ML20127L708
| ML20127L708 | |
| Person / Time | |
|---|---|
| Issue date: | 01/22/1993 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9301270271 | |
| Download: ML20127L708 (143) | |
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i UNITED STATES OF AMERICA t
NUCLEAR REGULATORY COMMIS SION l'
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$ ( $l BRIEFING ON STATUS OF MEDICAL USE ACTIVITIES j
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LOCat10n:
RoCxv1LLE, MARYLANo i
h&I6l JANUARY 22, 1993 3
i Pag 6S:
114 PAGEs 1
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NEALR.GROSSANDCO.,INC.
covet arrontras aun-inAuscousses j
J 1323 Rhode Island Avenue, Northwest Washington, D.C.
20005 (202)-234-4433 i
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.. - - -.. - ~..
r DISCLAIMER-This is an unofficial transcript of a meeting of ie the United States Nuclear Regulatory Commission held on January 22, 1993 in the Commission's office at One l
White Flint North, Rockville, Maryland.
The meeting was i
open to public attendance and observation.. This transcript has not been reviewed, corrected or edited, and it may contain inaccurocles.
l The transcript is intended solely for generai informational purposes.
As provided by'10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed.
Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs.
No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
NEAL R. GROSS court REpoeTERS AND TRANSCRISERS 1323 RMoDE ISLAND AVENUE, H.W.
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1 UNITED STATES OF AMF2ICA NUCLEAR REGULATORY COMMISSION I
BRIEFING ON STATUF OF MEDICAL USE ACTIVITIES i
i.
I l
PUBLIC MEETING Nuclear Regulatory Commission One White Flint North Rockville, Maryland Friday, January 22, 1993 i
l The Commission met in open
- session, pursuant to
- notice, at 2:00 p.m.,
Ivan
- Selin, Chairman, presiding.
=
f COMMISSIONERS PRESENT:
IVAN_SELIN, Chairman of the Commission KENNETH C. ROGERS, Commissioner FORREST J. REMICK, Commissioner 4
JAMES R.
CURTISS, Commissioner E. GAIL de PLANQUE, Commissioner i
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2 STAFF SEATED AT THE COMMISSION TABLE:
SAMUEL J.
CHILK, Secretary l
WILLIAM C.
PARLER, General Counsel JAMES TAYLOR, Executive Director for Operations i
HUGH THOMPSON, DEDO ROBERT BERNERO, NMSS CARLTON KAMMERER, Director, Office of State Programs l
RICHARD CUNNINGHAM, Director, Division of Ind. & Med.
Nuclear Safety, NMSS VAN'DY MILLER, Assistant Director, State Agreements Program f
JAMES LIEBERMAN, Director, Office of Enforcement i
JOHN GLENN, Chief, Med., Acad. & Comm. Use. Safety Branch i
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1 3
1 P-R-O-C-E-E-D-I-N-G-S 2
2:00 p.m.
3 CHAIRMAN SELIN:
Good afternoon, ladies 4
and gentlemen.
The Commission is pleased to be.here 5
to receive a briefing from the NRC staff concerning l
6 the regulation of the medical use of byproduct 7
materials.
=
4 l
8 In connection with this briefing, the i
9 staff has provided the Commission an information i
i 10 paper, quite a long and thorough paper called " Aspects '
i
~
11 of the National Medical Use Program Related to 12 Prevention of Misadministrations."
Copies of this
)
i 13 paper are available at this time in the conference l
14 room.
j 15 Today's briefing will include a discussion l
{
16 of current regulatory practices of the NRC and the
{
17 agreement states directed to prevent medical l
18 misadministrations.
The briefing will also address l
l 19 issues raised in this area by the series of articles jo l
20 published in the week of December 13th in the
=
21 Cleveland Plain Dealer.
22 It goes without saying that the Commission P
23 is intensely interested in this matter and we're 24 greatly concerned that our regulatory program meet 25 both the test of public scrutiny and the need for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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ew e
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1 health and safety protection.
As a matter of fact, a
2 our concern about the program lead to Commission-3 initiated review starting last September which I'm l
4 sure Mr. Bernero will discuss at some length this 5
morning.
I 6
Given the past events, the recent over 7
exposure and subsequent patient death following a 8
recent administration in Indiana, Pennsylvania and a 9
number of other events, there can be no doubt as to e
10 the importance of our role in this area.
I'd like to 11 emphasize that our role in this area is not one of I
deciding medicine of efficacy of doses of diagnosis or 12 j
13 prescriptions, it is to review the processes of our 14 licensees to make sure that those medical processes 15 ordered by physicians which involve nuclear byproducts 4
l 16 are, in fact, carried out the way they are ordered 17 with due attention paid to the health both of the 18 patients and of the health workers. We have a limited 19 but very important function, charter in this area and e
20 we'll concentrate on both the limitations and the
}
21 depth of our program within this charter.
22 We must assure that our regulatory program 23 for medical use activities is
- upgraded, its 24 effectiveness continues to be
- improved, even as 25 technology evolves and completely new procedures and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W.
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1 5
1 equipment come into use.
It's especially important 2
that we assess our current activities at this time to i
3 see what more may need to be done.
4 I assume, Mr. Taylor, that one of your 5
topics will be the overall plans at different levels e
6 and different time periods for continuing -and
)
i e
7 sharpening this evaluation.
8 Commissioners, do you care to make any 9
point?
10 Mr. Taylor?
j 11 MR. TAYLOR:
Good afternoon.
12 Mr. Chairman and Commissioners, I'd like 13 to introduce those at the table.
Jim Lieberman from 14 the Office of Enforcement, Vandy Miller and Carl 15 Kammerer from the Office of State Programs, my deputy 16 for this area Hugh Thompson, from the Office of HMSS, 17 Bob Bernero, Dick Cunningham and John Glenn.
We're 18 all involved in this program and I thought we'd get 19 the widest representation we could specifically for 20 questions.
21 Mr.
- Chairman, you noted the extensive 22 paper which is available at the entrance to the 23 meeting room.
This paper was a culmination of weeks 24 of effort.
But I would like to emphasize that some of 25 the material was put together over a period of just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 nHODE ISLAND AVENUE, N W.
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6 1
several weeks and particularly with the agreement 2
states and some of the numbers were obtained 4
1 3
telephonically and through fax, So, I think these 4
have to be looked at in the view of further
~
5 verification by the agreement states as this paper 6
gets distributed.
j 7
CHAIRMAN SELIN: That's reasonable, but it j
8 was very useful even in a preliminary stage to have 9
those numbers available.
4 10 MR.
TAYLOR:
That's right.
I would j
l 11 appreciate if the commission would look at those in a i
12 more preliminary sense.
It was a great effort i
13 particularly to the agreement states, which are 29, 14 and to try to put a sensible paper together.
15 With that opening thought, we'll go into 16 the detailed portion of the briefing and Bob Bernaro 17 can begin.
18 MR. BERNERO:
Thank you, Jim.
19 Members of the Commission, today we're 20 discussing the medical use program, but particularly 1
21 related to misadministrations in the practice of 22 medicine.
a 23 (Slide)
May I have the first slide, 4
l 24 please?
25 We have an outline in the slides that l
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covers two pages.
For starters, I hope to cover the 2
key milestones in the current medical use regulatory 3
program because I think they set an important context 4
for the Commission and the members of the audience to 5
understand the purpose of the program and the guiding.
e 6
policy of it.
I will also cover our efforts to e
7 identify, evaluate and to prevent misadministrations.
8 Then Carl Kammerer will cover the state programs.
9 Recall that-with evolution over the years we now have 10 approximately twice as many medical licensees in the 11 agreement state programs as we have in our own 12 program.
13 (Slide)
Then we will return -- I will 14 return to discuss the misadministration issues raised 15 by the Plain Dealer and then on that second outline 16 slide you can see I
will then speak to the 17 reevaluation initiative, some of which you referred 18 to, Mr. Chairman, and the observations for further 19 consideration.
Our Commission
- paper, which is 20 available at the door, ends.with observations, not i
21 really conclusions but observations of things that are 22 going on, evaluations and there are some very 23 important points to be made in that portion of the 24 briefing.
25 CHAIRMAN SELIN:
Before you go on, Mr.
l NEAL R. CROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2')4 4433 WASHINGTON, D C. 20005 (202) 234-4433
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1 Bernero, I failed to note,-I'm sorry, that there are 2
2 a couple of other public meetings to be held in the 3
next two weeks in this series.
Next week we will be 4
receiving a report from the investigation of the 5
incident in Indiana, Pennsylvania and some related 6
investigations and the week after that we'll be 7
briefed by our Advisory Committee on the Medical Use c
8 of Radioisotopes.
So, we'll have these other two
)
9 meetings scheduled and eventually we'll have a --
10 MR. TAYLOR:
There's also a meeting with 11 the agreement states.
12 MR. BERNERO:
Yes, a week from today.
13 MR. TAYLOR:
Right.
That's the 29th.
14 MR. BERNERO:
The 29th.
15 CHAIRMAN SELIN:
So, this one meeting, 2
16 although very important in itself, is even more 17 important as one of a number of building blocks in l
18 this overall program.
19 MR. BERNERO:
Part of the set, yes.
i 20 (Slide)
If I could have slide 3, the key 21 milestones, there are three milestones over the last 22 14 years that I think reflect the NRC's policy anu 23 requirements for the identification and reduction of 24 errors resulting in misadministration.
25 The first of these is the 1979 medical i
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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i i
policy statement.
That policy statement was quite-a
{
2 lot _of work in development and-it basically set'out i
~ to
{
3 three principles, that the NRC would regulate 4
provide for the radiation safety of workers and the-L 5
general puolic as distinct from patients.
- Secondly, 6
that the NRC would regulate to provide radiation I
7 safety of the patient where risk - warranted _it and t e 4
i 8
where extant practices were inadequate.
You know, j
9 practices for control of procedures with patients.
u j
10 Lastly, the third principle was that'the NRC would i
11 recognize but minimize -intrusion.
The-NRC was 12 consciously trying to avoid excessive intrusion'into 4
l 13 the practice of medicine.
Obviously regulating the i
i 14 field
.is going to.
constitute.
some intrusion l-l 15 nonetheless.
j 16 Now, a second milestone actually tock a-l j_
17 longer time to develop.
In
- 1980, the first l
18 misadministration reporting rule. It actually started l
19 in the 1970s, in the early 1970s under_the=AEC'and
~20 through the transition from AEC to' NRC and then
- g 21 through the incidence, particularly the Riverside--
f 22 Hospital-incident in 1976, a great deal of attention-23 was put on this and finally by.1980, in concert with I
j 24 the development of the policy statement of 1979, the J
i-25 first misadministration rule was 'put out.
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basically set down a
standard for when a
2 misadministration should be
- reported, whether 3
diagnostic or therapeutic misadministration, and it 4
also included perhaps the most controversial part, was 5
a requirement to notify the attending physician and 6
the patient unless the attending physician made a 7
medical judgment that the patient should not be 8
notified for medical reasons.
9 The third milestone is the most recent one 10 and it is listed here on this slide as the 1992 11 quality management program.
It actually became 12 effective January 27th, 1992.
That rule, which we 13 call the shorthand QM
- rule, represented the 14 culmination of an extensive debate about how NRC 15 should regulate medical practice and I think it's best 16 to define it in a very simple way.
It is the NRC 17 requiring a rigorous formal program on the part of the 18 licensee to minimize errors and that we would, by 19 requiring that program, then have the ability to 20 inspect and to hold the licensees to compliance with 21 or adherence to the program they set.
We don't set 22 down a prescription of how to practice medicine, the 23 licensee does.
But the important thing is that there 24 is a program that has rigor, procedures, requirements 25 and that we then have a basis to say, "Say what you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W (202) 234 4433 WASHfMGTON. D.C. 2000G (202) 234 4433
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v 11 1
intend t do.and do what you intend to do."
i 2
Another point that-.was.important in the i
I 3
-'92 milestone was that there was a sharper focus on i
f 4
the higher risk procedures, the definition of l
5 misadministration and reportable misadministrations 6
was focused on the therapy and large diagnosis doses 4
4 f-7 where-you have significant consequences possible.
(
8 (Slide).
May I have slide number-4, j.
t 9
please?
i
~
I 10 Now I'd like to-discuss the NRC efforts i
i 11 for identification, evaluation and-prevention of 12 misadministrations, starting with the way.we identify i
I 13
- them, i
14-As I just said a few momeL a ago, back in 15 the 1970s we debated long and. hard about how to a
s l
16 identify or hear of misadministrations'and we-set up i
17 a misadministration reporting requirements rule and we i
18 have been trying to make that framework for reporting j
19 clearer and clearer, more sharply-focused-for these 20
. years since 1980 and that,.in fact, is why.we changed l
21 the definition of misadministration in the 1992 QM:
l l
22 rule to focus on high-risk or high-impact procedures. -
i i-23 We also have -a variety - of 1 techniques, h
24 including the review of records at the faciliC 2s and i-
-25 interviews of licensee staff.-
We inspect and often i
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COURT REFORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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(2o:n asmaa wAssiNotoN. o c. 2com (2023 ce u sa 1
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22 J
1 check records and can discover the records of 2
procedures that perhaps should have been identified e
3 and as in all of the things that we regulate, there is l
4 a process by which allegations are raised.
In all of 5
our licensed activity, allegations will come up from 6
time to time and we follow these allegations.
We 7
follow up by inspection or investigation if need be 8
and that can involve records checks, that can involve j
9 interviews with licensee staf f.
In other words, there l
10 are a number of pathways by which we can discover l
11 misadministrations that should have been reported.
f 12 Nevertheless, I would be compelled to say, 13 we have no qualms in saying there are probably-l 14 misadministrations that aren't reported. Our yield of l
15 reports is certainly not 100 percent.
One of the l
16 things I would just register here as an aside, under i
~
17 the new QM rule we're getting reports of more 18 misadministrations already.
The rigor of the QM rule 19 is now narrowing the focus to a treatment by treatment I
20 basis rather than the entire campaign of treatment for 21 a patient.
In other words, if a patient is supposed 22 to get 2,000 rad to a tumor and the first application 23 of 300 rad is mistakenly made 800 rad, it's still 24 within the ultimate prescription.
But under the new i
2$
regulations, under the new procedures, there has been NEAL R. GROSS i
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{
1 an exceedence and that would be reported and we're 2
beginning to see reports like that.
3 3
So, we're looking deeper and we're 4
4 identifying more misadministrations in that fashion.
]
5 COMMISSIONER REMICK:
Bob,. to help me 6
understand some of the things you just said, I assume 7
when you were talking about looking at records and 8
reports a.nd inspections, you were referring to the NRC l
9 licensees, not agreement state, or are you --
t 10 MR. BERNERO:
Oh, yes, yes.
Actually --
I 11 COMMISSIONER REMICK:
It would be helpful 12 in making your statements if you --
13 MR. BERNERO:
Okay.
I'11 try to do that, i
14 Much of what I say applies to both NRC and agreement i
j 15 states.
But as a matter of practice, what I'm saying i
16 about the particulars of inspection or enforcement l
17 applies to NRC licensees and Carl will be-giving the 18 corollary information on the agreement state i
19 licensees.
<o i
20 COMMISSIONER CURTISS:
Bob, before you go i
4 21 on, would it be fair to say that in paraphrasing what 22 you've just told us, that under the recently adopted 23 QM rule that you have a greater confidence than we had
]
24 in the past that when an administration occurs, 25 misadministration occurs, as we now define that under I
i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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14 i
the QM rule, that that will actually be reported and l
2 hence the database that we have is one of high i
3 credibility?
4 MR.
BERNERO:
I would say that in my 5
personal opinion that is the case.
The greater rigor t
6 that comes with that rule and the greater specificity 7
by going to the licensee's own procedures and 8
treatment by treatment rather than whole campaign.
I
)
l 9
think that will give us a greater-rigor of reporting 4
10 and then, of course, the treatment by treatment simply l
j 11 adds to the number because in the previous regime a l
12 licensee might have defined an initial treatment of 13 '
800 rad as simply a correctable thing, Change the
~
14 prescription to be 80C and then divide up the 15 remaining 1200 rad and the patient ultimately receives 16 still 2000 rad.
17 COMMISSIONER CURTISS:
Second question.
18 Is there any evidence to suggest here, at least under i
19 the new QM rule, that misadministration reporting is a
20 less than we would like to see because of the l
21 terminology that we have used, the use of the term l
22
" misadministration"?
i-23 MR. BERNERO:
I'm not sure -- there has 24 been a lot of adverse reaction to misadministration 25 rather than what we use elsewhere, a reportable event.
i, l
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1 We've had a debate on whether we should call them 2
reportable events or misadministrations.
But I don't l
3 kr ;w of any evidence that they are not reported i
4 because of the name, of the pejorative implication of 5
the name.
3*
6 COMMISSIONER CURTISS:
Okay.
2 i-7 MR. BERNERO:
(Slide)
If we go to slide i
8 5, we have the efforts to evaluate misadministrations.
4 9
I would just recall for the Commission that when we 1
l 10 look at a misadministration our primary objective, a
11 according to our own policies, is to discover the root 12 causes so that whenever information may be gleaned I
13 from this event is used to prevent the occurrence of i
14 other similar events, generic issues, weaknesses in l
15 practice, whether licensing practice or regulatory l
16 practice.
17 Now, we have a scaled response to the 18 evaluation of misadministrations.
When they are l
19 raported, we set up inspections and those special i
20 inspections can range from, oh, simply having the 21 regional inspector go out there ahead of the usually-22 scheduled inspection to check on things or sometimes 23 these are for more serious events, they are escalated 24 to include either an augmented inspection
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- earlier, the incident investigation team for the 2
Indiana, Pennsylvania event.
There, of course, a 3
death was involved.
It was a very grave occurrence 4
and we established an incident investigation team and 5
that's consistent with the management practices for 6
event follow-up that we have.
7 Now, we generally look to the engagement 8
of medical consultants.
We have used medical 9
consultants for many years and especially on a more 10 complicated or serious misadministration we engage one 11 of our medical consultants to assist and they assist 2
4 12 in the investigation, they identify any special 13 expertise we mi'ght need to understand the significance j
14 of the event or the complications of the event and 15 they are a valuable adjunct for consultation with the 16 other physicians involved. You know, the licensee and 17 other related medical authorities.
They are not and 18 have never been used by us as an evaluation to second i
19 guess or reevaluate whether the prescribed dose was 20 the right prescribed dose or to say would they follow i
21 this regime of treatment or not.
They're not for that 22 purpose.
Their medical expertise is applied to our 23 understanding the event and its causes.
24 Now, we have in the past also, by just 25 custom, often used them to communicate with affected NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 4
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people.
Now, our rules require that the licensee 2
notify the referring physician and the patient subject 3
to the conditions in the regulations and we often 4
communicate using our medical consultants. When other i
5 people are exposed, that's a very difficult issue.
6 That is the case in Indiana, Pennsylvania.
You'll 1
7 hear more about this later.
l 8
Other people, not_the patient, not the 9
doctor, but people nearby, attendants in the nursing 10 home or truck drivers or other
- people, are 11 inadvertently exposed to radiation and you get into a 12 system where you need to nctify those people.
We use 13 our medical consultation service to assist those 14 people who may have been exposed to determine the 15 significance of the exposure they suffered. You know, 16 if someone received 100 or 150 rem whole body dose i
i 17 inadvertently, there are blood tests that can be run 18 to determine medical needs that would ensue from that l
19 kind of a dose.
So, the medical consultants often i*
20 have that role.
21 I would make the observation here, I'll 22 come back to it later, that although we have used 23 medicEl consultants for many, many_ years, I don't l
24 think we have all that clear a discipline or statement 25 of requirements, what is your job, what do we expect l
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1 18
?
1 from you, what is your role, what are the limits on i
2 your role and so forth.
That's one of the things 3
that's coming out of all these investigations, that we r
4 are not too sure what we're asking for and certainly 5
the medical consultants are often not too sure what
{
6 we're asking them to do.
]
7 COMMISSIONER de PLANQUE:
Bob?
1 8
MR. BERNERO:
Yes.
9 COMMISSIONER de PLANQUE:
Before you go i
10 on, is there always a process or is there a procedure f.
11 for follow-up on the fate of the patient or others 12 exposed in terms of harm or death?
13 MR. BERNERO:
No, I would say it's not a 14 clear procedure or follow-up on the fate of anyone
]
15 exposed, either in medicine or in other activities.
16 There is a
general process of discovering the i
17 consequences.
In the previous memorandum to the 18 Commission where we discussed the Riverside Hospital' 19 ovents, our medical consultants followed up for I 20 believe two of the deaths and then it was going on and 21 on and there was an exchange of_ debate.
22 This was a very grave event.
No one ever 23 questioned that.
It was a
whole series of 24 misadministrations and it was clearly capable of going 25 as far as causing death. The medical follow-up by NRC NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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stopped after about two or three of those fatalities.
2 Other fatalities ensued and I think the ultimate i
3 follow-up,;it's a number close to 16 or-18 deaths in
[
i i-4 that:one set.
But NRC --
I 5
CHAIRMAN SELIN:
I might' just correct you i'
I' 6
for the record.
According to Doctor Polycove's e
i 7
report, there were ten deaths where the radiation was i--
8 clearly at least a complication and then 18 more where 4
i 9
there were signs.of radiation damage but not
[
i 1
10 necessarily contributed to the death.
Very large i
f 11 numbers.
l 12 MR. BERNERO:
Yes.
Yes.
It depends on i
i 13 how one would bin them.
Of course, these are all l
14 cancer patients, and so there are deaths that are
{
15 clearly not attributable, deaths that might have had l
16 some contribution from radiation and deaths that are i
17 clearly related to the radiation.
18 CHAIRMAN SELIN:
I realize this event was i
19 a long time ago, but I was struck by_the_ independence 20 with which the medical consultant made major decisions'.
i.
21 about whether to follow up and- - how to follow up, 22 apparently not under supervision from the NRC.- I m9an 23 beyond the medical question about what happened versus 24 how long'to keep up and who to talk to about this.
I f
25 assume that wouldn't happen again.
i l
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20 l
1 MR. BERNERO:
Well,-again, I think we're 2
troubled by the ambiguity of what do we expect the e
3 medical consultant to do and what do they expect us to 4
obtain from them.
This is quite a bit different from 5
medical misadministration, but there's a very good 6
case in point.
The last incident at Sequoyah Fuels 7
released oxides of nitrogen to the atmosphere.
You 8
were briefed on that not long ago.
In the emergency-9 response follow-up, I was involved with the region and i
10 AEOD on how do we do the emergency response and we i
11 talked to EPA and the state authorities and everybody, 12 We ended up getting medical consultants out to the 13 field to provida technical assistance on the physical 14 or clinical effects of oxides of nitrogen.
- Frankly, 15 I don't think any of us had a clear idea of what we i
s' 16 were doing.
We just felt like we ought to help and we 17 were providing assistance to the state and local 18 authorities.
19 I think what you see there as well as in 20 the medical field is a lack of a clear role, lack of 21 a clear definition.
22 MR. THOMPSON: That 's true. Mr. Chairman, 23 I can assure you that the oversight that we give today 24 to these types of incidents are quite a bit more --
25 we're sensitive to these type issues with respect to NEAL R. GROSS COURT REPORTERS W10 TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202' 234 4433 WASHINGTON, O C. 20006 (20r) 234-4433
__._._.___-_.._.w 21 1
follow-up and we would clearly be in consultation with 2
the region and with the team if, in fact, it had to be 3
With respect to guidances,.how far 4
they went up in particular with the case in Indiana, i
5 we were there giving some directions and concurring l
6 with the role that Doctor.Flynn played in that role.
l 7
So,-we would have a lot more dialogue than occurred I 8
think in the Doctor Sanger case.
9 MR. BERNERO:
Yes.
That's --
10 MR.
TAYLOR:
- And, of
- course, the i
11 regulations now require-going through the referr'ing 12 physician and assuring these patients are informed 13 too.
l 14 MR. BERNERO:
Yes.
15 MR. TAYLOR:
That did not exist at the 16 time of Riverside.
17 CHAIRMAN SELIN:
Commissioner Curtiss?
18 COMMISSIONER CURTISS:
Just two 19 observations on this question of. using medical 20 consultants, and I do think there are two' separable 21 issues here.
22 As I understand the Agency's practice, we 23 turn to the use-of medical consultants-to give us a 24 perspective on-a particular event that we might not be 25 able to obtain given the expertise of the staff here NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS
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23 1
1 within the agency.
In my view, that's a commendable 2
thing to do.
Some of these events involve issues that 1
3 I
think necessitate going to a
member of the 4
fraternity or sorority, the medical community if you i
5 will, to ensure that we fully understand the events 6
and deal with the sensitivities that we have talked 7
about and that your paper addresses in some detail.
8 The first issue I guess I see is that 9
there's a
careful balance to be struck between 10 ensuring that we have somebody who is able to bring i
11 that expertise to a particular event and give us an 12 evaluation that is reflective of a contemporaneous 13 expertise that the individual has in the medical 14 community.
I'm not Oak Ridge is capable of doing that 15 in every case and the medical consultants provide us 16 with that expertise.
17 But the balance, it seems to me, to be C
l 18 struck here and the purpose that we retain a medical 19 consultant for, at least we have used them in this i
20 context in the past, is for them to give us an i
21 objective assessment of what occurred in a particular 22 event so that in carrying out our regulatory 23 responsibilities we can then take that objective 24 assessment and act accordingly.
I guess my sense has 25 been that there are instances where it's difficult to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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l i
23
.[
]
1 separate one's role in the medical community and 1
2 perhaps an unwillingness to be objectively critical in 1
3 the context of evaluating the particular event from 4
our desire to have that kind of objective evaluation.
5 So, it's a judgmental question that it l
6 seems to me needs to be addressed in the context of 1
I-7 each specific case where we retain a consultant to l
l 8
ensure that we have somebody who has the sufficient t
9 expertise, but at the same time is able to step out of i
10 the-role that he or ~ she plays in the medical J
i 11 community, a practicing doctor in many' cases, and give 4
f 12 us an objective and, if necessary, critical evaluation 13 of the event.
I'm not sure that's been done in every-t 14 case in the context of some of the reports that I heve j.
15 rende 4
1 l
16 Secondly, it seems to no, and Bob I think l
l 17 you touched on this point squarely, that the issue of f
{
18 defining the procedures, of defining the groundrules 19 that govern - or guide the conduct of the medical--
,l*
l 20 consultants is a matter that probably deserves further i
e 21 attention.
I have read the recent letter, in fact I 22 just received. it today,.from Doctor Sanger'~that 23 details-laying out in some-detail--- actually, it's a f
24 letter to the chairman, I should say, that lays out in 25 some detail areas. where he's concerned that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS f
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34 1
procedures haven't been fully explicated.
It seems to 2
me that question as well, and I hear you saying, 3
deserves some further attention if we can define in 4
greater detail what the groundrules are.
5 Here, in the case of one who we hava used 6
over several years, there's some evident lack of 7
understanding as to what those rules are and perhaps 8
that's something we can address.
9 MR. BERNERO:
Yes.
I might just add, 10 there's a job of work in our shop that is suspended 11 because the project manager is on the IIT for Indiana, 12 Pennsylvania and it arose from the previous IIT and it 13 does involve the role of the medical consultants and 14 this is notifying people other than the patient.
The 15 Amersham IIT was a radiation source that was loose in 16 shipment.
There was no licensee directly involved in 17 it. We ended up backtracking and reconstructing doses f
18 to people all over the country and we used our medical 19 consultants to communicate with those people, to 20 inform them of their radiation exposure and for 21 whatever medical attention they needed, blood tests 22 and so forth, through their companies, like the truck 23 drivers.
24 CHAIRMAN SELIN:
If you'd just stop for a 25
- second, I'd add another category to Commissioner NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W.
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1 l
25 i
j 1
Curtiss' analysis.
It's sort of included in the first i
j 2
point.
But traditionally, as fsr as I can sco, we've i
l l
3 used the medical consultants to help us in our i
4 regulatory effort, but now we seem to be moving and I 1
s i
5 think it's probably the right direction to use the 4.
6 medical consultants more or less the way you l
7 discussed, Mr. R2rnero, which is to reconstruct not 1
l 8
only enough cases to figure out that a f ailure was 9
made and either a licensee has failed to do his job or 10 our regulation needs improvement, but to go to the
)
l_
11 point of looking at each individual that was exposed i
l 12 and at least get some assessment of how much radiation a
13 and perhaps how much damage at that point to turn over l
14 to the physician and his or her -- I mean the-patient
{
15 and his or her physician, i
l 16 MR.
BERNERO:
Yes.
Well, we use the 17 consultant there, but we also have expertise in staff l
18 to reconstruct the doses, the health physicists who do 19 that.
But again I would go back and be the first to g.
I 20 admit-that we need to define
-the
- role, the l.
21 responsibilities much more clearly than we have now.
1 22 There's too much ad hoc decision making.
23 COMMISSIONER REMICK:
- Bob, before you l
-24
-leave that, going back to my earlier question, has i
25 there ever been a case where we have an NRC-initiated I
NEAL R. GROSS U~
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i 26 1
special inspection use of medical consultants or 2
review licensing reports in agreement states, NRC initiated, or do we leave that to the responsibility u
5 l
- the agreement states?
I assume it's that.
5 (I MR. BERNERO: To my knowledge, we've never done an IIT or unique thing.
We provide technical 7
assistance.
I'll let Carl answer it.
i 8
MR. THOMPSON: Just to mention, we do have 9
some federal licensees in agreement states.
j 1
10 COMMISSIONER REMICK:
That I understand.
I 11 MR. THOMPSON:
You're talking about the 12 agreement state licensees.
l 13 COMMISSIONER REMICK:
Right.
14 MR. KAMMERER:
We don't know of any.
l 15 MR.
BERNERO:
Yes.
We will provide i
16 technical assistance from time to time which includes 17 special inspection or technical support in hearings or 18 something like that, but I know of no --
19 CMAIRMAN SELIN:
We should point out that 20 this Indiana, Pennsylvania was the first time we've 21 ever done an IIT for a medical licensee agreement i
i 22 state or direct licensee period.
j 23 MR. TAYLOR:
That's correct.
l 24 MR. BERNERO:
(Slide) May I have slide 6, 1
25 please, Jim?
l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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l 27 4
1 In our efforts to prevent l
2 misadministrations, we of course have regulatory i
3 requirements that would set the discipline for the f
4 medical practice. Here I would just'like to emphasize 5
once again the quality management rule.
I really i*
l 6
think that a quality management rule, after all of -the 7
controversy we had with it, in the long run will be i
I 8
looked upon by both sides, by us and by the regulated l
i i
j 9
community as a sound process, a sound procedure l
10 because it challenges the medical community to set the j.
11 standards, to set the procedures or requirements and 1
l 12 then to adhere to them, to. implement them fairly and 13 rigorously.
That's, in ny view, the primary way to
~
i l
14 prevent misadministrations within human frailty 1
l 15 limits.
16 We, of course, have inspection and we will 17 continue to use that.
- Training, part' of our l
l l
18 inspection, it's an linportant part of our inspection, i
{
19 is to make sure that the licensees not.only specify f
20 the training required but that it's there, that j,
21 personnel turnover doesn't undermine it, that they-22 have people currently trained in the procedures with 1~
23-the equipment that they have.
I think you1will hear 24 a dramatic demonstration of the difference of training h
25 when you hear that IIT report because there-are -
i NEAL R. GROSS i
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1 28 1
actually two events in it.
1 2
On the enforcement --
l 3
COMMISSIONER REMICK: Excuse me, Bob. How a
l 4
do we determine the adequacy of the training?
Is it 5
something that they specify and then we inspect to see a
6 if they are carrying out what they specify or do we 1
7 have regulatory mandated --
i I
8 MR. BERNERO:
It's some of both.
9 COMMISSIONER REMICK:
-- ours?
I l
10 MR. BERNERO:
Yes, it's some of both.
We 1
11 have training and qualification requirements in the 12 regulations and, in fact, that in itself is an area of 13 some debate about how far should we go, what sort of 14 training. We have chronic arguments with some members 15 of the community that we demand too
- much,
)
16 cardiologists are too busy to do certain kinds of 17 training or something.
So, we have certain specified 18 training requirements and they need to be established i
19 and validated.
But also, there's very important l
20 training in specific equipment, especially nowadays.
21 Medical devices, some of them are very complex.
It's 4
22 not a simple teletherapy machine with a shutter and it 23 opens and closes with a timer.
They're much more 24 complex.
25 Now, if I could turn to slide 7 --
s NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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.n.
29 1
CHAIRMAN SELIN:
Before you go --
2 COMMISSIONER ROGERS:
You didn't say 3
anything about the enforcement program.
i 4
MR. BERNERO:
Yes.
I'm going to talk i
)
5 about the enforcement program on slide 7.
i 6
CHAIRMAN SELIN: Before you go on, one way i
- e 7
of rephrasing what you just said about the QM approach 8
is that we rely on the licensee to establish a f
9 program, presumably some program we can review for 10 adequacy and then we audit his performance against' 11 that program.
Do we go a step further? Do we have an 12 independent way to check on a sample basis the 13 misadministration reporting? Do we depend entirely on 14 the licensee's reporting of misadministration and 15 rates or do we have some type of audit on that?
16 MR. BERNERO:
Well, as I said earlier, we 17 have an inspection process that might discover -- if i
18 they record the procedure, we have an inspection i
19 process that could discover an unreported a
s 20 misadministraticn, but that's only if they recorded 21 it.
Then there is also the allegation process, which 22 is not uncommon to have an allegation that something 23 happened and they didn't record it either.
We have a 24 mechanism to follow up on that.
25 (Slide)
Now, the enforcement program, I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENVE, N W.
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1 want to move to slide 7 because I think it warrants a 2
particular attention.
There are two underlying 3
principles of our enforcement program and this is not i
4 unique to medicine, but if I would say it in a manner 5
specific to medicine, we want to encourage licensees 6
to prompt identification and lasting corrective i
7 action.
That's principle number one.
This is the 1
l 8
identification of misadministrations, of course 9
reporting them.
Then we want to deter them by using j
10 sanctions.
This is the idea of setting up the lesson 11 for others, the lesson for others to see.
12 We do have escalated enforcement in the 1
i 13 medical arena and medical activities using the medical 14 circumstances, over exposures of patients or 15 significant potential over exposures of patients, loss 16 of control of sources in particular.
You know, you 17 get these high radiation sources if for some reason or l
18 other the proper safe control of the source is lost.
1 i
19 Misadministration for f ailure to follow a i
20 procedure. We had an unfortunate misadministration at 21 Tripler Army Hospital in Hawaii where a procedure 22 called for the technician to verify that a woman i
23 patient was neither_ pregnant nor nursing.
Due to 24 distraction ano -- they had a procedure. There was no 25 question.
The hospital had a
procedure, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W.
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31 1
technician was following it.
There was a distraction 2
and the investigation revealed that he went back to 3
the wrong step or never got back to it.
He failed to 4
ask the question, "Are you nursing a child?" A large 5
dose of lodine was administered and since the mother
,i
- 6 was nursing a child, the child's thyroid was severely i
7 damaged, in fact destroyed, in that misadministration.
8 So, we have escalated enforcement and had 9
it there for failure to follow procedures.
It's a l
10 forecast of the QM rule, willful violations or what is 11 sometimes discovered, breakdown of control, breakdown 12 of management.
Many times a single event may betray l
13 this, but sometimes our inspections will betray it.
14 You go into a facility and you find that the radiation 15 safety officer isn't really doing the job or the i
16 radiation safety committee isn't doing the job and 17 there's a host of small events, each one not a very i
6 18 big event but in tra aggregate what it betrays is a 19 breakdown of management control.
So, we get into 20 escalated enforcement there too in medical licensees.
l l
21
- Now, we are reconsidering the civil 22 penalty assessment process.
We're trying to focus on 23 the root cause and we think that the enforcement 24 process we have is reasonably effective, but we are 25 consulting with others, in particular the Advisory NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS i
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l 1
Committee on the Medical ' Use of Isotopes.
We're i
2 hearing views from them that, "Well, the dollar value 3
of civil penalties really isn't that big a dollar
)
4 value when you're a big licensee.
It's more the press i
5 coverage or the bad image, the press release that i
6 hurts more than the dollar."
of course, in other 7
licensing cases, that's often the case.
i 8
We're reconsidering the whole enforcement 9
process, what-we should do, how we.should.put these l
f.
10 sanctions out.
.It's-not clear to me at.this time.
11 Jim Lieberman is here and could speak with greater 4
i 12 expertise about what the prognosis might be.
But.I i
13 would.
just leave it myself as it's under 14 reconsideration and it is a very significant and a
)
l 15 knotty problem.
i l
16 MR.
THOMPSON:
I would just. say the l
l 17 ultimate enforcement action is obviously to suspend-l 18 the license for those facilities'for which we really l
l 19 have not --
20 CHAIRMAN SELIN:
But'I don't'wish to ask
{
21 any body to 'try to guess-what the changes will be, but i
l-22 I think-it'would be useful, Mr. Lieberman, if you'd f
l 23_
~just. take ' a minute to' talk about the two or three
]-
24 points in the current enforcement process that you t-i 25 think -- not the conclusions but where you think there -
l NEAL R. GROSS '
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~.
33 1
are potential weaknesses that are to be reexamined.
2 What are the symptoms that lead you to do this 3
reexamination?
4 MR. LIEBERMAN:
Currently we use civil 5
penalties aF the basis for our escalated enforcement 4
6 actions.
Most of our civil penalties, as Mr. Bernero 7
said, are not very large for some relatively large 8
institutions. Civil penalties have been effective for l
9 many cases to get lasting corrective action, primarily 10 because of the negative publicity.
The question that 11 we're looking at is whether there should be a greater financial impact on civil penalties with the hope that 12 l
l 13 that might provide a greater deterrence #or other i
14 licensees to improve their performance and therefore 15 maybe expend the resources and the effect to look at i
16 their programs, to improve their performance before 17 incidents occur or before we have inspections.
So, 18 for the larger licensees, we are looking at the i
19 question of whether we should have larger civil l
20 penalties.
21 Now, the medical community has suggested 22 that instead of civil penalties we use some form of 23 probation to get the attention of licensees who need 24 to improve their performance. We'll also look at that 25 as we look at the mix of a sys we can improve sanctions l
l l
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5 l
34 I
)
I to get the attention of the poor performers in advance 2
of an actual incident.
3 CllAIRMAN SELIN:
Commissioner de planque?
4 COMMISSIONER ROGERS: I'd just like to say 4
5 something on this.
I hope you'll look very hard at 6
vhat ways that you can escalate enforcement and be 7
very tough in addition to dollar amounts.
It seems to 1
)
8 me there's a very serious question of whether it isn't 9
counterproductive on these large -- to consider large 10 civil penalties when the cost of medical treatment 1
11 already is very, very high, and whether that, in fact, 12 is really serving the public interest.
There's no 13 question in my mind that when enforcement must be i
14 escalated it really should take place.
I 15 I have a serious question personally about 16 largo dollar penalties in terms of the impact on the l
i 17 ability of that hospital, if it's usually a hospital, 18 to deliver health care in other areas.
It seems to me 19 that it's very easy to take a shortcut here and hit I
20 them with a very large civil penalty, but I think that 21 in dollar cerms that in fact may seriously negatively 22 impact the ability of that f acility to deliver health 23 care in other areas.
It seems to me we ought to be 24 aware of that because the whole question of the cost 25 of health care is a very, very big issue today, as you NEAL R. GROSS COURT REPORTERS AND TRANSCRtBERS 1323 RHODE ISLAND AVENUE, N W.
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35 1
know, and this is something I think we ought to be 2
alert to.
3 MR. LIEBERMAN:
I think that's a good 4
point.
Currently the civil penalties for a medical 5
institution is relatively low and in part because 6
we're considered the non-profit nature of the 7
hospitals.
We wouldn't be considering increasing the 8
civil penalties for the smaller institutions, it would 9
be for the larger broad-scope licensees.
But I think 10 your point is a good one that we'll definitely have to 11 considere 12 COMMISSIONER REMICK:
I share in
')
Commissioner Rogers' reservations about large dollar 14 penalties. The logic of what the staff just presented 15 led me to conclude that you would probably say a 16 larger press release was a but if that's the 17 greatest impact, and I believe it probably is, the 18 publicity, certainly it seems to me logic leads us to 19 consider are there other penalties besides dollars 20 that might be a better deterrent.
Dollars is the 21 easiest thing for us to think about, but there might 22 be innovative ways of doing it.
23 CHAIRMAN SELIN:
Well, we're not going to 24 prejudge what your answers are, but we are very 25 interested in what you see the problem was.
In fact, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W..
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j 36 j
j 1
I sort of heard you say that you have the feeling that I
{
2 the impact on the organization which is singled out, 3
whether it's the publicity or the dollars, is pretty i
4 strong, that you don't get a lot of recidivism from j
individual organizations.
5 G
MR. LIEBERMAN:
That's correct.
7 CHAIRMAN SELIN:
So, you seem to be j
8 suggesting that you're concerned about the deterrent 9
effect on other organizations rather than-the return
}
{
10 to the given -- poor behavior by the given licensee.
11 Did I misunderstand _that?
I j
12 MR. LIEBERMAN: No, yoe're entirely right.
i 13 It's relatively rare-that once we have a civil penalty 1
l 14 that that same licensee within a few years would have j
15 another significant issue.
We do regularly inspect i
16 licensees once they've had-a civil penalty to. make 17 sure that corrective action has been effective.
-So, 4
{
18 at least for a few years anyway, the performance' l
19 almost always improves, which is-the purpose.
20 MR. BERNERO:
I'd ljke to turn it over to i
21 Carl Kammerer now to cover the agreement state aspects i
l 22 of the program.
ij' 23 CHAIRMAN SELIN:-.Okay.
Hold on.
l 24 COMMISSIONER CURTISS:
I have a question.
f.
25 I apologize for going back to the previous issue.
i' NEAL R. GROSS i
COURT REPORTERS add TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W, j
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37 1
It's not on the enforcement question, but on this 2
issue of the extent to which we have confidence that 3
misadministrations, if they are occurring, are 4
reported to the agency.
It's the question the 5
Chairman raised on the earlier graph.
4 6
Bob, I understood you to say that if a 7
misadministration occurs that is not reported, we 8
wouldn't know about that and we probably wouldn't have 9
any way of getting at that issue today.
Would you 10 expand on that?
11 MR.
BERNERO!
No, no.
I wouldn't 12 guarantee it, but there's an alternative.
If it's not 13 reported and it's an event that should be reported, it 14 is possibly in the hospital records and subject to 15 discovery by inspection, that, "Why didn't you report 16 this?"
In addicion, even if it's not recorded and 17 subject to discovery that way, it is not uncommon to 18 have an allegation that a concerned person, a staff 19 member or someone who is aware of it raises an 20 allegation with the NRC and we pursue the allegation 21 and if need be conduct an investigation --
22 COMMISSIONER CURTISS:
Okay.
23 K11. BERNERO: -- and discover it that way.
24 I don't know how many are undiscovered.
I don't know 25 how I can know that.
It's just that, as I said, I NEAL R. GROSS COURT REPORTERS AND TRANSCR10ERS 1323 RHODE ISLAND AVENUE, N W.
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38 I
j 1
think the process is already sufficiently sensitive to 2
start picking up the new kinds of reports that we're l
3 getting with the QM rule --
i j
4 COMMISSIONER CURTISS: Yes, I was going to i
5 emphasize on that point because I think the QM rule e
6 establishes a pretty airtight process that will enable 1
i 7
us if we have the inspection resources and focus on 8
the question, first,. and second if the RSO is carrying i
i j
9 out his or her responsibilities that we've got a i
j 10 pretty airtight process in Part 35 to identify I
i 11 instances where misadministrations are occurring if ii i
12 they're not getting reported.
It's worth' emphasizing
}'
i 13 because the impression has been created, and maybe it i
j 14 was true several years ago, that these activit'es are i
15 going on and we're not aware of the events.
16 As I read Part 35, every -- Part 35.32 in-i 17 particular, every administration of a dose, not a i
18 misadministration but every administration of a dose l
19 in five specified categories has to be recorded by the i
f 20 party, the licensee-administering the-dose.
Those 1
j 21 records-then have to be retained under (d) (1) of that i
{
22 provision for three' years, second.
And. third, there 23 has to be a achanism in' place for the licensee-to.
1 I think, will play a j
24 audit compliance where the RSO, 25 significant role to ensure that. there aren't any NEAL R. GROSS q
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1 misadministrations and if there are they're getting i
2 reported.
I 3
Unless we've got a problem with licensees 4
failing to prepare written directives, which is sort 4
i 5
of the entry into this set of provisions, unless the 6
licensees are not preparir.g written directives, it i
7 seems to me that that mechanism in 35.32 is pretty 8
airtight, and on that threshold question of preparing 9
a directive.
Now, frankly, it seems to me-that our 10 role is to audit the work of the RSO in ensuring that 11 those written directives are actually prepared for i
2 12 every administration as defined in 35.32.
13 MR. BERNERO:
Well, I think the QM rule is 14 a very strong process because if the licensee is not 15 preparing written directives as required, that is, of j
16 course, discoverable by inspection.
Then, of course, 17 if they prepare them, then misadministrations are 18 quite readily discoverable by inspection.
19 CHAIRMAN SELIN:
Our figures seem to show i
20 that for every 10,000 therapeutic administrations 21 there, on average, are three misadministrations. It's 22 a very small number and it's also a very small sample.
4 23 So, it would be very hard to find misadministrations 24 not reported, except through procedural techniques 4
25 such as you're talking about as opposed to statistical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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_m.._
40 j
i i
sampling.
-The cost would be astronomical to try to i
2 sample administrations to see if it would be four r,c 1
five to 10,000 instead of 3.
{
3 1
MR. BERNERO:
Carl?
4 5
CHAIRMAN SELIN: Mr. Kammerer, you seem to f
e-1 j
6 have the floor.
7 MR. KAMMERER:
Thank you, sir.
8 Mr. Chairman, commissioners, the. first
)
9 thing I want to do is.to improve upon the answer I j
10 gave to Conmissioner Remick.
I was just handed a note -
i j
11 gl from hathleen Snyder - who says that technical 1
i 12 '
comittence in the misadminia;tration. case in Arizona, 13 which you'll. haar about a week from today, was given, j
14 that medical consultant for the NRC was asked to come i
l 15 out and do some work there.
l 16 COMMISSIONER REMICK:
No, my question was f
1 i
17 NRC-initiated.
I assume that if somebody asked us, k
l 18 we'd be more than willing to help.
I was just curious-l and I was trying-to distinguish from what Bob'was 19 20 saying, are we-talking about_just NRC licensees or' i
i 21 also agreement states.
-I assumed he was talking again
?-
1 22 about NRC.
W j
23 MR. KAMMERER:- All right.
Thank-you.
24 Before we begin, I' wanted to lo just' a j '
25 brief overview of the agreement state progran..
I'll
- y i
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be covering the following topics: the scope of the 2
agreement state program; adequacy and compatibility; 3
agreement state reviews; reporting and exchange of 4
information; regional results of our reviews; and 5
observations and recommendations for futt re review.
4 6
I'll be discussing the information that we've 7
collected from the agreement states and as.the EDO 8
said at the beginning here, this is-the first time 9
we've collected tl.is information in one place'in a 10 summary fashion concerning inspections, enforcement, 11 investigations and events reporting for the agreement 12 states.
13 In the area of misadministrations, the 14 agreement states, for the first time, were to have 15 this reporting requirement in place by April of 1990.
I 16 So, the 1991 data is the first such compilation.
17 We've gathered this information -in a very short period 18 of time, since mid-December, and I want.to stress that 19 it's unanalyzed and raw data.
If the data, however, 20 says anything to us in our. current review, it is that 21 we have to institutionalize this reporting so that we 22 can identify ' trends in the agreement state and 23
-eventually compare--them with NRC-data to identify 24 generic-situations.. We also-intend to make this kind 25 of information available to the agreement states.
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l 42 I
1 (Slide)
The slide two shows the national 2
licenses.
This is the scope of the national medical 3
license program.
You can see it in the color up above j
4 but not so much in your slides that the license 5
category for this program include the broad medical, l
6 community hospital, private practice and clinics and 7
teletherapy.
About 6,500 medical licenses in these i
i 8
categories nationwide and the agreement states i
9 regulate 4,500 approximately.
10 As you can see from the red and brown, 1
11 dark colors, four of the states have the largest i
}
12 number of medical licenses. They are agreement states 1
13 in California, Texas, Florida and New York.
14 Adequacy and compatibility.
The Atomic 4
i 15 Energy Act requires the states to be adequate. and 16 compatible before the agreement is signed for j
17 discontinuance of the NRC authority.
The agreement i
18 states also agree to use their best efforts to 19 maintain a program that is adequate to protect public 20 health and safety and compatible with NRC program.
21 In the SECY paper 92-243, the 22 compatibility paper, the staff suggests that the 23-issues of enforcement and investigations be examined 24 during the development of this compatibility policy.
25 So, states are evaluated based upon guidelines or core NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j
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43 1
criteria.
The guidelines were first published in 2
1981.
They were updated again in 1987 and the most 3
recent version of that was published in May of 1992.
4 So, here are some of the core indicators 5
from which the 30 guidelines flow.
As you can see up 6
- there, the
- statutes, and regulations,
- budget, 7
management, staff and training and so on.
The 8
guidelines include 30 indicators for evaluating 9
agreement state program areas.
The indicators are 10 separated into two categories.
Category 1 indicators 11 address program functions which directly relate to the 12 state's ability to protect public health and safety.
13 Category 2 indicators are those areas which have 14 program functions that provide essential technical and 15 administrative support to the primary functions.
16 In reporting findings, the Office of State 17 Programs indicates the category of eacn comment made.
18 If no significant category is are provided, this will 19 indicate that the program is adequate to protect 20 public health and safety.
7f one or more category 1 21 comments are noted as significant, the state will be 22 notified of those deficiencies and that it may 23 seriously affect the state's ability to protect the 24 public health and safety.
If a state fails to have 25 compatible regulations within the three year time NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 2344433 WASHINGTON. D.C 20005 (202) 2344433
44 i
i frame, t't,ey will not be found compatible.
4 2
NRC works with the conference of Radiation l
3 control Program directors to put new regulations into 4
what is called suggested state regulations for more j
5 adaptable use by the states.
4 6
(Slide)
Slide 4 is the agreement state i
7 reviews.
Some of the items covered in the agreement 4
8 state reviews are the inspection
- findings, 9
enforcement, investigation and events reporting.
We i
}
10 have reviews every approximately two year cycle with i
11 a visit in between those two.
Office of State l
12 Programs provides oversight and has internal 13 procedures which are used for evaluating the states 14 for adequacy and compatibility.
The procedures set 4
15
- forth, the general objectives for conducting the i
{
16 review, the procedures contain questions asked of and 17 information obtained from the states in certain areas 1
18 during the reviews. This information and the adoption 19 of regulations is used to determine the adequacy and 20 compatibility of the programs and their compatibility 21 with the Nuclear Regulatory Commission.
22 Review teams are always headed by the 23 regional state agreements officer and range in size-t 24 from one to eight members, depending on the complexity 25 of the issues and the size of the program to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHCDE ISLAND AVENUE, N W.
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45
.i i
reviewed.
Teams may include additional support from l
2 Nuclear Material Safety and Safeguards, the regions, 3
the office of General Counsel and also other state 1
4 J
4 programs.
5 The following areas that we'll be looking 6
at are not matters of compatibility.
However, they 7
are reviewed in terms of adequacy as've do our reviews 8
of each of the state radiation control programs.
9
-Inspection is a category 1 indicator and 10 according to our review procedures an assessment is 11 made of the ability. of the - state _ to maintain an 12 inspection program -adequate to assess th'e licensee 13 compliance with state regulations and license 14 conditions.
This assessment is made by accompanying 15 new inspectors on their inspections, reviewing 16 compliance files and noting overdue inspections, among 17 other items. When overdue inspections are identified, 18 the State Programs office requests that a state 19 develop a plan to eliminate the problem. This plan.is l.
20 reviewed and monitored and Iowa is a 'recent good 21 example of that - procedure.
They had a number of 22 overdue inspections and a lack of staff and.the state-23 was required to formulate-an action plan.and to-make 24 a monthly report to the NRC,.to. us.
We in turn l
l 25 reported that information to the EDO and progress is l-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W.
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46 i
1 being made on that.
I 2
COMMISSIONER REMICK:
- Carl, for i
3 clarification, you're talking about going along with l
4 the new inspector on some of their first inspection i
l 5
visits.
Our staff does that or we see that the state i
6 regulatory body does that for new inspectors?
That 7
wasn't quite clear.
8 MR. KAMMERER:
It's both.
j 9
COMMISSIONER REMICK:
Both.
But we do
.j l
j i
10 sometimes go out and observe their inspections?
}
11 MR. KAMMERER:
Yes.
In the case of Iowa, I
f 12 we're doing that.
It's more or less an OJT type 13 arrangement where our technical staff is going along 1-l 14 with their more junior staff and handling complex j
15 licensing and inspection actions.
16 COMMISSIONER REMICK: Now, is this because 1
i 17 we've identified some deficiencies and we're trying to i
18 help them get up to speed or is that something we 19 would routinely do as part of our oversight?
=
i l
20 MR. KAMMERER: It's something we routinely l.
21 do and -it's a part of our ' (d) (2) procedures that' l
22 require the state personnel to accompany their brand 23 new people and train their people and -bring : them l-24 adequately up to speed as a compete.1t inspector.
But 25 the other part applies as well.
}
l NEAL R. GROSS.
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a
. = u.- - :.
.a
i 47 l
l 1
Additionally, in order to meet the review 2
criteria in this area of inspection frequency, the 3
agreement states inspection frequencies can be no less 1
4 than that of the Nuclear Regulatory Commission.
5 Agreement states make pre-licensing visits, depending
~
j.
j 6
on the complexity - of the license,' potential hazard i
J1-7 from the licensee's facility or for'a new license.
f 8
For medical licensees, over 2,000 inspections were 1.
9 performed over the last' reporting period...There was 10 a small percentage -in overdue inspections 'and we l
j 11 calculated those to be about two percent.
1 l
12 Another area that's covered. in our l
l 13 procedures is the enforcement aren.
It also is a i
j 14 category 1 indicator.
In evaluating the enforcement i
j 15 program for the agreement states, the review criteria 1
16 indicate that the enforcement program should be l
l 17 sufficient to provide substantial deterrent-to I
18 licensee non-compliance with regulatory requirements'.
19 The staff reviews the state's enforcement letter. filed 5*
i 20 to see, for example, if enforcement letters are issued-
- l..
21 within 30 days.
They have1 appropriate. regulatory i
i 22 language and clearly -specify the areas 'of'_non-O j
23 compliance.
Specific questions in the area address-i 24 escalated enforcement actions, civil penalties issued
]
25 and the number of enforcement conferences.
i NEAL R. GROSS j=
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~ ~ ~. -.,,. -. - -. - -..
=
48 1
You'll note that 22 of the 29 agreement 2
states have civil penalty authority.
Twenty-seven l
l 3
have escalated enforcement, while 25 have severity o
j 4
levels. The states have issued 103 civil penalties in 5
the last reporting period.
\\
6 The investigation program, also a category 7
1 indicator covered in our internal procedures, all of 1
8 the agreement states have investigative functions as 4
l 9
part of their regulatory program.
Office of State i
10 Program procedures also include criteria for 11 evaluating a state's ability to handle incidents or t
12 alleged incidents.
These criteria include prompt 13 evaluation to determine the need for on-site 14 investigation and clear documentation of the incident 15 and/or the allegation.
Other questions in this area l
16 address procedures for avaluating wrongdoing.
i 17 In 1989 '91 review cycle, the states 18 conducted 123 investigations, 32 of which resulted in s
19 enforcement actions.
Again, te will include both I
20 enforcement and investigations in the compatibility 21 study coming up soon.
22 Events reporting is the next category. It 23 too is a
category 1
indicator on our internal 24 procedures.
States have adopted requirements for 25 their licensees to report certain events to the NRC, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W.
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i 49 l
l 1
as shown on the next slide, l
\\
2 (Slide)
Reporting and exchange of 3
information.
Internally here the NRC staff meets 4
monthly to discuss the events that occurred in NRC and 1
5 agreement state license programs.
The licensees must 6
report significant events to the agreenent states in 7
accordance with Part 20.
In their agreement, signed f
8 by the Chairman and by the Governor, states commit to 9
share information with the Nuclear Regulatory i
10 Commission.
In addition, our written communications
?
11 with states encourage them to report events to us.
12 The states annually summarize all events and transmit l
13 them to the Nuclear Regulatory Commission.
i' 14 Again, states have adopted NRC-related i
15 rules and policies and through the routine reviews and l
16 other communications throughout the year, states and
[
17 NRC routinely exchange information.
l 18 As you can see on this slide, we routinely 4
19 transmit PNs, information notices, bulletins out to 20 the states.
We hold conferences on various subjects i
21 as the need arises and involve the states in early 22 rulemakings.
That is to say we involve the states 4
23 early in the rulemakings.
24 In the area of misadministrations, a total 25 of 480 were reported in 1991.
Four hundred and sixty-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENVE, N.W.
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50 1
three were diagnostic, 17 were therapeutic.
Out of i
2
- these, two therapeutic misadministrations em 3
classified as abnormal occurrences.
4 (Slide)
Recent agreement state reviews, 5
looking at the chart there that shows how we reviewed 6
the states by region.
On January 1st, 1993, 24 of the 7
29 states, approximately 83 percent, were found to be 8
adequate as of their latest review.
In five or 17 i
9 percent, the finding was withheld.
10 COMMISSIONER REMICK:
Carl, in that area, 11 how long do we allow ourselves to withhold the 4
12 findings of adequacy or compatibility before we would 1
13 institute proceedings to retain or restore our i
14 authority in these areas?
15 MR. KAMMERER:
In that case, we do not 16 have any written internal procedures, but in a
17 judgment of talking with the Chief Executive Officer, 18 the governor of the state and all of the people below 19 him, if it's their determination that they will --
20 that they desire to have a program and make the 21 choices to have an adequate and compatible program, 22 whether it's staff that needs to be added or l
23 regulations gotten up to speed or whatever, if they're 24 making progress on that we're willing to help them 25 along.
When you say how long, we have two cases over NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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I 51 1
the years'that have gone on for-what seems to me-like 3
2 about three review cycles.- That's kind of stretching i
3
[
3 it.
We'd like to see action taken by the states far h
4 earlier than that and that's one of_the areas.we're 5
going to recommend that we try to find a.way in which 1*
i 6
both our office and the states can be stronger about i
7 getting their act together much more quickly..
3 8
In the Iowa case, I think I'll touch on it j
i 9
a little bit later, it is something that was.over two 1
f 10 review cycles and our later discussions with them have l
11 them turning their program around and certainly making l
12 every effort to do so.
So,,we don't have a written-l 13 standard on that.
4 f
14 COMMISSIONER REMICK:
Okay.
1 I
15 COMMISSIONER CURTISS:
- Carl, in your l-4 l
16 discussion of the two issues that we look at, adequacy I
}
17 and compatibility, it's obvious to me how a state, l
j-18 once we approve an agreement, might find'itself in a 19 less than adequate position.
Resources are strained, 20 qualified people are.not available,-budget cuts lead
'l i.
21 to. less than adequate staffing, a whole host of 1
i 22 circumstances that might have a state find-itself on I
23 the other side of the-line insofar as adequacy is l-.
1
'24 concerned.
I i
25 On the compatibility side, what I hear you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l
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52-1 saying is that prior to granting a state agreement 2
state status, we review the basic legal framework, if I
3 you will, the statute and the regulations that the 4
state in turn proposes to use in carrying out its i
5 authority for the purpose, as you've laid out in some
+
6 detail, of satisfying ourself that the program is 7
compatible as we evaluate that process.
Recognizing 8
that that decision gets made as a prerequisite to 9
granting agreement state status, is it possible, have 10 we confronted situations where once a program is i
11 declared to be compatible and they're off and running i
12 and assuming it's adequate at the front end, that a 13 state af ter that could lapse into incompatibility, and 14 if so how?
15 MR. KAMMERER:
By regulations,-by lack of l
16 passing regulations.
The point you're making is that 17 up front we have the largest stick.
Before somebody 18 wants an agreement state, an ability to carry on the 4
19 functions as an agreement state, clearly they have to i
20 fill in all the right squares.
They have to have all i
21 of the proper regulations, they have to have even the 22 staff.
All of those are put in the Federal Recistel.
s 23 Everybody is notified as to the quality of the state 24 before we enter into the agreement.
25 In both the legislation, Atomic Energy NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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53 1
Act, and in our agreements that we sign with those 2
various states, there is the best efforts clause where I
3 you have achieved both adequacy and compatibility j
4 before becoming an agreement state and then we use our 5
best ef forts, it's in those two documents., to maintain 4
6 adequacy and compatibility.
7 COMMISSIONER CURTISS:
Yes, but on the 8
compatibility front, it sounds to me like it requires 9
some sort of affirmative action by the state --
10 MR. KAMMERER:
Yes.
J 11 COMMISSIONER CURTISS: -- rather than just 12 not passing a budget or letting things develop to the 13 point where they're inadequate.
It requires some 14 affirmative action to change a regulation or to modify 15 a statute that we have previously evaluated in the 16-context of our compatibility review?
17 MR. KAMMERER:
No, as we come up with new I
18 regulations.
19 MR.
THOMPSON:
We will change our 20 regulations. In each one of those regulations that we 21 change, we evaluate whether we require the state to 22 adopt exactly the same regulations or they can have 23 one more stringent or we would just encourage them to 24 do it but not make it a requirement.
i 25 COMMISSIONER CURTISS:
Then the l
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J 54 i
i a
i 1
incompatibility rises potentially.when a state does
)
2=
not adopt regulations af ter the program is originally
[
3 approved?
i 4
MR. THOMPSON:
Correct.
And some states J
l 5
have a
much more cumbersome process-to adopt j
6 regulations than we do.
7 COMMISSIONER CURTISS:
Okay.
I f
8 MR. KAMMERER:
That's why we allow-three t
i 9
years for adoption of new regulations that are i
10 required for compatibility.
When there are problems l
)
11 in a state program, in the states programs, the Office i
l 12 of State Programs documents'the finding with a letter l
13 to the appropriate state officials and then meets with l
l 14 senior officials in the Executive Branch and in'some l
15 cases to the governor of the-state to expedite the l
16
- changes, i
f 17 I brought up the recent Iowa. example as a 18 good one to feature.
The regional administrator and-19 I participated in an excellent briefing conducted by~.
20 the regional state agreements. officer in the State.of-21 Iowa. The state radiation control program manager and-i i
22 two-senior levels above him were - present at-that' i
23 meeting.
I spoke to the governor and to-his staff and
[.
24 Jim Taylor signed our detailed findings letter-to the 25 governor.
So, we put a-lot of attention on making l
5 NEAL R.-GROSS COURT REPORTERS AND TRANSCRIBERS 1323'RHOOE ISLAND AVENUE, N W.
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t J
55 1
sure that to the extent that we can that changes are 2
made.
3 (Slide)
Slide 7 are observations and 4
recommendations for further review.
5 COMMISSIONER ROGERS:-
Defore you go to i 4 6
that, Carl, just on the slide with your data on it, 7
two questions.
One is the labeling of the columns.
8 I'm a little confused here on the column labeled A.
9 Is that number that are found adequate or is it what s
10 it says it is, compatibility, that are compatible?
11 MR. KAMMERER:
It is adequacy.
The first 12 one are the adequacy and compatibility.
The second 13 one --
i
)
14 COMMISSIONER ROGERS:
The next one is 15 adequate.
16 MR.
KAMMERER:
And the last one is 17 findings withheld.
18 COMMISSIONER ROGERS:
All right.
So, the 19 explanation at the bottom is a little in error there,
.s 20 that A doesn't mean compatibility.
4 21 MR. KAMMERER:
Very well.
22 COMMISSIONER ROGERS:
But that's just to 23 clarify the meaning of those columns.
But have you 24 found that any of the programs that have not -- are 25 there any programs that have been found not to be 4
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56 1
compatible that the incompatibility resides in the i
2 medical area?
You're talking here about general 3
everything, all of our --
4 MR. KAMMERER:
I would think that that 5
answer is no because the agreement states have not had to be compatible with that regulation.
The date was 6
7 1990 and then the new quality management rule is not 8
going to be until 1995.
9 COMMISSIONER ROGERS:
That's right.
But i
10 are there any other areas where there's an 11 incompatibility in the medical --
12 MR. KAMMERER:
The State of Washington?
13 There may be a state that doesn't have the rule, the 14 State of Washington.
I'm not quite sure.
15 COMMISSIONER ROGERS:
Well, it would be 16 interesting to know whether the lack of compatibility, 17 wherever it is, includes the medical area and how many 18 of those states?
19 MR. KAMMERER:
I'11 have to get that.
20 COMMISSIONER ROGERS:
On whether it's 21 basically in the materials area rather than the 22 medical area?
'23 MR. TAYLOR:
We'll get that.
24 COMMISSIONER ROGERS: Yes, I'd like to see 25 that number.
l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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1 COMMISSIONER CURTISS: At the briefing on 2
the 29th, when we get into this in more detail, and 3
going back to the question that I raised earlier, it j
4 might be helpful, maybe even off line, to explain to 5
me how we end up in a situation that I think we have
(
6 in Utah where the program in one respect has not been 7
declared to be compatible, but they have their 8
authority and it wasn't a result of anything that we
{
9 adopted subsequent to the approval of the Utah i
10 agreement.
I don't want to pursue it in detail here, 11 but I raised the earlier question because it does seem 12 to me that in that particular case we have a situation 13 where with respect to the land ownership issue this is 14 not medical, it's low-level waste, we've got a program j
15 that concerns us from a compatibility standpoint but 16 not as a result of something that we subsequently 17 adopted af ter the Utah agreement was approved. We can 18 pursue that in more detail, but I don't know why that i
19 is.
20 MR. KAMMERER: So, in the observations and l
21 recommendations, we offer the following.
22 Compatibility issue clearly needs to be addresred. We 23 need to look at the wrongdoer rule.
We also need to 24 look at alternative regulatory measures which will 25 shorten the time it takes for states to implement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W.
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58 1
significant regulatory improvements pending the f
2 codification of the rules.
What I'm thinking about 3
here is we've recently learned about the alarm rate 4
meter and the great improvements that are made there, 5
and perhaps one of the ways we can get a quicker i
6 turnaround here is to have agreement states encourage l
7 agreement states to use license conditions or 8
something like that while they still go on the 9
business of getting their rules in shape.
i a
10 It would be useful to have a national 11 database to track incidents and misadministrations and 12 we will review our policies for the withholding of 4
13
- findings, some of the points that you've made, 1
14 Commissioner, of the adequacy and compatibility. Then f
15 also we'll completely review 'all of our procedures 16 and, of course, there are a lot more lessons to learn 17 from this information gathering.
18 CHAIRMAN SELIN:
Before we get off this, 19 I would just like to _ make a couple of general l
20 comments.
There have been a number of reviews, GAO 21 review, et cetera, both our own materials program and.
4 22 the medical program.
Without getting too deeply into 23 it, the two findings that seem to have happened with 24 the agreement program that resonate quite strongly, 25 the first is that, as you've indicated indirectly, Mr.
H i
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l 59' 4-1 Kammerer,-in-the past we've concentrated mostly on the L
2-process _ and not on the results.
We've-kept good track j.
i i
3
'of whether. people do their inspections in' time and 1
4 whether.they-have training, but not what the results 5
l 5
are and haven't really done comparisons state to state 5 4 6
or agreement
'versus non-agreement on, say,-
'7 misadministration rates or other things like that.
f i
8 MR. KAMMERER:
Exactly.
i I
I
-- it's to be 9
-CHAIRMAN SELIN:
I think 4
{
10 commended that you start using these data on a regular i
{
11 basis, et cetera.
I j
12 MR. KAMMERER:
I concur.
i 13 CHAIRMAN SELIN:
The second is" that I 14
-guess people like deterrents to be used every now and t
l 15 then because it's been noted that :we've never i
16 disqualified a program one way or another.
I-don't-i 17 think your objective should be to disqualify programs,-
18 but there'is some question'.
i
}
19 On the other,;- hand, - some' of the outside I
20
~ criticisms h a'v e b e e n that we do-. more of a job of i
21 reviewing the agreement state programs than we.do of-i C
22 reviewing our own programs in a systematic wayyabout-23
'how late are inspections, h'ow well do people carry out 1-j 24 the processes and this all suggests-the desirability l
25 of,. on the one hand, doing-some more performance l
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l t'
60 i
{
1 oriented work in the state programs; on the other hand t
2 having somewhat more equivalent rules unless there's 3
really a clear differerace about why the. state shouM -
i 4
be expected to do something that -we don't expect-l_
5 ourselves to do.
But the end results'do have to be l
6 programs which at least at a certain level are less-t 1-7 different from agreement states to our own states.
i 8
The last thing I'd just like to say-is of l-9 all the things that should: have a - high level-.~of 4
l 10 regional variation and where we should probably go l
I think enforcement is one:
11 with a fairly light foot, j
12 of them because if the role of enforcement. is.to i
13 deter, presumably the agreement _ states have a much j
14 closer idea than we-do in. Washington or in. the l
15 regional offices about what deters and what doesn't 16 deter. the licensees.
So,
-a high degree of 1
17 compatibility might not be called for in the l
18 enforcement program.
The. key thing.is'the results,
!~
t 19 not saying if you do something_you will pay the same i.
20 penalty whether you're in Alabama or in New' York.
i f-21 But that was very interesting.
i:
j 22 MR.
KAMMERER:-
. Well,- : thank you.
LYou-o e
i
[
23 touched on one-point there that I'd -like to just i..'
j 24 exp'and upon a little bit and it_says that we've.never-i j
25 taken a program back.
While that'is-true, the Idaho-NEAL R. GROSS -
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61 1
example is, I believe, an excellent example, absent j
2 written procedures for sure, of just what to do to 3
assure that the citizens of the State of Idaho are 4
4 well protected.
5 In reading that documented file of a 6
couple of inches thick, there are a great number of 7
letters back and forth between myself. and various 8
officials in the government there, in talking with the 9
governor himself and the clear thing we were trying to 10 establish over a long period of time to be sure is for 1
11 that chief executive to make the decision, do I want i
12 the program or don't I?
Then in the case if I do, 13 what are the things that I need to do in order to get l
14 a quality program back on track?
And if I don't, we 15 let them know what that alternative is and I think the 16 last piece that encouraged the decision to be made 17 rather quickly was sending our letter over that said, 18 "In 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> we want to hear what your plan is."
We 19 gave them an extension for a couple of weeks, but the 20 decision ca.ae back the other way and were prepared 21 with a Commission paper to come to the Commission. We o
22 didn't start action right then.
We'd been doing it 23 all along and it was before the Commission in a matter 1
24 of a few days and the decision was agreed to.
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62 1
3
}
1 responsibility and do the job.
e i
2 MR. THOMPSON:
I'd like to respond.
I 1
3 agree with you, Mr. Chairman, and I'll be working with l
4 both State Programs and NMSS to evaluate and try to i
f j
5 take the best part of both of the program reviews and 3
4 6
make t sure that we apply those to evaluating both 7
programs and where there are differences we understand h
8 and can justify why don't we take a different approach l
l 9
to those.
That's part of the process we learned from i
{
10 this, as well as from the GAO effort.
11 COMMISSIONER REMICK:
Before proceeding, i
i l
12 I have a question that I'm hoping the General Counsel i
l.
13 can help me out-on and if not today, perhaps l
l 14-subsequently.
As I read Section-274, and I see words 15 that when we agree'to an agreement state status, that i
16 that's a discontinuance of the Commission's regulatory l
17 authority and those to me are very strong words, but i
f 18 at the same time I. realize 'we have some-oversight i.
h 19 responsibility.
Is there any. easily defined line of I
20 what is~ our authority-once we agree to agreement state 21 status?
22 MR. PARLER:
Our authority is, as you 23 pointed out, discontinued.
The maximum leverage is I
24 before the agreement'is executed"to' discontinue the 25 authority. After the agreement is entered into ~and if l
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1 thereafter for whatever reason the program 2
deteriorates to such an extent that in this Agency's 3
judgment the responsibilities are not being carried 4
out to protect the citizens in the state and the 5-public health and safety, there is a procedure that is 6
set forth in Section 274 of the Atomic Energy Act to 7
reacquire the authority which has been discontinued to 8
the state.
9 That is a part of the background, I think, 10 that Mr. Kammerer was talking about for the state, but 11 the thing was worked out without having to go through 12 the process that is called for by 274.
13
- However, since the authority is 14 discontinued, it cannot easily be taken back just 15
- because, say, the Commission might think on a
16 particular day that the program is not adequate and as 17 of that day the program should be reacquired.
There 18 is a discipline process that has to be gone through.
19 MR.
KAMMERER:
Commissioner
- Remick, 20 there's one more thing to add to Bill's point.
21 COMMISSIONER REMICK:
Yes.
22 MR. KAMMERER:
The legislation requires 23 that we periodically review the agreement states.
So, 24 we still have a responsibility in that.
25 COMMISSIONER REMICK:
I agree.
No, I
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1 64.
i The point I was really trying to get j
1 agree with that.
i I
2 at, I asked the question have we ever initiated a 3
special investigation on our own in an agreement state
{
1 l
4 or have we ever hired a consultant to go look at-an.
l 5
incident in a state without being requested.. I assume i
I 6
we would not have the authority to-do that.
l j
7 MR. PARLER:
There is -- I think that if f
l 8
we believe that there is something that needs to be i
9 examined to see whether the overall authority that we
?
10 have, which includes the authority to discontinue l
11 authority in specific areas, whether=the stewardship i
i 12 over that which has been discontinued is adequate, i
l 13 that we could do that.
There have been -- there was 14 a situation some years ago,'the details of which I'am
[
15 not familiar with, but within the State of New Mexico l
16 about a mine or a mill.
The situation there'was such l
17 that I think that that was examined in cooperation i
f 18 with the states and an agreed to resolution'of'the i
i 19 problem was reached.
l 20 I think yes, we could-do that, but not j
21 frequently.
22 MR. TAYLOR: I can recount one event which i
23 was at an irradiator in Georgia a few years.back, an 24 agreement state.
Late in the day, in the evening --
j 25 this was the cesium capsule issue.
We were in
{
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discussion with the state, but we became concerned 2
~that appropriate surveys had not been taken at the.
3 exit of the irradiator and there' were not state 4
personnel available to do the surveys.
.I ma6e the 5
decision and informed the state that we had people and 4
6 we sent people out.that night to. take surveys, 7
contamination surveys-outside because this was in an i
8 industrial. park and we: were concerned.that.any 9
contamination, cesium, might be tracked further.-
So, 10 we acted.
In that case, the state did not have, for 11 some reason or the other I can't recall, but we moved.
12 that night with our own equipment, did a survey, of 13 course advised the state promptly and worked'together-14 with the state for the remainder'of.:our involvement 15 there.
16 COMMISSIONER REMICK:
I'm glad to-hear 17 that.
18 MR. TAYLOR:
It would be rare, but I think 19 in that case we did act in;the public interest.
20 MR. PARLER:
I would think that in any 21 cxample such as this where.the event that'is being-22 examined could have interstate consequences as:far as-23 the protection of the public health and safety is 24 concerned, that this Agency vnuld have authority and 25 an role to play.
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1
. COMMISSIONER REMICK:
Thank you.
l I
i 2
' MR. BERNERO:
(Slide)
I'd like to resume, 3
if I could have slide 14..
4 The Cleveland Plain Dealer series 5
addressed these issues extensively in the - month of I
+
6 December.
i j
7 COMMISSIONER REMICK:
Comment to staff.
t 8
Numbers on the pages would be helpful.
[
9 MR.. BERNERO:
Y e s,.. m y. r e g r e t s. t h a t-I f
10 didn't.
They're handwritten numbers I'm using.
It's-I' 11
-the onc Cleveland Plain Dealer series title.
f, 12 Much of what we've already said speaks to 13 the principal issues raised in that series, but I'd-14 just like to summarize'the issues here.and hit some h
15 highlights on them before we get to our conclusions or i
16 observations.
i 17 Basically, we see the. series as focusing 18 on us and the agreement states in three -general e
i 1.
-19 categories or three general issues,_ the-first being.
l_
20 oversight. - The oversight issue being characterized as i-
[
21 small resources are dedicated to'the medical program, i
l 22 not.enough people, not enough expertise: presumably, 23
-that fines are small, that the amount is'too sm'all-to i
a 24-be significant, that lthere's no follow-up on 25 wrongdoers, people who have - done something wrong.
i NEAL-R. GROSS l
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- s. -
5 -
67 Ll-1 There.is inadequate reporting, that information isn't.
j
(-
i 2
shared with the
- states, that general oversight I
3 challenge.
4 The'second issue concerned: follow-up-of
(
5 patients subject.to misadministration and.the argument l*
1 l
6 being that we didn't know about the consequences, that-1 l-7 it raised the question of our responsibility to focus 8
not only on the circumstances of misadministration but i'
9 the con' sequences, especially following the' patient to i
10 determine did the patient -ultimately die. of the-11 radiation.
That. in particular' on the Riverside
{
}
12 Hospital-events, and thirdly.the expansion of theLNRC i
13 regulatory purview, the article series had a. gcod 14 number of incidents that.
were with linear 15 accelerators, whic'. are used for teletherapy purposes, 16 and as I recall it even said.that we repeatedly 17 refused to regulate such devices.
l 18 (Slide)' So, if I could just take the next 19 slide and touch-on the three issues,-just highlight-l 20 some of the concerns, the-NRC and agreement : state iU 21 oversight, Carl has-just -explained to you. the i
22 agreement states so my. remarks are going to focus on-j 23 NRC as a pattern.
3 t
24 First of all, as far as the! resources we 25 dedicate to this, we told you-in the Commission paper i-
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68 I
we just'sent up that we have'74 individuals in staff.
j i
j 2
directly involved.
This-is licensing and-inspection j
i i
3 and, you know, support individuals, dedicated to the s
i 4
extent that 41 full-time equivalents per - year are -
i.
5 dedicated to the regulation of nuclear medicine. That-4 1
6 is approximately one-third of-our materials regulation 2
7 program and they constitute approximately ono+ third of i
l 8
our materials licenses.
9 We also.have about a million dollars in 10 program support to assist in medical regulation. Now, 11 these are fairly well-qualified people.
We have,-as 12 you know, a medical ~ doctor on staff as a-visiting 13 fellow,' but our own staf f are non-medical-doctors,' but 14 many of them have advanced degrees including doctorate j-15 degrees.
They're generally health physicir:ts or' 16 physicists.
And we retain medical consultants,' of 17 course, as we were discussing earlier.--
i I
18 Our inspection activities are'--
I f
19 COMMISSIONER de PLANQUE:
Bob?-
20 MR. BERNERO:
Yes?
l 21 COMMISSIONER - de ' PLANQUE:
Before ' you -'go -
l
~
22 off the FTEs,'does that-41 include the FTEs required-23 to oversee the agreement states medical program or is-i j
-24
-that an additional --
i l
25 MR.
BERNERO:
No, no.
This is our-NEAL R. GROSS 1
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program.
2 Now, our inspection activities --
3 CHAIRMAN SELIN:
That's one FTE for every 4
50 licensees is basically what it works out to.
i 5
MR. BERNERO:
Yes.
o 4
6 CHAIRMAN SELIN:
And how many therapeutic 7
administrations are you talking about?
8 MR.
CUNNINGHAM:
In round
- numbers, 9
200,000.
10 MR. BERNERO:
Yes, something like that.
)
11 MR. CUNNINGHAM:
Roughly.
4 12 COMMISSIONER de PLANQUE:
That's nation-13 wide?
s 14 MR. BERNERO:
Yes, nation-wide estimates, 15 and yc.u'd say a third of them are in -- that's a very 16 crude estimate, because, as Carl Kammerer showed you, 17 the four big population states are agreement states, 18 so that I would tend to lean toward more like a 19 quarter.
o 20 CHAIRMAN SELIN: Well, it's a third of the 21 license -- we have a third of the licensees.
Maybe we 22 have a third of them.
23 MR. BERNERO:
Yes.
It depends on which 24 one you would use.
25 CHAIRMAN SELIN:
Okay.
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MR.
BERNERO:
But we do scale our i
2 inspection priority anywhere from a nominal annual-3 basis of inspection to every four years depending on 4
the size of the activity, a broad license, a big 5
facility versus a small community hospital or an s
6 individual licensee.
Frequently we have to use i
7 specific judgment to scale that, because it is 8
possible to have individual licensees who are going 9
bankrupt or aging, you know, elderly doctors who have 10 sources, teletherapy machines where you have to give 4
11 a lot of extra attention.
But, as a general rule, we 12 scale the inspection frequency to the size or scope of i
13 their licensed activity.
14 And then, of course, we do have extensive 15 enforcement and investigation activities, so in 16 general I would respond to the challenge that there is l
17 inadequate oversight as saying we do have extensive 18 oversight.
It isn't dozens and dozens of inspectors l
19 for any one state.
We review this every year through 20 the process.
It's an allocation of resources process 21 and we have to make that judgment every year and from 22-time to time we do shift and increase the emphasis or 23 increase the inspection frequency or something like 24 that.
25 (Slide)
If I could turn to slide 16 and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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just touch on the follow-up with patients, we talked
)
2 about this quite a ' bit before.
I would recall-for you 3
that misadministration reporting has-been a-4 requirement for NRC licensees now for 13 years and the 5
agreement states have come' into it more recently._ The 4
6 data that are available, you will see, for agreement 7
states cover only-one year.
They're really in the 8
misadministration reporting start-up mode, whereas NRC 9
has a longer period of reporting.
10 Mr.
- Chairman,
-you referred to the 11 notification data, you know, their reporting data as 12 being fairly sparse, 10-8 or lod annual frequencyfis.
13 our best estimate, somewhere in there, and they're not 14 many.
And when you start looking at individual 15 states, I would just say with a caution that it's very 16 hard to get meaningful data at these l'ow numbers or 17 sparse figures.
4 18 We do require in misadministration-19 reporting that the misadministration be reported to 20 the patient or to the referring physician and giving 21 the referring physician the --option to withhold the 22 information from the patient if it's deemed. medically-23 justifiable.
We do follow up on.that.
We try to 24 follow up to make sure that those notifications are 25 made and,. similarly, we have the procedure that I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE.- N.W.
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72 1
referred to earlier of reporting exposures to people.
4 f
2 You know, we have clear regulations for 4
3 reporting exposures of workers within a licensed 4
operation, but where inadvertent exposure victims, 5
victims of inadvertent exposure from a
source s
6 traveling across the country in a truck that fell out 7
of its shield or, in the case of this more recent 8
incident in Indiana, Pennsylvania, other residents of J
9 the nursing home that were inadvertently exposed, we j
10 have a less rigorous process, for sure, for notifying 11 those people. We often use the medical consultants to 12 do that and --
13 CHAIRMAN SELIN:
Can you just stop for a 14 second?
l 15 Mr.
- Kammerer, is it a requirement of 16 agreement states that they also require that patients l
17 in the agreement states be notified if there's been a l
18 misadministration, what the amount is and the likely 19 medical effect?
20 MR. KAMMERER:
I don't know that fine l
21 detail, but the answer is yes for notification.
22 CHAIRMAN SELIN:
See, I was struck.
It's 23 truly anecdotal and the Riverside event was a long 24 time
- ago, but basically the government stopped 25 investigating what happened to the patients when we NEAL R. GROSS I
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had enough information to say that there was a serious 2
problem, rather than saying we should look at each-3 patient to see if anything should be --
4 MR.
PARLER:
Mr.
- Chairman, a
prior 1
5 chairman of this agency told the Congress that they 6
were going to look at each-patient.
I just thought-I 7
would bring that out to you, sir.
8 CHAIRMAN SELIN:
Well, that's a long time 9
ago.
10 MR. PARLER:
Right.
11 CHAIRMAN SELIN: ' So the question is, do we 12 do that now?
There was also a case that was. brought l
13 up in an agreement state where an agreement was made 14 between the hospital and somebody else and one of the 15 conditions was that the information effectively not be 16 given to the patients.
N o w,- things happen.
I 17 understand that they can-happen',- but one of the things e
18 I'm concerned about is how systematically we follow up 19 on the follow-up provision both in NRC licensees. The 20 policy is clear, but the practice is not so clear to 21 me.
22 MR.
BERNERO:
-.Well, I would question.
23 whether we have a clear statement of the purpose and 24 the extent of our follow-up for patients.
Are we 25 stopping at the point o f -- e n s u r i n g that they-are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS..
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.~ --
1 I.
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-74 i
i 1
notified or are we continuing to observe.the patient-1 I
2 or.to monitor the patient's progress toward ensuring i
3 appropriate medical care? We are not doing. the later.
4 CHAIRMAN SELIN:
Without getting into the
[
5 later, it's just clear that we do have an obligation 4
6 to do the fcrmer.
4 7
MR. BERNERO:
Yes.
8 CHAIRMAN SELIN:
And one'of the question i
9 I hope you review answers us whether we can be assured 10 that we are systematically ' doing the former.
The-1 11 later one, when you make a recommendation what you i
12 think we ought to do, -then the ' Commission will j.
13 probably speak on what it believes ought to.be done.
l 14 MR. BERNERO:
Yes,.indeed.
The'way I l
15 would put it is we have to have a sharp definition of 16 what our scope of follow-up and the extent and purpose i
17 of that. follow-up is and that the procedures..are being' i
18
. rigorously-followed.
19 I was using the_ example a few minutes ago-l 20 about reporting extraneous,-
that is non-patient j.
21 exposures.
That is-in a real state of confusion for
[.'
22.
us right now, because we don't have a rigorous system i
[
23 of who-does what, who reports _it.
.But the follow-up I
24 of the patients as we saw at Riverside and-as we'see i
25
' even in cases today; we don't have a long-term medical l-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS -
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follow-up.
We have an arrangement whereby on a 2
voluntary basis a patient may be monitored in an 3
epidemiological program, but the NRC does not have a 4
clear procedure for long-term follow-up.
5 COMMISSIONER CURTISS: Bob, could I pursue 6
that?
There are two discrete questions here that I j
7 think we're talking about and there's some confusion.
We have a policy that provides for initial l
8 1
}
9 notification of the patient and that policy I think is l.
10 one that's well-established and I think reaffirmed in 11 the QM rule.
There's a separate, maybe related, but 5
12 nevertheless a
separate
- issue, and I
think Mr.
13 Parler's comment touched on this question, and that is 14 what is our obligation with respect to following up on 15 a
patient who has been the subject of a
16 misadministration from the standpoint of beyond i
17 initial notification?
i 18 The policy, as I understand it, and it's 19 a relatively old policy but it is a policy that in the 20 exchange of communications back in the late '70s seem 21 to s: Jgest clearly what the policy was, is that we 22 follow up on the patients to the extent necessary to 23 carry out our regulatory responsibilities.
Now that 24 may not require us, the argument goes, to follow up 25 with respect to each patient to ensure that they get NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS t
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adequate medical care.
That might be the doctor's 2
responsibility, some would argue.
Nor does it
~
3 require, and the Cleveland Plain Dealer series focused 4
in particular-on this point'in a-critical way, nor 5
does it require, the argument goes, for us to follow s
6 up on each patient to determine whether, in the event 7
of death, as everybody will at some point encounter, 8
that death was-caused by the misadministration that 9
occurred and that the patient under the current policy 10 would be informed of.
11 I guess my question here at this point is 12 really twofold.
I read the discussion in the SECY 13-rsper and it goes on for some length beginning on page 14 14.
I read that discussion as laying out several pros 15 and cons of what you call long-term patient follow-up 16 with perhaps a heavier emphasis on the cons, but i
17 nevertheless a discussion of the pros and cons of 18 long-term patient follow-up.
19 Now, my questions are really two-fold.
20 One, this is a paper which the Office of 21 General Counsel has concurred in.-
22 MR.
PARLER:
- Well, there's no legal 23-objection to it.
24 COMMISSIONER CURTISS:
I guess the first 25 question -- I'm sorry, no objection to the paper.
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{
1 MR. PARLER:
That position was arrived at 2
after much internal effort and discussion and I
3 qualifications in the words.
4 COMMISSIONER CURTISS:
Us lawyers need to S
be careful about the terms we use.
is 6
MR. PARLER:
That means that all of the i
7 facts and stuff in here about what is going on for 8
current practices, these numbers from agreement i
9 states, et cetera, I cannot vouch for those.
10 COMMISSIONER CURTISS:
Okay.
11 MR. PARLER:
Given the input that we had j
l 12 and what these folks say that they are embarked on J
13 doing, I have no legal objection to that.
i 14 COMMISSIONER CURTISS:
Okay.
I had a 15 specific question.
Maybe it picks up on that point.
16 In laying out the pros and cons of long-term patient i
17 follow-up in the development of the policy in this 18 area and in suggesting, as I think you're going to, I
i 19 that this be something that would be evaluated by an 20 external group, do I infer from what ve have before us 21 that the question is basically a policy question and l
22 that we have a range of legal options ranging from 23 what I've just described as the policy in the late 24
'70s to something much more aggressive?
Essentially, f
25 it comes down to a policy question?
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MR.
PARLER:
Certainly the near-term 2
- actions, as distinct from the longer-term actions l
3 where your characterization was the same as my 4
understanding that perhaps for the longer-term the 1
5 cons were presented with greater weight than the 4
6 advantages, what governs me is that the Commission has l
t i
7 decided unequivocally that the patients have a right 2
8 to know when they have been involved in a serious l
9 misadministration, unless this information would be l
10 harmful to them.
There's nothing ambiguous about I
11 that.
That has been the policy that this Commission 4
12 has adopted since 1980.
And even before that policy 1
13 was adopted, the Commission prior to that time airy sed 1
l 14 the Congress in a particular situation that it would I
15 indeed follow up on patients that were involved in a serious misadministration.
16 i
17 COMMISSIONER CURTISS:
Inform the patient l
18 that they had -- or the referring physician?
19 MR. PARLER:
Yes.
l 20 COMMISSIONER CURTISS:
But the question 21 that I'm raising and the reason I make the distinction 22 between the two is because there in a dif ference in my
)
23 view between the initial notifir.;ation, which I think 24 you've summarized as I understand it, and the question 25 of whether we have an obligation, legal, or whether 4
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I 79 1
1 1
it's a policy choice for what you refer to in this
[
i 2
paper as long-term, after the initial-notification, 1
3 long-term patient follow-up to the point even of I
4 determining through, let's say, an autopsy what that i
j _
5 patient died of.
1 4 6
MR. PARLER: Well, whatever it is that the
]*
7 Commission believes, at least in my judgment, that I
8 they have to do to make sure that the patients who j
9 have been involved in a serious misadministration have i
10 been given adequate knowledge that the Commission has 11 gotten about the situation.
When you go beyond that, f
12 then I don't think there are any-legal requirements i
1 13 that are involved over the long-term.
That's why in 14 this paper there's a sentence added that, for_the 15 short-term things, that the General Counsel, the OGC, l
16 believes that these arguments for the notification and l
17 the advice and so forth are persuasiva.
18 CHAIRMAN SELIN:
Do you want to hear Mr.
3 1
19 Bernero's answer?
20 MR. BERNERO:
I would just like to add, by a
- f. -
21 the way, the citation that Bill Parler just made is i
22 low on page 16, if you wanted _to refer to it, about 23 that being persuasive for the short-term.
4 4
i 24 In order to respond to.the question, I 25 would like to put it in a framework and go back to the I
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1 80 1
1 Riverside Hospital incident and the confused history i
2 that followed it and ending with Doctor Polycove's 3
memorandum about what was the final count, you know, 4
the three categories of deaths attributable to that i
1 5
series of misadministrations.
6 In the original follow-up, the short-term 7
follow-up, our medical consultants were looking at j
f 8
pathology and following the cases and got to two 9
deaths which clearly established the gravity of the f
10 misadministration.
This was a
very serious I
1 11 misadministration or series of misadministrations and l
12 they got to two deaths and that, in my mind, is a way 13 for the Commission to say, "Yes, we know this is 14 serious.
The consequences are grave of this sort of 15 mistake or misadministration."
16
- Then, if you go through that l
17 correspondence, you can see the confusion.
"Where are i
18 we going to get the people and who's going to do it 19 and do we do autopsies and what-have-you?"
The j
20 follow-up which came and was summarized in Doctor i
21 Polycove's report -- not that we did the follow-up, 22 but the way it was done -- said, " Ultimately one can 23 categorize all of the victims of misadministration as 24 ones who died of the original cancer, ones who died of 25 the cancer but quite probably with a significant i
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contribution or deleterious effect of the over-2 irradiation, and lastly those who died of over-1 3
exposure."
^
4 And you may recall that even in one of 1
le 5
those cases -- I think you questioned it some time 6
ago, Mr. Chairman -- we ' re talking about something 7
like 25 to 50 percent over-exposure, not a real big 8
leap.
You know, you're dealing with high radiation 4
9 right on the threshold of very serious damage to the 10 person because you're trying to damage the tumor. Now 11 in that context I would say that, from what we learned
)
12 from General Counsel, the short-term arguments are 13 persuasive.
Yes, that's clearly a legal obligation 14 and we don't question that at all.
15 But the long-term follow-up is something 16 that I think the Commission would want to make as a 17 policy choice, look at the alternatives and then turn 18 and ask General Counsel in that context, "Is this a 19 good idea or is this a viable alternative? Do we have 20 either the legal authority or the legal compalsion to 21 do it?"
22 COMMISSIONER CURTISS: The reason I raised 4
23 the question, and I think it's clear that after we 24 originally notify the patient, which is legally 25 required and there's no disagreement about the 4
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question that arises as to what extent do we undertake 2
a long-term follow-up of individual patients, if we 3
have a legal obligation to do something-more than what-4 we're doing right now, I personally wouldn't support 5
referring this to an outside group to examine the pros s
6 and cons, if we've got something that we need to be 7
doing that we're not currently doing right now.
I 8
don't understand Mr. Parler to be saying that.
9 And so the remaining question,-then, is 10 whether in examining the pros and cons and defining.
11 the extent to which we would pursue long-term patient-12 follow-up whether there's a question about our legal 13 authority,- not our legal compulsion but our legal 14 authority to extend beyond what we have defined to 15 date as the purpose of our role.
16 MR. PARLER:
May I say something or not?
17 CHAIRMAN SELIN: You certainly may and, if j
18 Commissioner de Planque agrees, you may do.so right 19 now.
Please do.
20 MR. PARLER:
These longer-term things are 21 good questions.
One of my problems is that I have not 22 been able to clearly understand what our-practice has 23 been for_the short-term, whether in_this. event __where 24 there were 400 people that presumably suffered Eterious 25 misadministration were they notified.
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notified about, et cetera?
That's what bothers me, 2
sir.
3 COMMISSIONER de PLANQUE:
It's still not 4
even clear to me if we can answer the question. Where 5
there has been a
misadministration, is there a
e 6
radiation-related harm or death as a result?
7 CHAIRMAN SELIN I'd like to follow up on 8
that observation, if I might.
There are two things 9
that I'm concerned about in addition to the questions 10 that commissioner Curtiss raised.
One is this 11 distinction between short and long-term isn't as clear 12 as it sounds.
13 For
- instance, i'
there was a
14 misadministration and we tell the patient what it was 15 and how much it was, et cetera, that might let us off 16 the hook in general.
But if you know that a couple of 17 people have been killed, you might have a very 18 different view of when you have enough information in 19 the short-run, in other words whether just knowing the o
20 radiation at that point is enough or whether you need 21 to monitor for a while even to meet the "short-term."
22 23 When you do your review, I'd like you to 24 do two things we haven't discussed.
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84
.i 1
that.says, particularly in the case of a therapeutic 2
misadministration, that the patient must be apprised i
)
3 of the misadministration no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> af ter q
l 4
its discovery unless, A, the referring physician says j
i 5
he'll do something or other or, B,
based on the t
6 medical
- judgment, telling the patient would be 7
harmful.
'l 8
I've heard from anecdotal information that 9
we've taken too generous a view as to when the patient 10 need not be told, in other words somebody saying, "Oh, 4
11 don't worry about it.
It wasn't such a big deal," et 12 cetera.
I mean, the statement is very clear that 4
13 somebody has to say it would be harmful to tell the 14 patient.
The patient is in such a delicate frame of 15 mind that telling that patient at this point might 16 impede his or her recovery.
17 Would you look in practice to see if we've 18 applied that tough a standard or we've been put off by 19 a much more casual standard?
20 COMMISSIONER REMICK:
In what time frame 4
21 would you look at that?
22 CHAIRMAN SELIN:
Whatever reviews --
23 MR.
BERNERO:
In the required 24 notification.
25 CHAIRMAN SELIN:
No, no.
Commissioner NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON. D C 20005 (202) 234-4433
l l
85 l
)
there's no sense in going back to the 1
Remick 2
Riverside event, but when you look at the recent l
3 events have we been pretty rigorous at telling'the.
t 4
patients or do we accept a much lighter excuse for not 1
5 telling the patient than would be called for by the lo L
l 6
rules?
7 MR. TAYLOR:
Go ahead, Hugh.
I think you 8
should --
j 9
MR. THOMPSON:
Yes.
Mr. Chairman,LI just i
10 wanted to make sure'the record reflected'that there i
11 was_ no follow-up reporting requirement-for the t
i 12 patients at Riverside.
We-clearly.have that l
13 responsibility. today and we wouldl clearly do that 14 follow-up.
15 CHAIRMAN SELIN:
No, I'm sorry.
Nothing i
j 16 I was talking about was suggesting _ Riverside.
I just i-l 17 want to make sure when you.look at these cases that l
18 you do a reasonable post-audit about,_if we didn't l
l 19 tell the' patient, that we had what you would today l~
l 20 feel was sufficient --
l lo 21 MR.
BERNERO:
Yes.
In our-current i
j 22
-activities, the way the reporting: requirement is-l-
23 structured,_we are really. deferring to the judgment of 24 the referring physician-to make that conclusion and we i
25 don't override it.
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i i
86 3
1 MR. TAYLOR:
We can get that information i
j 2
for you.
}
f 3
MR. BERNERO:-
We can review that, and 1
4 that's a significant factor.
I 5
CHAIRMAN SELIN:
The second is sort of an j
)
6 analytical suggestion.
When you look at what.you 1
)
7 believe are the pros and the cons of longer-term-i 8
follow-up, I would like you to apply that as if there-3 l
9 were a Riverside.today.
In other words, in a really
~
i
]
10 serious event where a couple of people have been known
~
11 to have been killed, _' don't just take the dry legal i
12 analysis and say what.are our obligations, short-term i~
l 13 versus long-term, but say, if we followed this policy, t
14 what would that tell us about a new Riverside?-
You l
15 know, would we stop after two people?
Would we i
)
16 continue to follow people? So that_ you have a sort of j
17 a meta experiment to say, if we applied this policy, l
i 18 if this case happened today and if we applied this l
19 policy, -is it intuitive ' account or -intuitive that we'd i
20 be coming up with the right answer?
I 21
. I mean,
-I go on the general ~ view, to i
i 22 paraphrase the General Counsel,-that we are obligated i
1 23 due to the short-term involvement.-
. We have vast 1
{
24 authority and therefore, should we choose on a policy 25.
= basi's to do the long-term follow-up, that nobody would i
1 NEAL-R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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87 f
1 say we're not allowed to do it, but that we have I
flexibility about why would we do it and how does it 3
support the regulatory function.
At least, that's my 4
going in view and therefore I'm very interested, as 5
I'm sure the other Commissioners are, in the policy 6
pros and cons as well as legal.
7 MR. BERNERO:
In fact, I was answering 8
Commissioner Curtiss' question citing Riverside 9
because it is.-- not to-rediscover or redo Riverside, 10 but to use it as a hypothetical experiment.
11-CHAIRMAN SELIN:
Right.
12-MR. BERNERO:
If we had it to do over 13 again, what makes-sense?
What would-be sound policy-14 as well as what would be legally required?
15 MR. THOMPSON:
I would like to add one 16 comment in the discussion with respect -- excuse me.
17 CHAIRMAN SELIN:
Commissioner de Planque?
18 COMMISSIONER de PLANQUE: I would also ask i
\\
19 for some clarification of what the situation is in the l*
20 agreement states,-because,-if~you look_on the follow 21 up of patient section and on page 15, it-says, "A
22 special note:
some agreement _ states do follow-up.
)
l 23 inspections after serious---administrations," and it's i
24 not clear to me what the situation-there is in terms i
25 of patient follow up, what's the policy.
l l
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I
)
88 i
)
1 MR. KAMMERER:
It's basically the same as 4
1 4
2 the NRC and there's only, I'm believing, two or three 3
that have gone beyond.
4 CHAIRMAN SELIN:
Mr. Thompson?
i 5
MR.
THOMPSON:
I think there was a
6 question on how far do we go to evaluate.
One of our 7
responsibilities to evaluate the significance of an f
8 over-exposure to the individuals goes to the potential 9
enforcement actions.
Obviously, the death or loss of 9
I 10 an organ elevates the enforcement actions. that we l
11 take, so it is incumbent upon us to evaluate the
~
i i
12 significance of the over-exposures in order for us to i
13 take the appropriate enforcement action.where l
14 appropriate.
15 COMMISSIONER CURTISS: Just an observation l
16 on that.
I mean, if your point here is take 17.
Riverside and you've got 400 people, and I'll defer to i
l 18 the lawyers here on this, or these lawyers, if-the l
19 magnitude or nature of the enforcement action that we i
20 take requires us to understand in a long-term context 21
'beyond the short-term notification and' relatively.
22 limited period of time what-the ultimate disposition h-23
-of-each individual was in terms of-whether there was i
24 a fatality directly attributable to the radiation 25 over-exposure over an extended period of. time, that l
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4 I
(
89 li I
deserves some careful analysis by the enforcement arm
{
2 because it suggests that enforcement action would need a
3 to be deferred until you 've _got that information.
l 4
That almost implies that we've got a. legal obligation I
5 to do long-term follow-up so that we know what the i*
6
_magnitudo is.
7 CHAIRMAN SELIN:
Let's not get too far 8
out.
There are a lot of interesting questions, t
4 9
They're very important policy questions we would;like i-I 10 your advice on, et cetera, taking into account one of i
l 11 the regulatory functions is the enforcement.
-Don't i
12 try to make a judgment whether two fatalities would 13 lead to one enforcement action or four would lead to I
14 another one, but, just as you go through this, take a l
15 look at some real things that_have happened and see 16 what would the results have been had we had these 17-policies at the time and do they match or go against i
l
_18 your intuition as to what good regulation _would be.
l 19 It's clear there's a lot of stuff to'look j-20 at.
I mean, that's the one clear conclusion of this-a.
I 21
--discussion.
j 22 Maybe you'd want _ to continue with-your i
23-analysis of the Plain Dealer --
t-j J
24 MR. BERNERO:
- Yes,
,i j
25 (Slide)
I'd like to go to slide 17 and
}
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just touch on the third major issue, the expansion of 2
our purview.
The Plain Dealer suggested that NRC 3
should regulate all medical uses of radiation, 4
especially linear accelerators, because of the history 5
of mishap with them.
6 how the Cleveland Plain Dealer, as I 7
recall, said we refused repeated requests to regulate 8
that.
We know of no formal request that anyone over 9
made for us to regulate that.
I do note here that the 10 issue of natural and accelerator-produced radioactive 11 material was before the Commission a few years back.
12 We produced a report on that subject to discuss the 13 pros and cons.
It was focused on discrete sources.
14 The Conference of Radiation Control 15 Program directors suggested that we ought to seek 16 regulatory authority over discrete sources, things 17 like radium needles, quite different from linear 18 accelerntors, and we went through a process of self-19 review, discussion with the Commission.
We referred 20 that issue to the CIRRPC, the Committee on Interagency 21 Radiation Research and Policy Coordination, and we 22 have declined to pursue that regulatory authority.
23 CHAIRMAN SELIN:
Commissioner Curtiss has 24 pointed out that either I might be less than clear or 25 I might, God forbid, actually be suggesting something I
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91 3
1 1
that's a bad idea in my remarks.
l 2
I'd like to make clear I'm not saying that 3
part of this review about how far we go beyond the 4
immediate notification has to be part of your internal a
5 review.
Just, you know, you'll come back to us and ae 6
you'll say, "Here are the questions we want to do on 7
the internal review and the external review, et l
}
8 ceters." And when you do that question, I'd like you 9
to follow some of the logic that I put out, but I'm 10 not suggesting that it's necessarily an immediate 11 short-term need to address this question of follow-up i
12 tracking.
We're open to suggestion from the staff.
13 MR. BERNERO:
I'm just going to turn to j
14 the reevaluations.
I think it's a good idea.
15 (Slide)
Slide 18.
I make a somewhat i
16 artificial distinction-here between technical or i
i 17 narrow evaluations and management evaluations of broad 18 programmatic character.
j 19 As an example of the technical evaluations 1
d 20 that I think are important the Commission should be 1
l.
21 aware of, we have a few contracts and technical i
22 activity within the staf f to look at risk analysis and i
23 human factors associated with medical administration.
I 24 The technology changes year by year.
The devices 25 become more powerful, higher energy density you might i
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n.,
-.,..,.-.v.
. -. -.. - _.. ~..-
i 92 l
l 1
say, where more radiation can be deposited on a solid l
2 tumor in a shorter period of time by the use of 1
And we re looking at the human
)
8 3
advanced technology.
4 factors of using such equipment and looking at risk 1
l 5
analysis to see if there are insights there that would
]
6 help us a great deal in how we regulate.
2 7
A word of warning.-
We're looking at B
devices
- and, under the
- law, the Food and Drug 9
Administration has-authority over devices.
We have j
10 authority over how devices are used, and the states 11 have certain authority also, and so it gets to be a 4
12 bit rurky there.
But we're doing technical 4
13 evaluations that can be useful-to all of us, all the i
j 14 regulatory parties.
i l
15 COMMISSIONER REMICK: Along that line, not t
l 16 in the same-vein that you're using risk analysis here, 1
1 17 I understand what you're saying,_but has any thought i
i 18 been given to whether it's practical or not to'have l
19 some kind of overall guidance in the medical area j
j 20 about the concept of a safety goal like we now use in
~
L 21 the reactor area where it helps us at least put things g
22 in perspective?
Has any thought been given on the
-23 practicality? -I realize it might be difficult, but in-1 l
24 the reactor area it was difficult too to come up_with 1-1 l
25 something that might be a goal by which we judge
[
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i 1
93 i
success or lack of success in these areas?
I'm just i
I l
2 asking has thought been given.
I'm not asking you for i
3 a solution.
4 MR. BERNERO:
Just for background, in the 5
debate on the QA rule which ultimately became the QM 4
l 6
rule and the suppression of misadministration rate, in 7
that debate there was a great deal of discussion of i
8 what is the real rate of mishap or misadministration i
9 and why can't it be pushed further toward zero and the i
10 Commission itself was involved in that debate.
The 11 data are sparse.
It's very difficult to make a broad i
12 judgment like that.
4 1
13 We also have been looking and our medical 14 visiting fellows are pulling together the context i
15 mishap rates or error rates or ' fatality rates-16 associated with medical procedures in general.
I 17 think you all realize that simply going under a 18 general anesthetic is a
relatively hazardous l
19 operation.
20 I was advised in my own case.
I took a 21 thallium stress test a little over a year ago and the 22 cardiologist advised me that I had one chance in a 23 thousand of very serious result to-that test, in other 24 words keeling over on the treadmill and dying from the 25 stress.
So we're looking to that as a context for are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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1 we trying to get a safety goal that is unrealistic or L
j 2
that's not achievable.
j 3
COMMISSIONER REMICK:
I i
Is that zero?
Is 4
zero a safety goal?
Is it a risk that is no greater i
5 than other medical procedures?
I'm just questioning.
i j
6 Has anybody given thought if there is a way of 7
approaching this --
j l
8 MR. BERNERO:
Yes, we are giving that l
9 thought.
I 10 COMMISSIONER REMICK:
-- to give.us some i
[
11 perspective on judging on whether we are doing. an j
12 adequate job or not?
1 f
13 MR. BERNERO:-
And-as you said, when I t
i 14 spoke of risk analysis here, I was talking about --
1 4
15 COMMISSIONER REMICK:
I understand.
sensitive engineering 16 MR. BERNERO:,
17 risk analysis of' devices.
i
{-
18 COMMISSIONER REMICK:
That I. understand.
19 You just reminded me of'the question.
l 20 COMMISSIONER de PLANQUE:
May. I. just ' add?.
t i
' 21 COMMISSIONER REMICK:
Yes.
t -
22 COMMISSIONER de PLANQUE:. In that context, l
23
-if you look at the rate of misadministration which, if l-24 my numbers are correct, are about-one in 10,000-for.
f.
25 both diagnostic and therapeutic, that's the. rate of NEAL R. GROSS I'
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1 misadministration.
If you're looking at a comparison j
2 with something like the risk of death from anesthesia, 1
3 it's the death rate or the harm which-is, again, a 3
l 4
significantly lower number --
I l
5 MR. BERNERO:
Exactly.
i 1
6 COMMISSIONER de PLANQUE: -- that you need i
7 to compare.
i l
8 MR. BERNERO:
Yes.
You have to-compare i
9 mishap with mishap, death - with death or whatever i
l 10 consequence.
i 11 CHAIRMAN SELIN:
But at the same-time, i
i 1
l l
12 it's just=the mishaps.
We're not. looking at the 13 places where the prescription-is-intrinsically risky.
l 14 I mean, we're not talking about'the right dose'was l-15 applied but the patient became ill because of that.
{-
16 I mean, it's just a.very small part'that we're looking 17 at.
l 18 MR. BERNERO:
It's a very narrow context.
19 One of the Cleveland Plain Dealer events
!~
20 that was reported in-there was not'
.a 21 misadministration. It was an argument that the doctor 1
22 prescribed too severe a radiation dose to treat the 3
23 cancer and that that led the patientito despair'and I,
24 suicide.
Our system is unable lto discern that.
25 We also have, in technical evaluations of NEAL R. GROSS
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i 96 j
1 the narrow type, incident--investigation reports.
The 4
i 2
brachytherapy incident in Pennsylvania is a salient i
l 3
example.
You'll hear about that shortly.
l 4
(Slide)
If I could turn to slide 19, I'd i
5 like to talk about the more generic programmatic 6
things.
l 7
The Chairman mentioned at the outset-an
.i 8
NRC initiated evaluation.
Last summer in management 1
t i
9 consideration the staff decided that a nuclear medical t
l activities management plan was an appropriato thing to 10 11 do.
In order to clarify our role, try to focus on the 12-safety issues.and pick up many of the things, we 13 developed an issues paper.
The -plan we were 14 following, we informed the Commission last september, i
15 I think, about what'we were doing.
16 We developed a medical issues paper and I
j.
17 have already had extensive discussion of that paper-l 18 with the Advisery Committee on Medical Use of Isotopes 19 last - October, with the agreement states also ' last 4
20
- October, with our regional. staff management. in i
j.
21
. November, last November, and we.'re. proceeding to 22 develop what.we thought was the right. evaluation and i.
23 conclusions to come-forward to the Commission.
24 I must admit'that we did..not have all of
}'
{
25 the right issues with today's perspective, that events
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97
)
I have overtaken that plan to a substantial event, and j
2 the Commission itself has directed us to do further 3
evaluations catching that one in midstream and you've 4
admonished us to coordinate the further evaluations l
5 with this, so we now have what amount to three I'
6 evaluations in process.
This one I would call a line 7
management program management plan.
3 8
(Slide)
And then, if you-turn to slide i
9 20, on December 21st the Commission instructed us to j
10 do two oversight reviews, the first review by HRC I
11 senior management on the effectiveness of the existing 12 program and that one to be particularly coordinated 13 with our own line management one and we're trying to 14 work out just how to do that right now, i
15 And then secondly, a review by an external j
i 16 group, the Commission calling for a review of the l
17 adequacy and appropriateness of the current framework 18 of regulation and, as we said in the paper, we have 19 initiated contact with the National Academy of j
20 Sciences and their broad spectrum of capability.
l, 21 We're looking into that and we believe that we can i
22 come up with an appropriate plan in the near future 23 and of course we'll be coming to the Commission as you 24 requested for how to do that and whethc.r it will serve 25 the purpose you seek.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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So we have three independent audits or 2
three oversight reviews going on all in some sense of 3
coordination, I hope, in the coming months.
I would 4
expect the internal one and the internal NRC manager 5
oversight to have a
time scale of months to 6
completion, whereas the external review would be much, 7
much longer, more like one or two years to review, so 8
we should be prepared for that.
9 (Slide)
Now if I could turn to slide 21 10 and just summarize, in the Commission paper itself wo 11 had a
concluding section that we entitled l
12
" Observations and Further Considerations."
I would 13 just like to highlight that we enumerated in the paper 14 a number of aspects -- Carl Kammerer spoke to some of 15 them -- where analyses of program -effectiveness or 16 needs stand unsatisfied for improvements in program 17 effectiveness.
Those we intend to go forward with, i
18 but I want to single out the two as perhaps the more-s 19 knotty problems that we need to deal with.
20 One is the evaluation of regulation of 23 devices.
This is going to come out especially clear, 22 I think the need will be shown in the IIT review when 23 Carl Papparello reports on that, because that's right 24 at the heart of the affair, the regulation, how the 25 device was regulated.
That's going to - be a very NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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1 1
99 4
1 difficult problem institutionally.
What are the i
2 various agency responsibilities, authorities? Is this i
j 3
the right way to do it and how is the public safety i
2 4
interest best served.
l i
5 And the other is of course what we've
- e i
6 discussed extensively already, the policy for patient j
}*
7 follow-up.
What are we really trying to do? What is i
t 8
the scope?
What is the extent of it?
And I want to l
both 'of. these issues, but 9
try and work that l
i 10 especially that one on patient follow-up -- into the i
l 11 internal reviews and not simply sit back and wait-for l
12 a one to two year external review.
13 CHAIRMAN SELIN:
The first review or the i
1 14 second review?
~
j 15 MR. BERNERO:
Into both, if I can, but we 16 have a tough row to hoe there.
I don't think it would i
17 be proper for the Commission to sit back and say,= "Let 18 an external body take-a year or two to review it
}
f 19 before we pursue the matter."
I think.it's timely.
20 that we do it ourselves.
At least, we certainly want 21 the independent view --
22 CHAIRMAN SELIN: Let me just say one thing -
l 23 to this, Bob.
However you decide to do the policy 1 k
24 thing, I think your first level review has got to at i.
I 25 least_ ascertain what we do today, what we really do-I
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today.
2 MR. BERNERO:
Exactly.
3 CHAIRMAN SELIN:
As opposed to what the 4
papers do today, with some critique there.
Whether 5
you'd want to raise the policy issues there or do your e
6 middle level internal review, I think,.is'open.
7 Commissioner Rogers?
4 8
I'm sorry, did you have anything further?
9 MR. BERNERO:
No, no.
That concludes it.
10 CHAIRMAN SELIN:
Mr. Taylor, did you have 11 any other --
12 MR. TAYLOR:
We-have nothing further.
13 CHAIRMAN SELIN:
Commissioner Rogers?-
14 COMMISSIONER ROGERS:
Well, it's been a 15 very helpful,.I think, and detailed discussion.
16 I don't really have very much.
I wonder 17-if in any way you have considered the possibility - -
l 18-I -think the issue has been raised maybe-in the-l l
19 Cleveland Plain Dealer, I don't know of the l
20
-question of tracking. chronically bad practitioners in l
21 this area and in any way we can or should play a role-i 22 there in identifying those people, at least calling--
1 23 the attention-to the proper. authorities in these i
j 24 matters.-
25 MR. BERNERO:
Yes, we have, and we'have a i
i I
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l 101 1
wrongdoer rule and I think Jim Lieberman is better 2
qualified to explain what we have done.
That's a 3
tairly recent change.
4 MR. LIEBERMAN:
We do have the wrongdoer 5
rule.
That provides for taking action against and W
6 tracking people who make a deliberate decision to 7
violate requirements.
Many of the problems that we 8
see in the medical area as well as other areas is not 9
so much deliberate noncompliance but sloppy work.
10 COMMISSIONER ROGERS:
Sloppiness, yes.
11 MR. LIEBERMAN:
Lack of caring, lack of 12 attention to detail.
13 We're considering, and this is truly at a 14 very early stage of consideration, what can we do to 15 get a better idea about radiation safety officers or 16 authorized users who tend to have repetitive problems.
17 There are Privacy Act considerations that we'll have 18 to consider.
There may be some other legal type 19 issues, but we are planning to look into that matter.
20 COMMISSIONER ROGERS:
Well, I'm glad to 21 hear that.
22 The question of the National Academy of 23 Sciences study, it seems to me that that's a very 24 important activity to carry out, but it's also going 25 to take some time.
You've said that.
I don't think NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENVE. N W.
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we can wait-for that.
I think it will be a very 2
valuable addition once it has taken place, but these 3
things usually take several years.
It's very hard to 4
see how it could be done in less than two years, the 5
way they normally operate at any rate.
And by the 6
time we wot. d be able to incorporate any of the 7
results of that, it's two to three years and I don't 4
8 think we can wait for that before we take serious 9
account and stock of where we are and what we ought to 10 be doing right now.
So I think that's an excellent 11 initiative, but-I don't see any way in which we can 12 wait for it.
13 I don't think I have any other questions 14 or comments.
15 CHAIRMAN SELIN:- Commissioner Curtiss?
16 COMMISSIONER CURTISS:
I-just have three 17 specific questions, 18 First, picking up on Commissioner Rogers' 19 question about wrongdoers, the situation that we 20 typically encounter -- and I've seen this come up more--
21 in the context of reactor enforcement proceedings --
.2 2 -
is a case where we get into a particular situation and 23 somebody's engaged in conduct that troubles us and 24 that also troubles the licensee and the licensee 25 typically will release'the individual.
And when the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W,.
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enforcement package comes before us or comes before
- 1 2
the Agency, that consideration, the individual is no 3
longer employed by the licensee, is taken into account 4
generally when the enforcement action is under 5
consideration, 6
It might be worth taking a look at a case 7
where we haven't proceeded all the way to a formal 8
finding of wrongdoing but where the action is taken at t
9 an earlier stage, an individual is released.
We 10 recognize that that's an important step that the 11 licensee has taken and in fact our enforcement: action 12 takes account of that, but the individual has the 13 potential for showing up at some other licensed 14 facility, not a formal wrongdoer but nevertheless 15 somebody that perhaps there ought to be a mechanism 16 for us to at least inform those who are hiring these 17 individuals and let them make-their own judgment of 18 the situation as we understand-it.
'It might be 19 worthwhile, as I say, in the context of what you're 20 taking a look at, Jim, if you'd focus'on that.
21 Second, the one area that you did ' not 22 mention here that I'd just like to emphasize, my-23 impression in looking at the University of' Cincinnati g
24 and Riverside events is that'in both of-those cases'it.
25 was astounding to see the degree of tension that had-l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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1 arisen between the RSO and those who were engaged in i
j 2
the conduct-of authorized activities, i
l 3
I guess what I would encourage you to do, i
4 based upon that and in view of I think our mutual 5
experience that the RSC plays a critical role and q
)!
6 where the RSO has established an effective working 7
relationship within the licensed operation,-that can 8
go a long ways towards addressing some of the concerns l
9 that in the case of those two events we found were 10 traceable at least in part _to 'something that had 1
11 aricen that created a great. deal-of attention, 12 tension, and lack of communication between the RSO and I
j 13 those engaged in the conduct of authorized activities.
f 14 I don't.know whether that needs to be i
15 addressed in the context of our inspection. activities i
16 or as a matter that you could 'or should take up in the i
17 internal review, but I'd like to see yourLthough'ts on l-i j
18 how we might improve or focus on that very crucial i
19 relationship.
i l-20 MR. BERNERO:
Well, from time to time in.
I 21 cases other than the two you mention we have 22 situations of RSO either falling into neglect and not l
23 doing ~the job or the RSO being bypassed by the t
24 practitioners or-use'rs, especially.in..'a large scope i
25-license.
I can recall instances where. we've _gone -
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after that as a
characteristic of management 2
breakdown.
3 COMMISSIONER CURTISS: That's a recipe for 4
trouble.
5 MR. BERNERO:
Safety management breakdown
~
6 is a very serious problem, especially when they q
7 bypass, when they ignore the restrictions that the RSO 8
tries to put on them.
9 COMMISSIONER CURTISS:
I'd be intesested i
10 in seeing your recommendations in the internal review 11 that you have underway as to whether there are steps 12 that need to be taken to encourage or foster or 13 whatever a much more productive working relationship between the RSO and the authorized users.
14 l
15 Dick?
16 MR. CUNNINGHAM: We are working on a guide 17 pecifAc to medical RSOs and we can incorporate some I
18 of these kinds of thoughts in that guide.
i 19 COMMISSIONER CURTISS:
Okay.
One final 20 question going back to the notification of patients.
i 21 The QM rule requires that for those 22 patientt i b n, are notified of misadmir.istrations, 23 which is every patient except for the ones where the 24 doctor determines that it's not appropriate, that 25 within 15 days the patient is to be notified in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. H.W.
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106-T l
I 1
writing of that either through a. summary of the. event j
2 or through the report that's submitted to the NRC.
Do q
3 we currently or do we have plans to audit-the written ii 4
. reports that are prepared to ensure that the process 1
i
[
5 of notifying the patient, except in those rare cases, 6
is actually going on and. notification-is getting:
y l
i
'7 through to the patients?.
4 t
8-MR. GLENN:
Currently it's looked at.as a j
l 9
part of the inspection; process.
If-it's soecial j
10 inspection looking at a particular. misadministration,
?
11 that may be looked at.
In terms of an. audit by.the 12 Headquarters group of the regions and how well that is l
I i
i 13 done, we have not done that.
i j
14 I -did have Mark: Rottman, our other l
15 visiting medical fellow, look through.the documents 16 that we had available to us here in Headquarters. And 17 the documents he was looking at, in the great majority
.1 18 of cases, the individual had in fact been informed ~on b
time.
Now, the actual documents that were Gent were j
'9 i
1
~s o not there and so we did not look at those.
21 COMMISSIONER CURTISS: - Okay. tit's pretty 22 obvious from the' discussion earlier that-there's a 23 l'egal obligation and it's reflectedlin this. provision -
l 24' in the QM rule that the patient be notified.
It might.
25 be worth looking at the feasibility in the conduct of NEAL R. GROSS COURT REPORTERS AND TRANSCAtBERS 1323 RHODE ISLAND AVENUE, N.W.
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I 107-3
}
1 your inspections of conducting an audit specifically
~
(
l 2
on the patient notification question.
It was one of
't j
3 the maln points in'the Cleveland Plain Dealer series-i 4
and a source: of some vulnerability if the--patients' s
j 5
aren't being notified.-
- o 6
That's all I haves I
1' 7
COMMISSIONER REMICK:
On page 2 of the-8 SECY ---you don't have to refer to it, it. indicates-9 that - the causes of these administrations, -talking l
10 about therapeutic
- misadministrations, can-be i
11 characterized by insufficient supervision, deficient l
i 12 procedure or failure to follow procedures, inattention l
13 to detail and inadequate training.
In a briefing that I
i 14 Commissioner Curtiss/and.I had with the staff back b
15
-some weeks ago in this general area, I. asked the 16 question if it was possible to
.take the 17 misadministration data'and break it down into those l
18 bins.
I thought it would be helpful'.
The fact that l
l 19 I don't see it here, I assume the answer is that you 20 were not able to do that.
Is it a question of not i
21 being able to do it at.all or in the time span that we 22 were -- time.
i 23 MR. CUNNINGHAM:
It was the time.
24 COMMISSIONER-REMICK: ' But_ you do have the 25 data.
It.could be broken down that way.
i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS f
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i 1
MR.-TAYLOR:
We'll try to do'that.
e j
2 MR. BERNERO:
But a' word of caution.
I i
3 would wonder as-to the validity of it.
Remember we ' re 4
dealing with relatively small' numbers.here.
i l
5 COMMISSIONER REMICK:
And a little bit of 4
6 data is better than no data'in this case.
7 MR. BERNERO:
Yes.
But we do have --
f 8
COMMISSIONER REMICK: It's just to give me 9
an -- I'm trying to get some feeling for it.
l-
' the - ability because i
10 MR.
BERNERO:
i l
11 actually we made this summary characterization from l
l 12 the data.
I 13 COMMISSIONER REMICK:
Yes.
1 --
14 MR. BERNERO:
We just didn't sort it out.
}
i 15 COMMISSIONER REMICK:
I'm just.trying to i
16 get a feeling for how it breaks down.
17 MR. THOMPSON: I'11 add-one thing, that we 4
l 18 do have a contract with the Idaho National Engineering 3
l-19 Laboratory looking at misadministrations and they sent l
20 out a
team -to look at about a-half
. dozen j-1 21 misadministrations that occurred in-the:last year. In' t
.l 22 May we're expecting a document from them that will:
l-h 23 describe the root causes and'the lessons learned from 1
4' i
'24 those particular-studies.
So, we'll' have a small 1
25 sample that will do that.
i r
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W,
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109 i
1 COMMISSIONER.REMICK:
Okay.
And I
1 2
appreciate your saying you will get that data.
I l
l 3
realize that there are five of us here throwing out 4
many. ideas for you to do.
We do.have a process called i
5 an SRM.
i 6
MR. TAYLOR:
We'll look forward to.that, 1!*
7 sir.
8 COMMISSIONER REMICK:
I want to get the i
9
. Chairman's attention here.
Chairman, what is your 10 intention here?
Will we be issuing an'SRh based on i
l 11 this meeting or do you foresee that --
(
j 12 CHAIRMAN SELIN: No, I would prefer not to f.
13 do one based on this meeting'because basically what we 14 have is a lot ~of individuals saying, "Here are things f~
15
.that are important to me," and the staff has already f
16 developed a project plan for going ahead.
So,
'I i
i l
17 assume that they will look at the transcript and the 1-1 18 discussions and take these into account as they go on i
l 19 and then we have two more meetings-in the immediate l,
j 20 future.
}_
21 MR.
BERNERO:
Yes.
The subsequent i.
j 22-meetings are quite important for the process.
23 COMMISSIONER REMICK:
Okay.
24 CHAIRMAN SELIN: So, really I was thinking 25 about what would an SRM say and it would be a whole i-NEAL R. GROSS
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l 110-1 lot of Commission X said this and commissioner Y said r
2 that, you know, look at these points as opposed to I
3 here's real guidance.
4 COMMISSIONER REMICK:- Okay.
I say lots of l
j 5
luck to the staf f then. - But I do appreciate it.
It's i
6 been an excellent briefing from'my standpoint and I 7
really appreciate it.
i r
j 8
COMMISSIONER ROGERS:
Could I just ask a l
9 question?
Commissioner-Remick talked abGat page 2.
i 10 Could _ somebody tell me what.a. deterministic health 11 effect is?
I have an idea, but --
l 12 MR.
BERNERO:
The - usual. term is non--
j i
13 stochastic, meaning it's not a cancer that showed up 14 from a low level of. radiation in the past that' is most l
15 probably_due to that radiation or is probably due to 16 it.
But it's like someone gets 1,000 rad to the thigh 17 and it leaves a very visibla deterministic effect.
18 You know, it burns a hole in~your thigh.
19 MR. CUNNINGHAM:-
Where-you have-tissue P
20 damage or organ function damage, deterministic effect 21 there.
Acute effects as opposed to --
22.
COMMISSIONER ROGERS:
It's really a short 23 term --
24 MR. CUNNINGHAM:
Yes, as opposed to the--
25 COMMISSIONER ROGERS: - Short-term evidence NEAL R. GROSS
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really of effect.
2 MR. CUNNINGHAM:
Yes, as opposed to the-3 stochastic effects which are random cancer induced - -
4 radiation-induced cancers..
5 COMMISSIONER ROGERS:
Okay.
6 CHAIRMAN SELIN:
Commissioner de Planque?
7 COMMISSIONER de'PLANQUE:
I'11 be quick 8
since we've discussed'most of the major issues on'my 9
mind.
I would just say that, