ML20133C202

Transcript of 880126 Conference in Bethesda,Md Re Advisory Committee on Medical Uses of Isotopes.Pp 1-166.Supporting Documentation Encl

ML20133C202
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Issue date:	01/26/1988
From:	NRC OFFICE OF INVESTIGATIONS (OI)
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NACMUI, NUDOCS 9701070071
Download: ML20133C202 (191)

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, )i jl IN THE MATTER OF:

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e ADVISORY COMMITTEE ON THE,).~s fL/?.

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1 UNITED STATES NUCLFAR REGULATORY COMMISSION 2

OFFICE OF INVESTIGATIONS 9

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In the Matter of:

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ADVISORY COMMITTEE ON THE MEDICAL USES )

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OF ISOTOPES

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Tuesday, January 26, 1988 9

Room Versailles III 10 8120 Wisconsin Avenue Bethesda, Maryland 11 The conference in the above-entitled 12 matter convened at 9:05 a.m.

13 14 COMMITTEE MEMBERS PRESENT:

15 RICHARD E.

CUNNINGHAM, CHAIRMAN 16 Washington, D.C.

l 17 VINCENT P. COLLINS, M.D.

Houston, Texas 18 JACK K.

GOODRICH, M.D.

19 Erie, Pennsylvania 20 MELVIN L. GRIEM, M.D.

Ogden Dunes,_ Indiana 21 l

B.

LEONARD HOLMAN, M.D.

I 22 Boston, Massachusetts I

23 GERALD M.

POHOST, M.D.

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Birniingham, Alabama 24 EDWARD W. WEBSTER, Ph.D 25 Boston, Massachusetts l

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1 COMMITTEE MEMBERS PRESENT:

(Continued) 2 DAVID H. WOODBURY, M.D.

Westland, Michigan 3

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NORMAN McELROY 4

Washington, D.C.

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5 CONSULTANTS:

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6 PETER R. ALMOND, Ph.D.

Louisville, Kentucky J

7 j

CAPTAIN WILLIAM H. BRINER, USPHS (Ret) 8 Durham, North Carolina l

9 PARTICIPANTS:

l 10 DR. ANTHONY TSE d

HERBERT W. MOWER, Sc.D.

11 JAMES A.

DEYE, Ph.D.

J. AUSTIN j

12 MOODY D. WHARAM, JR. M.D.

DR. STILLWAGON M. O.,.47. p.

13 NORMAN D.

LaFRANCE, M.D.

CAROL S. MARCUS, Ph. D., ///. O.

14 GLENN L. TONNESEN, M.D.

JAMES L. TICI!!E".

M.D.

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PROCEEDINGS 2

MR. CUNNINGHAM:

Good morning, ladies and gentlemen.

3 I'd 1 Ne to welcome you to this blustery day in Bethesda.

4 I'm Richard Cunningham a member of the NRC staff.

We 5

had considered cancelling this meeting because of difficult

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6 weather conditions, not only here but througho'ut the country.

7 However, while we could reach members of the committee we were 8

concerned that others might come and travel long distances and 9

be disappointed, so we decided to go through with the meeting.

l 10 I'm pleased to note that most committee members who 11 had said they were coming, I think only one committee member 12 was not able to make it, have arrived.

Two others might arrive l

13 later on, we don't know where they are, but hopefully they will i

f 14 show up.

I 15 This meeting of the Advisory Committee on Medical 16 Uses of Isotopes is being held in accordance with the rules and 17 regulations of both the General Services Administration and the l

18 Nuclear Regulatory Commission.

It was announced in the Federal 19 Register on December 7th.

20 The meeting is being recorded and a complete 2]

transcript will be placed in the public document room.

22 I should begin by introducing members of the 23 committee.

I have to get my crib sheet here because while I

'24 know all the members of the committee I'm not sure exactly what 25 their titles are.

Starting at the end of the table on my right l

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or your left is Dr. Griem who is with the -- is Director of the 2

. Chicago Tumor Institute, University of Chicago.

Next.to him is 3

Dr. Peter Almond who is a consultant to the NRC and the j

4 committee in medical physics.

Next to him is Dr. Collins who 5

is Director of the Houston Institute of Cancer Research.

Next L

6 to him is Dr. Webster Director of Radiological Sciences, 7

Massachusetts General Hospital.

Next to me is Norm McElroy a 8

member of the staff and head of the section that deals with l

9 nuclear medicine.

On my left is Dr. Pohost who is Director of l

10 Cardiovascular Disease, University of Alabama.

Next to him is I

11 Dr. Leonard Holman. Chief of Clinical Nuclear Medicine, Women's 12 Hospital in Massachusetts.

And then next to him is Dr. Jack i

13 Goodrich of Nuclear Medicine Radiology Associates in Erie.

And 14 next to him is Captain William Briner who is our 15 radiopharmaceutical consultant to both the committee and the l

16 NRC.

17 In addition to members of the committee I would like i

18 to just briefly introduce a few members of the NRC staff who I 19 can pick out here, I don't want to overlook anybody.

Let me pointoutMr.VfndyMillerwhoisheadoftheMaterialsBranch 20 21 that licenses nuclear medicine activities.

Mr. Glenn Sjoblom 22 who is Deputy Director of'the Industrial Medical Safety 23-Division.

Where is Glenn?

He was here earlier, I don't see 24 him right now.

25 I will introduce other members of the staff.

I see Heritage Reporting Corporation (202) 628-4888 l

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1 Dr. Donna-Beth Howe back there who recently rejoined us as a 2

member of the staff working with No,rm McElroy.

I'll introduce i

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other members as we go along.

4 Finally, I would like to introduce Mr. Hugh Thompson 5

who is Director of the Office of Nuclear Material Safety and i

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Safeguards to which the Division that I am in reports.

And I l

7 would like to ask Mr. Thompson if he will say -- have a few i

8 comments for.the committee.

9 MR. THOMPSON:

Thank you, Dick.

1 10 I guess I really would like to thank Dr. Pohost for 11 this weather.

Anybody coming up from Birmingham, Alabama ought i

12 to have a memorable event, so we certainly appreciate it.

Last 13 year we had 18 inches of snow rather than just these pitlings 14 we have this week.

So we'll have to bring you back up every 15 year at this time so we'll get you accustom to this weather up 16 here.

I understand there is a ski resort for those vf you who 17 don't know it in Alabama, it's up in Menitone, I believe.

You 18 probably are an experience} skier, so this is probably no 19 experience for you.

20 DR. POHOST:

Not much experience there.

21 MR. THOMPSON:

This is my first time to meet with the 22 committee.

I joined the NMSS staff about a year ago and I l

23 certainly heard many good comments about the work that you do.

24 The one thing that we find is that your collective 25 expertise is really not available anywhere else.

The nuclear l

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medicine area is the one area that NRC regulates that is really-2 different from many of the other areas.

Here in most cases l

3 where we regulate we try to avoid the radiation exposure to i

4 individuals, try to minimize it.

And in the nuclear medicine, i

5-in fact, it's intentional.

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It's intentional for good purposes, and we certainly l

7 think that your activities have been essential in advising us 8

and the Commission and being.able to develop a regulatory i

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program in which that~ activity is done with the appropriate 10 balancing of the attention between proper use of medical 11 practices and the regulation of radio isotopes and the handling 12 of radioactivity.

13 Often when we have problems in other areas that we l

14 regulate, whether it's reactor accidents such as.the TMI 1

15 incident; whether it's the transportation of nuclear material i

l 16 where we have accidents associated with that or even where it's l

17 with the waste handling and other activities.

18 We never have had an individual die from the l

19 radiation exposure activities.

However, often or at least l

20 there are a few occasions where there is an indication in the 21 medical area there have been individuals-who -- whether their lt t

22 death was directed attributed to the misadministration, but 23 there is, at least, a causal connection.

And this is something i

24.

that the Commission has -- concerned the Commission.

The l

25 activities of misadministration are of a key interest of the

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Commission.

And we certainly appreciate your input, your j

2 wisdom, your counsel in advising the Commission of this 3

activity.

4 The Commissioners themselves are visiting hospitals.

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5 Years ago the Commissioners would,be spending their time at l

6 reactors, reactor sites.

Today, I,think some of you in_the L

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7 audience have had opportunity just to meet some of the l

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8 Commissioners at your facilities. '

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9 But it is one that is really getting increased f

10 attention by the Commissioners, personally.

And they've also 11

'provided us with additional guidance, staffing, and as you are 12 here today to focus on quality assurance and excellence in the i

13 area that we regulate.

14 So I welcome your counsel, your interest is 15 appreciated and I look forward to today's meeting and l

16 activities.

t 17 MR. CUNNINGilAM:

Thank you, Hugh.

l 18 Before we begin the deliberations I would like to l

19 make a few more comments about the purpose of the committee and 20 the ageo* which we will cover.

21 First, the function of the committee is to advise the 22 NRC staff on issues and questions that arise in the medical use l

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23 of byproduct material.

The Commission does not direct the l

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- staff, but rather provides counsel.

And this has worked very I'

l 25 well for us over the years.

As most of you in the audience Heritage Reportine Corporation (202) 628-4888 1

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1 know members of the Committee either personally or by

'2 reputation.

We have a broad cross-cut of. experience on the I

3 committee that enables us to address a series of questions

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4 related to nuclear medicine.

5 The purpose of this meeting is to discuss the NRC's I

6 oversight to the medical use of byproduct material.

We plan to 7

_ spend most of the time on two rules.

One is a proposed rule on l

8 basic quality assurance requirements for radiotherapy which l

9 stems from concern about, Co'mmission concern about the 1

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10 misadministration that can lead to substantial patient harm.

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'll The objective is to try to reduce the number of thke i

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12 misadministration;which occur.

J 13 The second part of the discussion would deal with 14' what we term an advanced notice of proposed rulemaking which is

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l 15 an exploratory paper to try to get comments on to# specific l

16 subjects.

This advanced notice in cuestion carries us a few l

i 17 steps further into quality. assurance and radiotherapy, and 18 after we discuss the proposed rule we will discuss the advanced l

19 notice which explores further ideas as to what might or might 20 not be appropriate for quality assurance and radiotherapy.

The 21 advanced notice did ask questions which we would like to ask 22 the public or members of the medical community to address.

23 We also plan to expand the scope of the discussions 24 with some discussions about medical standards, voluntary I

25 standards, professional organizational standards, what have Heritage Reporting Corporation (202) 628-4888

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1 you, and see how they fit into the rulemaking that this is j

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currently under consideration by the staff.

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3 Our objective is to use voluntary industry, medical 4

community developed standards to the extent we can.

Our l

5 objective is not to interfere with these standards or conflict

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6 with these standards but to adopt them in our regulatory 7

framework where they are appropriate; and we want to discuss j

8 that, spend a little bit of time on that.

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In the afternoon we would like to discuss with bot'h i

10 members of the committee and members in the audience new 1

l 11 technologies that might be developing.

Our objective here is I

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12 to understand what we foresee in the future and how the 13 regulatory regime should fit in to wh'at is coming in the 14 future, both from two standpoints really.

15 One, to be sure that we have regulations that protect 16 the public health and safety with advancing technologies.

And 17 on the other hand we do not want to have regulation / that is 18 going to interfere with the development of these technologies.

19 So we have a dual objective there.

20 That should pretty well cover what or describe what 21 we hope to cover today.

One purpose of a public meeting is to 22 let those in the audience participate and provide comments to 23 the committee.

And also, to participate to the extent i

24 practical in the discussions which take place.

We will have l

25 members of the audience participate to the extent we can.

Some l

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members, some persons in the audience have requested for time I

2 to make comments.

We certainly will accommodate that, and we 3

are pleased that they are making these comments.

Others in the i

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audience who have not made such~ request we will try to

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accommodate to the extent we can.

I do ask that your comments i

6 be as brief and concise as possible.

If you have written i

7 statements you can submit them for the record; they will be l

8 ingluded in the record which will be put in the public document 9

room.

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10 That concludes my introductory comments with one 11 exception, I would like to introduce Dr. David Woodbury who j

l 12 just came in.

Dr. Woodbury is Director of Nuclear Medicine at 13 Westland Medical Center.

And before we proceed into'the agenda l

14 itself, I would ask if any members of the committee have any l

15 comments they wish to make at this time?

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16 (No response.)

17 MR. CUNNINGHAM:

If not we will proceed with the 18 agenda.

Does everybody have a copy of the agenda?

There were 19 copies outside at the registration desk.

You will note on the

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20 agenda we have identified people who want to speak at various 21 sections.

I hope we have this correctly identified, but if not i

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22 raise your hand and we will try to accommodate you as we move 23 on here.

24 Oh, inci' dentally, our Office of Research is very much 25 involved in the development of regulations governing nuclear

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1 medicine.

I would like to just introduce Dr. Bill Morris who i h-2 is head of the Divfsion in our Office of Research that's C

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involved in that development.

And Dr. John Telford, is he i

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here?

Oh, yes, John, thank you.

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Finally, our first member of the staff, Dr. $nthony 6

Tse who will discuss the first ru1e, this is the proposed rule I

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7 for basic quality assurance requirements for medical

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radiotherapy.

What Dr. Tse will do is first describe the rule.

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9 I think then we might call on one or two people who want to l

i 10 make comments.

And then Dr. Tse will discuss some of the 11 comments we have received and have some questions for the r

i 12 committee.

13 In addition to Dr. Tse who is a member of the staff, 14 he has two consultants that kindly assisted him in the work on 15 the proposed rule, those are Dr. Castronovo from Massachusetts 16 General Hospital, and Dr. James Rodgers from Georgetown 17 University Hospital who are in the audience there, and may be 18 called on to help in this discussion at various times.

19 So, Tony, why don't -- I think probably the easiest 20 thing to do is go up to the podium and start running through 21 this.

Do you want to sit up here?

Would it be better to sit 22 up here, it might be?

23 DR. TSE:

It doesn't matter.

24,

MR. CUNNINGHAM:

Your choice.

Up here.

25 DR. TSE:

Thank you.

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MR. CUNNINGHAM:LI think everybody can see you, we

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have a smaller group than we initially anticipated here.

3 DR. TSE:

Thank you, Mr. Chairman, for allowing me 4

the opportunity to prasent my case here, to seek the advice of

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'this committee.

6 Members of the committee and ladies and gentlemen, my l

7 name is Anthony Tse, I work for the Office of Nuclear 8-Regulatory Research of the NRC.

Among my tasks this is my most l

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~ recent assigned task is to wo~rk on this particular rulemaking.

10 With me -- Chairman Cunningham already introduced my 11 consultants.

They are helping me in looking at the details of 12 the clinical and research aspects of those particular therapy,,

I 13 radiation therapy.

14 I have prepared a handout material.

Everybody, 15 please get a copy of the material because I will follow-the 16 material closely.

If you don't have it, it should be in the 17 back on the table.

18 The first page is an outline of what I'm going to 19 discuss; Mr. Chairman already indicate.

I will briefly discuss i

20 the rulemakings at the beginning and then I will stop to permit 21 the members of public to make their views, and then I will 22 continue with the major comments and also will seek the advice 23-of this committee.

24 Next'page, page two is the purpose of my 25 presentation.

My purpose of the presentation is to seek the 3

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members of this committee to give the staff some advice or 2

recommendations of how this staff should or should not adopt 3

the suggestions made by public comments.

And we certainly will l

4 value your suggestions.

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The next page indicates a brief discussion of the

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6 first rulemaking, which is the basic quality assprance in l-7 radiation therapy.

We published a proposal rule on October 8

2nd, 1987 for 60 days public comment period.

And the.public 9

comment period ended December 1st of 1987.

We received 68 10 public comment letters; about 80 percent of them supported the l

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. rule or suggest some modifications of the rule, about 20 l

12 percent opposed the rule.

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13 At this point I have to say thanks to my colleague, l

14 Norman McElroy, for doing such a good job in the proposed rule I

15 so I only have to worry about 68 comments or 600 or 6,000 l

16 comments.

Thank you, Norman.

17 MR. McELROY:

I'd like to thank Dr. Tse for his kind 18 remarks, but I'll keep thinking about them.

19 DR. TSE:

We will consider your comments or 20 suggestions or advice in conjunction with the public comments l

l 21 provided to us.

And also, comments from agreement states, NRC 22

' offices and the regional offices; together we were formulating l

23 the final rule.

24, The next page is a brief discussion of the advanced i

25 notice.

The advanced notice is published to try to seek the i

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j public comments on each source of error that may lead to 1

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misadministration, each source of error.

3 I think the basic quality assurance I talk.about on ca:ed 4

the earlier page is to avoid the misadministration ennt by j

5 simple human errors.

So.they are two different aspects.

The i

6 proposed rule is trying to reduce the siinple -- the 7

misadministration due to simple human errors, but the advanced 8

notice is more broader, trying to address each source of error L

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that could lead to misadministration.

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10 We also published the advanced notice on October 2nd, 11 1987 for 90 days, public comment.

The comment period closed on 12 December 31st, 1987.

We received 14 comment letters, and 70 13 percent of them stated some sort of action might be necessary, 14 and about 30 percent says, no additional regulations is 15 necessary.

16 At this time I will stop here so that the two members 17 of the public who wish to make their statement could make their 18 presentations.

After that I will continue on my discussion of 19 the public comments and seek the advice of this committee.

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20 Thank you.

21 MR. CUNNINGHAM:

We do have listed two persons who do 22 want to make comments, Dr. Herbert Mower.

Is he here?

Oh, l

23 yes, Dr.' Mower.

Okay.

And then following that, Dr. James 24, 'Deye.

25 Dr. Mower, would you like.-- I think the easiest Heritage Reporting Corporation (202) 628-4888 l

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DR. MOWER:

Mr. Chairman, members of the NRC Staff, ig 2

members of the Advisory Committee on Medical Use of Isotopes, 3

ladies and gentlemen, in reference to the proposed rule changes j

4 in 10 CFR 35:

Basic Quality Assurance, we, the members of the f

5 Radiation Safety Committee of Danbury Hospital wish to'present j

6 the following points:

7 Although we have concerns with some of the proposed 8

rules concerning pharmaceuticals of radio-iodine, we understand 9

that the Commission has already received several comments 10 concerning these and we wish here to primarily address proposed 11 rules concerning quality assurance in radiation therapy.

1 12 In particular, Section 35.43(b)(2) Brachytherapy 13 Prescriptions.

We wish to address th'ese three problems:

14 (1) Often, the dose is given in mgm hours radium 15 equivalent using standard tables and geometries.

Allowance 16 needs to be made for this in the regulation.

17 (2) The dose is usually given relative to a point or 18 volume.

This may be for a tumor bed or to boost a nodal area 19 with no specific total tumor definition.

20 (3) Although a theoretical plan can be prepared in 21 advance, the actual prescription often cannot be formalized 22 until after the true geometric location of the sources is 23 known. Thus the sources often must be inserted before the 24, prescription can be finalized.

25 For these reasons, the method in which the dose is l

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prescribed should not be dictated in standards but should be t

2 left up to the physician and conventional use of terms and 3

nomenclature.

4 Section 35.432 Annual Source Strength Measurements.

5 We agree with the need to verify the original source strength.

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However, the remeasurement of the sources, or 'a representative 7

cource from each group of sources, seems contrary to the ALARA 8

principle especially when one considers:

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9 (1) The manu.facturer often has better equipment to 1

l 10 measure the source strength.

To make such a measurement 1

11 requires a special well in order to achieve an accurate 12 measurement.

This type of equipment normally would not be 13 found in a routine hospital setting.

14 (2) Semi-annual leak / wipe tests are already required

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15 which would indicate if there is any loss in the integrity of l

l 16 the source capsule.

l 17 (3) The regulation proposes if there is a i

i 18 disagreement in the decayed manufacturer's strength and the 19 licensee's measured strength that the licensee is allowed to i

I 20 use the manufacturer's strength.

i 21 If the manuf'acturer's strength is to be taken as the f

22 more reliable measurement and to be used in cases where there 23 is a discrepancy between the manufacturer's reading and the l

24 licensee's reading,-why is there a necessity to increase i

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from the Radiation Oncology Department to the-Nuclear Medicine

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2 Department merely to accept the original stated value?

3 section 35.454 Check of Dose Calculations -

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Brachytherapy.

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5' (1)-Such checks require a second person qualified to l

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6 make calculations, i.e.,.a radiation physicist or a l

7 dosimetrist.

If the second person is not qualified, they 8

cannot make a bona fide independent check.

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'(2) The requirement that the independent check be 10 done before 50 percent of' treatment is delivered is also 11 overbearing.

Often the treatment takes place within 24 to 72 i

. 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.

If a second qualified person is not available, on site, 13 the hospital would have to pay a consultant to come in for this 14 calculation.

15 Section 35.45(a)

Manual Calculations in 16 Brachytherapy.

There should be provisions which would allow' l

17 the calculations to be compared with published tables to verify 18 the results within acceptable limits rather than requiring.a.

i 15 second person.

Another alternat.'ve would be to allow the same 20 person to do the calculation by a second independent method.

21 35.454(b)

Computer Calculations.

In order to check 22 the computer calculations, it should be sufficient for the same 23 person to do a manual calculation to a specified point in order 24, to verify the numbers generated by the computer.

Since the two 25 methods are completely independent, the fact that they were i

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done by the same person would not compromise the QA goals.

2 Section 35.633 Independent Check of Full Calibration 3

Measures in Teletherapy.

Requiring a second teletherapy l

4 physicist to do an inoependent check of the output (as I

5 described in 35.632(b)(1)] with a different dosimetry ' system 6

than that originally used for the calibration'is no small l

7 requirement.

This process is time consuming and expensive. It l

8-would take three to four hours of on-site time per teletherapy i

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machine to do the output measurements referred to.

On top of 10 this, there would be the travel time and time necessary to 11 prepare the report for the institution.

Thus, the institution 12 would have to hire a consultant for a minimum of one full day i

13 for one machine.

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14 Since dosimetry systems must be calibrated by i

15 accredited laboratories, there is no justification to 16 transporting a second unit to the site when a calibrated unit i

17 is available on site.

Transporting such a unit only increases l

18 the chances of altering that unit's characteristics and l

19 nullifying the calibration.

A far better approach would be to 20 reinstitute the RPC's, Regional Physic 5 Centers, through the

[umum & w, hvr{f/

AAPM to do a compre en/ 6sfr n.M Buk d 21 sive, though affordable verification of 4

l-22 system performance.

23 35.654 Teletherapy Dose Calculations and Checks.

24 Similar problems and comments are here as were noted and 25 discussed for Section 35.454 for brachytherapy.

i i

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

20 s

1 35.654(a)

For manual calculations, we see very few i

I i

l 2

problems with having a second person doing the calculation.

3 Since all therapy institutions have or should have registered i

4 RTT's, and since they are capable of doing manual calculations,

~

5 this. expertise is available for routine use.

i 6

35.654(b)

For computer calculat,lons, again we feel-4 that a manual check by an independent means, though done by the 7'

8 same person should be more than sufficient to provide adequate 9

quality assurance.

~

[

10 Together, these describe basic tenets of a good j

f 11 quality assurance program.

Who should require it?

No question i

i 12 that we should have good quality assurance programs.

These 13 should be required and evaluated b the NRC, ACR, ASTRO, AAPM,

[All-Gw ed/c e 0.Gb ; AS,7EO-Grsndo.% jb:afw&i /saQAm Omhjnbj 1

d 14 ACMP, and s lar or anizations.-

ggf.4fg //jf.JfAgdf r//J 15 Who should define it?

Designing such a program i

16 should probably be the prerogative of the AAPM and ACMP or done j

17 through a joint venture with the AAPM, ACMP and ASTRO due to 18 the knowledge and expertise of the members of these

-19 organizations.

An example of the possible results is the new 20' calibration procedure that has come out of Task Group 21 of the 21' AAPM.

22 Who should carry out the QA program?

This should be 23 done by. individuals who are qualified and trained and for the H2 4,

tasks indicated as' demonstrated by their credentials'and 25 certification.

This must be true of the individuals doing all Heritage Reporting Corporation (202) 628-4888

r 21 a

1 measurements, calculations and checks.

2 How many levels of redundancy are required?

It is 3

hard to answer this.

In general, two independent checks should 4

suffice.

5 What expertise is required? No one who cannot make 6.

the initial measurements, calculations or computerized 7

calculations is properly trained or qualified to do an l

1 8

independent measurement or calculation to verify the original 9

results.

In order for quality assurance to work, the person 10 doing the checks must be equally qualified to have done the 11 original work in order for the checks to have any degree of 4

12 validity.

1 13 Checks and balances are necessary.

A program l

14 utilizing qualified personnel, properly calibrated equipment, 15 regional intercomparisons through an organization such as the 16' RPC's, and proper protocols from the AAPM and ACMP will provide 17 an excellent network to assure maximum benefit, maximum 18 protection for the patient and staff, and minimum i

19 misadministrations.

20 Cost vs. results:

As with radiation exposure, we

~

21 must think ALARA.

The new rules, as proposed, would place most 22 community hospitals in the position of having to add one H2 3 fulltime qualified person plus making arrangements to have a 24 qualified backup consultant in order to do the routine double 25 calculations and to provide coverage for vacation time, absence i

l i

Heritage Reporting Corporation (202) 628-4888

l 22 I

for meetings, and unexpected absences.

Depending upon the size 2

and location of the hospital, this could cost anywhere from 3

$40,000 to $100,000 a year with no appreciable effect on the 4

quality assurance program or the misadministration rate.

~

~

5 Submitted by Herbert W. Mower, Senior Radiation z

6 Physicist, on behalf of the Radiation Safety Committe,4 7

MR. CUNNINGHAM:

Thank you very much, Dr. Mower, for 8

this very thorough analysis of the rule.

Your comments 9

certainly will be taken into account in the public part of the i

10 rule.

Before you sit down, I would like to ask if any members l

11 of the committee have a question of Dr. Mower on his r

12 presentation.

There was a lot of information in there.

And 13 many of us have not had a chance to d'igest it, of course.

14 DR. MOWER:

There are several copies of that.

15 MR. CUNNINGHAM:

Yes, we distributed the copies and, i

16 of course, it will be part of the record of this meeting.

17 Ar y questions of Dr. Mower?

Yes, Dr. Holman.

18 DR. HOLMAN:

Dr. Hower, is it possible to have 19 sufficient independent calculations so that there is no 20 redundancy in terms of either the method or the information,

~

21 itself, so that a simple error in arithmetic that crept into 22 one method would not creep into the second by the same 23 individual calculating the dose?

24 DR. MOWER:

As long as you are doing it by an 25 independent means, right.

The same problem should not reoccur Heritage Reporting Corporation j

(202) 628-4888 l

23 1

or come up, again.

You should get one answer ene way and a 2

second answer another way.

And this says, "Something is wrong.

3 Go back and check all the data in both and see where the error 4

came from and what it is."

t 5

MR. CUNNINGHAM:

Dr. Tse has a question.

l

~

6 DR. TSE:

Dr. Mower, I agree with you that the 7

different method, you might reach the same conclusion, you i

8 might say that calculation is okay.

However, if somebody's 9

input value is incorrect, would you think that would' discover a 10 input error?

11 DR. MOWER:

You are talking about computerized i

12 calculations or manual calculations?

13 DR. TSE:

It doesn't matter'because, for example, if 14 I read a number, 3 centimeters or 5 centimeters, as a tumor 15 dose, so I input that value into either a computerized or 16 manual calculation.

Now, if somebody reads the number wrong or 17 makes the wrong problem, if he did another calculation, would 18 that error still be in or would be able to detect it by a 19 single person?

20 DR. MOWER:

What I am 'roposing is that a single

~

21 person would do it by a second independent method so that if 22 you used a tabular form the first time, you would use some i

23 other type of table or something for the second one.

So, the 24,

chances of making a second error in a different method that 25 would be in the same direction would be highly unlikely.

Heritage Reporting Corporation (202) 628-4888

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24 a

1 DR. TSE:

Thank you.

2 MR. CUNNINGHAM:

Dr. Griem?

4 3

DR. GRIEM:

On page 2, the second paragraph from the 4

bottom, I like Dr. Mower's idea because should there be 5

software bugs in the computer which we know can creep in, this 1-6 would catch those bugs.

i 7

DR. MOWER:

By the way, this is not addressed in the 8,

regulations which only require that somebody look at the

]

9 numbers that went in and make sure that somebody copied off the 10 numbers that came out, but there is no double check to.make l

11 sure that the computer did what the computer should do.

12 DR. GRIEM:

That's my point.

[

13 DR. MOWER:

So, a second person there, looking at 14 what has been done, would never pick up the error.

So, there 15 is two people -- but to answer Dr. Tse's question, two people 16 who have done what they should do who have completely missed 17 what the computer did, whereas one person using tables and 1

3 18 doing one or two points where they know what the answer should 19 be and comparing that with the computer printout, would 20 immediately have picked that up. So, one person would have been 21 better than two in that case.

I 22 MR. CUNNINGHAM:

Dr. Tse?

23 DR. TSE:

Yes, I agree with that.

But remember, we 24 have two rulemakinds.

The first rulemaking is to address only 25 the simple human errors and the second advance notice would be i

Heritage Reporting Corporation (202) 628-4888 i

l 1

l

25 1

more broad, trying to address each source of error.

So, in the 2

proposed rule, we try to address only the errors due to simple 3

human errors.

i 4

MR. CUNNINGHAM:

Yes.

I think Dr. Mower was talking 5

more broad context than just those rules because it is'all part 6-of the system.

1 4

7 DR. MOWER:

It is a fine line of where you draw the 8

line between the two.

One is not independent of the other; 9

and, therefore, cannot be looked at completely independent of -

1

?

10 the other.

I g

11 pR. MCELROY:

Dr. Mower, we discussed this idea of i

12 doing a manual calculation to verify a computer printout when i

13 we were developing the proposed rule that was published.

And 14 there were a variety of opinions as to the feasibility'of i

15 having an individual duplicate a computer calculation because 16 some of the computer codes are so complex, now.

They have so 17 many parameters.

Do you believe that forgmost computer codes 18 that are commercially available for radiation therapy 19 calculations that an individual can reasonably duplicate at 20 least one or two dose points with a fairly straightforward 21 manual calculation?

22 DR. MOWER:

Sure.

One knows the data for the beams, 23 know where you are looking at in the volume or region of 24 interest.

And it is a matter of taking the weightings which 25 the computer has generated, then plugging these back into the Heritage Reporting Corporation

]

(202) 628-4888 k

j 26 tables you have for tissue maximum ratios or percent depth I

1 i

2 doses, output factors, wedge corrections and seeing whether or 3

not the dose you get for that point agrees with the dose which I

4 the computer said you would receive from that point.

Requires

~

5 not that you know anything about what the computer is doing.

6 It really-goes back to the method that was used prior tg 7

computers where we did all this by hand, except instead of 8

doing every single isodose line, we are talking a couple of 9

points where we can measure things where we aren't in a rapid 10 fall-off right at the edge of the beam, where you are dropping 11 from 80 percent to 20 percent in a matter of a few millimeters.

l r

12 And you are looking at a small degradation there, but you look 13 at a point that is a reasonable point within the volume and you 14 can very easily calculate this with manual calculations.

15 MR. MCELROY:

Thank you.

16 MR. CUNNINGHAM:

Thank you very much, Dr. Mower.

As 17 we go on, we may come back to you and ask more questions, if it 18 is all right with you.

Thank you very much.

19 DR. MOWER:

Certainly.

20 MR. CUNNINGHAM:

The next person who would like to 21 speak here is Dr. James Deye.

I should point out that Dr. Deye 22:

did help Norm McElroy in the initial drafting of this rule.

In i

23 having said that, however, the question of whether or not 24, Dr. Deye agrees.with whether that rule is needed or not is l

25 open.

He simply helped Norm with the drafting of the technical I

Heritage Reporting Corporation (202) 628-4888

l 27

{.

1 part of the rule.

Dr. Deye?

l j

2 DR. DEYE:

Thank you for the opportunity to speak.

3 Actually, in toto, I think that the overall concept of a 4

quality assurance program, especially at the basic level, Ed j

-5 radiotherapy is maybe a concept whose time is overdue.' So, it l

6 was in that vein that I took on the responsibility somewhat

~

i j

7 hesitantly, but still with some enthusiasm, to work with Norm s

8 on this program.

We had a very limited time in which to put i

9 - the program together, though.

And I think, luckily, a lot of 10 the comments that came back publicly pointed out some of the 11 misnomers and errors in logic, possibly, that existed'in the i

i 12 first document.

And I was glad to see some of the comments l

s 13 that came back that alluded me on my first reading of the l

14 document.

l 3

5 15 In general, the comments I would like to make this 16 morning relate in a corollary fashion.and somewhat even-l 17 specifically to the previous comments. In re-reading this, and 18 1 think every time you read a document like this, you read it 19 with a slightly different outlook than you did the first time.

20 I know I certainly did.

When I read it the first time, I read 21 it in the context of t"he environment in which I work where, at l

22 Fairfax Hospital, I am the Chief Physicist, and we have three j

23 fulltime dosimetrists and there are double and triple checks 24 built into the system, and one gets into a mindset that thinks, 25 "Well, that's the way radiotherapy typically is."

Heritage Reporting Corporation (202) 628-4888

I i

28 1

However, having gone out-on patterns of care studies 1

2 with the ACR and other kinds of investigations into the field, 3

I find that is really not the case.

And if I read this l

4 document looking towards what I^ consider to be the most 1

5 probable radiotherapy installation out there, then I come up 6

j, with some serious reservations about specific wording within j

7 the document.

4 8

I apologize I don't have a written document of these 4

9 comments to hand out, but with the snow yesterday, our 10 secretarial services were a bit strapped and nothing got typed 11 in the hospital for niy purposes.

r 12 The comments I would like to make are in three 13 general areas.

The first area has to do with page 38 of the 14 Section 2 of your handout, that is the. handout that was to the i

15 Advisory members pn the briefing book. It is the handout i

16 relative to the draft rulemaking and specifically page 38.

17 Page 38 relates to the qualifications of these 18 individuals who will be doing the checking, whether it is of 19 the computerized calculations or the hand calculations in 20 radiotherapy.

21 MR. MCELROY:

Excuse me.

Can I interrupt, Dr. Deye?

22 DR. DEYE:

Yes.

1 23 MR. MCELROY:

Those of you who are looking for the 24, handout, it was just distributed to the Advisory Committee 25 because it was pre-decisional.

So, you don't have the document Heritage Reporting Corporation (202) 628-4888

1 29 1

that Dr. Deye is referencing, but I think he can explain the 2

comments.1'#

3 DR. DEYE:

But the concept is there.

I don't know 4

the exact reference.

I guess it was 35.454, if memory serves 1

5 me.

It is the regulation that deals with the checking of M

teletherapy dose calculations before 20' percent of the dose has 7

been delivered.

8 And, specifically, in that regulation, there is a 9'

discussion of the qualifications of the individual who would do 10 this checking.

And I think those qualifications paraphrased in 11 my mind right now state that that individual should be a 12 physician, a physicist, a dosimetrist, a technologist or 13 another individual with appropriate t' raining.

14 Now, in reading that the second or third time, it 15 finally struck me what those words are really saying.

And they 16 raise a great deal of concern in my mind.

Namely, those words, 17 without further definition, say that the radio oncologist in a i

18 small hospital in Timbuktu, or the physicist consulting at 19 multiple hospitals throughout Timbuktu might by his or her 20 definition say that a secretary working in that facility whom 21 they have spent an hour with showing them the output of a 22 computer program and showing them the data tables from which 23 the calculations are done is, therefore, an appropriately 24 trained individual.

That worries me greatly.

And I think it l

l 25 would develop a false sense of security within the institutions l

l Heritage Reporting Corporation (202) 628-4888

i

~

i i

30 i

i l!

I feeling that they were meeting the letter of the law within the r

2 Nuclear Regulatory Commission standard, here.

3

.So, I would make a plea on that issue that we either l

4 further define this appropriate' additional training for these t

1 S

individuals or reword it to some extent to get rid of these j

I 6

nebulous individuals beyond the physician, the physicist and

)

7' the dosimetrist I even have great reservations about just the 8

therapy technologist. Most of those technologists, if you look i

i f

9 into their craining programs, receive just a smattering of l

i 10 information, enough to pass their Board exams on how to do a 11 calculation, but that is it.

It goes not much further than i

12 that unless they get' routinely involved in dosimetry in their 4

l 13 respective institutions.

So, I think'some kind of an 14 experience requirement would be very beneficial there..That l

15 was in the comment 1 area.

s o r o dar y l

l 16-A ca vict to that comment 1, there is a statement, I i

17 guess it's page 48.

Yes, page 48.

At the bottom the_ response t

1 18 of the NRC states that most computer programs should have input 19 values indicated on the printed output or the screen.

i l

l 20 Well, in fact, that is not my experience in dealing i

21 with four or five commercially available and popular 22 computerized dosimetry systems.

They should have, maybe --

23 that was a judicious choice of words -- but, in fact, they do 24, not have a complete set of input parameters on the output hard 25 copy of the program. And it goes on to say that there will be a i

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six month lead in period of time.

I don't know of any of the 2

major manufacturers of software who have ever made a 3

significant change in their software program within a six month l

4 lead time.

So, I think that is unrealistic and it is not 5

correct that they have that information already on their 6

output.

7 And then when you add on the screen, I think that i

8 also is misleading because, in fact, this check person is not 9

going to :come back to the computer when the information is up 10 on the screen.

In all likelihood, this is done possibly even 11 after hours and the checker is checking a hard copy output.

12 So, in fact, Atomic Energy of Canada, who I am familiar with 13 from their treatment planning system, does have a lot of the 14 input parameters on the screen, but does not have them on the 15 hard copy output.

And I think what you need to look for is 16 what is hard copy output that can be checked retrospectively by l

17 one or two or three further people.

All that relates to this 18 issue, then, of checking the teletherapy and, for that matter,

- 19 brachytherapy calculations.

l 20 Second point -- no.

It is really a corollary to the

~

21 same point on the computer mistakes.

I think the l

22 qualifications of the individual, it is stated in here that 22 23 percent -- no, 22 out of 28, which would have been 80 percent 24 of the computer problems, and this was earlier on, would have 4

25 been picked up by simple arithmetic checks.

Heritage Reporting Corporation (202) C28-4888

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32 1

If I go back to the Federal Register publication that 2

summarizes the misadministration of dose experience, the very i

3 first page runs down teletherapy programs and I won't bore you 4

with an item-by-item listing, but I only count roughly five out kc

)

of may/ wenty that would have been picked up by simple 5

t i

6 arithmetic mistakes.

(

l 7

For example, a tumor depth was incorrectly measured.

8 That is not going to be picked up by a simple arithmetic check.

l 9

Under the computerized treatment planning, let's see, here.

l 10 Total daily dose was delivered from each port.

I am not sure l

11 that would have been picked up by a simple check by someone

\\

12

.with less than adequate qualifications.

13 Physical measurements:

Wedge factors were measured.

1 I

14 We know that was a major problem at an institution that l

15 involved 53 patients.

That would not have been picked up by 16 the lower level qualified individual who was doing these 17 checks.

My point is that -- it is the reemphasis of my first 18 point.

And that is that we really have to carefully look at 19 the qualifications of the individuals who were going to ask to 20 perform these checks in an adequate fashion.

21 It is the old thing with computers:

Garbage in; 22 garbage out.

And, if the person who is reading the input 23 doesn't recognize the difference between garbage and valid 24, data, then we are g'oing to have garbage out.

And I think a i

25 very necessary aspect of recognizing the input of garbage to a Heritage Reporting Corporation (202) 628-4888

I j

l z.

33

.j 1

computer is to know what the computer's limitations are.

A

'2 piece of data that might.look totally valid becomes garbage in i

i 3

the context of the software that it is subjected to within the i

4 computer.

And the individual who is reading that would not i

l 5

understand that if they didn't have a deeper background in l

I 6

these calculations.

t i

7 RMR. CUNNINGHAM:

Dr. Deye, I am reluctant to l

i;

~

L 8

interrupt you, but we do have to move on on this.

I wonder if l

9 you could summarize your comments and that gets to the Staff on l

10 some of these specifics..

a 11 DR. DEYE:

Okay.

Two more quick comments.

And they l

12 l

are much quicker because they are less nearer and dearer to my 13 expertise.

On page 28 with regards t'o checking with the 14 primary care physician by the radiation oncologist. 'Even as a i

15 non-MD, I find that to be obtrusive logistically and r'

16 professionally.

I think some of the MDs in the audience may 17 speak to this later, but I think it somehow is a supposition 18 that the primary care physician understands better than the 19 fully trained radiation oncologist when a patient is 20 appropriate for radiotherapy treatment.

And I do not believe 21 that to be the case. -

22 Lastly, under the regulatory analysis section of your 23 handout, there are just two minor points on page 9 of that 24 analysis, which is in the back of Section 2.

There is a l

25 statement that.these checks would require essentially one hour Heritage Reporting Corporation (202) 628-4888

34 l

1 per patient.

I think that is an overestimate by a factor of 4.

2 I think a check of a chart should be able to be done in 15 l

3 minutes by people who are qualified.

4 And, secondly, the second sentence of that paragraph 5

on page 9 states that physical measurements of single therapy 6

treatments would cost approximately $50.

That is an 1

7 underestimate by about a factor of 2 in my estimation.

That l

8 summarizes my comments.

9 MR. CUNNINGHAM:

Thank you'very much, Dr. Deye.

l 10 Do members of the committee have questions of l

11 Dr. Deye?

l i

12 DR. ALMOND:

Well, I would just like to point out on 13 the qualification of the person doing the check or the 14 measurement or the calibration or whatever, that I think 15 Dr. Mower summarized that very well in his fifth point, his 16 summary here.

And that is that no one who is not qualified to l

17 do the initial measurements or calculations or whatever really 18 is not qualified to do the check.

If you have an inferior 19 person doing the check, then you are likely to have errors

{

j 20 slipping through.

So, I think that point is well taken.

1 l

21 MR. CUNNINGHAM:

Thank you, Dr. Almond.

22 Any other questions of Dr. Deye?

I hope you will be.

1 23 here the remainder of the day, Dr. Deye, to participate in l

24 these discussions.'

l 25 DR. DEYE:

Yes, I will.

Heritage Reporting Corporation (202) 628-4888 i

35 1

MR. CUNNINGilAM:

Does anybody else want to make a 2

brief comment on this part of the rule?

If not, we will return 3

to Dr. Tse.

i 4

Dr. Tse has outlined a large number of questions.

I l

5 plan to spend -- if ue have to sacrifice something, I think it r) 6 should not be at the expense of this rulemakin'g or the AgPR, 7

but the later things on technology development.

So, we wil?

l 8

want to spend a little bit of time on this.

Nonetheless, we do J

9

-- Dr. Tse does have a fair number of questions, some of which 10 will probably engender a fair amount of debate.

We will have 11 to move on so that we can cover those things that Dr. Tse most 12 wants to feed back into his work on the rule.

13 So, Dr. Tse, why don't you proceed?

14 DR. TSE:

Thank you, Mr. Chairman.

(

15 Before I go on, I want to make one statement.

That 16 is the document that Dr. Deye is commenting on is a preliminary l

17 draft of the final rule, which my input is in, but nobody l

18 else's input is in.

Nobody else means the Advisory Committee,

\\

\\

i 19 which we are seeking their advice, the other members of NRC l

i 20 Staff and Agreement States and the regional offices.

And, l

21 therefore, we did not " include that in the briefing because it 22 is very, very preliminary.

But thank you for comments anyway.

23 Now, I am going to continue on my discussion of most J

24 significant comments and also I will seek your advice at that

(

25 time, one by one.

Heritage Reporting Corporation (202) 628-4888 l

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l l

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

l' 36 1

On page 5 of my handout material is general comment l

2 No. 1, which some people have.already' talked about.

The l

3 comment essentially said the probability of misadministration j

4 is already very low.

Then, therefore, the rule-will not be

~

i-5 effective in reducing the probability further.

~

l 6

My question to th'e Advisory Committee is that if the L

7 implementation of the rule couldn't reduce the number of I

8 misadministration, then would the rule be a useful one.

Now, 1 9

.think sonebody, maybe Dr. Deye, did you say that the' number of 1

10 misadministration reduction would not be that great?

r 11 DR. DEYE:

I didn't men' tion that.

l l ^

(

r l

12 DR. TSE:

Anyway, I reviewed the misadministration 13 cases and if somebody did do the double check, independent 14 double check, assuming he did do the double check and also 15 checked the inputs and so on, it will reduce a substantial i

16 number of -- not reduce, but will detect substantial number of 17 misadministration.

18 So, my question is:

If that is the case, do you l

19 think the rule will be useful?

l j

20 DR. DEYE:

I did raise that point.

l 21 MR. CUNNINGHAM:

Does the committee want to comment 22 on this?

Dr. Goodrich?

23 DR. GOODRICH:

I am not a statistician, but somehow 24 or other the subject of raw number statistics comes to mind.

{

25 If you reduce -- if you have a number of 10 and you would i

i Heritage Reporting Corporation 5

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I 37 1

reduce it by 1, that's a 10 percent reduction.

Aren't we i

2 dealing in that range of figures.

And aren't we imposing on l

l 3

the audience a misunderstanding.

The relative frequency of l

l 4

this misadministration is very small.

So, a small number 5

reduced by any part is a large percentage reduction.

~

6 DR. TSE:

Well, I think what I am ta1 king about is a 7

number of -- for example, I will.give you some general idea.

8 Between 1980 and 1984, we have 27 misadministrations in I

9 th'erapy, radiation therapy.

I have to make some judgment when l

10 I look at each case, which I did, myself.

And if this rule is l

11 implemented at the time, probably 22 errors can be detected.

i 12 Also between 1982 and 1986, there are 14 diagnostic l

13 misadministrations that result the doses in therapeutic range, 14 meaning like 5 millicuries.

And all 14 could be detected if' 15 this rules are implemented.

And that is what I am talking 16 about:

If a substantial number of misadministrations which 17 occurred in the past can be detected, if it is detected it can 18 be corrected, would that be, even though the probability is 19 low, would that rule be useful?

20 MR. CUNNINGHAM:

Dr. Holman.

21 DR. HOLHAN:

One of my concerns is the use of the 22 word " effective."

Yes, it is effective in the sense that you 23 may reduce 22 to 19 to 10, depending on what you do.

The real 24,

issue is how much is it going to cost to be effective.

And the 25 issues that have been raised today, suggests that to do an 4

6 Heritage Reporting Corporation (202) 628-4888 l

l

m._ ~ _ -. _

l 38 1.

adequate: job, we will not be able to accept individuals who are 2'

poorly trained at measuring dose.

We would have to have people 3

as qualified as made the first dose and that this, in many j

4 cases, may add substantially the cost of the hospital's budget.

5 And, if we expand that from one hospital to an unknown' number 6

of hospitals that would have to add substantively to the staf f, 7

we could be talking about a considerable number of dollars.

I l

8

. think it is going to be very important for you to determine, 9

first of all, the order of magnitude of the qualifications of

-i l

10 the individual and then determine the total cost that such a 11 rulemaking will have in the way that radiation therapy is being l

a 12 performed.

And in that way, you will be able to define the 13 cost per incident that is prevented, which will be very high, I l

l 14 am afraid.

1 15 MR. CUNNINGHAM:

Dr. Pohost?

l 16 DR. POHOST:

Yes, I really agree with both 17 Drs. Goodrich and Holman with respect to their comments. I 18 think the other issue is effectiveness.

And the one missing i

j l

19 component from your notes regarding the number of incidence was l

20 the denominator.

Of how many cases did the 27 incidents come 21 from and of how many cases did the 14 come from.

I 22 And I believe the denominator is very high.

And i

23 speaking in clinician terms, medical terms, the incidence of i

24 misadministration is really rather low relative to some of the 25 other types of medical problems we have even, if I may use the i

i Heritage Reporting Corporation (202).628-4888 L

i

(

l l

39 1

cardiological analogue, difficulties in the catherization i

2 laboratory, which is only a diagnostic test, not even a 3

therapeutic test, which can result in mortality and morbidity 4

much more frequently than we see here.

I

\\

l 5

So, the question of cost and effectiveness really l

6 needs to lx3 considered in'this overall strategy for rulemaking.

l l

7 I think the rule, your question, the answer is, yes, that it 8

should be effective in reducing the number.

But'the question I 9

think we all have is cost effectiveness.

It is costly and j

10 maybe it will be effective in a few cases, but is it worth it.

11 MR. CUNNINGHAM:

Yes, for the information of the 12 committee, if you don't already know this, our best estimate of 13 misadministration rate, both for therapy and for diagnosis is 14 about 10 to the minus 4.

Now, that is based on the 15 misadministration reports we receive which we expect are fairly 16 complete.

So, we have a reasonable hand on that.

That will 17 vary from time to time.

So, we are talking about a relatively 18 small number.

And small in comparison to other fields of I

19 medicine, we believe.

20 Dr. Webster?

21 DR. WEBSTER:

Well, I would like to follow up on what 22 has already been said but with a slightly different complexion.

23 The number that I calculated for four years' worth of 24 teletherapy or three and a half years was 360,000 treatments, j

25 patients being treated.

And if you do look at Table 1 in the lieritage Reporting Corporation

(

(202) 628-4888 1

i

l 40 1

original Federal-Register notice on October 2, 1987, most of 2

these errors which are being cited occurred once, at the most, 3

three times, except for the wedge factor error which affected a

[

4 relatively large number of patients.

5 So, the probability, for example, t_ hat the tumor 6

depth'was incorrectly measured or the tumor depth was 7

incorrectly recorded, or the dosimetrist used the wrong 8

computer program was 1 in 360,000.

10 to the minus 5, not 10 l

9 to the minus 4, for any particular error.

10 My point is related to the question, I am going to 11 turn it around.

If these rules are finalized and become l

12 effective, then among the thousand or so teletherapy licenses I i

23 guess there are, now, we must conclude that 999 of these i

teletherapy licensees are probably doing a good job with regard 14 15 to any one of these errors, already.

So, then you are asking 16 999 out of 1000 people to do things in a different way, 17 perhaps, which they are not doing wrong now.

And that bothers 18 me.

19 MR. CUNNINGHAM:

Norm?

l 20 DR. GOODRIQ.H:

"If it isn't broke, don't fix it."

21 MR. MCELROY:

The question is whether it is broken.

22 Dr. Webster has done an excellent job in establishing the l

23 denominator of this elusive fraction.

But I point out 24 frequently within the halls of the NRC in the public i

25 presentations that a therapy misadministration is seldom a i

Heritage Reporting Corporation (202) 628-4888

t 41 i

I self-flagging event.

Diagnostic misadministrations self-flag

.i 2

themselves because the diagnosis is submitted for a patient 3

when the primary care physician didn't request that kind of l

l 4

study or the camera is positioned over one organ and 5

radioactivity appears in another organ.

So, the event. flags 6

itself promptly.

l 7

In radiation therapy, people are there because they 8

are ill and we know that the success rate in radiation therapy 9

is not 100 percent.

And there is very little incentive,-I 10 suspect, to go back and double check or triple check every l

13 ch rt where the care provided the patient was unsuccessful.

9 l

l 12 So, we have a handle on the number of reported therapy 13 misadministrations.

What is eluding us is the real number of

i l

14 the misadministrations.

So, I would'like to just keep that in l

15 mind as we continue our discussion.

16 MR. CUNNINGHAM:

Dr. Almond?

i 17 DR. ALMOND:

Let me just make another point which has j

18 to do with your definition of misadministration.

Which here in l

j 19 Table 1, at least, and in the report that was written, it was a 20 misadministration in fact a calculation.

That was not the l

21 number of patients affected.

That is a different number.

l l

22 Slightly higher, because in some misadministrations more than l

23 one patient was affected by that.

24 And Dr. Webster correctly pointed out that the real i

25 misadministration here was the wedge factor and that might have Heritage Reporting Corporation (202) 628-4888

.m _._ _ _. _ __.___ _ __

j 42 I

affected 53 patients.

That kind of misadministration is going 1 - g 2

to be very, very' difficult to eliminate altogether.

And, so, 3

this number of patients that are going to be affected will 4

bounce up and down.

5 And getting back to your statistics.

You're dealing-l 6

with very low numbers.

It might be 3, you know, but it could 7

be 100 if one misadministration gets through that affects 100 j

8 patients, which is very' difficult.

e 9

Anel it seems to me that we are dealing with such l

. 1 10 small numbers here with-regard to the total number of l

11 tr,eatments, it is going to be very, very difficult 12 misadministration down to zero.

There will always be then j

l 13

. probability of 1 patient or 10 patients-or 100 patients because 14 of one misadministration to be affected.

And, again, it gets 1

15' back to:

What is the cost of doing this?

And we have had some L

16 indication today that, in fact, it might be much more costly l

l 17 than has been indicated so far in the information that we've-l 18 got.

And I don't see us really gaining much by putting a lot l

19 more rules in there.

20 MR. CUNNINGHAM:

Thank you very much, Dr. Almond.

i 21 Dr. umlem?

l 22 DR. GRIEM:

I would like to focus on brachytherapy in 23 Table 1.

-The report covers 43 months.

There are approximately 24 l

42,000 or 40,000' brachytherapy administrations per year.

And I

25

'that is about 280 to 300,000 procedures.

There is (1) the fact Heritage Reporting Corporation i

(202) 628-4888 l'

i i

l

'I i

l 43 lj.j

1 that the source fell out of the applicator is 1; the fact that 2

the source was improperly sealed in._the applicator is 1; and 3

the wrong sources loaded in the applicator is 2.

That makes a 1

4 total of 5 out of 280,000.

l L

5 Now, the fact that the source fell on the floor and l

L 6

was improperly sealed won't really be picked up by all the 7

calculations here.

The wrong sources loaded in the. applicator 8

won't be picked up by the regulations. So, we boil down to 1 in D/ //h k.nlenance drydykond i&

L 9

280,000. I wonder if the HMOs would be happy with the increased 3

10 cost placed on them by these?

(

11 MR. CUNNINGHAM:

I think we have enough comments from 12 the committee to get a sense of where they are going on this i

i 13 question.

t i

i l

14 Question No. 2, I think it has already been addressed j

15 to some extent.

And, in the interest of time,'perhaps we could 16 move on to the next one.

Is that acceptable to you?

17 DR. TSE:

Yes.

Question No. 3 is essentially dealing i

f l

18 with the cost effectiveness which the members have discussed 19

earlier, i

20 MR. CUNNINGHAM:

I think here we have been discussing i

21 this, but which parts of the rule would affect cost most 22 significantly?

I think we addressed that some. Do committee 23 members have a comment on this?

pea l 24 There is no single thing that piques the cost?

1 l

25 (No response.)F' '

l-Heritage Reporting Corporation (202) 628-4888 i

i e

. ~., _.

.4__.

_ _ _ _. _. ~ _ _ _. _. _.. _ _ _ _ _ _ _ _.. _.____ _

44

-)

1 MR. CUNNINGHAM:

Well, I think the record shows that

[

2 the group ruled in' toto, the' sense of the committee'is that the 4

j

'3 rule, in toto, significantly pffects cost without

~

4 identification of single parts of the rule that stick out as

+

l 5

exceptional' costs compared to the others.

[

,6-DR. TSE:

As'I understand it, please correct me'if I 7

am' wrong, many hospitals and licensees probably -- somebody 8'

told me, said they already have a quality assurance and they

{

9..

are already doing a double check in calculations.'I wonder 10 whether'the: committee members agree with that or do not agree 11 with that.

12

'(No response.)

1 1

13 DR. TSE:

You would agree with that.

1.

f 14 In that case, then, the fffect of the rule is not to

{

15 have 300 or 3,000 or 5,000 or 7,000 hospitals to do all this, i

j 16 but to require the ones who do not do -- a small number may not 17 double check, to ask them to do the double check.

18 DR. GOODRICH:

It is still redundant.

The quality i

19 assurance programs in all of the hospitals that are inspected i

20 by the Joint Commission of Accreditation of Hospital 21 Organizations -- they have added another alphabet to it -- all 1

22 of those quality assurance programs in all of those hospitals l_

23 apply to everything that is done, except the billing of the 24 patient.

And I say that advisedly.

25 At any rate, you want to put yet another tier of Heritage Reporting Corporation (202) 628-4888 i

. - ~. -.

4 45 l,

1 oversight on what already exists which will undoubtedly require i

Wearebeinginundated;Hammerfilld' 2

additional documentation.

3 is based in Erie, Pennsylvania.

And it is making a fortune 4

making the paper that you all are causing us to have to fill 5

out and generate.

6 So, my commer.t simply is this s Why add yet another 7

layer on what already exists?

And, again, if it isn't broke, 8

if quality assurance in these hospitals is working, and I 9

submit that it is, let's not add another layer.

l 10 MR. CUNNINGHAM:

Well, let's not move on too quickly, l

11 here, Jack.

Are you saying that there is another layer of 12 quality assurance laid on by these rules or is there another l

l 13 layer of regulatory oversight?

Clearly, there is another layer 1

14 of regulatory oversight.

Is that the question?

Or are we i

15 actually increasing the amount of quality assurance that good 16 medical practice would have the hospitals follow in any event?

17 DR. GOODRICH:

It is probably all of the above' I

i 18 think that you are adding ---with this, you are probably unduly 19 complicating what is already being done and is reasonably 20 successful in being done.

And I see ao need for adding further j

21 to it.

l 22 MR. CUNNINGHAM:

Is it in conflict with present 23 qual.ity assurance rules?

Not rules, but voluntary standards, 24 those procedures which are normally followed in hospitals?

i 4

j 25 DR. GOODRICH:

Portions of it are redundant.

Heritago Reporting Corporation (202) 628-4888 l

I 46 1

Portions of it are unnecessary and unachievable while there is 2

still good quality of service rendered in these hospitals.

The 3

comments that have already been made speak for that.

4 MR. CUNNINGHAM:

Thank you.

Who is next?

1

\\

5 CAPT. BRINER:

I think what I am hearing here, l

6 Mr. Chairman, is'that there is, in fact, a large measure of 7

quality assurance in hospitals today.

After looking at this 8

thing for a good many years with these same" people, many of 1

9 you, I have come to the conclusion that the few bad apples that 10 there may be out there, you are not going to keep them from 11 going their separate ways by another rule or another stratum of 12 regulation.

I don't think you will improve it.

The system is 1

l,

13 in fairly good -- very good control right now and I don't think i

14 an additional rule in this area is going to change it.

l 15 MR. CUNNINGHAM:

Thank you.

Dr. Almond?

16 DR. ALMOND:

Just a brief comment.

Quality assurance i

l 17 in many places as being done would to a large extent cover what 18 is in this proposed rule.

But there are parts of this which 19 are now additional.

For example, the double calibration of the 20 cobalt unit.

I am not sure that anybody does that with an 21 independent system at all.

That would be extra work.

l 22 Then there are some other things in here which would 23 be extra work.

I think you should realize with the present 2'4 climate within hospitals, hospital administrators are looking i

25 every way to cut their budgets.

And the hiring of extra Heritage Reporting Corporation (202) 628-4888

i i

47 1

personnel or extra equipment is very, very difficult to justify 2

to get done.

And there are situations where, in radiotherapy,

)

i 3

with the dosimetry system; are short staffed as it is because 4

of the economic situations.

And I am aware of these because I l

l S.

get called by people who are' frustrated because they don't have 6'

time to do what they know needs to be done and they can't get i

7 the extra staff to do it.

t 8

This kind of rule is going to place an additional

~

9 burden upon those people and additional reguests to l

10 administrations who are going to find it very difficult to find j

11 mopey to hire extra people.

And, as we have said, really for 12 sort of questionable guidance.

13 MR. CUNNINGHAM:

Thank you, Dr. Almond.

l-\\

14 Any other comments?

Dr. Webster?

l l

15 DR. WEBSTER:

Just one final thing.

I think in this 16 question we are now being asked, we are probably looking at the 17 wrong question.

I think there is no doubt that extra rules 18 will reduce the probability somewhat of misadministrations in 19 brachytherapy and other therapy, for example, but the real 20 question I think is:,

is the impact on the public health.

What L

21 And the impact on the public health is obviously going to be 22 very tiny.

And then, so, you really need to put a price tag on 1

23 the denominator of improvement of public health.

And I don't i

24 think the case has clearly been made that the public health is r.

l 25 going to be improved in any substantial way.

i i

Heritage Reporting Corporation (202) 628-4888 l

48 i

1 MR. CUNNINGHAM:.Some people have speculated that it 2

might, in fact, have a negative impact on public health since 3

you would divert resources from the total pocket resources in a 4

hospital to fixing a problem that might be minor compared to 5

other problems.in the hospital.

Speculative, 6

DR. WEBSTER:

Particularly, if no extra manpower is 7

going to be introduced.

8 MR. CUNNINGHAM:

Should we comment on'this one, Tony?

9 DR. TSE:

To Dr. Almond.

10 MR. CUNNINGHAM:

Yes, surely.

11 DR. TSE:

Thank you.

Dr. Almond, I appreciate your 12 point that ir. dependent check of the output is extra step which 13 may, in your view, cost substantial -- or whatever the word is 14

-- for the effort.

15 I think I have shared the though with you that that 16 is the kind of thing I was trying to gather from the committee 17 is that which one may cost a substantial amount of effort.

And 18 we will have a question on that particular point.

Thank you.

19 MR. CUNNINGHAM:

The fourth comment is a big one.

20 And we are struggling with how to deal with it because the 21 - issue is:

The rule is unenforceable because no documentation 22 is specifically required in the rule.

And I think that our 23 thought was initially that the hospital maintain sufficient 2'4 records that additional record keeping isn't required.

But it 25 becomes an issue.

Would anybody care to comment on.that?

Heritage Reporting Corporation (202) 628-4888 i

49 r

1 MR. MCELROY:

Mike Lesar from the Office of 2

Administration is here and when the Staff was working on this 3

rule originally, the idea was that the hospital.probably kept 4

most of the records'that reflected these checks and our J

5 inspectors would be allowed to see them.

6 Under the Office of Management and Budget program, 1

7 any rule making that any federal agency promulgates has to be 8

cleared 4by them for information collection process.

The impact 9

on information collection.

10 My question to Mike is:

Based on the fact that a' 11 fipding was made that the proposed rule did not impose 12 information collection requirements, can you tell me if that 13 finding was made within the NRC or.at OMB?

i 14 MR. LESAR:

That was made by the Records Management 15.

Branch.

16 MR. MCELROY:

The Records Management Branch within i

17 NRC?

18 MR. LESAR:

Within NRC.

There was no new 19 requirement.

20 MR. MCELROY:

That no new requirements were being 21~

imposed by the rule as far as records go.

Okay.

Thank you.

22 MR. CUNNINGHAM:

No comments from the committee on 23 this?

24 DR. WEBSTER:

What if there are no records?

How can 25 you demonstrate that people are in compliance?

I don't Heritage Reporting Corporation (202) 628-4888

50 I

understand the rationale.

2 MR. CUNNINGHAM:

The rule doesn't require additional 3

records for the hospital presently.

The rationale being that 4

there are enough records maintained by the hospital qn management of the patient and quality assurances assoclated i

6 with it, that we could tell whether or not the quality 7

assurance procedures were followed.

8 DR. WEBSTER:

Well, let me give you a case in' point.

9 Suppose there is a specific patient treatment chart.

And that 10 is looked at and that's mentioned in the discussion in these 11 doc 2ments.

That might be necessary to look at the particular 12 records.

Then how do you know that a second person has made a 13 check calculation unless somebody signs their name to it and 14 says, "Yes, we did it on April the 24th, 1989."

Whatever.

15 MR. CUNNINGHAM:

That's true.

That's a good point.

16 DR. WEBSTER:

So, I think there is a need for 17 additional documentation of some kind.

18 MR. CUNNINGHAM:

If the rule is to be implemented and 19 enforced then that additional documentation is required, is 20 appropriate.

~

21 -

Tony?

22 DR. TSE:

Thank you, Mr. Chairman.

23 Consider documentation, of course, is necessary if 24 you must demonstrate the person did the thing and he initialed, 25 he checked this off.

Again, it is in considering the cost and Heritage Reporting Corporation (202) 628-4888

_..___.m.____m._-_._.___

i 51 1

the low probability of the event.

My question is:

Whether'it 2

is advisable or necessary to require everybody to keep a 3

document to indicate whether they did the check or did not do 4

the check is cost effective.

5 Now, the one question is that suppose some 6

misadministration occurred. Suppose somebody finds'out the 7

quality assurance is not followed, then the poorly performing hiev 8

licensee could be required,all the QA records.

Now, is that a 9

proper thing?

10 MR. CUNNINGHAM:

Dr. Holman, did you want to make a l

11 copment on that?

12 DR. HOLMAN:

I cannot accept a middle position.

13 Either the rule is too costly and will take resources away from 14 areas in which there is a greater need. Or there is a true need 15 for enforcement, in which case the addition of record keeping 16 is minimal compared to the actual calculation, itself.

My i

17 opinion is that the overwhelming evidence at this point is that.

18 the cost benefit is exceedingly low and that one should not 19 implement a rule that one feels uneasy about enforcing because i

20 it costs too much.

21 MR. CUNNINGHAM:

That's a very clear statement.

22 Dr. Collins?

i 23 DR. COLLINS:

A couple of aspects of this of a 24 general nature.

We're talking here of keeping records in an i

i 25 area where misadministration is our major concern.

This is i

l Heritage Reporting Corporation (202) 628-4888 i

L

52 1

'also.the major concern of some plaintiffs' attorneys. And this 2

having been_ reported, the first thing they will look at will be 3

the chart.

And the thing that 5: 11 delight them will be a 4

failure to keep such records as have been recommended,by the.

5 NRC.

Nothing less than agreement on total record keeping can 6-really be advised.

7 MR. CUNNINGHAM:

Thank you very much, Dr. Collins.

8' Any more comments on this subject?

~

9 (No response.)

~

10 I think we have a clear' understanding of where the 11 committee is coming from on this point.

And, essentially, I 12 think Dr. Holman summed it up.

There is a question of,--

13

-members of the committee has said the rule has very 14 questionable cost effectiveness.

But, however, if the 15 Commission moves forward with the rule, record keeping is an 16 essential part of the rule.

And the record keeping, itself, i

17 should be a small part of the total cost of implementing the I

18 rule.

I'think I have that about right.

-l 19_

We now have on the agenda a coffee break. But, on the 20 other hand, we are not finished with the detailed comments.

I 21 think maybe a 15-minute coffee ~ break would be worthwhile here.

22 I do ask that you do come back in 15 minutes and we will try t'o 23 move on smartly with this part of the meeting.

24 (Whereupon, a brief recess was taken.)

25 Heritage Reporting Corporation (202) 628-4888

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l i

53 1

MR. CUNNINGHAM:

I have a small change in the 2

agenda.

Dr. Carol Marcus was originally scheduled to comment

~

3 after the comprehensive quality assurance requirements.

But in 4

talking to Dr. Marcus during the break, it appears th,at a lot i

5 of her comments are addressed and really deal,with-the.

J 6

practicality and cost of implementing the basic quality 7

assurance requirements.

So I would ask Dr. Marcus if Ehe would

'8

.give us her comments now, the benefit of her comments.

i 9

DR. MARCUS:

Thanks very much, Mr. Cunningham.

For 10 those of you who do not know me, I practice nuclear medicine at 11 UCLA in Los Angeles, and I am president of the California 12 chapter of the ACNP, and have done a lot of work over the years 13 in radiopharmaceuticals for a variety of organizations.

14 Many of the questions that Dr. Tse brought up were 15 issues that I wanted to discuss.

And I think from an 16 interesting point of view that after the October 2nd Federal 17 Register article came out, since I do all the nuclear medicine 18 for thyroid at the institution, I decided to act as if the 1

19 regulations had been passed, and implemented them in my 20 division just to see..how they would work.

21 Part of the problem is that I am in a large county 22 hospital and sometimes changes take awhile, and I did not want 23 to be in the situation of having to do things overnight.

So we 24 started on October 21st, just a few weeks after the Federal 25 Register announcement.

Heritage Reporting Corporation (202) 628-4888

l 54 i

1-And the reason that I am here today is that I am i

2 really concerned about those proposed regulations, not only

~

3 from a theoretical point of view as many of the panelists have

~

4

' discussed today, from the very practical aspect of making them 5

work.

6 Being involved in radiopharmaceuticals, I think a lot 7

of safety and efficacy.

And I am here concerned about the 8

safety and. efficacy of these regulations.

It would probably be i

9 effective in stopping some misadministrations, but it is too 10 expensive.

11 i

My point of view is going to be that it probably will 12 r.ot be effective in stopping misadministrations, but it will I

13 probably be deleterious to patient care, and it will be I

14 expensive.

So I do not want to be subtle about.it.

I want to 15 say exactly my conclusion is right off.

16 From the point of view of efficacy, and I want'just l

17 to limit my comments to nuclear medicine and p

l 18 radiopharmaceutical therapy.

There was a study done in my 19 radiopharmaceutical therapy at County USC Medical Center in 20 Los Angeles showing _that the rate of misadministrations for l

21 non-radioactive pharmaceuticals and adverse reactions in 22 patients in that hospital was about one in three.

23 Tony Tse tells me that he has some data suggesting 2'4 about 15 percent.

Okay.

But we are dealing with significant 25 numbers, whether it is one or three or half that.

For therapy Heritage Reporting Corporation (202) 628-4888 l

T

55 l

1 misadministrations, as Mr. Cunningham said, ten-to the.minus 2

four.

Maybe with the data that we have got, we are talking 3

about one in'15,000 to 20,000.

4 So first off, I think that is very good.

But when 5

you look at the circumstances in which misadministrations have 1

6 occurred, because nuclear medicine physicians have not 7

interposed themselves between the patient and the 8

administration of iodine-131, you find that it has been the

~

9 standard of nuclear medicine not to ever let that happen.

10 These are very rare individuals who are not obeying 11 th,e standards of their own profession.

I do not know anyone 12 who would not consluce a case before allowing I-131 to be 13 administered.

14 I wonder whether making it a regulation would have 15 any effect on these people at all.

If they do not go along

'16 with the standards of their own medical societies and i

17 professional societies,-probably they will not obey a new

)

18 regulation either.

So I worry in terms of efficacy that this 19 rule is not going to change these very, very rare individuals, i

20 who were not paying much attention to begin with.

j 21 As far as the inadvertent blunders, I think that has 22 been pretty well covered.

There are always going to be a 23 certain number of inadvertent blunders, and we have to try for 24 the best trained people we can. So I think that there is a real 25 question whether there would be any efficacy of these new Heritage Reporting Corporation (202) 628-4888

56 1

regulations.

2 I want to talk about the safety.

That is how it 3

impacts on the timeliness, appropriateness, and cost of patient l

4 care, and just to give you an idea of what kind of vo,1ume that 5

we do in my department.

Last year, we did 50,6 thyroid uptakes,.

i 6

236 thyroid scans, 58 thyroid I-131 treatments.

We ordered l

lz 7

2.7 curies of I-131, and 108 millicuries of I-123.

And we 1

8 follow about'200 patients who have been given I-131 in the 1

L 9

past.

10 Now this is a-500 bed hospital.

This is probably not 11 an, unusual volume.

I know people who have three times that 12 volume.

But it gives you an idea.! This is not an unusual 13 occurrence.

14 Sometimes when I was reading the Federal Register 15 article, I got the feeling that people thought that these were l

l 16 sort of rare cases that you deal with.

I deal with them every 17 day.

I have an average of more than one treatment a week.

18 These are not unusual things.

t 19 When we started trying to act as if the proposed regs l

l l

20 were actually in effect, the very first thing that we had to 21 abandon was the idea of ordering the I-131 on a patient-by-22 patient basis.

And basically according to the new regs, it 23 says that you cannot order it unless you have ascertained that i

24 it is appropriate.

And in order to do that, you have to

]

25 examine the patient, talk to his primary care physician, look a

Heritage Reporting Corporation (202) 628-4888

. =..

. -. _ _.. - ~.

l l

57 1

'at his hospital chart, et cetera.

2 And we have abandoned this because of cost, plus the 3

fact that I need an. extra clerk putting in all of the orders

[

4 and running around picking up all of the packages.

The way l

l 5

that I-131 is sold, at least the way that we pay for it, up to 6'

the first 5 millicuries is $25, and every millicurie afterwards.

7 is another $2.

And if I had ten doses of 5 millicuries each,

]

I 8

it would cost me>$250.

And if I have.one shipment of 50 l

9 millicuries, which is what I order at least every other week, q

10 that is going to cost me $115 which is more than half in 11 sa,vings, plus a lot less paperwork.

12 So most people in this business do not order on a 13 case by case basis.

It raises the price enormously.

There is 14 a lot of paperwork,.and it is very confusing, and it costs a i

l l

15 lot more money, And the last thing that your hospital 1

16 administrator is going to do these days is double your isotope

)

17 budge't.

18 Okay.

The next problem was this necessity to review 19 the patient's chart.

I know that for those of you are not l

20 physicians that it sounds obvious to you that the patient's 21 chart should exist.

It seems like a perfectly reasonable thing 22 to ask for.

23 In fact, in many county hospitals and VA hospitals, 24 very, very busy hospitals that work on small budgets, it is 25 very difficult to accomplish that.

In my hospital, the odds of Heritage Reporting Corporation (202) 628-4888

l l

58 getting a patient's chart are about one in three.

And that is 1

2 not unusual in many county hospitals.

3 If you are willing to valt a month and hire someone 4

to run around hunting for it, and it is usually in the quality 5

assurance office somewhere, and I not kidding, that is usually 6

where you find it these days, you can get t'he number up to 7

about two out of three.

O If your patient's chart is in Mexico, Guatemala, 9

El Salvador, Cambodia, Vietnam, Thailand, Taiwan, India, O

Pakistan, Iran, or Ethiopia, and all of these happened to me 11 tt>is year, it is very hard to get the patient's chart.

12 And on occasions obviously, we simply cannot honor 13 this requirement.

We get poor people in from all over the 14 world who describe thyroid disease in about thirty languages.

15 And many of them come from Third World countries where their 16 care was questionable, and where their understanding of their i

17 care was even more questionable.

18 The patient could die waiting for his chart to be 19 located.

And I do not like to practice that way, so I just do 20 not worry about it.,.But I think that you have to understand 21 that it is not like smooth data retrieval, to juct get hold of 22 these charts.

23 Other problems are very simple.

In my hospital, 24 people give false names, so that they will not be billed.

You 25 know, Maria Gonzalez one day is Guadalupe Garcia next week.

I l

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1 mean you have to understand their point of view.

It is very 2

.important.

But charts for the same people, they exist in six 3

names.

And it is a real thing.

4 The next item was the requirement to discuss the case 5

with the referring physician.

Of course, any nuclear medicine 6

physician is going to discuss the case with a primary care 7

doctor if they have any questions.

But most nuclear medicine 8

departments have a long form that a referring ~ doctor fills out.

9 And you ask why do you want this test, and he fills it out.

10 And if he does, you do not have questions.

So the idea of 11 paging him and talking about the weather seems kind of silly.

12 So I quit asking him questions, if I did not have any to ask.

13 And then there is the problem that sometimes it is 14 just not clear who the primary care doctor is.

Last year, I 15 had the police bring in a patient from the county jail with the 16 news that all they found on him was my card in his pocket.

But 17 he was half dead, so they brought him in.

And he was half 18 dead, and I took care of him.

But you know, who is the 19 referring physician.

20 You do not need a M.D. degree to know that somebody 21 is half dead.

Maybe you need a M.D.

to figure out which half, l

22 but that is about it.

23 Sometimes patients just walk into my clinic saying l

24 essentially Joe sent me, no referral, nothing. Somebody said go l

25 to the county.

And I take care of them if they have thyroid i

Heritage Reporting Corporation (202) 628-4888

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n 60 i

j 1

disease, but I will never know who referred them to me.

I I

2 never send out reports to a lot of these people.

You just hope l

3 that you do the best you can.

l 4

And=I would hope that the people putting together l

5 these regulations understand that there is a huge population of 6

patients in this country that fall into categories like this 7

that are not the wealthy insured people, but the poor people 8

and the ones that get the best they can without necessarily, 9

following al:1 of the rules.

10 The next stipulation in the suggested regulations was 11 the examination of the patient.

And sometimes obviously this s

12 is essential,-but sometimes it is absolutely no/ essential.

And 13 I think that you have to leave that to the discretion of the-14 physician.

15-If a patient has had surgery for thyroid carcinoma, 16 and the referring surgeon fills out the form, gives you the

< hbloi13 17 op note, the pagp report, the discharge summary, and even I get j

18 those sometimes, and then you have some recent data on the 19 patient's lab values including their thyroid function test, I 20 do'not need the patient to come in an extra time and be billed 21 for it when they are broke anyhow for me to examine them, 22 because-all I am going to find is that there is a scar on their 23 neck, that is all.

24, So I will make plans for them to come into the-l 25 hospital and get their 100, 150, or 200 mil 11 curies or l

l i

i i

Heritage Reporting Corporation (202) 628-4888

61 I

whatever, and I would not even see them until the day that they 2-come in.

But the stuff is ordered, and the room is set up.

3 They do not need an extra visit ahead of time for me to do my 4

physical when I know that the surgeon had done his and I have 5

.all of this data.

1 l

6 It is just happens sometimes that you do not need to.

1 l

l

-7 And I do not think that it is right to say that you have to all l

8 of the time.

I think that you just have to. trust the physician 9

to make the judgment on that.

10 Well, it is now three-months after I tried to 11 implement these new regulations.

And the only change that l

12 remains from the whole thing is that instead of writing 13 "Okay, Marcus" on the top of the request form, I write a

.l' 14 prescription for radioiodine and date it and sign my name.

15 It does not change patient care at all, but I can i

i 16 live with that beautifully.

It just means that I looked at the l

17 form, and I think that everybody should.

18 But I just caution you about the impracticality of 19 the other parts.

It can be expensive.

It could cause terrible 20 delays.

And it does not serve anyone.

21 I know that it is all very well-intended.

And the i

22 Nuclear Regulatory Commission has a wonderful backlog of i

23 efforts supporting nuclear medicine making new regulations as 24 needed.

It is not one of those agencies that just sits there 1

25 and refuses to change.

And I have enough problem with some of l

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those.

1 1

{

2 But I think that they should recognize that it is 3

very, very risky to try to pass regulations determining the 4

exact, specific, detailed practice of medicine when those 5

practices vary all over the country ~with different groups of

~

6 people with different kinds of resources.

And you cannot 7

possibly comply with everything, and you cannot possibly cover l

8 everything.

9 Physicians spend a lot of time learning how to do the 10 best they can with what they have got.

And I think just i

11~

directing every single detail of the way they treat a patient 12 would be a good idea.

13 I think that is about it. 'Thank you very much for i

14 your attention.

15 MR. CUNNINGHAM:

Thank you very much, Dr. Marcus.

I 16 know from years of experience that you bring problems to us or i

J j

17 to agencies in a forthright and practical way, and we certainly 18 appreciate it.

19 Are there any questions of Dr. Marcus; Dr. Woodbury?

I 20 DR. WOODBURY:

No, I did not have any questions for 1

21 her.

I just wanted to support and applaud what she has said.

22 Part of my practice is in a county situation too.

And you run 23 into the situation where two government agencies tell you to do l

24, two different things at the same time.

[.,Q,,, ~

i e

l 123 1

professional bodies that we've been hearing about.

And, you 2

know, that when you fill out an application for a license there l

3 are a number of things that you have to check that you have, 4

and usually you have to provide some details on what you have.

)

5 And this might be one subject area.

[

6 So I think the licensing process would be, in those 7

general terms, might be a very good vehicle-for ensuring that 8

people who may not have a quality assurance program indeed do 9

have one with regard to misadministrations to the conduct of 10 their work, in other words.

And I would put that down as my

. 11 suggestion.

l l

12 MR. CUNNINGHAM:

Well, thank you very much, Dr.

13 Webster.

I would like to comment on the point you brought up.

14 As a matter of general policy the Commission uses 15 performance-based regulations where they think it's possible or l

16 practical to do so.

And only use prescriptive regulations 17 where they feel its necessary.

18 The thirig that the Commission has sensed, at least I 19 have of the Commission's view point on nuclear medicine at this 20 time is that some prescriptive regulations might be indicated.

21 And I say this only br on some initiatives that the staff 22 has taken to the Commission over the past several years of a 23 more performance-based and we have received instructions to be 1

24 somewhat more prescriptive.

That, of course, can change.

I 25 I think the kinds of information being developed out a

4 i

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124 l

./

1 of this meeting will help the Commission balance those kinds of 2

decisions between performance and prescriptive regulation.

So 1

i 3

this is useful.

4 Dr. Pohost.

l.

5 DR. POHOST:

I just want to make a,few' comments.

l i

6 First of all, one of -- I didn't get the Federal Register 7

Notice because I'm on a broad license and I just wonder how 8

many --

9 MR. CUNNINGHAM:

You're also in an agreement state.

10 DR. POHOST:

In an agreement state.

And is there any j

11 way to distribute to agreement states and to broad licensees or 12 not to individuals that participate in broad licenses?

Is that 13 something that you can do?

14 MR. CUNNINGHAM:

I would have to check into it.

15 Certainly we provide copies of these to the states themselves.

16 There may be a protocol question of our uending information to 17 state licensees and possibly creating some confusion of, are 18 thesr, cegulations applicable to them?

But there should be a 19 mechanism to get this kind of information out.

20 I think our preference, not preference, but perhaps 21 cEt'he better way to do it, based on what Dr. Woodbury said, would l

22 be to go through the professional organizations and put 23 something in newsletters that I suspect. physicians are more 2'4 inclined to read than the fine print and poor quality of paper 25 sent out in the Federal Register.

Is my assumption correct Heritage Reporting Corporation (202) 628-4888

t i

125 l

!/

1 there?

l 2

DR. POHOST:

I agree.

Absolutely.

l 3

MR. CUNNINGHAM:

This is more likely to be the case, l

l 4

their professional newsletter type of thing.

Is that a fair t

5 assumption?

I see nodding of heads.

6 Dr. Pohost.

7 DR. POHOST:

Yes, I think that is a fair assumption.

l 8

I'd like to make some other suggestions.

I know that maybe the 9

NRC is not yet in the kind of business of providing l'iterature 10 to individuals who might not -- who might have questions about 11 hpw to get licensed.

Who might have questions about how to use i

12 new approaches about -- and even to the lay public.

And would i

1 13 really, you know, from my perspective, would really ba nice if 14 one could describe in layman language what you have in the i

15 Federal Register which is not in terribly easily understood 16 language until you've been on this committee for several years.

17 MR. CUNNINGHAM:

Now, I must say I'm shocked because 18 there's been a lot of energy writing licensing guides that puts 19 this in easy language.

20 DR. POHOST:

So you already have such?

We'resupposeftohavethesethings.

21 MR. CUNNINGHAM:

22 I mean, I thought that's what we were doing when we wrote these 23 licensing guides and explained the guides.

And the licensing 24 guides not only explain the rules in perhaps a little bit more i

25 st.aightforward way that the lawyers won't let us do when we Heritage Reporting Corporation (202) 628-4888

l 1

126 1

write the rules themselves.

{

l 2

DR, POHOST:

I understand.

3 MR CUNNINGHAM:

But it identifies ways to comply

)

4 with the rules that are in common usage.

And this is where we 5

use some guides from the various professional, organizations, 6

and what constitutes an adequate survey or what constitutes ali 7

adequate calibration method and so on and so forth.

L 8

DR. POHOST:

But the knowledge nf the availability of i

9 these is not widespread.

i 10 MR. CUNNINGHAM:

Well, that gets back, because I i

11 thpught at one time it was, but most people are longstanding 1

l 12 licensees that perhaps aren't aware of these.

But I think it i

13 might be well worthwhile to print a reminder every once in a

)

14 while that we have all these guides.

Now when the-guide is 15 printed, I think we send it to all our licensees, but that's 16 another document.

As Dr. Woodbury characterizes, it's a 17 Federal Register perhaps.

18 We are going to put out a publication at the office 19 level that would cover some of the -- cover other things, but 20 include nuclear medic,ine and we can reprint and publish in any 21 professional' journals all these guides and things that are 22 available.

23 Now, having said that, you might want to take a look 24 at some of these things and we would appreciate any suggestions l

25 from any member of this committee to improve what we have, to l

f Heritage Reporting Corporation (202) 628-4888 I

1 127 1

make it more useful and practical to use it, because it is

{

2 addressed to the licensee or to the users.

Licensees are the j

i 3

hospitals, but to the people that have to use them.

4 DR. POHOST:

And the trouble getting through the

)

5 agreement states, is that something'you can come around?

6 MR. CUNNINGHAM:

We could send it to anybody that 7

asked for it.

Now I'd have to check.

Is somebody from the

(

8 agreement states here, yes.

I think these are supplied to the

9 agreement states, and I think they use the same guides.

They 10 don't reprint it ander their own cover, do they?

11 MR. BOLLING:

Usually not, no.

l l

12 MR. CUNNINGHAM:

So these guides should be available.

l 13 And if you ask the agreement state and they don't have it, they 14 will -- we will be pleased to supply it.

15 DR. ALMOND:

I do know that my state which is an 16 agreement state received it from you, and then they sent it out 17 to all of their licensees.

So I got it from them in the form 18 that vou sent it to them.

So there are some states that just 19 automatically send it on.

20 MR. CUNNINGHAM:

Maybe that's something you want to 21 take up with the people.

22 Dr. Griem.

23 DR. GRIEM:

Yes.

I have in front of me a 1

24 solicitation contract form from the NIH which deals with the 25 patterns of care.

The actual -- what they plan to do in the 48 i

Heritage Reporting Corporation (202) 628-4888

128

{

month period is in here and so forth.

But in here are all of 1

2 the radiotherapists and so forth.

They have -- the patterns of 3

care study has looked at all the facilities of the United 4

States and made two reports including cobalt machines, and how

~

5 many people are involved and on their staff and all these 6

details.

7 They have also looked at the outcome analysis for the 8

use of it around this country and reported on that.

This now 9

takes that same process and carries it out another four years.

10 Now, this was a contract announcement and certain 11 pe,ople have bid on this contract, and that, of course, who 12 those people are I think is privileged information at this 13 time, but is one of the reasons I'm here this week.

So much 14 for that.

15 It seems to me that the suggestions, some of the 16 suggestions made ;'ere that one might use this as an educational 17 process and going together with the College of Nuclear 18 Physicians and working with the American College of Radiology 19 or whoever is doing the patterns of care, might be a much more 20 effective way of getting the task accomplished.

And might give 21 you much higher profile.

22 Incidentally, the patterns of care publishes a 23 monthly newsletter.

24 MR. CUNNINGHAM:

Believe me after this meeting I'm in 25 deep trouble.

And we will publish a newsletter, I guarantee Heritage Reporting Corporation (202) 628-4888 j

129 1

you that.

c

.2 DR. GRIEM:

My. wife is a dermatologist and if you 3

want to see how to get the message across you should see how.

4 the cosmetic groups get to the dermatologists; she gets two 5

video tapes a month.

6

-(Continued on next page.)

7 8

9 10 11~

12 13 14 15 16 17 18 19 20 21 22 23 24 25 s

Heritage Reporting Corporation (202) 628-4888

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MR. CUNNINGHAM Any more comments?

2 Capt' Briner?

3 CAPT. BRINER:

We have been talking about finite pots 4

of money, people out there and the topic of Agreement, States 5

has come up several times, not the least of which by something 1

l l

6 that I said.

Agreement States in recent years have also felt 7

budgetary pinches.

And they have had a lot of things laid on them by Congressional mandate, not a regulation that you. guys j

8

~

9 say, "You've got to be compatible with this or you lose your 10 274-I Agreement State status."

Congress says, "You have got to l

11 do,certain things."

It requires money.

It requires people.

12 Now, I would caution NRC in anything that they do 13 which would add any more budgetary constraints on people in 14 Agreement States.

You have got 29 or 30 states out there that

-15 you say, "You must be compatible with what we say."

You may l

16 have deep trouble at River City.

Believe me.

17 MR. CUNNINGHAM:

Thank you, Capt. Briner.

18 Any more comments on this subject?

19 (No response.)

20 Let me try to summarize what I have gathered from 1

21 around this table, the discussions.

The first is that in 22 approaching new standards or seeking ways to improve the l

23 quality of medical care through the regulatory process, we 24 should consider several things.

Joining existing groups who l-25 have some overview responsibility so that we enhance perhaps I

Heritage Reporting Corporation (202) 628-4888

131 1

have some synergistic effect rather than work at cross-

{

2 purposes with them:

patterns of care, the various professional 3

colleges, perhaps the JCAH, the new name of the Joint 4

Commission.

So, join to those organizations if possible.

5 Another thing that we should do is use to the extent 6

practicable existing or developing voluntary standards.

And in 7

participating in the development of those voluntary standards 8

which we c,an later adopt.

9 Prior to considering adoption, however, there is a 10 recommendation that we should do some sort of-pilot study so 11 thpt we fully understand before we put ef fective regulations 12 into a very large medical community, what the consequences of 13 doing that are, to avoid things that simply aren't practical 14 for a variety of reasons and to take into account what it is j

15 going to cost' compared to the benefits which might be gained.

16 Finally, that better communication with our 17 licensees, the medical community, would help.

That information 18 has to be packaged in a certain way so that the very busy 19 physician really notices it and reads it and understands it and

-20 that, also, that physicians should know easy mechanisms to 21 obtain information from regulatory agencies; namely, the NRC, 22 should they desire to have.

23 That summarizes the kinds of things I have found.

24' Dr. Webster mentioned the question of performance based rules l

I 25 compared with prescriptive based rules.

We agree that p

i f

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l performance based rules should be our objective.

Prescriptive 2

based rules should be used only when necessary.

That some of 3

this information that we are developing today and the system 4

that has been proposed to develop the rule might be 1,ead to 5

more prescriptive based rules -- I mean more_ performance based 6

rules than is the case for prescriptive based rules.

7 Does that summarize the sense of what the committee 8

.said on this point?

9 (No response.)

l 10 Okay.

Before we leave this subject entirely, I would 11 note that, as you are well aware, the Commissioners, 12 themselves, are very interested in this subject.

We have had 13 the benefit, and it is very useful, of three Commissioners' 14 assistants, the Chairman's assistant and two Commissioners' l

l 15 assistants being here today. I would ask if any of them have i

16 any questions that they would like the. committee to think about ufan o'cc O wn lee ?

17 or comment on. Janet Doulce.

Janet?

18 MS. KOTRA:

I guess I would say only that --

19 MR. CUNNINGHAM:

Perhaps you could come up to the j

20 microphone.

This is, Janet Kotra, Commissioner Burnthal's l

21 assistant.

22 MS. KOTRA:

I guess I would only comment, in having 23 heard the opinions expressed this morning, and I tnink it is 24 fair to say that.there wasn't a lot of difference among those 25 opinions expressed this morning that:

"It really ain't broke.

i I

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1 Don't fix it, guys."

2 I am not quite sure that this Commission or even 3

previous commissions that have tried to w.estle with that 4

question are prepared to accept that. If there is a better way 5

to get it across,_I would encourage you to de it.

I would also 6

say that if you believe that we are going or the Commission is 7

going in the proper direction, but is doing it the wrong way, 8

that every constructive suggestion as to how to best accomplish 9

what should be a common goal be put before it.

I think the 10 Commission wants-to consider those alternatives, to think about 11 them.

But, if just told:

" Don't fix it because it is not 12 broken," I just don't think that is going to be adequate to the 13 Commission's needs.

But that would be my only comment.

It is 4

14 not a specific question.

It is just an observation.

15 MR. CUNNINGHAM:

I think that is very important, 16 Janet.

I think it is a very good comment and one we have to 17 bear in mind. And I think it is very correct. Thank you.

18 MS. KOTRA:

And on behalf of my Commissioner, at 19 least, we certainly appreciate the time and energy that go into 20 dealing with this. And if there is a better way that the 21 Commission as a whole could communicate with the regulated 22 community, I think that we would be remiss if looked aside and 23 didn't take that into account.

24 MR. CUNNINGHAM:

Thank you very much, Janet.

25 Margaret?

Margaret Federline, Commissioner Carr's as-Heritage Reporting Corporation (202) 628-4888

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/

1 assistant.

Margaret, could you come up to the microphone, i

2 please?

3 MS. FEDERLINE:

I would really second what Janet just 4

said about the communication.

I think the Commission,at this 5

point is most. interested in improving communi, cation with the 6

regulated community.

-And I know a' number of the -- the 7

Chairman and a couple of the Commissioners have actually been 8

out on visits meeting with, licensees.

9 One point that came up this morning that I would like 10 to explore a little further wast You feel that there are' ample i

f 11 regulations in place, already.

And that perhaps we ought to i

12' take better advantage of those.

What improvements could we l

13 make in inspection or enforcement that would take better 14 advantage of the regulations that are already in place?

l

- 15 MR. CUNNINGHAM:

I forget who made the comment. I 16 know the comment was made, but I forget who made it.

17 MR. CUNNINGHAM:

Dr. Holman, would you care to 18 comment?

19 DR. HOLMAN:

Basically, I think Norm LaFrance said it 20 best in his testimony which is that in many ways the regulatory 21 process is adequate. I think you need to put it in perspective.

22 That is the number of misadministrations is small.

"' e 23 consequence of those misadministrations is small relative to 24 other -- in terms of-morbidity and n ortality -- and, therefore, 25 the regulatory process is working quite well.

!t I

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i 135 What we discussed this afternoon is looking into I

l 1

2 voluntary quality assurance programs to try to garner 3

additional mechanisms to enhance the manner in which programs j

4 evaluate themselves.

And I think that without going through 5

the processes that I suggested, it becomes very difficult just j

6 to come up with, at this table, more rules.

I think that 7

defeats the whole purpose of what I said, which is that we need 8

to carefully look at programs, including the existing 9

regulatory programs, voluntary quality assurance programs, and j

10 to test them out in the field and determine if they do, indeed, 11 improve the -- reduce the number of misadministrations in any 12 measurable way and if that is -- if the additional regulations 13 or quality assurance programs are worth the effort.

14 MR. CUNNINGHAM:

I think there is something -- well, 4

15 two points. First, when 'a. talk about voluntary standards and 16 NRC participating in these in some sort of way, I think that 17 eventually what may happen is when we have a voluntary standard 18 that we know works, and that it is one that the medical 19 community largely agrees to.

And there is undoubtedly a 20 mechanism to have these voluntary standards proved, that we 21 would very likely adopt these are regulatory requirements to i

22 have some enforcement capability on the few outliers that 23 really don't comply with what is believed by the medical 24 community to be good practice.

And I think that is one of the 25 types of things we can do.

l Heritage Reporting Corporation (202) 628-4888

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1-

{

The other thing is that in considering how we can 2

improve the quality of medicine, we have talked a lot about

)

l 3

misadministration and the incidence of morbidity / mortality as a 4

result of misadmis.tstration.

We should not focus entirely'on 5

misadministration.as our ultimate goal. I thi,nk that there are l

'6 other things that the regulatory process, in trying to deal 1

l 7

with this, can do or do as part of the overall picture to raise i

l

{

-8 the quality in medicine, in this particular field of medicine.

j 9

Because if we talk about training, training might or might not 10 prevent a misadministration.

However, training also might 11 repult in better diagnosis, better and more accurate diagnosis 12 or what have you.

So, this thing should not be thought of in 13 terms of misadministration alone when we talk about the 14 regulatory process. I think that there are other effects that 15 this can have that in the long run can be beneficial.

16 Dr. Webster?

17 DR. WEBSTER:

The question was raised about what can 18 the inspection process do.

