initiative.

18 COMMISSIONER BERNTHAL:

All right.

Thank you very 19 much.

On the question again of cost benefit, I suppose that <n 20 the basis of the various numbers we have heard here today I 21 could have and should have worked out the arithmetic here but 22 maybe someone can tell me whether the staff has arrived at or 23 one of the professional groups has arrived at another statistic l'

24 here.

25 I don't know how many people receive diagnostic and

t 69 1

therapeutic administrations in a year or any other time for 2

that matter.

I have heard various numbers and suggestions for 3

the overall cost to an operation or a hospital, I should use the term hospital, of such a program were it to be put in 4

5 place.

6 Has anyone datermined the estimated cost per 7

administration or cost per patient and determined what percent 4

8 of the bill so-to-speak for an administration this would amount 9

to?

In other words, suppose you implemented the rule as written and I doubt that we would do that but suppose, 10 are we 11 talking about one percent of the cost to the patient or are we 12 talking about ten percent or a tenth of a percent, does anybody

\\

13 have any idea per administration?

i 14 DR. MARCUS:

It depends whether you are talking about 15 cost to satisfy the prescriptive regulations or cost to satisfy j

16 a performance based standard.

17 COMMISSIONER BERNTHAL:

I really was referring to the 18 prescriptive regulation in the proposed rule.

19 DR. MARCUS:

All right.

In my practice, it would i

20 cost and we don't have any misadministrations or radioiodine 21 but to conform to the original regulations as writtan including I

22 overhead for personnel, personnel costs would be about l

23

$50,000.00 per year and we double the cost or a little more

(

24 than double the cost of I-131 and I could go through the 25 numbers because I hpve my total amounts and it would just me a

70 1

{

few minutes and those would be the major costs I think for my 2

practice as an example.

3 But you are getting into something that is going to 4

end up being between $50,000.00 and $100,000.00 per year for a 5

department that had, I think it was about, 500 uptakes, about 6

almost 400 scans a year and it was 58 I-131 treatments last 7

year.

That was the size of my operation so you are getting 8

some idea.

9 COMMISSIONER BERNTHAL:

So $50,000.00 to $100,000.00 10 per year.

11 DR. MARCUS:

For a moderately large department.

12 COMMISSIONER BERNTHAL:

Right, and it sounds like you i 13 are talking roughly about a 1,000 or so patients per year, is 14 that what your summary was?

15 DR. MARCUS:

Well, some of those patients are the 16 same ones.

You do an uptake on them and you do a scan.

L 17 COMMISSIONER BERNTHAL:

All right, but neverthelesc.

i 18 per administration in effect.

19 DR. MARCUS:

Yes, something like that.

j 20 COMMISSIONER DERNTHAL:

So we are talking $50.00 to e

21

$100.00 per administration, is that the rough arithmetic here?

22 DR. MARCUS:

I suppose but I will say this, that with 23 what I would consider to be perfectly appropriate performance 24 based standards, the costs would be practically nothing because 25 basically the isotope costs would remain the same and I 4

---m

%..e-

-- -=

,--r-

-,--i,-

71 1

wouldn't need new people, we simply do things a little 2

differently.

3 COMMISSIONER BERNTHAL:

Yes.

4 DR. MARCUS:

I think that is a really important point 5

to bear in mind.

i 6

Cot 1MISSIONER BERNTHAL:

All right.

Thank you very 7

much, Dr. Marcus.

I should stress that I think that the 8

Commission in other areas and I assume in this one has indicated some inclination toward performance based standards 9

10 and I personally have not at all ruled that out as the path we 11 might take here and if we can work with you to arrive at a 12 sensible performance based regulations here, in my judgment r

k 13 that would be preferable.

14 A proposed rule is designed to do exactly what this 15 one obviously has done.

We have learned in what areas there 16 may be flaws and will go on from here now I trust working with 17 you to arrive at what I hope will be the best solution that wo 18 can possible devise.

19 That is, I believe, the summary of my comments for 20 now.

I want to thank you all for taking the time to come to 21 Washington on a miserable day and present us with this 22 information.

I appreciate it.

23 CHAIRMAN ZECH:

Commissioner Carr.

24 COMMISSIONER CARR:

Would someone speak to the 25 agreement states part of the problem and see if we are about to

i l

72 h -

1 get into a dual requirement, dual regulation area, or do you 2

have some comments on that?

.i 3

CHAIRMAN ZECH:

Perhaps the staff could speak to 4

that?

5 MR. CUNNINGHAM:

Dick Cunningham.

Mr. Chairman, we 6

proceeded on the basis that the rule would be a matter of 7

compatibility so that if it is adopted by the Commission it 8

will have to be adopted by the agreement states.

i 9

CHAIRMAN ZECH:

Thank you.

l 10 COMMISSIONER CARR:

In the Minutes of the earlier 11 meeting there was a comment about the quality of training and 12 the fact that when we inspect, we don't ever look at training

(

13 and never ask how good it is.

Do you really want us to get 14 into that area?

We are very good at looking at training 15 programs?

16 (Laughter.)

17 DR. WOODBURY:

The question was, were you good at 18 funding them?

19 (Laughter.)

20 COMMISSIONER CARR:

No.

I don't have to worry about 21 funding them.

That is somebody else's money but I would be 22 more than happy to comment on the quality of your training 23 programs if you want us to and I just wanted to follow up and 24 see if that was one person speaking or if generally you would 25 like us to put down some kind of requirements on your training i

73 1

programs?

I see some heads going this way and some going this

't 2

way.

Yes.

3 MR. LINTON:

You deserve an answer, sir.

There are 4

many existing programs which we think more than serve the 5

purpose and we would welcome your endorsement of those rather 6

than inventing yet another one.

Thank you.

7 COMMISSIONER CARR:

Well de don't always bless what 8

we are looking at.

9 (Laughter.)

10 COMMISSIONER CARR:

The other comment in that meeting 11 was that one person said, "Your problem is you ought to put 12 some teeth into the regulations you already have" referring to p

1.

13 the rad safety officer who falsified the minutes for ten years 14 before we caught up with him.

Do you have any more comment?

15 Would you like to amplify that statement about putting a little 16 more teeth in the regs we have?

17 (No response.)

18 CHAIRMAN ZECH:

No takers so far.

19 COMMISSIONER CARR:

Silence reigns.

20

[ Laughter.)

21 MR. TAY LOR:

As the director of enforcement or ex 22 director, I would take that to heart.

23

( Laughter. )

24 COMMISSIONER CARR:

Well, it was in there so I 25 thought I ought to mention it.

I would certainly agree on two

74 1

points.

One is the communications.

We need to be able to get

(~

2 the word out not only to the major hospitals but to the little 3

guy who is 200 miles from the local area that you were 4

mentioning there.

5 We have to make sure that the word gets all the way 6

down to the people doing the work and the other one is whatever 7

we do, we have to run the pilot program.

I appreciate Dr.

8 Marcus' trying it out.

9 One of my precepts is how do you know it won't work 10 if you haven't tried it.

She has tried it and she knows it 11 won't work.

I believe that.

So we want to make sure that 12 whatever we do does work and I do appreciate your coming and 13 meeting with us today.

Thank you.

l 14 CHAIRMAN ZECH:

Let me just make a couple of brief 15 comments. First of all, I think somewhere earlie' t in the 16 discussion the definition of misadministration in the rule was 17 or perhaps in our regulations was brought up.

If that isn't 18 clear, it ought to be clear.

It was brought up again recently 19 here, I think.

20 Would anybody like to talk about that?

Is that not 21 clear?

22 MR. BERNEPO:

Excuse me, but I think the definition, 23 most would agree the definition is clear.

I think it is a 24 matter of whether it is too broad.

It defines by percentage, 25 diagnostic or therapeutic dose but the question is, is you have

75 1

essentially harmful or harmless ones.

s 2

CHAIRMAN ZECH:

Is it too broad?

Should it be 3

improved?

4 COMMISSIONER CARR The question is whether it was 5

clear or whether it was fair, I think.

6 COMMISSIONER BERNTHAL:

Ten percent was the number 7

that we heard.

8 CHAIRMAN ZECH:

Plus or minus ten percent later and 9

earlier I thought someone said that it should be defined more 10 clearly and then the plus or minus ten percent so my question, 11 I guess, really is, is there a problem with the way we have 12 talked about misadministrations and should something be done 13 about it?

Yes, sir.

14 MR. LINTON:

In the opinion of the expert committees 15 of the American College of Radiology, that rule badly needs 16 rewriting, sir.

The way in which misadministrations are 17 defined as a percentage of dose can be enormously misleading.

18 Many of those which technically quality as misadministrations it as I believe D;. Almond said actually represent underdosing and 20 not overdosing and all-in-all, what is a misadministration for 21 Dr. Collins may be a totally different dose than Dr. Griem and 22 his is good and his is bad and all-in-all, sir, half your 23 problem is in how to figure out how to answer the 24 misadministration rule.

25 CHAIRMAN KECH:

How to answer what again?

~

76 1

MR. LINTON:

How to know when I have misadministered.

2 CHAIRMAN ZECH:

How to define misadministration?

3 MR. LINTON:

Yes, sir.

4 CHAIRMAN ZECH:

This is what we need help on then so 5

we are asking you to help us define it.

i 6

MR. LINTON:

All right, sir.

We have supplied that 7

in writing several times.

We would be glad to do it again or 8

to expand now as you might wish.

9 CHAIRMAN ZECH:

Let me hear from the staff briefly 10 then regarding a definition of misadministration.

We are 11 hearing right now that it is not very well defined.

I would 12 like to know what your view is, g-k.

13 MR. McELROY:

I would take a slightly different 14 opinion from that expressed by Mr. Linton.

The basic 15 definition is clear.

Where the staff has seen problems for 16 gray cases or serious of events that have on occasion arisen 17 and there is honest dispute within the staff and the medical 18 community as to whether certain events have fallen within the 19 definition of misadministration.

20 To respond to this problem, the staff is working with 21 the Office of General Counsel on examining past events and 22 other events that we can think of that might possibly be 23 considered misadministrations and try to develop some i

24 additional guidance on whan reporting is required but we share 25 to some extent Mr. Linton's concern that perhaps the basic

h 77 m

1 definition should be reviewed.

(.

2 COMMISSIONER CARR:

There must be some degree of 3

meesurement that would be required.

If we are going to have a 4

performance based standard you have to measure performance

(

5 somehow.

6 Dk. COLLINS:

I do think that some instruction or 7

elaboration on the nature of dose would be entirely appropriate 8

because the same number could have an entirely different result 9

if it were delivered through a single field, through opposing 10 fields, through a small field, through a large field, in a 11 short time or a longer time.

The number might be the same but 12 the effect would be totally different and the very fact that f*

3, 13 dose is not a number.

l 14 Dose is a concept that for any given agent whether it 15 be a biological one or a chemical one or an energy one, if the 16 circumstance of delivery are precisely duplicated and if it is i

l l

17 given to a precisely duplicable organic system then a l

18 predictable result will occur.

19 To the degree that we have not controlled the 20 physical, chemical or biological agent offered or that we knov 21 precisely all the details of the organism or tissue to which it i

22 is being given, then the effect is chancy.

23 Dose is not a number.

Dose is a prediction that you

[

24 can produce a given effect with a given biological medicinal 25 agent.

One number may be entirely different as far as the l

b J

78 1

effect is concerned.

1 2

COMMISSIONER CARR:

But our measurement would only 3

control those things you can control.

I 4

DR. COLLINS:

That doesn't control anything.

l 5

COMMISSIONER CARR:

Well, you centioned the things l

i a

6 you could control and then you mentioned the things you were 7

unable to control.

t

}

8 DR. COLLINS:

Yes, but not in a numbor, not with a 9

number.

10 COMMISSIONER CARR:

You can certainly control the 11 ar'ea, the distance, those kinds of things, t

12 DR. COLLINS:

But that is not recognized if you have 13 a single number of dose and if you put in all the other nutbers s

4 14 and then we begin to describe it.

15 COMMISSIONER CARR:

So we should look at your j

16 computation rather than your answer?

Is that what you are 17 trying to tell me?

I wanted to make sure I understood what you 18 said and I am not sure I do.

19 DR. COLLINS:

When we describe a misadministration in 4

20 terms of a single number for dose or a percentage of that, that i

j 21 is a totally inadequate description of dose delivered.

4 22 COMMISSIONER CARR:

Can there be an accurate 1

j 23 description?

)

24 DR. COLLINS:

If we describe all the features of the 25 physical agent and describe the condition or volume or organ i

I e

a 79 1

l j

being treated, then there is a chance we may predict what is

[

\\

2 going to happen.

To the degree that you and I are in good j

3 rapport and we know exactly what we are talking about, I may f

l 4

say, "Let's give it 5,000" and you know I am talking about rads i

5 or another unit, you know I am talking about the distribution f

6 we are considering.

You know the unit.

We ca,. communicate.

i 7

But if we do this without knowledge of what I imply 8

and you infer, the result is very, very questionable.

{

9 CHAIRMAN ZECH:

Dr. Almond.

10 DR. ALMOND:

To some extent I think misadministration 11 is an unfortunate term and I think we have alluded to the fact 12 that in the performance type of rule, we would look at it as

\\

[

t 13 working as ALARA where you have action levels rather than 14 misadministration levels.

15 So if the dose is different by ten percent from the 16 prescribed dose and actually that does allow for differences I

17 i

between radiotherapists or cases, I mean, there is a 18 prescription which is given but if it varies by a certain 19 percentage from that, that is an action level to alert you that 20 you better look and see that something needs to be done.

21 That actually in the report here worked fairly well.

22 They found the doses were different by more than ten percent in 23 thers cases and took action on them.

So I think perhaps if the i

24 word was changed a little bit and redefined, it does need t

25 redefining, but more in terms of an action level which then

t s

80 1

requires some action to correct that and to make sure that 2

things are put right.

3 CHAIRMAN ZECH:

Mr. Cunningham, would you like to 4

make a comment?

i i

5 MR. CUNNINGHAM:

Yes, Mr. Chairman.

I think it would i

i 6

be well to just mention the genesis of the misadministration 7

rule.

Initially the misadministration rule was intended for 8

the staff to analyze on a statistical basis generic things 9

which we might correct through regulation.

10 The staff with our advisory committee has struggled l

11 with this definition over the years and we have modified it or 12 adjusted it a little bit from time to time.

The 7

l

(

13 misadministration rule now is being used in a little bit J

}

14 different way.

It is used to meariure some aegree of a

15 s

performance on the part of the licensee and it is getting i

16 closely connected with tl.a quality assurance part.

17 So it is being used a little bit differently both by 18 us and by the medical community.

We are changing our th3ughts 19 on the misadministration rule including the definition or t he I

4 20 title of the rule and all this is being looked at in 21 conjunction with the quality assurance procedure.

1 22 CHAIRMAN ZECH:

All right.

Thank you very much.

I l

23 would also like to emphasize the importance of improving 24 communications certainly with this group of professionals that 25 has appeared before us today.

i

3 81 1

Certainly I think a performance based rule in this i'

2 regard is something that ought to be given serious 1

3 consideration.

It seems to me that we ought to review, the 4

staff should for us review what we have heard here today and 5

perhaps come back and give us another briefing here sometime in 6

the future.

7 I think what we have heard today has been very 8

valuable.

I would particularly like to thank all of our 9

presenters who have come here today from all over the country 10 and I upologize for restricting the time we have given you to 11 talk to us.

12 I know many of you are very learned in your field and i

~

13 you have published documents and you have worked in this very 14 professional field for many years but it was so important that l

15 we hear from you, that we, the Commission, hear from you 16 briefly before we proceed any further in our progrens on this 17 rule and that is why we called you back here and we really are 18 grateful for your appearance here today.

19 I think you have given us an awful lot of things to 20 think about.

The staff has briefed us in the past.

We all 21 have our own views and most of us feel that you do indeed do a 22 remarkable job of practicing the field of medicine.

23 We do not want to intrude.into the medical practice

{

24 but we also recognize that from time to time even though there i

i 25 are a very small number of problems that if there is something

,4 82 1

that we have responsibility for in nuclear materials we should

\\

2 be mindful of those responsibilities and so we have asked the 3

staff to look at this very carefully to see what we could do to 4

improve our performance and do a better job ourselves.

5 We relate with you on this because you are the ones 6

thct are practicing medicine and so you have a responsibility 7

to your patienta.

We have a responsibility to the American 8

public across-the-board for public health and safety and so we 9

do come together in that regard.

10 I think we have a very common ground.

We are trying 11 to do something, I think, that is to benefit those who are the P

12 benefactors of the byproduct material that we are talking about

\\

13 and I think that together we can perhapa both improve our 14 performances.

I still think that there is that room for 15 improvement although I recognize that it is going quit.s well 16 across the board right now.

17 So I would like the staff to come back to us it. a 18 reasonably short period of time but I want you to have time 19 enough to think about what we have heard here todcy and to feel 20 like we are not rushing headlong into something that we have so 23 many people here that deserve our attention and our respect, we 22 want to listen to them.

I want to listen to them and I know my 23 colleagues do, too.

f 24 So we do want to take aboard what we have heard today 25 and we would ask the staff then to come back to us and perhaps

i

~,

83 1

give us their views.

k I think we should review the 2

misadministration definition, take aboard other suggestions we 3

he,' heard here today and see if we can't get a little closer 4

with this community of professionals that not only is our 5

advisors but others in the scientific community that we have 6

listened to.

7 I think the staff frankly has done an excellent job 8

in the past of trying to carry out the Commission's desires to-9 make some improvement in this area but I frankly think today's 10 discussion has been very valuable and very helpful and I would 11 ask the staff to come back to us and give us their views after 12 they have had a chance to review the very thoughtful things we i.

13 have heard here today.

14 I particularly would like to thank all of you again 15 who came here today and who have been working in this area and 16 trying to help us for so many years.

I am impressed not only 17 with what you have said today but the things that I have 18 reviewed prior to your coming here.

19 I agree that Dr. Marcus and her pilot program 20 certainly, I like pilot programs, too, and she did it and it 21 didn't seem to work very well.

Well, perhaps we should learn 22 from that and maybe we can design a better pilot program that 23 is maybe more performance bared.

24 I sensed in Dr. Marcus and in others here a 25 willingness to try to come up with something that is a little

4 4b 84 1

bit more reasonable, perhaps less prescriptive but something 2

that gain is going to bring the results that I think we would 3

both like to see and so I think some kind of further 4

communications and further suggestions and recommendations from 5

those of you who have as you leave here today and head back to 6

your homes and your practices, perhaps if you have other 7

thoughts that you think we should hear, why we would like to 8

hear those thoughts, too.

9 So let's keep this open.

Let's have the staff come 10 back to us in a reasonable period of time and try to see where 11 we should go from here.

Are there any other comments from my.

12 fellow Commissioners?

r k.

13

[No response.]

l 14 CHAIRMAN ZECH:

If not, thank you very much.

We 15 stand adjourned.

16

[Whereupon, the Commission meeting was adjourned at I

17 4:05 o' clock p.m., to reconvene at the call of the Chair.]

18 19 20 21 22 23 24 25

4/7/88 SCHEDULING NOTES TITLE:

' BRIEFING ON PROPOSED SASIC CA RULE WITH REPRESENTATIVES OF hRC ADVIS0F,Y C0FWITTEE ON THE MEDICAL USES OF ISOTCPES AND INDUSTRY SCIENTIFIC COMMITTEES SCHEDULED:

2:00 P.E., THUR$ DAY, APRIL 7,1988 (OPEN)

DL' RATION:

APPR0X 1-1/2 H0S PARTICIPANTS:

(60 MIN.)

COMMUNITY HOSP!TALS. THESE TWO PHYSICIAfiS USE BYPRODUCT MATERIAL FOR PATIENT CARE. THEY WILL SPEAK ON REGULATORY INITI ATIVES AND OUALITY ASSURANCE.,

CAROL S. MARCUS, PH.D., M.D.

Lc5 ANGELES CO. HARBOR-UCLA (NUCLEAP MEDICINE)

MEDICAL CENTER (ALSO REPRESENTING THE SOCIETY OF NUCLEAR MEDICINE /

AMERICAN COLLEGE OF NUCLEAR PHYS IC I Af!t )

OLENN L. TONNESEN, M.D.

FAIRFAX HOSPITAL (NOTE:

1 (RADIATION CNCOLOGY)

DR. TONNESEN GUIDED CHAIRMAN 2ECH WHEN HE TOURED FAIRFAX HOSPITAL)

OpG4NIZATIONs. THESE If!DIVIDUALS WILL SPEAK CN VOLUNTARY CUALITY ASSURANCE INITIATIVES, AND PROVIDE LICENSEE COMMENTS ON THE RULEMAKINGS.

OTHA LI!!TCN AMERICAtt COLLEGE OF RADIOLOGY (RADIATION ONCOLOGY)

FA!Z XHAN, PH.D.

AMERICAN ASSOCIATION OF (MEDICAL PHYSICS)

PHYa! CISTS IN MEDICINE SUSANNAH PRIBYL AMERICAN HOSPITAL ASSOCIATION

( ADMill! $TRATOR)

FOOD AND DRUG ADsrNISTc4TIcn (FDA) THIS INDIVIDUAL WILL DESCRIBE THE REGULATCRY PROGRAMS AND VCLUNTARY INITIATIVES OF FDA'S CENTER FCP DEVICES AND RADIOLOGICAL HEALTH RICHARD E. GRcSS CENTEP FCR DEVICES AND RADIOLCGIC (INTEPGCVERNMENTAL PPCGRAMS) HEALTH OF THE FDA i

~Et~

~

ADvrSOPY COMMITTEE..ON_7HE MEDICAL USES Or ISOTCPES (ACMUI)

IHESE It.'Div! DUALS WILL DISCUCS THE CCMMENTS THEY MADE AT A RECENT ACNUl NEET!!1G CN THE SUEJECT RULEMAKING VINCENT P. CcLLINS, M.D.

PRIVATE PRACTITICf:ER, HOUSTCt;, TX (EADIATION CNCCLOGY)

MELVIN L. GRIEM, M.D.

UNIVERSITY OF CHICAGO (PAD [ATICN ONCOLOGY)

DAv!D H. WCCCBURY, M.D.

WESTLAND l'EDICAL CENTER, (NUCLEAR MEDICINE)

WESTLAND, NI PETER R. ALMCND, PH.D.

UN!vERSITY OF LOUISVILLE (MEDICAL PHYSICS) m

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