ML19296D066

Transcript of 800221 Meeting in Washington,Dc Re Effective Amends of 10CFR35 to Require Reporting of Misadministrations of Byproduct Matl.Viewgraphs Encl

ML19296D066
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Issue date:	02/21/1980
From:	NRC COMMISSION (OCM)
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References
REF-10CFR9.7 SECY-80-026, SECY-80-26, NUDOCS 8002290298
Download: ML19296D066 (53)

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UNITED STATES N UCLE AR REG UL ATO RY COMMISSION in the matter of:

EFFECTIVE AMEDNMENTS OF 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMINISTRATIONS OF BYPRODUCT MATERIAL

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P1 ace:

Washington, D.C.

Date:

February 21, 1980 page3:

1 through 52 INTERNATICNAL VERSATIM REPCRTc.nS. INC.

499 SCUTH CAPITCL STRs.:.. S. W. SUITE 107 WASHINGTCN, D. C. 200C2 202 484 320 soo2e9039g i

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1 JCNITED STATES I

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NUCLEAR REGULATORU CO>S1ISSION A

EFFECTIVE A>ENDMENTS OF 10 CFR PART 35 TO i

3 REQUIRE REPORTING OF MISADMINISTRATIONS OF BYPRODUCT MATERIAL i

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to Room 1130, Eleventh Floor II I

1717 H Street, N.W.

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Washington, D.C.

13 l

l Thursday, February 21, 1980 j 13 t

The Commission met, pursuant to notice, for the

,6 presentation of the above-entitled matter, at 2:05 p.m.,

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BEFORE:

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JOHN F. AHEARIE, CHAIRMAN i

19 i

RICHARD T. KENNEDY, COFD!ISSIONER 21 i.

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1 PgggggplNgS CHAIRMAN AHEARNE:

We have a full complement to 2

meeting this afternoon, two subjects on the schedule.

Do not look so puscled, Bill, there are two subjects 4

l on my schedule.

e 3

So, without further ado, Bill, do you have any words of wisdom, advice, or--

MR. DIRCKS:

No, j us t to remind you that this is 3

an old, kind of an old favorite subject that has been around 9

f r several years and itis the subject of reporting of 10 misadministrations.

Bob Minogue is here, of course, and Ed Podolak i.

is here on my right, and he will pick up most of the briefing.l I

1 I do want to point out that Bill Walker is sitting back rhere f 14 from MNSS, who will be participating from time to time, I am sure, when the case arises, i

I do not want to say too much except there are two issues here that the Con: mission has recognized for a couple of years; should medical licensees be required to report misadministrations to NRC, and the second issue is to whom decides NRC, should such reports be submitted.

Bob, I do not know what else to say, but this record,

2 I think, is fairly ccupleted; it has picked up the co= cent

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and Ed should pick it up at this point.

l CHAIRMAN AHEARNE.

Thank you.

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1 MR. PODOLAK:

We have several questions that we are 2

going to raise and answer.

First, what are medical mis-r 3

administrations of radioisotopes; what is the difference l

4 between the diagnostic and therapeutic misadministration; why 3

does NRC need reports of misadministrations; and, why should 6

patient be informed of misadministrations.

And in going 7

through this, c e thing to keep in mind is that these, in 3

terms of Federal requirements, these requirements would be 9

unique in medical practice.

There is no other agency that to would require this sort of reporting.

Basically, we are talking about two types; therapy and diagnostic.

In therapy, we are talking about, in terms i

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l of practically thousands of RADS given to small tissue volumes to, in most cases sterilize a tumor, cancerous tunor; over doses can kill healthy tissue; under-doses can fail 1.,

to sterilize the tumor, increase the probability of recur-l g

rence of cancer.

Diagnostic is a different story.

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talking about injections of millicurie amounts of relatively harmless radionuclides.

They are choses because their radiation characteristics favor detection and disfavor harm.

i 20 l

The medical misadministrations of radioisotopes is not a 21 theoretical problem.

We currently reports of misadministra-tions, either voluntarily, through allegations, or through Inspector Purusle (?) of Licensee Files.

We have a snapshot ;

24 of misadministrations that NRC became aware of between s

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January of '77 and November '78.

There were 18 incidents, I

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four therapy and 10 diagnostic.

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The first case resulted in--

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.t CHAIRMAN AHEARNE:

The slide is not supposed to be tracking with what you are saying.

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MR. PODOLAK:

Yes, it is.

This is four therapy I

I 7

misadministrations that occurred during that time.

The first 3

l was a teletherapy overexposure, twice a prescribed dose.

A j

9 technologist misinterpreted the physician's instructions.

The.l i

h 10 P ysician told him to give 2850 RADS from two angles and he -

gave, that was supposed to be the total, instead 2850 was delivered to each of two angles and there was intestinal g

l impairment.

The last two where four sources were left with I

a patient, and the Riverside incident which we are familiar with, where both of these resulted in rule changes, as example w

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of how we might use reports.

In the case of the sources left

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in the patient, we now have a new rule which requires radiation survey of the patient.

In the case of the l

telecherapy overexposures, we have a rule requiring annual 19 calibrations and monthly fross (?) checks.

l CHAIRMAN AHEARNE:

An'd the calfunctions?

• 1 MR. PODOLAK:

The malfunction was a--the source

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accidentally flipped on as the head was being coved to a new l

4 treatment angle and it resulted in an overexposure of the

• 1 patient of 10 RADS out of 200.

But, it was unnecessary 3

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' overexposure, it was to an angle which did not enhance the treatment.

I The diagnostic misadministration--

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CHAIRMAN AREARNE:

That, that you have there, is that lustrative or are those the total four over some period I

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f Cime?

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MR. PODOLAK:

Those are the total four.

These are all the misadministrations that we are talking about now 3

occurred between January '77 and Novmeber of '78.

This just y

coincidentally, I asked ISE to provide me with a years time.

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I also ask that they span the Riverside incident, because that

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happened to be a central incident in this progress of this rule.

j CHAIRMAN AHEARNE:

This is more like, what, a la i

i year and three quarters?

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l MR. PODOLAK:

Yes--no, it is less than year, just

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a little under a year.

November of '77 to--January '77--oh, it I am sorry, yes.

A year and three quarters.

18 MR. KENNEDY:

Is that typical of a longer period?

19 l

MR. PODOLAK:

That is a good geestion.

We have no

o idea and that is really the basis for this rule.

We just j

21 do not have any idea.

l In the diagnostic case, I just picked a group of l

five misadministrations because they occurred at the same

• s institution.

Now, these, coincidentally, the institution 13 l

said that they were required to report these to the State of

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I Michigan.

And our inspector came across this during an l

inspection.

This is an example of the trends that might occur I

at a single institution.

They are all mistakes.

These typify {

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the kind of misadministrations that we see in the diagnostic e

area.

6 MR. KENNEDY:

You say that these were required to be 7

reported to the State of Michigan.

Is that typical?

MR. PODOLAK:

That is atypica.?.

3 MR. KENNEDY:

Atypical.

.7

}EL. PODOLAK:

That is the only thing case that I am

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,i aware of where the state requires reports of misadministrations.'

FEt. KENNEDY:

Can we come back to that later and I

discuss what state involvement in licensing or supervising this1 is kind of activity might Le?

MR. PODOLAK:

For sure.

As

.1 matter of fact, it was IL l

one of the alternative on how to implcment the rule.

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CHAIRMAN AHEARNE.

Remind ae.

Is Michigan an agreement state?

18 MR. PODOLAK:

Michigan is not an agreement state.

19 CHAIRMAN AHEARNE.

So this is outside of any system-,

o MR. PODOLAK:

Correct.

This is just something that j 7

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they decided to do.

Now the states, and we will revisit at this point, the states have been after us, the agreement states {

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i have been after us to implement this rule, several of them

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• 2 are very interested in it.

2 The outline of the presentation essentially follows

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chronology of the rule.

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2 CHAIRMAN AHEAPSE:

Before you--

I MR. PODOLAK:

I am sorry.

i CHAIRMAN AHEARNE:

On these you mentioned, tHat this cluster of five were chosen because it was from the same e

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hospital and it typi fie s.

Does it--it typifies, but does j

i it typify something where there would be--where you would i

I 7

expect there to be thousands of these over the same time period 3

or one or two other instances over the same time period?

MR. PODOLAK:

Again, I have to keep relying on the i

answer that we just do not know.

And this is what has beguiled GAO--

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CHAIRMAN AHEARNE:

Well--

l 13 MR. PODOLAK:

I am sorry.

1.L CHAIRMAN AHEARNE:

I think--

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MR. KENNEDY:

I&E found it; is that correct?

t4 MR. PODOLAK:

Correct.

17 i

CHAIRMAN AHEAFSE:

Did I&E find any others during fa the same time period?

t 19 i

MR. PODOLAK:

Yes.

There were 14 instances during f

20 this time period and the others were of similar ilk, and the 1

21 others that we have had over the years in diagnostic area have,

been similar to this.

The original GAO recocmendation was i

based on 12 instances of 20 misadministratiens 'oetween '62 and '

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'72.

Again, there were like this.

One of these cases the nurse went into a rocc, asked if Mrs. Jones was there, "Are r,,m wm vo = :_, _ ! e es 23uTM Cwr*Ca. #T,Pa?. L e. sutTT'Of

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you Mrs. Jones?"

she said yes, injected the material without I

i checking the ID bracelet and it :urned out that Mrs. Jones had been moved.

A In other cases they just cross the doses.

This is i

3 the kind of thing that is in the diagnostic area.

6 CHAIRMAN AHEARNE:

Yes.

I 7

MR. PODOLAK:

This really charts the chronology of I

the rule.

We are talking about a rule that was originally 3

proposed by the AEC in '73 and we are trying to bring it to 9

resolution.

Now, I do just want to give ycu a little bit of l

10 i

l an example on the next slide of what we are talking about.

We talk about diagnostic applications and therapy applications :

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and the next slide you see--if you were to walk into atypical nuclear medicine department this morning, you would find the

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technologists drawing up a radiopharmaceutical and a syringe t.!

and measuring the millicurie amount in a dose calibrator.

14 i

This is unique in medicine in that they can measure 17 the dose before it is administered to a patient.

Whereas, la normally, the physician has to rely on the label for other 19 drugs.

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o In this case, we are looking at a heart scan with j

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a gama camera, this is what they use for diagnostic misadmin-l l

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istrations--for diagnostic administrations, typical diagnostic l studies.

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I' Therapy applications, we are talking in some cases, i

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f therapy, for example, P32.

We are talking about Cobalt 60 f

I teletherapy, that is therapy over a distance.

The source is outside the body radiating the body.

Implants; sources im-planted in the body, Merridian 192 is an example of that.

1 Now, in 1973, the AEC proposed a rule which was 3

based on a GA0 recommendation, I said that was 12 instances of 6

I 20 misadministrations, they had a very simple recommendation.

s They said, AEC, you need to have reports of misadministrationsi in order to try to prevent future misadministrations.

You regulate this area, it should not be regulated different than 10 other areas where you do receive reports.

It The recommendation was a bit narrow, they did not I:

include reporting to the patient or the family.

This was l

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added; a Staff recommendation and endorsed by the AEC at that j

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time.

So the rule that went out required reporting to NRC l

and to the patient, i

i I4 There were 98 comment letters.

This typifies

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the comments that we have on our presently proposed rule.

18 The last item--this is on the '73 AEC propcsal.

I 19 MR. KENNEDY:

These are--these comment letters were

-*o on the '73 proposal.

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l MR. PODOLAK:

That is righ*

22 MR. KENNEDY:

Okay.

22 MR. PODOLAK:

We knew that.

In other words, we knew U

this going into our '78 proposal, which ir, what we are here to 2

discuss today.

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l And the last item is worth dwelling on for a second.

2 These nuclear medicine physicians do feel singled out.

They 2

feel that they are operating in an arean which is already heavily regulated compated to other areas of medicine and they 4

I feel that in most c_ses they again have that advantage of s

measuring the product before it is delivered to the patient.

7 So, on balance--

3 MR. KENNEDY:

Could you describe what that other 9

regulation is?

to MR. PODOLAK:

Yes.

Debbie, could you put up the slide with the circles, please?

7 MR. KENNEDY

Well, are we going to come to that?

e MR. PODOLAK:

No.

She is getting it.

It is quite g

l heavily regulated.

I do not know if she can hear me or not.

4 I

MR. KENNEDY:

She should be able to hear you.

g MR. PODOLAK:

The slide with the other agencies.

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She is getting it.

The primary age-c.y, of course, is the 1 1 Food and Drug Administration, and we are all quite familiar with that.

The other agencies are the Enviromental Protection:

Agency, the OSEA, the Agreements States, other state--here

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we are.

Peer groups, there are many peer groups involved--

,1 4

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this is the slide in which we used in presenting you the

_v Policy Statement.

The Drug Commission on Accreditation of 23 i

hospitals.

They do surveys of hospitals and they also l

examine the nuclear medicine department.

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the JCOH spends very little time in the nuclear medicine 2

department because their surveyors have found that the recordsI that are required by the NRC make their job very easy and 4

they are frankly impressed with the way things are run down 3

there because of this regulation.

6 Social Security Administration--

I l

7 MR. KENNEDY:

How does that cut it?

It sounds 3

to me like we are already doing what needs to be done?

9 MR. PODOLAK:

Most of these other groups do not--

I understand--

10 MR. KENNEDY:

I am referring to your comment about the Joint Coccittee on the presentation, MR. PODOLAK:

Most of these other groups do not f

g get as intimately involved in regulating medical practice as I

to required the reports of misadministrations.

j g

MR. MINOGUE:

Also, I think, the answer to j

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Commissioner Kennedy's questions is that not the number of 17 i

i these procedures that are carried out.

There are enormous numbers of these and just keeping records of procedures and 19 reporting misadministrations is a very, very small subset.

,0 MR. MALSCH:

Also, at the Federal level, we are the only agency with authority to put rule such as this.

There is no other agency which actually regulates the ad-I ministration of drugs to patients.

There are agencies that 24 which control funding of hospitals, labeling, and things of

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i this sort, but the actual administration--there is no other agency that would be empowered to act.

i MR. PODOLAK:

We are going to revisit that point.

4 In fact, the Food and Drug Administration does not regulate 3

the use, they are not empowered to do it.

They regulate the 1

6 manufacture and distribution.

They regulate the investigation +

7 use.

l We can go with the slide, the next slide in order 3

which is--in addition to the comments that we are looking at, 9

the 98 cocments, we did have the problem of FDA.

FDA coming l

10 en board and regulating radiopharmaceuticals.

The staff of 3;

the AEC did not know, and I worked for FDA at the time, FDA g

was a little uncertain as to how far they would go in 13 regulating radiopharmaceuticals.

Ic was a new area, in fact, 14 I

eventually, the NRC found out that they do not regulate the use of isotopes; they do not regulate misadministrations.

They would regulate, for example, adverse reactions to proper-ly administer drugs.

They currently get reports on a i

voluntary basis of adverse reactions.

So, we decided to 19 I

ask the Commission--okay, we did not know what the policy of i

o I

the Commission was at that time.

We decided to ask the il Commission--we went through this deliberate rulemaking process which ended up with a final policy statement in February of ' 78.

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4 The policy statement came in three parts.

NRC 2

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I would continue to regulate the radiation safety of workers in the general public; it would regulate the radiation safety of patients, where justified by the risk of patients, and were 4

voluntary standards or compliance with them or inadequate.

3 That is a qualified statement.

The last statement was that 3

NRC would minimize intrusion in the medical judgments affecting l

7 patients, and to areas traditionally considered a part of the practice of medicile.

So, what we see is a balancing of these 3

last two items; the risk to patients and interferring in 9

medical practice ti.oughout this consideration and many others 10 that we deal with.

)

The question might arise why should NRC be interest-g i

ed in misadministrations in light of the policy statement.

{

This is the slide that is left out of your packet.

You will not find it.

If we can look at a report of a misadmini-stration and determine that it might hcppen somewhere else, we can simply notify other licensees that this kind of thing l

1 1 occurs; be careful.

We can issue orders to them, tell them to take specific steps to prevent "this kind of nisadmini-stration again".

We can change license conditions or we 20 I

caa issue regulations as we gave two examples of that.

We can also check to see if the licensee that had the mis-i C

administration had taken corrective steps.

22 l

MR. DIRCKS:

Did not we do this one time with a i

4 Molly (?) break through?

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i MR. PODOLAK:

That is correct.

2 I

MR. DIRCKS:

That was an interesting point where it 2

was not just at the patient / doctor level; it was a problem 4

that uas generic, that we traced back to the manufacturers.

3 Is that--am I getting that right?

6 MR. WALKER:

That is correct, yes, sir.

7 MR. DIRCKS:

So in this case, it was just not for 3

the physician problem there, it was treating as a generic i

9 issue and finding out that there was a generic problem with to l

the manufacturers.

MR. PODOLAK:

You should be seeing the final 11 rule, the Malebium (?) break through rule, in about a month.

3 It was a case were the generators were faulty and they were doing something which generators, of course, had not done for years, and that is let Molly (?) crack through.

l 73 The last point is looking at individual trends, 14 I

this is kind of a report card, and we saw that on the second g

slide.

You know, how are things going?

We issue a license based on a one time evaluation of the physician's qualifi-cations, it is the license's rechecked every five years, as j

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far as facilities and equipment, what they are doing and what

,1 4

controls they have.

But we really--other than the inspections.

we do not know how they are doing.

This would give us a 22 i

report card.

l MR. KENNEDY:

We license the physicians?

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i MR. PODOLAK:

We license--basically, we license the 2

individual institution.

The institution with a named physician on the license.

Years ago, we used to license--and l we also licensed individual physicians outside of an A

3 institution, in that case the name and the license coincides.

6 We used to license individual physicians in the institutions, 7

and you could come across a case where you would nave an i

3 institution with a license and you would Dr. A under that f

license and Dr. B and C with their own licenses; so we cut 9

that out.

We made a rule change that stopped that and 10 gradually as these things come up for renewal, we are having 11 the institution to have the license.

7 CHAIRMAN AEEARNE

Well, when the institution has i

la.

i the license, does that mean that any individaul at the institution can--

g MR. PODOLAK:

It means that there are named l

physicians on the license who we evaluate their qualificationst, and they are called authorized users.

They are listed in the license.

19 CHAIP}!AN AREARNE:

Those are the only ones.

j FR. PODOLAK:

Those are the ones who suit--other il physicians are allowed, excuse me.

Other physicians are I

allowed to use material under their supervision and this is 23 l

basically the way the people are trained.

t MR. KENNEDY:

What is the process for evaluating

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I qualifications?

MR. PODOLAK:

Good question.

Bill, please?

MR. WALKER:

This is the process that we have set up using our advisory committee on the medical uses of 4

i 3

isotopes.

Tnat group is primarily responsible for setting 6

these and helping us with the evaluations when the physician i

1 7

who applies, is outside of the specific guidelines that they l

have given us.

We are in the process now, as we have done 3

frequently for the last few years of updating these require-9 ments as the field changes.

We have a set of requirements 10 I

I which we use in licensing; we look at these, we judge that physician against these.

If he meets them then we authorize

7 that physician; if he does not meet them, then we either say you are very far from what they have required or we send it to the Cccaittee and have the Committee act on the information.

that we have submitted.

If may be of interest that at this present time, the Committee is working with the representatives of a number of professional organizations in nuclear medicine and some other ones; nuclear cardiology for one to establish 19 some new criteria to update it to meet today's situation.

I 20 l

MR. KENNEDY:

Are there standard Board qualifications 21 in the medical society?

I MR. WALKER:

There are standard Boards gauli-l Ao fications, but these--

4 MR. KENNEDY Do we accept those?

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1 MR. WALKER:

We accept those, yes, sir.

MR. KENNEDY:

Thank you.

MR. PODOLAK:

These concerns, in the light of the policy statenent brought us the proposed rule which came up--

4 the proposed nisadministration rule which came up as the e

f 3

policy statement.

The key feature of this rule, is that all I

i 7

therapy misadministrations would be reported to NRC and those 3

diagnostic misadministrations having a clinically detectable 9

adverse affect on the patient.

Additionally, these would be l

10 reported to the referring physician and to the patient; unless i

the referring the physician said it would be harmful to the patient.

..u

3 In the Federal Register Notice, the Cccmission expressed concern about intrusion into the physician,,acient I

relationship, so that was actually stated in the Federal Register's notice, I think that Commissioner Kennedy will l

remember the discussion at that time.

The Cc=2ission also wanted us to get the word out to as many physicians as possible to find out how this affected them and, in fact, we sent it to 2,000 state and local medical societies, hal: a 20 i

dozen public interest groups, and a list I had of concerned

,1 4

indiviudals.

We got a 150 comments, 90 percent opposed to the rule.

There were basically the same source of cccments I

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that we had on the first rule; che concerns about malpractice,l the concerns about interference in the physician / patient 2

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We also got many cocnents which technical and 2

helpful and we changed the proposed rule.

If you look at the next slide, we can see how the final rule is, in fact, set up 4

at a glance, we broke everything into fault units into every 3

section.

The important thing here is that therapy misad-6 ministrations and diagnostic misadministrations are handled 7

completely separately.

In the final rule, it is the therapy 3

misadministrations which are reported to NRC and the patient, 9

l or the patient's responsible relative.

In the diagnostic misadministrations they are reported to NRC only, and we will to see that on the upcoming slides.

Next slide, please.

)

In terms of the definition, we made two changes, j

l The first three items are the same; wrong product, wrong patient, wrong route.

The first change we made was to i

define a diagnostic misadministration as an error of 50 percent IJ l

l greater that 50 percent.

The previous definition was nearer i

14 l

20 percent.

This caused considerable concern because it was nearer the state of the art, and the physicians were irri-I tated, quite irritated that we would call something that l

19 close to the st ate of the art in misad:rinistration.

0 The 50 percent level is an area of where you get into the possibility of retakes; 50 percent too high or 50 percent

^2 too low, causing you to--

similar to an X-ray.

If you get i

22 i

an X-ray, the X-ray tech says stick around we will see how

4 that came out; you might have to have another ene.

Also t

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I I

there is a possibility of misdiagnosis and 50 percent is an area where few people can argue successfully that they have 3

not made an error.

4 In the therapy area, we broke it out of the two 3

sections recognizing radiopharmaceutical dose and recognizing 3

radiation dose and we added an adj ective, " final" prescribed 7

total treatment dose to make sure that we were talking about I

l the final dose.

Next slide, please.

3 CHAIRMAN AHEARNE:

The 10 percent number, is that of 9

similar concern as the 20 percent originally had been for to i

the misadministration?

MR. PODOLAK:

It was and as a matter of fact, it g

was not from the same standpoint.

In other words, there were l

a few people, few physicians who said that 10 percant was 14 too low in terms of an error but what their concern was in a radiation dose, that 2800 RADS that we were talking about I

14 is fractioned over 10 to 20 sessions and they were concerned that we might be talking about an individual session, many l

ta j

of them were concerned.

And that we had really talked about originally, and we emphasized it in the final rule, is the total treatment.

This also recognizes that physicians vary the dose in the middle of these treatments.

There were some i

=

l that said that 10 percent was too low from the same standpoint; D

they just said that it was in effect, but we had found

A several references that talked t hat 10 percent--see, this 2

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1 is an area where 10 percent too high and you damage tissue that you did not want to and 10 percent too low and you increase the 2

i probability of recurrence.

So, here we are talking about a

lirit which is based on harm and the other case we are talking 4

3 about a limit which, somewhat different, we are not talking 3

about harm in the case of the diagnostic misadministration.

7 CRAIRMAN AREARNE:

Are the effects calcuable, 3

precisely, that 10 percent higher leads to tissue damage?

9 MR. PODOLAK:

Okay.

What I have put together is to an enclosure in the rule, it is at the end of the co=ments.

It

)

is a string of votes that were prepared by the Bureau of l

Radiological Health.

Let me just pull one out.

Easier said

~

t.

than done.

l.a MR.' KENNEDY:

Here it is.

l i

MR. PODOLAK:

Is that the end of the comment Sectionl 12 4?

M i

MR. KENNEDY:

No.

l 17 e

MR. PODOLAK:

Basically, what they are saying is that some therapists feel that they ca, see at the 5 percent level, differences in the response to the tumor.

They are l

, ),

l saying that error is that find; not that is controversial.

i

.i l

We assume that at the 10 percent level, we are talking in l

significance.

)

l CHAIRMAN AHEARNE:

So, it is an assumption of the l

10 percent level?

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MR. PODOLAK:

It is an assumption based on about 2

10 or 15 votes of people who are convinced that the area of 3

5 percent and some of them were up in the 7, you know, talking 4

about 7--

CHAIRMAN AHEARNE:

No.

I was getting at the 3

question that I had thought you had said that 10 percent s

I 7

greater dose would lead to tissue damage and that is what my 3

question is.

Is it sufficiently, precisely calculated that 9

if you go above 10 percent you get tissue damage that you 10 were talking about.

MR. MINOGUE:

Let me make a statement.

All of these It g

therapeutic exposures are very, very high doses and the l

t g

question really is healthy tissue damage and there is some i

i y

amount of healthy tissue damage involved even in--

CHAIRMAN AHEARNE:

Well, that is what I thought.

g i

It sounded though, the description sounded like there was l

g 1

some sharp--

l I7 I

MR. MINOGUE:

I do not think so.

CHAIRMAN AHEARNE:

The 10 percent flipped you over.

0 i

MR. MINOGUE:

You have gone into a gray area where

,1 l

the total exposure involved in this treatment are typically l

so high that the incremental exposure is quite a substantial l

nurber in terms of dosage.

I think you want to cut it fairly l 4

tight.

It is somewhat arbitrary.

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1 MR. PODOLAK:

Correct.

And the question that when you got into this kind of thing, you start to say well where 2

is a mistake, where are we talking about a mistake?

Then 4

you start to say where is -- what is the significance of the 3

mistake in trying to pick a threshold or a number.

In some 6

therapies, 10 percent, for example, thyroid therapy 10 percent, 7

is meaningless.

But it is an error and we are talking about t

radiation doses where unnecessary radiation, we are talking 3

9 about significance and not of unnecessary radiation, in our 10 pinion.

I CHAIRMAN AHEARNE:

But, you say in some cases that 77 this is meaningless.

77

.1R. PODOLAK:

In the case of tryrnid treatment of i

Graves (?) Disease, 10 percent is not as significant.

l

3 l

MR. WALKER:

If I may cccment.

There are cases j

3 where the 10 percent can be, as a matter of fact, fatal as the

,d i

I treatment of the pons, for instance, the base of the brain.

You have to work in a very narrow range of dose; too little does not stop the tumor and you go 10 percent over and the possibility of either damaging the cord, resulting in

,0 paralysis or permanently damaging the pons, themselves, it

,1 4

can be fatal and that is one instance.

j MR. PODOLAK:

In these examples of radiopharmaceut-l

)

ical therapy, it is a very straight forward matter with that same dose calibrator that you measured the diagnostic.

If

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t CHAIMIAN AHEARNE:

Yes.

MR. F0DOLAK.

To make that particular measurement.

In the case of therapy misadministrations, we are talking about informing the licensee being required to inform 4

4 3

NRC with the physician and on occasion the patient within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

Focusing on this, the patient be the way that the 6

7 rule is set up, the licensee would first inform the referring i

9 3

physician and then the licensee would inform the patient, unless the referring said that he would inform the patient 9

or that it would be harmful to the patient.

Everytime that g

i I am saying patient, I en really saying, patir.nt, relative, or' guardian.

1,.

l The change from the proposed rule was this business about allowing the physician to report--the referring 14 i

physician to report to the patient, that was a result to the 15 i

l comments.

la l

In the next slide, we see something that we would 17 l

like to change in the final rule frca what we have presented 18 to you.

This came up during a dry run.

The additions are 19 l

underlined in this slide, this is from what we presented to

a s'

you and the final rule.

The reason--

21 MR. KENNEDY:

This is different--

C MR. PODOLAK:

This is different from what ycu have 22 j

in the Commission tape.

They are asking you at the risk of 3

24 distracting you, we are asking you to endorse this change J'

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I because this makes clearer our intention in this case.

This iq 2

a cause for concern when the referring physician cannot be contacted right away.

The choice is, do we have or do we 4

force the licensee to tell the patient.

In the absence of I

consulting with the referring physician and we have not in-4 tended to do that, and this makes it clear, that we did not 7

l intend to do that.

The next slide, please.

l I said the diagnosite misadministrations would 3

be recorded to NRC only--we essentially abandoned the 9

to threshold of clinically detectable adverse affect which we had in the proposed rule, which on analysis this was not a

11

7 very wise choice.

3 MR. KENNEDY

Why not?

3 MR. PODOLAK

Well, originally we used the term

3

" clinically detectablt adverse affect" we did not define it I

i because it was of--it could be one thing and it could be j

16 i

many things.

We thought that the term was well understood.

j

),

Many commenters said that they could not apply the g

test without a definition and they did not like the word

" crib cause".

And, in fact, many ccamenters pointed seme-l

,0 I

thing that we knew and that was that a clinically detected j

i adverse affect in a misadministration of a diagnostic i

22 radiopharmaceutical is so rare, that perhaps not to occur.

l 22 i;

And, so we decided and the Ccamission--

l MR. KENNEDY:

Does not imply that there are no i

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significant effects?

MR. PODOLAK:

Clinically detectable adverse affects. '

4 MR. KENNEDY:

Yes.

4 MR. PODOLAK:

We are talking about something that 3

you can notice.

It is not to imply that there are no 3

adverse affects because as we know we subscribed to the 7

linear hypothesis uhich says that we should minimize unnecs '

ry radiation.

3 MR. MINOGUE:

May I?

If you think in terms of 9

10 immediately detectable affects by normal means, the doses involved, would be very, very large, much more than you would have in this misadministration.

I think the problem is that i.

there are more sensitive techniques that maybe used or there 3

maybe latten affects that do not show up for a long time.

,s s

And this term, which initially in some of the early thinking s eem to te rm o f argument, why have they not used for years,

,d I

i f

when you really look at an art, no two people really agree l

on exactly what it means.

>2 PODOLAK:

And, in fact, the final rule in the l

19 l

statement

.ansiderations we discuss at the ending of the i

threshold, and we say that the Cc= mission is interested, would 21 list to see patients informed of all misadministrations.

i i

However, the risk from a diagnostic misadministration is i

l such that we do not feel that Federal intervention in this

4 matter, whether the patients informed of a diagnostic l

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i misadministration is warranted.

We are saying that the--

many of the commenters felt that if they told their patient.

of again they are commenting about a 20 percent misadministra-A tion, that the anxiety that they caused and then consequently would be liable for is unwarranted.

e 3

MR. KENNEDY:

Totally aside from the liability I

7 question, the anxiety could be a very serious question, couldn't it?

3 i

MR. 20DOLAK:

That is correct and I am not even 9

certain that--

10 MR. KENNEDY:

Indeed it is conceivable that the nxiety affects could be worse than the affects that might 12 be suffered from the misadministration.

g MR. PODOLAK:

That is the thrust of the ccaments 7,

and we agreed with those.

MR. KENNEDY:

Truly?

MR. F0DOLAK:

Yes.

Basically, again, what we are 7

saying is what we are recocmiending is that we not require reports of 'iagnostic misadministrations to patients that we leave this up to the normal grocesses within the hospital,

,0 within the medical community.

And it is up to the physician

,1 4

to decide, essentially, whether he would tell the patients or not.

l I

The referring physician--oh, I am sorry.

The

4 next slide, please.

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t This is the Section that also focuses on a new 2

change in this rule.

In the final rule, we are recommending that the Ccamission require the licensees to report the 4

patient's name and social security number.

In the proposed 3

rule, we did not require this.

We said that they would be 3

kept at the licensee: that is a good question why.

i 7

Basically, we have found, particularly as a result i

3 of the Riverside incident, that the public expects the Government to do more for them in this area than we do.

9 10 Several people called up and said, I was treated there, was I

i I misadministered; was I one of the 400?

We did not know.

11 MR. KENNEDY:

Is not that an obligation of the g

hospital?

g

>EL. KENNEDY:

The hospital discharged its obligccion.

,a i

by informing the referring physicians.

g MR. KENNEDY:

Why do not they ask their referring

,d i

physicians?

,,o MR. PODOLAK:

That is a good question.

I guess they could, I guess they could.

We have a string of reasons, but--

o MR. KENNEDY:

I get concerned when I hear that the public expects the Federal Government to do more.

l MR. PODOLAK:

That is one of many reasons.

l 2

MR. KENNED"-

I would hope it is not the only l

1 l

reason.

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MR. MINOGUE:

By no means, it is the best reason.

2 I think a better reason to state is that this would provide a data base if at some later time there was an indicated need i

t for any kind of follow-up studies, maybe because of systematic patterns of misdiagnosis or possibility of radiation injury.

e Y u w uld be able by going into this data base to identify 6

1 7

broadly, throughout the Country, people that might have been exposed to this particular procedure.

3 MR. PODOLAK:

We have examples of this today where 9

Patients that were treated 20 years ago with what was then 10 1'

considered to be harmless treatments, in fact, increase their chances of getting cancer.

And in many cases, the hospital l'

has been unable to identify these patients.

In some cases, f

1,,

unwilling t identify these patients.

And we feel that if we

,t rely on hospital records, after a couple of years these things j

get very iffy, and in fact, a few commenters said that we i

14 t

should be keeping--we should be requiring the hospitals to l

I i

keep records for 50 years because of the long latency period-- !

MR. KENNEDY:

Requiring hospitals to keep--

to MR. PODOLAK:

That is correct.

0 l

F The problem there is that hospitals do not last 21 l

50 years.

They--some do but some do not.

Also in going back--

22 l

CHAIRMAN AHEARNE:

What makes you think that the 22 l

agency will last that long?

4 MR. PODOLAK:

That has jumped through my mind many i

me I

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etnes.

2 MR. KENNEDY:

Mine, too.

2 MR. PODOLAK:

Okay.

We de have a similar system 4

for registry of overexposures which has persisted through the AEC and now through the NRC.

We do run that system.

3 i

6 Another example of the problem is the atomic test, 7

you know, smoke test, the difficulty in getting touch with the]

3 PeoP e.

The first reason, I think, is has this--does have l

r some merit.

We ger Congressional request.

We may have 9

10 a member of the public call in and say I was at a certain hospital, I think I was overexposed.

Do you have a record of it?

g l

CHAIRMAN AREARNE:

What would you propose to do?

i g

MR. PODOLAK:

We would simply tickle the computer--

I I am walking into a trap here.

We would determine, see a j

1 person can have this information about themselves.

The 14 t

i exception tron FOI is not.

And if we determine that we did 17 l

have a record we could tell them that and we could give them i

18 I

the record if they wanted it.

CHAIRMAN AHEARNE:

How would vou know that it was 20 I

them that was asking?

21 MR. PODOLAK:

Well, that--we have to build safe-i guards in the system, you would not do it on the basis of a 23 I

telephone call.

^

4 CHAIRMAN AREARNE:

Well, I thought that is what you 5

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I just said.

2 MR. PODOLAK:

No, I said people telephone us and ask us--

4 CHAIRMAN AHEARNE:

And you would tickle the system 3

and you would be able to tell them.

i 6

MR. KENNEDY:

Suppose the person's physician were 1

7 to ask?

MR. PODOLAK:

The way the rule is written or the 3

9 way the freedom of information exception is written.

The

g overexposed person or designee, and in this case it would be the misadministration.

So, in other words, the patient could authorize a lawyer, they could authorize a physician; if they 1,4 did not, we would not give the information, it is j us t my

,..a opinion.

>EL. SHAPAR:

The safeguard is built even with the 15 i

privacy act.

l 14 I

I MR. PODOLAK:

Right now we have a person who is 17 I

I familiar with the system and can explain it to you step by I

la l

i step.

19

>EL. KENNEDY:

I have a feeling that the privacy 20 t

I act works best and it does not have to be applied.

That is 21 l

that we do not so intrude into the individuals life that he C

does not have to call upon the act to protect him.

l 6

SEL. SHAPAR:

Well, that gets to the President's 24 statement and we will get to that later, I think.

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1 MR. PODOLAK:

I had not intended to and we can 2

quote it, but there is two things that work here.

One is the concept that patients have a right to know things about A

themselves, and we try to address that by saying in a case of l

potential harm, that we want the patient to know.

The other 3

4 thing at worth is the--I am trying to think of the right 7

words, it is a tough thing.

We feel that we need, in order 3

j to protect the public, in the long run, and we are talking 9

about a long run, that we need their name; we need the ic names and the identities of these people.

We also feel that we can safeguard them.

We have a current system that works; 12 we have had Congressional inquiries; we have had all kinds 77 of different ways of people trying to get the information on the identify of these overexposed people, and they have not been successful.

And looking at it, we have identified j

g i

a couple weaknesses in that system, which we can tighten up.

l Io, But the long-term benefit of being able to go back and contact these people, if necessary, I think, out weighs the intrusion of their name being on file in a computer.

MR. MINOGUE:

I would like to really stress this l

20 i

point of the ability to do follow-up studies.

That is the biggest and most compelling argument to me and it is not j

coming out properly.

22 MR. KENNEDY.

Do you have to have the individual I

to do the follcw-up study?

What kind of folicw-up study are i

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I we talking about?

I MR. MINOGUE:

Well, it could be a matter of an i

I epidemialogical assessment of some later date, or it might be i

l A

an effort to get back, abnost like a recall of some defective part in an automobile industry to get back to specific patientsi l

i 6

that were given some procedure, or who may have been subject i

to certain classes of misadministration.

It is a question of 1

health studies and a question of individually oriented studies 3

I to give you the ability to identify and get back to the

~

l specific person.

l

,0 i

6 MR. KENNEDY:

Why does not HEW which it seems to me is appropriately in the business of makigs such studies worry l

l about that?

l l

MR. MINOGUE:

I think that is a very legitimate ia question.

This data base would be closely related to the t.5

{

data base that you would have for overexposed workers, and I l

think it might very well be as the shift and the research i7 emphasis moves into HEW that this type of data base would end is I

up under HEW cust.ody and it would be used as basis for pro-19 grams that they would run.

The present information system j

0 I

is that Oakridge, as I understand it, under DOE.

Il MR. PODOLAK:

It is under us, but the follow-up.

t

~

No, the data system is under us, the long-term follow up is with--under an agreement with DOE.

~

I#

MR. MINOGUE:

But, there is some kind of a transition!

e here.

Some of the--Transurantic (?) Worker Registry and so, m ee v - r e m-

c f

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32 I

and things like that.

Many of these go back to the war years,I i

years right after the war.

There is a long-term or maybe a l

short-term trend to ship this type of stuff into a health I

A oriented agency.

This certainly would be an appropriate i

candidate.

e MR. PODOLAK:

There are, of course, several reasons 3

7 why we would not want to reveal the identity.

I think that they are almost self-evident.

But, in many cases, patients 3

would not want their fenily to know, they would not want their employer to know, they would not want fellow employees to know.

CHAIRMAN AREARNE:

What--the point that Harold raised, speaking to the President, that is the Bill that is sebsitted?

l 1

MR. SHAPAR:

Yes.

ia i

1 MR. PODOLAK:

Yes.

This is the--it is in the iJ i

i Staff, I can quote it.

This is more--this more touches on the ;

id i

i first part of patients having the right to know thing about i7 them.

It is called the Privacy of Medical Information Act.

i8 This was transmitted by the President to the Congress, there 19 have been several hearings--several Committee Hearings on it l

20 l

and basically it says that it establishes privacy protections i

21 for information maintained by almost all medical institutions.

C The Act will give the indiviudals the right to see their own l

medical records, if direct access may harm the patient the

• 2 Act provides that that access maybe provided through an intermediary.

This legislation allows the individual to ensure.

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i cetera.

But that addresses the first question; this is the 1

f question of the right to have information about this.

i CRAIRMAN AHEARNE:

That would enable any individual j

A i

tc get from us once we have that record; is that correct?

e MR. PODOLAK:

The intention--that is exactly correct.

6 I

i The presently have to--

i I

MR. KENNEDY:

It would not if his physician were i

3 to say that this in fact was going to harm him; but if his

,y physician does not know that, how is he going to b'e able to 10 i

n state that?

11 MR. MINJGUE:

The ruling in the regulation concerning i.

the referring physician, that is only in terms of the l

13 licensee.

The licensee consults with the referring physician.

14 i

The regulation that we propose is silent on whether the NRC, i

if approached by the patient, should or should not consult id with the referring physician.

l 17 i

MR. KENNEDY:

I en referring to the line which was l

!3 just read about the act about the proposal.

Which is unless 19 it would be harmful to the patient, and in such a case it would be provided through an intermediary.

"1 I

MR. PODOLAK:

That is right.

I had not considered that.

What you are saying is exactly correct.

Under this m

misadministration rule --

MR. KENNEDY:

We will be in conflict of that law, a

if that begins--

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I MR. PODOLAK:

If that law was passed, that i., correct, t

you would have to modi fy it.

I 2

MR. MINOGUE:

We might have to adopt administrational i

safeguards; I do not think the rule really speaks to what l

NRC does or does not do.

If we were approached by a patient, e

3 what you are really saying is that we need to establish some 7

saftguards to make sure that we do not give the person 3

inf rmati n that would be harmful to them.

I MR. PODOLAK:

And even perhaps even amend the part y

on freedom of information act exemption; if it is not already i

10 in there.

11 CHAIRMAN AREARNE:

I certainly would not want us in the business to making that hannful to the patient judgment--

l,a MR. MINOCUE:

That is a real question, too; I do 14 i

not think that is a academic point at all; I think it is real.!

i.!

s' MR. KENNEDY:

The only oroblem that I had--

t 14 i

MR. PODOLAK:

It would certainly be consistent with

,F the way we made the rule to go that next step.

The way we wrote la I

the rule was the intention that the referring physician would f

19 1

be able to act as an intermediary and--

t 20 CHAIRMAN AHEARNE:

Thatwouldthenrequireinadditied

1 patient 's nan.e, date of birth, social security number, that the referring physician would also have to be retained.

~~

MR. KENNEDY:

Which would have to be continuously

~

updated.

~

MR. PODOLAK:

I think that that information has f

& W ?H V P Y M me scs/Phe "JPPCI. m*EZ*. L 4. SUM '97

ncz we. _35 l

=

=

I already been required by the rule.

The name--that is part of I

the original report and it is--

l i

CHAIRMAN AHEARNE:

Referring physician.

A MR. PODOLAK:

That is correct.

4 3

MR. KENNEDY:

May or may not be the physician at the j

f 3

time the patient asks for the information.

t 7

MR. MINCGUE:

That is correct; it could be some years later.

3 MR. PODOLAK:

I think in any event that these

.y freedom of information requests, and particularly in the

,O li case of overexposures, and things like this, do take a lot of

~

,1 6

work and lot of checking and these would just be additional I

things that we would have to do.

The alternative is to 1:3 i

require that these things be maintained by licensees for l

1.6 I

50 years, which is a considerable, not an insignificant burden,;I i.!

and then when person quote calls us or contact us, we would i

td have to say that we do not have that information.

We are

-I t --

trying to protect you or your identity, we did not request it.

'a We could get itbydoinganinspectionandinspectingthefiles{

19 and getting or the person could contact the licensee.

o i

In the past, this has not worked well.

01 MR. KENNEDY:

If the President's proposal were to

~.

~

beccme latt, one of the problems that I have understood all of l

~

this that is the fact that the patient may or may not be able

's to get this information; it would be eliminated because the law a

l

_ _ -.= ~...

. m..

=

c 36 i pacz sc.

I i

would say he is entitled to it; is not that correct?

MR. PODOLAK:

From the institution.-

I i

MR. KENNEDY:

From the institution, yes.

Therefore, j

i f

l why do we have to get in the act from that point of view.

The 1

i answer is that we do not; since he is not entitled to it.

e MR. PODOLAK:

Well, there is a settle difference.

3 7

The--as I read the legislation, it says that the patient is entitled to the infor=ation if he asks for it, he or she asks 3

t i

i for it.

In the case of this regulation, what we are talking l

9 is requiring the licensee to inform the patient o$ a therapy 10 misadministration.

I il MR. KENNEDY:

He gets it whether he wants it or not.

MR. PODOLAK:

That is abnost it.

In other words, 13.'

i we are requiring the licensee to tell the patient, unless is i

the referring physician obj ects.

I I.!

MR. KENNEDY:

Okay, even if he obj ects?

16 MR. PODOLAK:

If obj ects, he can object on two 17 g

grounds.

This is the final rule.

He can either say I am l

!8 going to inform the patient or it is harmful to the patient 19 I,

or relative or guardian, that is way the thing is strung out.

2a If he does this we are notified.of that.

He is the sole judge i.

• 1 of that; we are notified of that because that is contained in

~

the report that comes back to us.

MR. SHAPAR:

There is no second guessing on that.

• L MR. MINOGUE:

That is right; no second guessing.

!.mmco v==n.

ic f

me 2:3JTb8 Curft:3. Fr5Ptr*. L

• SJf*t ' 87

.= --

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37 sacz se.

t I

i He is the sole judge.

j MR. KENNEDY:

And then later if the patient drops l

us a note and says by the way, I think I might have been j

1 overexposed; was I ?

Then what do we say?

If it wash (?)

we do not know.

No, we cannot say that because we do know.

3 MR. DIRCKS:

I think if you had, you know, conmon n

(

sense would say that we tell them.

l i

'R. KENNEDY:

No.

I 3

MR. SHAPAR:

I think so.

9 MR. DIRCKS-Having been in hospitals and knowing 10 i

many times they do not even tell you what your temperature is- -

11 i

MR. KENNEDY:

I think I have enough experience in this regard--

l l::

MR. SHAPAR:

If I thought I was overexposed and I 14 wanted that information from the NRC and I did not care what IJE

.I might physician thought, I think I have every right to it.

i td i

MR. KENNEDY:

Well, that is where you and I part i

17 i

company.

Because that is a direct intrusion in the patient /

!a doctor relationship and I do not think this agency has any i

19 I

business doing it.

I t

MR. SHAPAR:

The doctor / patient relationship is "I

not for the benefit of the doctor, it is for the benefit of f

the patient.

And I am the patient, and I want it.

8 7-MR. KENNEDY:

And let me tell you that there is one i

22 thing in the medical profession that is well understood, and

• 2 i,rer,.no.% < o n %

,.c.

f me M "M ST*G'. L e.

Sufft 'W7

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38 l

nacz se.

I would have thought even more broadly than the medical profession.

Patients are not always the best judge of what is i

i i

i the best thing for them.

Indeed, very seldom, is that true; l

t A

that is why there is so many patients, as a matter of fact.

l t

3 l

The patients thought that the things were good for them were in fact good, they would not be patients probably.

i 3

7 MR. SHAPAR:

Yes, but they may go out an get another physician because you do not like the first one that they got.

3 MR. KENNEDY:

That may well be and then that is a 9

judgment for him to make; not me.

MR. SHAPAR:

But if I do not get the information--

FR. KENNEDY:

Nobody elected me to represent the i

I::

l College of Physicians and Surgeons.

MR. SHAPAR:

If I do not get the information, hcw 14 do I know enough to go to get a different consulting physician?

CHAIRMAN AHEARNE:

Bill, let me get back to your l

14

.i answer.

We have the rule and the rule says there is a 17 misadministration, the licensee goes to the doctor, tell the 18 i

doctor.

The doctor says I do not think that it is a good l

l 19 idea to tell either the patient, therelative,ortheguardian,l

o the licensee then report, I guess, to us.

A, that there was i

~1 l

misadministartion; B, that they informed the doctor; C, the

~.

~

doctor said that the patient should not be informed.

Our file,

now contains that information plus the name of the patient--

~1 MR. MINOGUE:

In a separate place.

15 no,,

% v m.r- % _ x f

me 2:Mfts CAF*CI. STTEI* & e.

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.=

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macz sc.

f r

I CHAIRMAN AHEARNE:

Right.

That patient now requests l

from us information.

I am having a little difficulty with your l

l logic.

I assume you support the rule that is proposed to us.

I I

A And if you support the rule that is proposed to us, the rule l

3 says the doctor can block the patient from knowing.

Why do not you feel--

3 MR. DIRCKS:

I thought there was some confusion in 7

the answer at that point.

What happens then?

3 MR. PODOLAK:

Well, as a matter of fact, it is even I

9 a little bit worse--little bit more complicated than that.

In fact, we are talking about the physician has to say that it

,l i

is harmful to the patient to know--

i CHAIRMAN AHEARNE:

Yes, I understand that.

Yes.

13 But, the point is that, we have gone through this is system and the physician has made that j udgment that it is i.!

l, harmful for the information to be distributed.

It is now l

'4 in our file.

As the patient comes in and I thought, Bill, you 17 I

said you felt that the patient should then be told.

But, we already put in place a rule that says that they based upon 19 this judgment of the physician, that the patient should not be told.

1 MR. DIRCKS:

Now, is the rule perfectly clear at i

~.

~

that point?

i MR. MINOGUE:

The patient does not require the licensee to tell the patient if the physician says it would not be to his

.msmmo.% vo

m. e m_

.c.

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pacz sc.

(^

I interest.

It does not speak at all of what the NRC might do i

later approached by that same--

i 2

l CHAIRMAN AHEARNE:

Well, I recognize that.

I am just trying to follow it down as best to the logic.

If we had 1

rule that puts in place the principal, that the posi ton is y

the controling individual, of whether or not the patient knows,!

3 I do not understand why the logic of your relationship would 7

not be that if the patient asked us, we would similarly defer back--we would look at our record and not answer the 9

question.

MR. DIRCKS:

I would say answer the question.

11 l

CHAIRMAN AHEARNE:

If we would answer the question 12 then I do not understand why we even go through the process 13 of not telling the patinet i=nediately.

14 i

MR. MINOGUE:

Let me get a specific hypothetical--

l U

i MR. SHAPAR:

I think I can supply you an answer if Id i

you igve me a crack at it.

17 CHAIRMAN AHEARNE:

Bob is going to answer it.

18 MR. SHAPAR:

Let me get a hypothetical--

i 19 i

MR. KENNEDY:

I can hardly wait.

I MR. MINOGUE:

I will be brief.

A hypothetical l

l 1

illustration of a medical facility where there has been a systematic pattern in misadministrations and this gets a lot 22 of publicity.

Some patient unable to determine from the i

22 licencee because the licensee is deferring to--referring the e

e o m,,, w so.u m. : -

x me e C.nP*Q. JTWEI?. L

• WIT'E *C7

o 41 pacz sc.

physician.

Whether or not he was misadministered or not, comes to the NRC and says I understand that this massacre of that facility, I want to know if I am one of the people involved?

I 1

I want to know whether I should worry about that or seek some 1

3 other medical treatment?

The rule--it sounds to whether we would or would not answer that and that is it would give us l

3 some latitude to exercise some judgment that maybe you should tell them, maybe you should not.

3 MR. SHAPAR:

I do not want--

9 MR. KENNEDY:

Before we go on there is one point here.

,0 l

I am going to protect your right because I can hrrdly wait to hear what you have to say.

i 1

)

MR. SHAPAR:

I an loosing interest.

13 i

?

MR. KENNEDY:

I am not.

14 Bob, what logic is it that says we had any basis 1.!

for making that judgment?

Where did we require the basis j

is for making that judgment?

i 17 MR. MINOGUE:

We are not qualified to practice i8 medicine.

I 19 MR. KENNEDY:

That is right.

t

0 1

MR. MINOGUE:

Right.

l 1

l MR. KENNEDY:

So, we had the flexibility to exercise the judgment for which we are unqualified.

Now, please, that is what you just raid.

2#

MR. MINOGUE:

Such judgments are of ten made.

'I MR. KENNEDY:

But the patient--we have no basis making f

me sczK 4 CA N ITWEI*,i e.

Sufft 's?

=

42 f

=acz se.

i i

it.

Now, I can hardly wait, Counselor, please.

MR. DIRCKS-I think the patient has the right to make the judgment.

I think the person in charge--

1 MR. KENNEDY:

We will come back to that.

MR. SHAPAR:

This is not going to add up perfectly, 3

but I think I will get 90 percent of it.

We are using--

3 MR. KENNEDY:

You said it was going to be logic, now.

7 MR. SHAPAR:

Yes.

MR. KENNEDY:

Okay.

r MR. SHAPAR:

We are using our licensing leverage to 10 require the licensee to report to us and to certain others, i

11 namely the patient if the physician did not obj ect.

Now we are talking about t=nediate reporting, okay?

We are dealing 13 with a situation where there has just been a misadministration I

!4 and the question is whether or not the patient gets told right !

Idi t

away, okay?

The licensee is required to report to us, to the id NRC, and we have his name in the files.

I would think as 17 a practical matter, the patient is not going to know about it.

la I

i I am entering the real world here now.

He is not going to know 19 I

about it because no one has told him.

Either the referring O

physician objected, so he did not get told.

Now, I think, i

3 l

as a practical matter, he says that he does know about it, he 22 is not going to come to us right away.

Now the anxiety I"-

quotion applies during the period i= mediately after the 22 administration has suggested, not five years later, if he 2

ever ccmes to us.

Now, if he comes to us five years later, m ro. m m.=+

f as 33r'he che?CL STwa* L e Sufft 'W7

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n acz.w e.

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j MR. KENNEDY:

That is an interesting theory.

MR. SHAPAR:

Well, let me complete it.

The strong l

i l

l practical likelihood is, since he does not know abour the j

l t

administration, he will not ask for it right away, certainly.

If he does ask about it many years in the future, or a few 3

years in the future, the anxiety level has just about dis-3 l

appeared beyond that.

There all kinds of information that 7

the Government has in its files because of anxiety.

Tax t

returns, I could not begin to enumerate them, they will cause plenty of anxiety, more than a little misadministr'ation.

So I see a lot of logic to it.

But I get back to the principal!

that the patient--the physician priviledge or relationship is 12 for the betterment of the patient, not the doctor.

And if the 13 patient wants it at a later time and it is in our files and is he wants to know if I have had a misadministration of a drug, I

L!

l I think I sn entitled to know it and I do not see any serious j

id crosion of the doctor / patient relationship.

!7 l

MR. KENNEDY:

I think all that logic is great up to i

i la the point that it gets in our files.

I see no reason for it j

p'o I

to be there, yet.

Let me just--

I i

• g I

a MR. SHAPAR:

Well, that is a different question l

• 1 I

whether or not Minogue has convinced you that it necessary l

i

~,

for epidemialogical studies, that is a different question.

~~

22 MR. KENNEDY:

Well, we can come back to that.

U The anxiety quotion, what may suggest to you, that 13 our recent experience so widely publicized about tests which rie 6 wm. es _ : c.

as e C.Mu'Tch.fTWEI,s... slJrTE 37

.=

am,, -

44 l pacz sc.

I occurred in the early 1950's suggest that the anxiety quotion is in direct proportion to the amount of information to somebody has or misinformation.

And it is not really just a function of time because the anxiety level which expanded A

3 through several of thousands--hundreds of thousands, I guess, 6

of people, in very recent days when notice came that possible 7

exposures had occurred was pretty damn high.

So you cannot 3

say that anxiety level will be confined to the immediate host of that period, that is wrong.

Y MR. SHAPAR:

Except that I would guess in most 10 i

cases the referring physician would not want it told to the patient because the patient is in a sick condition.

And I guess the presumption is from the time he asked for it he is C

a healthy person and no longer sick.

la l

MR. KENNEDY:

My suggestion is that statistically, 13 f

I would think, that is his patient was being treated for 14 some manner of carcinoma, which in all probability he is, he is, t-i less likely to be a well person than a sicker person at the

'a time he is asking for it, timeelapsing;Imeanstatistically.f 19 He is not going to get better he is going to be less, well 20 not better in all probability.

l

• 1 l

CHAIRMAN AHEARNE:

I think that we have probably i

exhausted this particular point.

MR. KENNEDY:

Well, I want to come back to Bob's point because it seems to me what we are creating here is another brillant case where somehow or another great m ee vo,ur.=~,

ee me 2:nJTW CAF-Ch. fMP12*. L e. SufTE '47

45 l

~a sc.

I Government file, I share your concern and your anxiety.

It is i

precisely because there are so many sech files sitting around 2

l in Government offices, supervised and attended by vast numbers A

of bureaucrats who get paid for doing nothing else, except 3

supervising information about me, more information than I have f

3 myself about me.

I guess that I am anxious and I guess that i

7 I do not want this agency in that business.

I do not see i

any reason up to now--what, that is totally aside from the 3

question about the misadministration business which we need 9

i to tighten up.

That is a different question altogether.

I g

am wholly in accord with the need to tighten up on the regulations and try to prevent these things.

That is quite different foam all this question about how much information 1:3 1

I need to know about Jot Smith.

I do not think that I need la to know anything about Joe Smith.

I need to know about the l

misadministration, that is a whole different question.

But, j

id I do not need his name, rank, and serial number.

l 17 l

MR. MINOGUE:

These are our separate questions--

13 MR. KENNEDY:

That is what I think.

19 MR. SHAPAR:

Speaking of only for myself right now 20 you take out the ncme and you gave us the rest of the rule,

• 1 I would be happy.

MR. KENNEDY:

Well, we might have a deal.

CHAIRMAN AHEARNE:

Take out the name, you mean date

~1 of birth and security number?

MR. SHAPAR:

Yes.

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f me SOUTH. GN ffWW'. S. W.

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MR. PODOLAK:

That would track with the proposed rule,i but I en not very willing to give it up that easily.

l MR. KENNEDY:

I might not give you the chance later.

I CHAIRMAN AHEARNE:

I think that we better move 1

3 on to the rest of the points.

I really think that we have exhausted all sides of that particular issue.

6 i

MR. PODOLAK:

Next slide, please.

l t

I I

Okay, licensees would keep records of misadministra-tions for five years, this is to ensure that the inspectors l

10 during the inspection site would be able to review the files.

i I

And the last item is rights and duties of licensees.

Next 11 slide, please.

12 MR. GULLER:

Excuse me.

Does not that one point j

1:3 bare on the subj ect that we were discussing, Ed?

For five Is years, you are not talking 50 years, you are talking five years!

13 and after that it is lost.

i 14 CHAIRMAN.AHEARNE:

This is a different--

17 i

MR. PODOLAK:

Well, this is a different--

18 Ii MR. GULLER:

Perhaps he does not have any rank 19 and serial number.

t 0

i MR. PODOLAK:

That is. correct.

The proposed rule f

1 II read five years.

Several commenters cccmented that the five i

l years was insufficient that they should be kept for 50 years, j

71 one said 30 years.

This is actually not dissimiliar from I'

OSHA requirements when the know the latency period they require 2

records of workers for certain long periods of time.

However, I

i

~,,

f me 23Lt14e C.A#'"CI. N. L. SJfTE **F

.= =.

=

47 nez.sc.

I we have decided that it would be better if NRC kept the record I

i for the reasons that we have earlier.

I l

MR. KENNEDY:

Carl's point is that if one drops the l

1 other then one ought to go back and look at this.

5 MR. PODOLAK:

The more I think about it, but it opens 6

up several problems which we have touched on.

Next slide, 7

please?

I g

Okay.

Staffing requirements, the last item is NRC--

9 MR. KENNEDY:

Other NRC?

10 i

MR. PODOLAK:

Yes.

We are talking about 15 man years based on an u

assemption of a 100 serious misadministrations per year.

There!

L,a was--these are therapy misadministrations.

These are the ones that would require follow-up.

Perhaps a telephone call more likely, a site visit.

16 CHAIRMAN AHEARNE:

Now, this contrasts with the four 17 l

that you felt happen in the period January '77 to November

'78--

is l

MR. PODOLAK:

That we found out about, correct.

I I9 i

That is exactly correct.

20 l

MR. MINOGUE:

We are really not sure how many

{

21 events are out there waiting to be reported.

There may be O

a lot, there may be a very few.

'~

CHAIRMAN AHEARNE:

But, the man years are based on 3

~

an assumption of a rather large nunber.

MR. PODOLAK:

That is a good one to focus on because t-ro.=

vo m.w,._ x as & CW'TCE. N. 3, v. SurT1 '97

.= am,-

i 48,1 a

sacz se.

i e

i during that time one of those four was an event which required l

five man years of effort.

Other than rulemaking towards the future one, the Riverside incident.

A CHAIPM W AHEARNE:

Yes.

I e

MR. PODOLAK:

The point I wanted to make here was that I

3 this 10 man years is obviously the big requirement, the one l

that we want to focus on.

But this is based on a 100 mis-7 l

administrations which there was some analytical work, we did 3

extrapulate from some of the ones we knew about a little bit of this data base and figuring the size of the region and all that.

But, it is basically a guess.

Plain and simple; it is a guess.

We do not know.

CHAIRMAN AHEARNE:

Now, an equivalent way of looking l IC l

at this then if we approved a rule that when it goes into la effect, Vic Stella needs 10 more people?

13 i

'R. PODOLAK

That is the bottom line.

Within id a year he would need 10 people.

I 17 MR. MINOGUE:

When that was pointed out and this is an issut that they raised, we took a look with I&E at 19 some alternatives and one which is discussed in the attachment B

o which was added to the tailend of the package, would really i

1 i

involve using a contractor, say Oakridge, to operate the l

~

program.

It would not completely eliminate the I&E load, l

II you would still have the significant load there but it would be substantially reduced.

For the first year or so, in a sense run it almost, I am going to use the term "research r,no r% v m.

e.

f de e CA N STWEr*. S e,

sufft -W

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a 49 l

=acx sc.

l i

programer" you really try to get a handle on this, the mag-l nitude of the problem, so that the final action would be based I

on a better data base.

But that does not take the I&E re-t l

quirements away, it maybe halves them.

3 MR. SHAPAR:. You can adj us t the level of effort t

any elvel he wants.

4 7

MR. MINOGUE:

Yes, but that is partly on how many 3

g reports come in.

There are very few reports, of course, very little will be recorded.

MR. PODOLAK:

One of the nice things about this 10 rule in doing the value impact assessment, trying to determine the benefits of the rule versus the cost of the rule.

As it i

1 I

is in another situation, you will probably at some point deal-l ing in a linear range.

The more reports of misadministrations i

14 that we get, the more man power we are going to extend, but the, i

1.!

i more benefit we are going to get from them because we will 14 be able to prevent them, hopefully minimize them in the future.'

MR. KENNEDY:

Therefore in the less man power.

18 MR. PODOLAK:

Ultimately, bottom line, less man power.'

As an example, exclusive of rule changes to prevent future i

20 misadministrations, in the Riverside incident, we spent 5 man l

1 l

year of I&E time.

Now that is annommally, hopefully.

But, again, we just do not know.

l MR. PODOLAK:

And none of that depends upon the i

2' individual patient's name.

2 MR. MINOGUE:

That is right.

,,vo rwo

m. e_ _ x es 22tfbe &&

ff5PCI* L e. Suf*'T '87 i

R 50 snaz nc.

MR. KENNEDY:

Bob, could I come back to the i

ePedemioloB cal question for a second.

I understand the i

2 volidity of that argument, but we are talking here about i

a miniscule nunber of cases, if you are talking about from j

1 3

an epedemiological standpoint, what you really want to know, if it is going to do you any good, is the total universe of 3

exposures; not just the misadministrations and you see that I

would be tre next argenent, wouldn't it?

MR. MINOGUE:

Yes.

9 MR. KENNEDY:

Now, you have just got this small piece of what we need for a good epedemiological base.

So, 11 what we ought to do is get a report of every administration j

M:

l therefore, every patient.

1:1 MR. MINOGUE:

In another context--

14 MR. KENNEDY:

Please, God, forbid.

13 i

MR. MINOGUE:

Well, that is part of the universe of 14 possible samples that is being studies as part of this 17 Congressionally mandated feasibility study.

18 MR. KENNEDY:

I think that is a grand thing for 19 HEW to be considering.

• 0 MR. HANRAHAN:

They could not go beyond that if you 1

1 were really concerned about what other radiation exposure of 22 a person may have had.

In this one micadministration, it would not make a difference whether they had worked in an area of I'

high radiation.

2 MR. MINOGUE:

The next step of a better analogy

% % vomm. -.

x me p &&M ff1*EI*. L W.

SkiffT '97 am- = = =.

I

=

51 1

ncz sc.

l I

would be the Transurantic (?) Registry of the Platonium (?)

Work Registry.

This is a relatively small group of people i

i with some kind of special exposure pattern and it is not i

t really in the same context as a very large group where you are 3

looking for statistical or almost undetectable or statistically #

1 6

literally undetectable affects such you might get from normal 7

patient exposure in the diagnosis or from worker (?)

exposure.

MR. PODOLAK:

To leave this on the strongest argement, though, I think that the problem of contacting t

patients at some time in the future, 30 years from now to help 5

them in case we are wrong.

We are guessing now, we are think-i I:

j an educated guess that diagnostic misadministrations are not 13 i

as harnful as therapy misadministrations.

I en trying to I

1.&

I pick my words carefully.

We can come back and try and identify!

i 15 these people who might still be alive and who might still 14 need follow-up care that they do not know about.

This is 17 I

part impartial now of dropping the threshold or the business

!a of not informing patients of diagnostic misadministrations.

It is a back-up system that we have their names on file.

20 So that we can contact them if need be in the future.

j e

• 1 MR. KENNEDY:

But, I am suggesting.

I understand that argument; it becomes a stronger argument if you say you 22 have to have all administrations because you really do not

~1 know.

-a MR. MINOGUE:

I think it is--

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I MR. KENNEDY:

But even what we consider at this 2

jucture to be an acceptable level of administration is really i

acceptable.

We do not know what for sure.

i MR. MINOGUE:

I think in all fairness, we should l

4 i

3 make clear the biggest problem of misadministration in the diagnostic area is mis-diagnosis, not radiation exposure.

i 3

1 I hope we have made that clear.

I

/

CHAIRMAN AHEARNE:

Yes.

3 Bob, do you have any closing words that you wanted?

MR. DIRCKS:

No, I think we covered the whole issue.

10 I

l CHAIRMAN AHEARNE:

Ed, very good presentation.

MR. PODOLAK:

Thank you.

12 i

CHAIRMAN AHEARNE:

In the absense of a quorum there 13 is no further action that we could take right now.

It is i.t a very complex issue.

I i.!

MR. PODOLAK:

It is a change of pace, too.

l id l

CHAIRMAN AHEARNE:

It is complex, and I appreciate 17 it.

18 MR. PODOLAK:

Thank you.

19 CHAIRMAN AHEARNE:

All right the next group?

l Is anyone coming to the table?

If not--

MR. KENNEDY:

Well, I think that we are early, and that is the problem.

i

~~

CHAIRMAN AHEARNE:

Why don't we break for 10 minutes.

~-

2' (Whereupon there was a recess 13 for 10 minues at 3;20 p.m.)

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