And I think like most everybody 19 here I have been through a number of inspections over a 20-year 20 period or more and one thing strikes me as being rather 21 obvious.

And that is that the inspector will go around with a 22 copy of 10 CFR 20.

He is very familiar with the rules, but 23 certain general things which are very important in.the context

)

24 which we are discussing now, is training.

They never ask about 25 training.

They never investigate the quality of training.

And l

i j

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certainly not in my experience. And that is sort of an i-2 untouched area, even though people do present their credentials k

3 and they say they are qualified.

But.I am talking not so much J

4 about' people who are applying for licenses, but the programs 1

}

5 for' training are run in hospitals.

And nobody 1ooks at.them

~

i L JtANo]

6 from the NRC.

Even the people from the JQ,,whatever it is, the l

7 thing that ends with an "O."

j 8

The NRC should be interested in that because it is

~

9 the underpinning of their safety program is:.How good is the 10 training.

And, similarly, they. don't ask about the quality j

11 agsurance programs.

That is never looked at.

That is not a 12 mandatory, requirement, as I said, now.

But it ought to be.

It

- 13 ought to be.

And inspectors ought to look at that to see 14 whether people in fact are pursuing such a program and that 15 should be demonstrated by the licensee that he has one and that i

- 16 it is working.

i 17 MR. CUNNINGHAM:

Thank you, Dr. Webster.

That i

18 comment is helpful.

I might add that we are, in. fact, trying 19.

to upgrade the training program of both the inspectors and the 20 staff by first hiring people that have worked in nuclear 1

21 medicine laboratories and radiation therapy departments.

And 22-we are trying to change the approach to inspection that doesn't 23 necessarily do a check-list kind of thing against part 20, but

' 24-really look at the things that are more substantive.

But the 25 support we can get for that is certainly important.

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138 l'

Dr. Griem?

{-

]

3 i

2 DR. GRIEM:- Dr. LaFrance was really the first one to 3-bring up the whole question of education.

And the question 4

really is:

Should there be some continuing medical education,

]

I 5

even some CME credits for something like this for physicians

]

~

j 6

who deal with radioactive materials.

And make this a part of i

7 one of the college courses and so forth.

And bring the medical 8

community -- they,get certain points for CME in most states --

9 bring the medical community up to date on certain aspects.

10 Some of the physicians who~have been out for 5, 10 or 20 years 11 m4ght appreciate such support from the NRC.

12 MR. CUNNINGHAM:

That is an interesting point.

I 13 would like to hear some views of some other committee members 14 on training and perhaps some requirement for some periodic 15 retraining.

16 MR. MCELROY:

I would like, also, that we not 17 restrict that to just physician training.

The Commission'has 18 also demonstrated interest in technologist training.and 19 dosimetrist' training.

So, all of these individuals should be' 20 taken into consideration here.

21 MR. CUNNINGHAM:

This could be a very important 22 subject.

It is also one that I think we would draw a lot of 23

. interest.

We will hear the same cost question, again, I.. am 2-4 sure. What do other committee members, do they agree with 25 Dr. Griem?

Dr. Holman?

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1 DR. HOLMAN:

The State of Massachusetts has made, as 2

part of its licensing agreement, that five hours, for example, t

3 every two years be spent in risk management to address this 1

i 4

' issue. So, what you are saying certainly makes a good deal of i

5 sense that one could narrow the focus of the continuing 6

education that, obviously, in this case would be a factor in 7

terms of licensing for NRC licensing. And I think it would 8

address somes of the issues that concern me in terms of 9

publication.

Publication in the Journal of Nuclear Medicine or

~

10 in journals where those individuals who are probably spending 1

11 50, percent or greater in the pursuit 4 of this specialty can be 12 addressed in that manner. But, really, how do you get to the 13 people that are perhaps spending less time, are-not members of l

14 the societies and this might be one way to address that issue, 15 as well, and certainly could be applied to physicists, as well.

16 MR. CUNNINGHAM:

Okay.

You talked about.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> of j

17 training for licensure.

That is your license to practice I

18 medicine issued by the state?

19 DR. HOLMAN:

That is correct. In other words, it is 20 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> overall, but 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> actually has been focused in on 21 risk management.

22; MR. CUNNINGHAM:

Dr. Goodrich had a comment he wanted 23 to make.

24 DR. GOODRICH:

It occurs to me that perhaps in the 25 interest of training, the Commission has over the next, Heritage Reporting Corporation (202) 628-4888

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probably the next three years, scheduled inspections of all 1

2 their licensees.

Three years would cover that period.

That 3

won't cover the' Agreement States, but it will give you a 4

representative sample, perhaps, to answer the Commissions' 5

questions.

6 If, instead of having an inspection for the sake of 7

inspecting performance and writing citations, it could be at 8

least combined in, pardon the expression, "a missionary 9

effort," to have the inspector who has now been thoroughly 10 trained in the issues that you all have directed as important, 11 to,take this out to those licensees and conduct the CME 12 training of physicians and technologists alike by appointment.

13 And this would be done under your same travel budget because 14 they are going to be going anyway.

And, so, in the interest of 15 cost containment, your travel is covered.

You have to give 16 them some time to teach them what they have got to teach to 17 make the quality correct.

It just occurs to me that that is a i

18 little more missionary than it is punitive.

]

I CJA AlldfAA{

19 MR. MCELROY:

It could be done on a reasonable basis, 20 Jack.

21 DR. GOODRICH:

Correct.

And once you have learned I

22 how to do it, you can teach the Agreement States.

23 MR. MCELROY:

I suspect we might have to do this 24 under contract because I certainly wouldn't want to be the l

25 bureaucrat knocking at the front door saying I was there to

)

i 1

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1 help.

2 DR. GOODRICH:

What makes that any different than 3

what you do now?

l 4

(Laughter.)

l 5

MR. MCELROY:

We don't say we are there to help.

j 6

(Laughter.)

7 DR. GOODRICH:

No. I really am quite serious that --

8 MR. CUNNINGHAM:

I..think it is a very good idea and I 9

think it is worth looking into.

10 DR. GOODRICH:

Thank you.

11 MR. CUNNINr. TAM :

I would add that we presently have 12 budgeted but have not yet let a contract to examine the broad j

13 question of training, both physicians and technicians to get a 14 look at, first, what levels of training are required really, l

i 15 are appropriate at the various technician levels, whether it is 16 the dosimetrist or what have you.

And the second question is:

17 Do they have the training?

Where do they get it?

We will be 18 taking a broad look at that over the next couple of years, 19 probably, if our budget holds up. That is different than from 20 what you have discussed.

And I fully understand that.

That is 21 one thing we should consider.

22 Yes, Jack?

23 DR. GOODRICH:

I feel compelled to enter this into 24 therecordforti[eCommissionersaswell.

There is a serious 25 problem, there is a crisis situation arising in the training i

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1 programs for the technologists.

This crisis has arisen through i

2 cost containments and the refusal of the third party payers, 3

the " Blues," through Medicare, and now all third party payers, 4

to reimburse the training programs for those training l

5 activities in the nucioar medicine technology,, x-ray 6

technology, et cetera.

i 7

If you are concerned about.the quality of the 8

practitioners, including the technologists,be degraded or 9

showing evidence of degrading, I venture to say we are look at 10 the tip of the iceberg right now.

And, in three years, it is L

11 gofng to be critical.

This issue has been brought to the 12 attention of the AMA.

It is being looked at formally by the 13 Council on Medical Scientific Affairs, or one such. thing.

But 14 this ia a very serious issue.

15 The CAHLA, the Council on Allied Health Education 16 Programs, publication in November documents this.

And their 17 offices here in Washington can give you further information.

I 18 But that. is a problem.

And it is right upon us.

We are 19 experiencing it, now.

Finding and being able to employ trained 20 technologists.

And in three years, we will probably be 21 training folks who can read and write off the street just in 22 order to carry out the health care mission.

23 MR. CUNNINGHAM:

Is that peculiar to nuclear l

24 medicine, radiation therapy?

Or is that across the board?

l 25 DR. GOODRICH:

That is across the board.

Council on

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Allied Health Education Programs can give you chapter and 1

2 verse. But the Commission is interested in radiation and 3

protection and that directly impinges upon the radiologic 4

technology and therapeutic technology training and nuclear i

5 medicine technology.

Perhaps from California, we could have 6

some reinforcement of that.

7 DR. MARCUS:

Jack didn't even know that we lost our 8

x-ray tech program this year and we lost our nuclear med tech 9

program this year for exactly the reasons Dr. Goodrich states.

10 We have two people who were training with us for free, because j

we,can't support them, but it's a good department.

So, they 11 12 are learning for free. But it is really a terrible problem.

l l

13 While we are talking about education.

I just want to I

14 indicate that there is one group that no one has talked about f

15 and to my mind they are the biggest problem of all.

And that 16 is hospital administrators.

Because I don't care what kind of

L 17 program you want, when you go to your hospital administrator 18 and say, "I need this detector.

I need another half-time 19 physicist.

I need to belong to a group that sends me unknowns i

20 to measure."

They laugh in your face.

I 21 When we had our inspection, I asked our inspector to 22 cite ur for certain things so that I could use it on my 23 hospital administrator to get resources that I needed.

And I 24 think including the administrators in some manner is very 25 important.

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MR. CUNNINGHAM:

Carol, you are aware that this is a 2

public record and it will go in a public document.

3 (Laughter.)

l

.4 DR. MARCUS:

I am a Civil Service Employee.,

5 MR. CUNNINGHAM:

Janet Kotra?

6 MS. KOTRA:

Just to get back briefly to the point 4

1 7

that Margaret made earlier.

We have heard a number of very 8

helpful comments about perhaps how we could improve our l

l 9

inspection program.

Eut Margaret also mentioned the point of 10' enforcement.

And Dr. Marcus made the point earlier this l

l 11 morning that the people that the Commission really ought to be 12 concerned about reaching are those individuals who are in i

13 somewhat blatant violation of the standards of care of their l

14 own profession.

Is there an appropriate. role for NRC in taking l

15 enforcement action against these-individuals and, if not us, 16 who?

How does one get at that problem?

l 17 MR. CUNNINGHAM:

Would the committee like to comment?

I l

18 DR. WOODBURY:

Again, to beat a dead horse around the 19 stall. Again, sometime it is very difficult for the practicing l

20 physician to keep abreast of all the rules and regulations for i

21 the things we have discussed.

That is why I was very excited 22 about the approaches to an educational apprcach. I'll bet you 23 that if the NRC or one of their regions were to put on a one-2'4 day or a day-and-a-half program going over regulations for CME 4

]

25 credit, you would have to beat people away because there is Heritage Reporting Corporation (202) 628-4888 l

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145 1

'just no real format.

If you don't read the Federal Register,

{

l 2

if you don't send away to Washington for certain documents, to 3

know what has changed between 1980 and.1988.

4 And people are -- it is becoming even more l

5-restrictive particularly since budgets are becoming.

6 restrictive, even travel is becoming restrictive.

So, 7

practitioners are very concerned about where they pay their 8

dollars and what meetings they go te.

l l

9 The University of Michigan just this last week is l

10 cutting out $15 million out of -- the University Hospital is I

11 cytting out $15 million out of its overall program because of 12 reimbursement changes.

So, you go in and say, " Gee, you have y

c:

13 got to this; you've got to,that and the other," hey, the s

14 administrator is going to really look at you and scratch their 15 heads.

Programs are being cut out, yet we are still i

16 responsible for all the rules and regulations not on the books.

j 17 So, to look at a whole new hierarchy of rules and regulations 18.

just boggles the imagination.

1 l

19 MR. CUNNINGHAM:

Thank you, Dr. Woodbury.

20 Dr. Marcus would like to make a further comment.

21 -

DR. MARCUS:

The question you brought up is an 22 interesting one.

And there is a mechanism.

Every quarter in 23 California, I get a publication from the Board of Medical 2'4 Quality Assurance that gives me a list of physicians who have i

1 1

25 lost their license to practice in the State of California.

And i.

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L 146 i

I

{

they lose their licenses because they commit malpractice.

The 1

2 malpractice courts,=themselves, are very good about weeding out I

i 3

physicians who don't do a good job.

And they can't get 4

practice privileges at certain hospitals because thos,e i

5.

hospitals have to pay money to people when they allow these I

6 doctors to practice poorly.

7 In the end, the system gets them.

It is, at least 8

where I practice, you just can't commit bJ atant malpractice n

9 forever and get away with it.

It catches up with, especially l

10 now that there seem to be so many extra physicians around.

i

'll So, I think that the legal system and just the state i

12 medical quality assurance boards, if California is any example, 13 are doing that job. I mean the list I get is a piece of paper l

l 14 like this and it is like maybe three pages or four pages of i

15 names.

And that's kind of impressive.

)

16 MS. KOTRA:

So, you are saying that as far as you can 17 see there is no additional role --

18' DR. MARCUS:

There is a system that works very well 19 getting rid of very poor physicians.

We are talking about 20 very, very few, M

21 -

,pR. THOMPSON:

I think maybe the question might be a l

22 little bit:

If NRC identifies a poor practice, would you l

l 23 recommend that we do something with that other than with our 2'4 own internal tegulatory programs?

25 DR. MARCUS:

If you are inspecting someone and l

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something is grossly wrong, your report goes to that hospital 1

i l

2

. administrator.

It doesn't go to the guy who did the wrong l

3 stuff. It goes to-the administrator.

And the first thing he t

4 does is question tha people at fault very, very stri:ngly.

"Why 5

did this happen?

What are you going to do about it?".And, if 6

he isn't satisfied with the sort of answers he gets, that's j

7 grounds for getting rid of somebody.

If you think they are a 8

real liability to your hospital, you don't want_them.around.

l l

9 r.s, I think, again, the system really does work.

l 10 When you find these misadministrations, they are so few anyway, l

11 but it is not like the same guys over and over again are doing 12 these things.

And I don't think it is a real problem, because i

13 I think the system that is in operation takes care of it i

14 because your reports go to administrators, l

15 16 l

l 17 l

18 l

19 l

20 21 22 l

l l

23 24 i

25

?

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MR. CUNNINGHAM:

Dr. Tonnesen.

l 2

DR. TONNESEN:

We all want the same things which is j

3 to improve accuracy and reduce misadministrations of radiation 4

therapy.

I'm leaving out nuclear medicine because I,know

~

5 nothing about it.

But I think you want the same things we 6

want.

7 The question is, how to accomplish that within a l

l 8-reasonable number of dollars, because as one.of you gentlemen i

9 already said, there are only so many dollars out there and 10 we're under a lot of pressure from our hospital 1

1 11 administrations.

l 12 I think my hospital is as close to compliance already l

13 with the rule as proposed as any are going to be.

I think' l

)

14 maybe in order to be sure of documentation that you're likely l

l 15 to add to it if you promulgate the rule, we might need another l

16 tenth of an FTE a year to be sure that we're completely in l

17 compliance, and maybe as much as another $1,000 or so for 18 outside physics consulting or new equipment or something.

l 19 Maybe about $4,000 a year to bring my hospital into compliance.

20 And I think that's about as little as any hospital that's l

21 - possible -- and that's only radiotherapy -- that's as little as 22 any hospital could spend because c lot of hospitals don't have 23 these extra backup calculation personnel and they're going to 24 have to go and hire them.

25 Now, I don't know how many cobalt machines there are i

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out there, but say there are a 1,000 of them or 1,000 2

facilities that are affected, again, radiotherapy only, you've I

3 got $4,000 each times 1,000 is $4 million.

How much money is

]

l l'

4 the NRC and the agreement states going to spend on this?

I i

5 have no idea.

But it can't be less than a mi111on. dollars a I

6 year for site visits, publications, paying your air fare here l

7 for this.

But let's say $5 million a year.

l l

8 Now, if -- and that's a bare minimum estimate -- if s

9 you could reduce the number of misadministrations by half, 10 which I doubt because I think we're already down in what Dr.

11 Gr/em calls the noise level, we're down to almost an 12 irreducible level, but if you could. reduce it by half or 14 per 13 year you could do that at the cost of $360,000 per l-14 misadministration.

And as we've already pointed out, almost 15 none of these misadministrations is fatal.

So you haven't even 16 saved any lives or maybe one in the country for that $5 17 million, maybe.

l 18 Now, how else could that money be spent?

If you gave 19 me $4,000 and said, to benefit the people at my institution as l

20 best I could, probably the best thing would be to add it to the l

21 overall OA effort at the hospital.

To go after places where 22 misadministrations are more common, pharmacy, nursing, getting 23 the transporters to be sure they brought the right patient L

24 down.

I could also use it as a stipend to train an RTT, so l

I 25 that he or she could be a good tech instead of a bad tech.

l l'

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1 I could also use it to buy a fiberoptic nasal I'

2 furendoscope so that I could do better exams on my patients and 3

maybe I would pick up a T-2 tumor instead of a T-1 tumor and

~

4

'save a life directly.

l 5

I could also use it to buy immobil1zation devices or.

l 6

to upgrade the quality of the equipment that we use, all'the 7

little goo-goos that make up good radiation therapy.

8 There are so many better ways to spend that money in i

~

9 improving the quality of radiation therapy or improving the j

10 quality of delivered medical care.

i t

11 I just think this is kind of an overkill.

12 MR. CUNNINGHAM:

Thank you, Dr. Tonnesen.

i 13 I think Dr. Pohost is next.

14~

JR. POHOST:

I think with respect to the tone of the I

15 discussion that what I'd like to know from you is, what do you l

16

.do when you find out about a misadministration, 17 investigationally and ultimately what power do you have to L

18 exert over the culprit, if you find somebody at fault?

I 19 MR. CUNNINGHAM:

Well, if you take the history of l

l 20 these misadministration rules the first -- the first purpose of 21

'the misadministration rule is to look at the misadministrations 22 and see if there is something correctable through regulatory 23 action.

If you see not a single -- and it's almost a 24 statistical sort of thing, and we have people that -- Kathy 25 Black who is in the audience, was in the audience, job is doing t

6 Heritage Reporting Corporation (202) 628-4888' l

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I this kind of thing.

If we look at a series of l

l 2

misadministrations and find some commonality to it, they l

l~

3 misread a label, same drug, same label on it and people misread i

j 4

it, you have an obvious case to go and! change the label.

Now l

5 we might'do that through regulatory action ourselves, we might 6

tell FDA about it and have them change something.

We might go j

7 to the manufacturer and have them voluntarily change it.

l l

8 So there are, depending on what it is, there are 9

opportunities to correct a generic problem that you see looking 10 at repetitivensse misadministrations; that's the primary 11 purpose of getting this.

l r

l 12 The secondary purpose, the second purpose was to find 13 out or what has developed into a second purpose is to improve l

14 the quality and try to reduce the number of misadministrations w r (ud l

15 through just bad practices.

And we dan'+

52:: for much of the 16 misadministration, they really are, in large measure, human 17 errors that are not themselves a violation of the rules.

18 Very often when we have reports of misadministration, l

l 19 we don't investigate every misadministration, certainly.

We l

l 20 get about 400 -- what is it, 400 reports?

21 MR. McELROY:

400 diagnostic misadministration 22 reports each year just from the NRC states and about six i

i 23 therapy misadministrations each year are reported.

24 MR. CUNNINGHAM:

But we would look, from an 25 enforcement standpoint, to see if there was anything in the 5

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1 misadministration that was caused by non-compliance with 2

existing rules.

And occasionally this does happen.

A 3

3 misadministration of the wrong dose because somebody did not 4

use the dose calibrator as they are required to do.

We don't 5

take enforcement action against the misadministration,. but we 6

do take enforcement action because they did not use a dose 7

calibrator.

That is a function that it serves.

Does that l

8 answer your question?

9 DR. POHOST:

Yes.

But it does sound like the l

10 enforcement action should only be taken when there has been a 11 mi,sadministration under the circumstances.

That is, we know 12 that misadministration is not as catastrophic an event as an

[:..flelui aHins kb7 t

13 event in the cath Line, for$ example.

And it costs so much 14 money to investigate and to enforce that it seems to me that i

15 the appropriate thing to do is really just to reservu 16 enforcement and investigations the way you have been to those 17 that, you know, that have problems, and to prevent the problem 18 when the problem is so trivial at this point, is not a i

19 worthwhile investment of time and effort.

l 20 MR. CUNNINGHAM:

Well, I don't think it's quite fair 21 to -- it's trivial in one sense and you can say it's trivial 22 because of low incidence rate.

It is not trivial to the 23 therapy patient who gets a large exposure.

24 DR. POHOST:

In the statistical sense.

25 MR. CUNNINGHAM:

But ideally, what we would be aiming Heritage Reporting Corporation (202) 628-4888 l

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'I at in our regulatory program is to have a set of standards j

1 2

which tae medical community can agree are good standards and j

3 they-should follow as a reason -- follow as just simply good i

4 medical practice; that's ideal.

They should follow those in S'

the medical community, as the community agrees to those.

i l

L 6

What we would like to do, ideally, is to be'able to 7

adopt such a set of regulations if they exist.

So that for 8'

those people, a very'small number, but~they do exist as various 9

' people have said, do not follow what is considered to be good 10 medical practice across the board, we can take some action j

l l

11 agpinst them which will force them to do it; 'and thereby l

12 protect patients or improve the quality of the patient's core 13 that come across those type of people.

That's ideal.

That's l

14 what our objective is.

15 Now, how we get there, we have some ideas.

(

16 DR. POHOST:

So on an individual by individual besis l

17 looking at the offenders is one way.

And making it know, then 18 enforcement is something that is the penalty of not abiding by 19 the regulations.

t 20 The second way is education that you've discussed.

21 And one form of education that we've already, the American 22 College of Cardiology participated in is having one of your 23 staff come to lecture on regulations to a body that's 24 interested in nuclear cardiology, for example.

And if your 1

25 staff is available to do that at national meetings that will be l

l Heritage Reporting Corporation (202) 628-4888 l

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{'

yet another way to have a higher profile and to make'it clear.

L 2

I mean, a good higher profile and make it clear to the members 3

of that organization and those organizations who are l

4 responsible for the deliveries of these techniques.,That there 5

is a body of individuals and a body of information on..how best.

6 a body rules, and those regulations need to be spelled out.

1 7

And these~ courses and these meetings do provide the individual i

8 physician with the points for, you'know, for participating.

l 9

So I think one avenue is the national meeting'and 10 national meeting lectures are something that I'm sure all of us l

11 cguld help get staff members from the organization, from the-12 NRC involved in, if that's something that you would be willing 13 to participate in.

l-14 MR. CUNNINGHAM:

Well, we have. participated in that.

15 And we certainly, not only are willing to, but we want to do i

16 that.

There's a question of how much we can do now.

Certainly 17 I think if invited we would certainly participate at the l

l 18 national meeting, the annual meetings to give these kinds of 19 lectures.

20 We have algo attempted in recent months and we're 21 expanding this program to give regional meetings, regulatory o n es 22 prohasa, to various categories of licensees.

We've recently l

i 23 given some to industrial radiographers.

ed ClJebsI.vr3 24 I think, Tip, you were at a meeting about it last May-l 25 or so on, broad licensees.

And we could do this for the Heritage Reporting Corporation (202) 628-4888 1

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,=

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~ _ _. - _ - _ _.

l 155 1

community hospital practitioner on rules and regulations and.

2 what have you.

Ia fact, we might want to bring in some more 3

.than just the NRC staff into some of these meetings to help 4

give some balance and perspective on this.

Maybe members of i

5 this committee, point of fact, to provide some lectures.

6 Dr..Holman.

7 DR. HOLMAN:

I'm just wondering if we really

[

8 addressed the question that you asked.

We were talking about

\\

l l

9 whether enforcement by NRC is necessary?

When you identify l

10 that small sub-population of practitioners who are practicing 11 poorly, isn't that really the question?

12 MS.'KOTRA:

As practicing physicians yourself.

You 13 would want to do, you know, you would want to have an interest l

l 14 in seeing that these people are properly, either put back on l

15 the right path or no longer practicing to bring down the 16 reputation which is overall fairly good of this specialty.

17 Does NRC in your view have a role?

i i

l 18 DR. HOLMAN:

And that I think brings'up a very 19 important philosophical question that we have been grappling 20 with for some time, and that is the relative role of NRC in the 21 practice of medicine per se versus the eniorcement of 22 regulations that deal with the safe handling and usage of 23 radioactive materials.

l l

24 MS. KOTRA:

Well, it's a fine line, I understand.

I l

25 But I think the Commission sees this role as ensuring a safe j

l Heritage Reporting Corporation (202) 628-4888 l

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i 1

g use of licensed materials, whether it's in the field of 2

medicine, the fiald of radiography, in a nuclear powerplants or 3

anywhere else where the NRC has regulatory responsibility.

I 4

think that line can be drawn.

I think the Commission tried to

}

5 make that in the advanced notice of rulemaking and the notice 6

of proposed rulemaking.

But I grant you it's a difficult one 7

to draw, and if we're not drawing it at the right place we need

)

8-your input.

l l

9 MR. CUNNINGHAM:

Dr. Deye.

1 l

10 DR. DEYE:

I think along those lines there was a case 4

11 rgcently that I believe I read in the Federal Register of a 12 physician who was found guilty of falsifying the Radiation 4

i j

13-Safety Committee minutes for like 10 years running.

And the 14 only action taken against that physician, at least as was 15 stated in the Federal Register, was that he was taken off his 16 position as Radiation Safety Officer for the hospital.

l 17 Now, I think you have regulations in place which were

)

18 stated earlier today.

And I think the point is, you have to i

19 put some teeth into the regulations you've already got and take 20 action based upon those regulations.

I don't think we need 21 nore regulations at this point in time for the issues we've I

22 been discussing up to now.

Use the regulations that are 23 presently there.

24 But to slap somebody on the hand and just take away 25 their RSO status, seems to me to set the wrong precedent for Heritage Reporting Corporation (202) 628-4888

157 I

anybody who read that Federal Register and may be guilty of, 2

hopefully, not as gross an infraction themselves,.but an 3

infraction at all, they figure it's not that bad of a 4

situation.

If the NRC finds out, I'll just have this onerous 5

task of the RSO taken off of my back.

_6 MR. CUNNINGHAM:

Thank you.

7 Dr. Webster.

8 DR. WEBSTER:

Talking about enforcement again, I'm

~

9 sorry, I overlooked that part of your question.

It occurs to 10 me that there's another road to travel for physicians and 11 thpy're very much aware of it.

Namely, if there is a 12 misadministration and it gets to the ears of an appropriate 13 lawyer, they will be sued, and often are sued.

14 And it could be that maybe the proper way to enforce 15 is through tort law, and that due process is again to the 16 offender rather than have a regulatory agency do it.

17 I'm not recommending prosecution, particularly, but 18 that's the way it.happens.

19 MR. CUNNINGHAM:

I see the physician members of the 20 committee shaking their heads.

21 Dr. Holman.

22 DR. HOLMAN:

I think there are a number of issues 23 with regard to enforcement.

First is that line at which one 24 enters the practice of medicine per se, and I think one has to 25 be very careful because I do believe that while -- that it Heritage Reporting Corporation (202) 628-4888

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158 1

isn't a fine line, that is'a grey zone.

And it has been 2

debated for some time in terms of training' requirements, but 3-it's also true in terms of what types of regulations.

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4 But assuming that we are dealing with prima,rily safe

~

5 handling and usage of radioactive materials,,indeed the NRC has 6

regulations that need to be enforced.

7 I'would take the opposite attack and that is that I 8

would be very much concerned that as the NRC goes about-the j

9 process of tightening its enforcement that a very carefully 10 defined procedure be developed which ensures adequate mechanism 11 for appeal, adequate mechanism for the' individuals.who are 12 being enforced upon to have access to -- for us to have a clear 13 idea of what the enforcement process is, and for an adequate 14 processlof appeals to be in place and well understood by the t

15' community.

Because indeed what is happening here is that, the 16 enforced -- the logical end stage of enforcement, the L

17 retraction of the individual's license has a rather far 1

18 reaching consequence in his ability'to earn a living.

19 And I think that indeed there are going to be 20 instances where such enforcement will be necessary.

But when j

1 21 such limits of enforcement are reached adequate mechanisms and 22 procedures be in place to ensure fair treatment.

23 MR. CUNNINGHAM:

I think that there are a series of I

i 24 procedures in place to ensure fair treatment.

I suspect that lr 25 most of those people who are subject to inspection really are Heritage Reporting Corporation (202) 628-4888 l

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159

/

1 not very familiar with these procedures.

Something like that 2

could be included in any training program or program we have to 3

give information to physicians.

I think that's something that 4

could be included.

5 DR. WEBSTER:

To bring in a play of tort. action here,.

6 someone would have to ing charges or they could inform the 7

patient or perhaps more profitable still they might inform a

)

8 plaintiff's attorney,.they commonly pay for such information, 9

MR. CUNNINGHAM:

I think we've covered this subject 10 pretty well and I think its been a profitable discussion.

What

]

11 I'p like to do is close this meeting somewhere within the next

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12 15 or 20 minutes and then spend a few minutes with the 13 committee itself on a. couple of administrative things that we 14 can take up by ourselves after the meeting is -- the public 15 part of the meeting is closed.

16 I would ask at this time if there are things that the 17 members of the committee would like to bring up before the 18 staff here?

Any other subjects that we should bring up at this j

19 time?

20 DR. WEBSTER:

Related to misadministration?

21 MR. CUNN1hGHAM:

No, anything you wish.

I hope it's 22 related to nuclear medicine and therapy.

23 DR. WEBSTER:

I've had on the top of my head for some l

24 time and I'm probably at personal fault here, the question of l

25 waste disposal which is a huge problem.

I think a much larger Heritage Reporting Corporation

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problem than the one that we've been dealing with today.

And j

2 much more intrusive into the practice of nuclear medicine.

And i

3 one that I think might get some attention from the Nuclear j

o l

4 Regulatory Commission.

r 5

It's been raised before, the question that I have in l

6 mind is whether or not the NRC would entertain further i

l 7

deregulation of very low level but very bulky waste.

And there 8

has been a subcommittee on this, an informal one, which really 9

hasn't gone very far.

That's why I feel guilty.

I l

10 I think the question should be reopened and l

l 11 reactivated because it's of such importance in the way the ball l

l 12 is rolling with regard to waste disposal and the fact that the i

13 states haven't really done very much; and even those that have 14 done something are very forceful in demanding that the volume 15 should shrink.

16 So a deregulation is only one of a number of 17

. mechanisms that could be adopted to avoid disposing of 18 potentially radioactive material, which we're not really sure j

19 is radioactive, because nobody really looks at it to see.

20 MR. CUNNINGHAM:

Well, I think I can review for the 21.. benefit of people who might not have been involved in this.

l 22 Oh, six or seven years ago we did provide some relief on the I

23 disposal of tritium and carbon 14 waste.

24 We then tried to -- and what this involves is getting 25 the data so-that we can assess individual dose by logical 1

i Heritage Reporting Corporation (202) 628-4888

161 1

pathways, incinerator stacks, using maximum volumes,that might 2

be concentrations or quantities that might be used at a single 3

hospital, estimatir.g collective dose over the U.S. population.

4 Estimating the cost of waste disposal and doing environmental 5

impact assessment, and come up with this cost benefit halance.

6 And we had a very favorable cost benefit balance in addition to 7

really not having the disposal location, I think the benefit

'8 was about S16 million per year.

At very low potential 9

exposures, using very conhervative estimates.

10 We then tried to expand this into some other uses in 11 nu, clear medicine of very low quantities or concentrations, 12 iodine and the T-3, T-4 kits, things like that.

13 We ran into a problem obtaining the data to do an 14 environmental analysis similar to that which we attempted to do 15 earlier.

16 So there was an apparent lack of interest on the 17 medical community and radiopharmaceutical manufacturers, so we 18 let the thing drop.

That was reactivated under, I think, Dr.

19 Yallow was the primary mover of that, and I think, Ted, you 20 were on a committee, again to try to get data in which we could 21 do these various kinds of analyses.

And again, as you said, 22 not much happened on collecting the data.

23 Since that time the Low Level Waste Policy Act has 24 been -- I guess lt's an amendment to the Low Level Waste Policy 25 Act that was passed, which required the Commission to come up Heritage Reporting Corporation (202) 628-4888

162 1

with a basis for providing regulatory relief for these very low

,{

2 concentrations or quantities of radioactive materials.

3 About a year and a half ago, I guess it was, two 4-years ago we published a policy statement which said in effect 5

that we.are prepared to provide exemptions for certain types of 6

low level waste streams and it gave information about the 7

information which must be supplied.

8 What we have to do is identify a type of waste stream 9

and then write a rule which will exempt that waste stream.

A 10 category of waste stream or what have you, that would go across 11 the board, probably.

12 That policy statement was published.

I do understand 13 that people are proposing to submit proposals for rulemaking, 14 mainly the utility industry, with the necessary information to 15 provide the types of analysis asked for.

16 I think the policy statement, when it came out, 17 really requires a more rigorous analysis than we did with the 18 tritium carbon 14 rule.

Nonetheless, there is a mechanism that 19 exists today for having the Commission act on such a proposal.

20 The problem within the medical community is probably 21 a little bit different than it is in the power reactor a

22 community where they have business or professional 23 organizations that are quite closely tied to each other, the 24 NUMARC and Edison Electric Institute and they have the funds to 25 do the kinds of analysis and require people to do it.

l Heritage Reporting Corporation (202) 628-4888

163

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What I think might be lacking in the medical 1

2 community is an organization into which the pharmaceutical 3

manufacturers or the practitioners can feed this information 4

and then have a competent group of people devote thf. time 5

necessary to pulling this together in a'way whlen you.can 6

unalyze the environmental impacts and deal with it in a 7

professional sort of way.

-8 The problem being that it really takes, I.think, a 1

9 contract, not voluntary time, you know, Dr. Webster, how it 10 goes when you volunteer for something and you can spend a day a 11 mopth only or a day every quarter, that doesn't work.

You have 12 to have a concentrated effort by people dedicated for it.

13 Now, I would suggest that the medical community 14 through your professional organizations might_ consider how you 15 come to grips with this problem.

I mean, to pull the 16 information together and to deal with this.

in 17 Certainly,the staff under Hugh. Thompson we have a low 18 level waste management division that would be pleased to talk 19 to anybody that wants to about it..

About this subject and what 20 needs to be done.

And if you need to know who to contact, just

'21

,give me or Norm a call and I'll put you -- or Mr. Thompson, and 22 we'll put you in touch with exactly the right people.

23 Dr. Almond.

24 DR. ALMOND:

I have a different subject to mention 25 briefly.

Heritage Reporting Corporation (202) 628-4888

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MR. CUNNINGHAM:

Good.

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[58433 2

DR. ALMOND:

Which has to do with your notice _EE&T of 3

April 8 of last year, which is the unauthorized service on i

4 teletherapy units by non-licensed maintenance personnel.

This 5

was, I think, a stricter interpretation of the license, the 6

wording that's in the license, having to do with in-house l

7 personnel -- hospital in-house personnel who repair the total 8

of 60 units.

9 This has been interpreted completely, strictly by 10 some -- for one group, the manufacturers who will now not sell 11 yo,u spare parts for the cobalt unit, so that if something goes 12 wrong with your cobalt unit, even if it's a small replaceable 13 part or it's a plug-in part, they -- because they interpret 14 this to mean that only authorized users, that is their service 15 personnel or other source handlers can come in and do this.

16 And this has created, I think, a problem or can create a 17 problem.

I've run into it.

I think other people will or have 10 run into this problem.

19 What is not clear from your notice is how uniformly 20 this will be enforced.

And also, the suggestion that you send 21 an amendment for your license to get an in-house person.

And I 22 did that within my study.

I sent an amendment to the state and 23 said, I want a certain person, here is his qualifications; 24 these are the things I want him to do on the cobalt unit.

It 25 was not the source drawer or the source, but it was the other l

i Heritage Reporting Corporation (202) 628-4888

165 1

parts of it.

But there were not guidelines to that.

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2 They, I believe, are sending that up to NRC for some 3

guidance and assistance cn1 that.

I think it's very important, 4

'though, that we have some guidelines and some consistencies on 5

how people are going to have to amend their 1icense to..do this, 6

because there's a lot of people'out there with cobalt units who 7

have in-house personnel, you know, repairing things when they 8

break down.

And I think they should have that right to do 9

that.

I have no objection to them being, you know, amending 10 their license to do that.

11 But how that license is amended must be consistent, I 12 think, from state to state and within'the NRC.

13 MR. CUNNINGHAM:

We will take your comments and take 14 a look at where we stand on that and review it, and try to make 15 more clear what we have in mind and how to go about it.

I 16 thank you.

17 Any other comments?

18 Dr. Goodrich.

19 DR. GOODRICH:

I'd just like to express my thanks to 20 the assistants to the Commissioners for their comments and Input, recognizing that the Commissioners are thoroughly well 21 22 represented by staff here~.

But this is the first for me to 23 hear from the Commissioners directly, and I appreciate that 24 opportunity.

25 MR. CUNNINGHAM:

No more comments from the committee.

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1 Anybody in the audience have any more comments?

2 (No response.)

i p

3 MR. CUNNINGHAM:

I# not, I will close the meeting, a

i 4

but ask that the members of the Advisory Committee stay.here 5

for just a couple of minutes.

i 6

I thank you all very much for coming, both members of l

7 the committee, members of the audience, particularly those who 8

made statements and were very helpful to us, thank you one and j-9 all.

The meeting is closed.

j 10.

(Whereupon, at 3:20 p.m. the meeting was closed.)

3 11 12 13 I

14 1

1 15 3

16 17

. 18 1

19 20 21 22 23 24 25 lieritage Reporting Corporation (202) 628-4888

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1 CERTIFICATE i

2

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3 This is to certify that the attached proceedings before the 4

United States Nuclear Regulatory Commission in the matter of:

5 Name:

6 Advisory committee on the Medical Uses of Isotopes 7

Docket Number:

8 Place:

Bethesda, Maryland 9

Date:

January 26, 1988

. 10 were held as herein appears, and that this is the original -

11 transcript thereof for the file of the United States Nuclear 12 Regulatcry Commission taken stenographically by me and, 13 thdreafter reduced to typewriting by me or under the direction 14 of the court reporting company, and that the transcript is a j

i 15 true and accurate record of the foregoing proceedings.

16

/S/

0" N

17 (Signature typed):

Joan Rose 18 official Reporter 19 Heritage Reporting Corporation 20 21 22 1

23 24 25 f

Heritage Reporting Corporation (202) 628-4888

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Danbury Hospital The Community health Center Danbuty, CT 06810 Tel. 203-797-7000 January 26, 1988 Members of the NRC Staff Members of the Advisory Committee on the Medical Use of Isotopes In reference to the proposed rule changes in 10 CFR 35: Basic Quality Assurance, we wish to present the following points:

Although we have concerns with some of the proposed rules concerning pharma-ceuticals of radio-iodine, we understand that the Commission has already received several comments concerning this and we wish here to primarily address the proposed rules concerning quality assurance in radiation therapy.

35.43(b)(2)

Brachytherapy Prescriptions. We wish to address three problems here:

1.

Often the " dose" is given in mgm hours radium equivalent using standard tables and geometries. Allowance needs to be made for this in the regulation.

2.

The dose is usually given relative to a point or volume. This i

may be for a tumor bed or to boost a nodal area with no specific total tumor definition.

3.

Although a theoretical plan can be prepared in advance, the actual prescription often cannot be formalized until after the true geometric location of the sources is known.

Thus the sources often must be inserted before the prescription can be finalized.

For these reason's, the method in which the dose is prescribed should not be dictated in standards but should be left up to the physician and conventional use of terms and nomenclature.

35.432 Annual Source Strength Measurements. We agree with the need to verify the original source strength.

However, the remeasurement of the sources, or a representative source from each group of sources, seems contrary to the ALARA principle especially when one considers:

1.

The manufacturer often has better equipment to measure the source strength. To make such a measurement requires a special well in order to achieve an accurate measurement.

This type of equipment normally would not be found in a routine hospital setting.

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2.

Semi-annual leak / wipe tests are already required which would

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indicate if there is loss in the integrity of' the source capsule.

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3.

The regulation proposes that if there is a disagreement in the j

decayed manufacturer's strength and_the licensee's measured strength that the licensee is allowed to use the manufacturer's 1

strength.

p If the manufacturer's strength is to be taken as the more reliable F

measurement end to be used in cases where there is a discrepancy between the manufacturer's reading and the licensee's reading, why 1

is there necessity to increase exposure to personnel, of ten requiring transporting sources from the Radiation Oncology Dept.

i in the hospital to the Nuclear Medicine Dept. in the hospital, merely to accept the originally stated value?

}

35.454 Check of Dose Calculations - Brachytherapy.

[

j 1.

Such checks require a second person qualified to make calcula-j tions, i.e.: a radiation physicist or a dosimetrist.

If the second person is not qualified, they cannot make a bona fide i

independent check, i-2.

The requirement that the independent check be done before 50%

i of treatment is delivered is also overbearing. Often the treatment takes place within 24 to 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />.

If a second

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qualified person is not available, on site, the hospital would i

i have to pay a consultant to come in for this measurement.

35.454(a)

Manual calculations. There should be provisions which would allow i

the caculations to be compared with published tables to verify the j

results within acceptable limits rather than requiring a second

{

person. Another alternative would be to allow the same person to 7

do the calculation be a second' independent method.

35. 454 (b,)

Computer calculations.

In order to check the computer calculations 7

. it should be sufficient for the same person to do a manual calcula-l tion to a specified point in order to verify the numbers generated by the computer.

Since the two methods are completely independent, the fact that they are done by the same person would not compromise the QA goals.

35.633 Independent Check of Full Calibration Measurements in Teletherapy.

Requiring a second teletherapy physicist to do an independent check of the output (as described in 35.632(b)(1))with a different dosi-metry than that originally used for the calibration is no small requirement. This process is time consuming and expensive..It would take 3 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of on site time per teletherapy machine to do the output measurements referred to.

On top of this there would be the travel time and the time necessary to prepare the report for

the institution. Thus the institution would have to hire a consultant

'l 1

'for a minimum of one full day for one machine. Since dosimetry

(.

systems must be calibrated by accredited laboratories, there is no justification to transporting a second unit to the site when a calibrated unit is available on site. Transporting such a unit-only increases the chances of altering the unit's characteristics and nullifying the calibration. A far better approach would be to '

l reinstitute the RPC's through the AAPM to do a comprehensive, though affordable verification of system performance.

35.634 Teletherapy Dose Calculations and Checks. Similar problems are I

. noted here as were discussed for Section 35.454 35.654(n)

For manual calculations, we see very few problems with having a second person doing the calculation. Since all therapy institutions L

have, or should have registered RTT's, and since they are capable l

of doing manual calculations, this expertise'is available for l

l r,utine use.

l 35.654(b)

For computer calculations, again we feel that a manual check by l

independent means though done by-the same person should be more than sufficient to provide adequate quality assurance.

i I

BASIC TENETS OF A GOOD QUALITY ASSURANCE PROGRAM i.

1.

Who should require it: There is no question but that we should have good quality assurance programs. These should be required and evaluated by the NRC, ACR, ASTRO, ARPM, ACMP, and similar organizations.

2.

Who should define it: Designing such a program should probably be the prerogative of the AAPM or done through a joint venture with the AAPM, ACMP, and ASTRO.due to the knowledge and expertise cf the members of these organi-zations.

An' example of the possible results is the new calibration procedure that has come out of Task Group 21 of the AAPM.

3.

Who should carry out the QA program: This should be done by individuals who l

are qualified and trained-for the tasks indicated as demonstrated by their credentials and certification. This must be true of the individuals doing i

ill measurements, calculations, and checks.

4 How many levels of redundancy are required? It is hard to answer this.

In

)

general, two independent checks should suffice.

5.. What expertise is regtiired? No one who cannot mah the initial measurements, calculations, or computerized calculations is propetly trained or qualified

{

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to do an independent measurement or calculation to verify the original results.

j in order for quality assurance to work, the person doing the checks must be l

equally qualified to have done the original work-in order for the checks to j

i have any degree of validity.

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6.- Checks and balances are necessary. A program utilizing qualified personnel, properly calibrated equipment, regional intercomparisons through an organi-l zation such as the RPC's, and proper protocols from the AAPM/ACMP will l

provide an excellent network to assure maximum benefit, maximum protection

[

for the patient and staff, and minimum misadministrations.

7. ' Cost vs 'results: As with radiation exposure, we must think ALARA.. The new l

rules, as proposed, would place most community hospitals in the position of L

having to add one fulltime qualified person plus making arrangemehts to have' i

a qualified backup consultant in order to do the routine double calculations ar.d to provide coverage for vacation time, absence for meetings, and unexpected l

absences. Depending upon the size and location of the hospital, this could i

cost anywhere from $40,000 to $100,000 a year with no appreciable effect on i

the scalicy assurance program or the misadministration rate.

Resp ctfull O

V hN' I

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[

Herbert W. Mower, Sc.D.

Sdnior Radiation Physicist i

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3 January 26, 1988 I

l Dr.

R.

E.

Cunningham j

Office of Nuclear Materials Safety and Safegaurds US Nuclear Regulatory Commission Washington,'DC 20555 (301) 427-4108 Comments presented at the Nuclear Regt ory Commission Hearing on

)

January 26, 1988 at the Holiday Inn, 8120 wisconsin Avenue, Bethesda, MD and requested by Dr.

R. E.

Cunningham for inclusion in the formal report of these hearings.

I.

According to the data provided within the Nuclear Regulatory Commission pocuments-circulated, the rate of misadministrations" for Brachy Therapy procedures corresponds to 0.OO29Y. (2.9 x 104) cnd for Teletherapy Units corresponds to O.OO5Y. (5 x 10 -5

).

These percentages, however low, reflect only the administrative definition j

l of misadministration and not patients harmed since an attempt was not I

'I-made to relate patient misadministration to the risk of harm or damage

.to a patient.

Therefore, prior to the recommendation of any final rule we urge a thorough evaluation of "misadministrations" for the purpose of avsluating the degree of severity of any particular misadministration to more accurately reflect harm to a

patient as a result of any l

misadministration.

This would be important since the stated goal of l

the Nuclear Regulatory Commission is to impact on public safety.

l Therefore, if patient misadministration would be reduced from the current 10-5 to, for instance, 10 - b, yet no impact on public safety l

was occurring at either the 10-5 or the 10" level, such a reduction would not be justifiable on a cost effectiveness evaluation.

Such ovaluation would be critical to justify the additional personnel and material that will be required to meet any new regulations.

I 11.

Proposed and announced ruling recommend usage of a separate

[

dosimetry system for full calibration of Teletherapy units and suggest i

use of a mail in TLD system.

1 Respgnt Generally, the onsite Teletherapy physicist spendsa vast amount time determining the most optimal system to utilize.

I Therefois the requirement for a second calibration using a presumably inferior system seems questionable.

Especially if this involves the use of a TLD system which is widely known to be inferior to the ion f

chamber measurements currently used in full calibrations.

Also, the 4

facilities that administrate the mail in TLD systems may not be I

capable of handling one or two orders of magnitude increase in the 1

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Dr.

R. E.

Cunningham (cont) page 2 number for processsing and this should be evaluated pripr to the implementation of any new rule as well as the advisability of.

perforrning a second calibration using an inferior inethod to"the one used to perforra the initial full calibration.

l III. Recommendation is also rnade regarding independent calculation using different individuals and different rnethods prior to the l

achievement of either 20 or 50% of the prescribed total dose.

L

Response

This ruling does not take into account some of the briefer fractionation re g irnens used in such treatment as total body irradiation or the palliative t reat raent of Ka pos i ' s Sarcoma where possibly enly 1, 2, or 3

fractions of teletherapy treatment may be given.

In this scenario, the 20 or 50% of the total prescribed dose may actually be reached during the actual first t reat raent which would require, according to the letter of the r'gulation, e

an independent recalculation by a

different individual using a different method jj during the 2-3 minute treatment time period.

We recommend a thorough re-evaluation of this r egulation.

IV.

Physicists and/or Dosimetrists, in reality, are really the only ones qualified to perform the independent rneasurements, re-measurements and re-calculations as specified in these new proposed l

and announced regulations since they were the ones performing such procedures in the first place.

Therefore, in order to roeet these new regulations, significant numbers of additional full time physicists and dosimetrists will need to be hired.

As a full member in the American Association of Physicists in Medicine, as well as a Board l

Certified Radiation Oncologist, it is my view that due to the difficulty already noted in hiring these individuals that the factor l

of 1 and 1/2 or 2 greater numbers of individuals that will be required t

to roeet these new reDulations simply do not exist within our current national population of these individuals.

A thorough determination of this fact would be therefore necessary by the Nuclear Regulatory l

Commission before any consideration of i rnpl ement at i on of such a i

regulation to ensure that such individuals would, in fact, even be available at any income level to be hired by the various facilities.

l l

l ThanR you for consideration of these cornments.

l S'ncerely, o

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(t

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b?W!

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//

ary B.

Sti11 wagon, ph. D.,

M. D.

Assistant Professor, Oncology Radiology and Radiologic Sciences The Johns Hopkins Oncology Center

7 l

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I RULEMAKING ON l

BASIC QUALITITY ASSURANCE IN RADIATION THERAPY Presentation Before ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOFES

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l BY 9

ANTHONY N. TSE t

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Office of Nuclear Regulatory Research l

U. S. Nuclear Regulatory Commission i

1 January 26,.1988 i

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OBJECTIVE OF THE PRESENTATION i

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t To-seek the Advisory Committee's advice l

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on l

l the formulation of the Final Rule.

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Basic Quality Assurance Requirements.

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l TABLE OF CONTENTS I

RULEMAKING ON BASIC QA REQUIREMENTS IN RADIATION THERAPY l

A.

BACKGROUND l

(About 5 minutes) 1.

Objective of the Presentation 1

2.

Proposed Rule on Basic QA Requirements 3.

A related action - Advance Notice on Comprehensive QA

'?

l B.

GENERAL PUBLIT COMMENTS ON THE PROPOSED RULE l

r 1.

Presentation of Most Significant General Comments l

l-2.

Advice from Members of the Advisory Committee i

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C.

DETAILED PUBLIC COMMENTS ON THE PROPOSED RULE 1.

Presentation of Most Significant Detailed Comments 2.

Advice from Members of the Advisory Committee 4

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l ADVANCE NOTICE ON COMPREHENSIVE QA REQUIREMENTS I

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1.

Purpose of the Action i

o To seek public comments on comprehensive QA requirements that will address each source of error that can lead to a misadministration.

i 2.

The Advance Notice o

Published on October 2, 1987 in the Federal Register.

i o

Comment period ended December 31, 1987.

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o About 20 specific questions were asked.

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Invited any public comments related to this topic.

o About 3000 copies were sent to licensees and others.

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3.

Public Comments o

14 comment letters were received.

o 10 letters (70%) stated certain actions might be needed, o

4 letters (30%) opposed additional regulations.

4.

Future Actionc o

The NRC etaff will consider public comments and advice from the Advisory Committee in formulating a proposed rule.

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t PROPOSED RULE ON BASIC QA REQUIREMENTS l

i 1.

Purpose of the Rulemaking o

To reduce the chance of misadministration in therapy due to simple human errors.

I 2.

The Proposed Rule o

Published on October 2, 1987 in the Federal Regieter.

o Comment period ended December 1, 1987.

o Simple QA steps were proposed to detect and prevent simple human errors.

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About 3000 copies were sent to licensees and others.

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Public Comments

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68 comment letters were received.

o 54 letters (80%) supported in principle or with suggested modifications.

o 14 letters (20%) opposed the rule.

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Future Actions o

In formulating ^the final rule, the NRC staff will consider:

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public comments, 2.

advice from the Advisory Committee, and 3.

comments from Agreement States.

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GENERAL PUBLIC COMMENTS ON BASIC QA PROPOSED BULE (4 most significant comments) l

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l GENERAL PUBLIC COMMENT NO. ~ 1 i

The probability of misadministration is already very low, the rule will not substantially reduce the probability.

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QUESTION t

If the implementation of the rule could have prevented a substantial i

number of the misadministrat' ions that had occurred in the past, l

would you think the rule is effective in protecting public health and safety?

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GENERAL PUBLIC COMMENT NO. 2 Regulations would not affect the level of attention of an individual performing a particular task, and, errors would not be reduced if individuals are disinclined to prevent them.

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S QUESTION s

If the required QA steps are implemented by the licensees, 7

such as, an independent check of calculations by a second per, son, t

I would it be more-likely that an arithmatic error made by the first person would be detected and corrected?

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GENERAL PUBLIC COMMENT NO. 3 1

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Patient care cost would be significantly increased if the proposed rule.is implemented.

i QUESTION Which-requirements of the proposed rule, if implemented, would cause r

i t-E the licensees to spend significant amounts of financial resotirces?-

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GENERAL PUBLIC COMMENT NO. 4 i

l The rule is unenforceable because no documentation is required.

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QUESTIONS l

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Are the current patient recorde kept by the licensees suff1Cient?

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Should poorly performing licensees be required to keep 1

records specified by license conditions?

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Is it necessary to require all licensees to keep records?

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DETAILED PUBLIC COMMENTS ON BASIC QA PROPOSED RULE 1

(7 most significant comments)

_ DETAILED PUBLIC COMMENT NO. 1

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Proposed pection 35.39, Paragraph (a):

A licensee may not order any radiopharmaceutical of iodine - - - without the approval of the authorized user.

Public Comment:

E This requirement would cause delay in certain procedures but would,not t

prevent a misadministration.

1' Question:

In light of the other QA requirements, do you think the i

requirement in this paragraph will contribute to the reduction of the probability of a misadministration?

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DETAILED *PUBLIC COMMENT NO. 2 1

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Proposed Section 35.39, Paragraph (b):

l A physician may not prescribe administration of a radiopharmaceutical of iodine for diagnosis or therapy, or any radiopharmaceutical for therapy-l-

without personally examining the patient and the patient's chart, and

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consulting with the referring physician if reasonably available.

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I Public Comment:

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l This requirement should exenpt small dosages of I-131 or I-125 (30, 50 l

and 100 microcuries were st<gested as criteria for small dosages) ac j

sodium iodide and other iodine compounds for diagnostic uses.

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Question:

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~1 If small dosages of sodium iodide should be exempt, which of the above three values (30, 50, or 100 microcuries) would you suggest as l$

a criterion for small dosage?

l Public Comment:

l Replace " personally examining the patient and - - - if reasonably l

available" by "first ascertaining the appropriateness of the intended l

diagnostic study or therapy."

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Question:

l Is it appropriate to specify how the physician would ensure that the patient needs the diagnostic or therapeutic procedures?

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1 DETAILED PUBLIC COMMENT NO. 3 l

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Proposed Section 35.43, Paragraph (b), Subparagraph (2):

For brachytherapy, the prescription must also identify the sources of radiation and the total-tumor dose.

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-Public Comment:

Methods of prescription specifications for clinical brachytherapy are not standardized, thus, " total tumor dose" may not be meaningful.

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Question:

Should the physician be allowed to write a prescription that may contain specifications other than the total tumor dose, such as l

isodose rate contour and treatment time, milligram-hours of radium

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equivalent, or number of sources to be implanted?

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DETAILED PUBLIC COMMENT NO. 4 1

1 Proposed Section 35.43, Paragraph (c):

Prescriptions and other records made regarding the medical uses of byproduct material must be legible 'nd unambiguous.

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Public Comment:

e Since there is no standard for legibility, how is the NRC to inspect or enforce this requirement?

1 Questions:

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Recognizing the difficulty of, applying the definition of legibility, do you think that this requirement could be useful in preventing unclear or ambiguous instructions or information in prescriptions

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and other records' i

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DETAILED PUBLIC COMMENT NO. 5 Proposed Section 35.432, Paragraph (a) - Brachytherapy:

A licensee shall measure the source etrength of sources'(for brachytherapy) before the first use and annually thereafter.

Public Comments:

1.

There may be no commercially available instrumentation'(calibrated by using NBS-traceable standards) suitable for measuring the full range of brachytherapy sources.

2.

It is impossible to measure the strength of I-125 seeds in a sterile absorbable suture without compromising sterility.

3.

Personnel performing these measurements will experience an unnecessary increase in radiation exposure.

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Question:

Do most licensees have instrumentation with enough accuracy to measure the full range of brachytherapy sources?

Question:

l What has your experience been with respect to the accuracy of

-manufacturers' source strength measurements?

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t DETAILED PUBLIC COMMENT NO. 6 Proposed Section 35.454.- Brachytherapy:

A licensee shall check (by a.second-individual) dose calculations for accuracy before 50 percent of the prescribed dose has been administered.

Public Comments:

1.

There are not enough qualified people to perform timely independent checks on dose calculations.

2.

The logistics of-obtaining a second physicist in the required time would be insurmountable, especially in isolated communities.

Question:

For a simple check of dose calculations, could the checks be r-

. performed by a physician, physicist, dosimetrist, technologis,t?

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i DETAILED PUBLIC COMMENT NO. 7 4

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Proposed Section 35.633, Paragraph (a) - Teletherapy:

A licensee shall have an independent check of the output determined within one month after completion.of the full calibration required by Section 35.632.

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Public Comment:

The independent check of output should be performed only after full calibrati6n of a new source or whenever a recalibration is required because of observed deviations of 5 percent or more from predicted.

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Question:

1 Is it necessary to independently check the output following an annual full calibration, when the output of the full calibration can be checked against the predicted decay of output from previous full calibrations?

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