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Transcript of 880126 Conference in Bethesda,Md Re Advisory Committee on Medical Uses of Isotopes.Pp 1-166.Supporting Documentation Encl
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Issue date:	01/26/1988
From:	; NRC OFFICE OF INVESTIGATIONS (OI)
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	NACMUI, NUDOCS 9701070071
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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

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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

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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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2 (Continued on next page.)

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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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t 31 I

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' 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

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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

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

e i

(t

)(

b?W!

i

//

ary B.

Sti11 wagon, ph. D.,

M. D.

Assistant Professor, Oncology Radiology and Radiologic Sciences The Johns Hopkins Oncology Center

7 l

i l

l

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I i

t i

I RULEMAKING ON l

BASIC QUALITITY ASSURANCE IN RADIATION THERAPY Presentation Before ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOFES

+

l t

1 l

l BY 9

ANTHONY N. TSE t

r l

Office of Nuclear Regulatory Research l

U. S. Nuclear Regulatory Commission i

1 January 26,.1988 i

i I

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a

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l i

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OBJECTIVE OF THE PRESENTATION i

i i

i l

t To-seek the Advisory Committee's advice l

l e

\\

on l

l the formulation of the Final Rule.

i r

i concerning i

(

Basic Quality Assurance Requirements.

l O

.b Y

I k

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i n

4 a

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1, i

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l l

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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

l l

C.

DETAILED PUBLIC COMMENTS ON THE PROPOSED RULE 1.

Presentation of Most Significant Detailed Comments 2.

Advice from Members of the Advisory Committee 4

l 1

l

-.. =.. ~

l l

i i

I l(

l ADVANCE NOTICE ON COMPREHENSIVE QA REQUIREMENTS I

I i

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.

l*

o About 20 specific questions were asked.

i o

Invited any public comments related to this topic.

o About 3000 copies were sent to licensees and others.

e s

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.

1 l

4 l

~

l l

(

i

~

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.

l o

About 3000 copies were sent to licensees and others.

j E

t

=

3.

Public Comments

~

l o

68 comment letters were received.

o 54 letters (80%) supported in principle or with suggested modifications.

o 14 letters (20%) opposed the rule.

4.

Future Actions o

In formulating ^the final rule, the NRC staff will consider:

1.

public comments, 2.

advice from the Advisory Committee, and 3.

comments from Agreement States.

l

)

l 3

I 1.

t I

GENERAL PUBLIC COMMENTS ON BASIC QA PROPOSED BULE (4 most significant comments) l

~~

1 l

s l

l l

l GENERAL PUBLIC COMMENT NO. ~ 1 i

The probability of misadministration is already very low, the rule will not substantially reduce the probability.

l l-l l

[

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?

l t

5 l-

e s

i

(

i t

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.

o l

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?

(

6

~...

__.-___._-._..__..-_._m.

l i

I

. g I

l

- 1 i

GENERAL PUBLIC COMMENT NO. 3 1

I I

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?-

's l

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I 4

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GENERAL PUBLIC COMMENT NO. 4 i

l The rule is unenforceable because no documentation is required.

l i

QUESTIONS l

l 1.

Are the current patient recorde kept by the licensees suff1Cient?

t,

l=

t-2.

Should poorly performing licensees be required to keep 1

records specified by license conditions?

I 3.

Is it necessary to require all licensees to keep records?

l l

i l

l l

l 8

i

, i.

i j

l l

[

t 1

DETAILED PUBLIC COMMENTS ON BASIC QA PROPOSED RULE 1

(7 most significant comments)

_ DETAILED PUBLIC COMMENT NO. 1

F l

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?

l l

I l

9

t l

1 l

DETAILED *PUBLIC COMMENT NO. 2 1

l L

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

[

consulting with the referring physician if reasonably available.

1 I

I Public Comment:

i i

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.

t l

Question:

l l

~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."

I l

Question:

l Is it appropriate to specify how the physician would ensure that the patient needs the diagnostic or therapeutic procedures?

10 1

i i

1 DETAILED PUBLIC COMMENT NO. 3 l

~

Proposed Section 35.43, Paragraph (b), Subparagraph (2):

For brachytherapy, the prescription must also identify the sources of radiation and the total-tumor dose.

l

-Public Comment:

Methods of prescription specifications for clinical brachytherapy are not standardized, thus, " total tumor dose" may not be meaningful.

t i

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

?

equivalent, or number of sources to be implanted?

E t

i l

4 i

11 l

~.

J 1

k i

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.

a l

Public Comment:

e Since there is no standard for legibility, how is the NRC to inspect or enforce this requirement?

1 Questions:

i I

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

{

and other records' i

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T j

1

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4 j

4 12

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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.

e n

,u w

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?

l i

13 l

l

(

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?

I 0

4 14

t V

4 l

i DETAILED PUBLIC COMMENT NO. 7 4

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1 l

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.

s

[

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.

1

~

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?

7

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ML20133C202

Text

Response

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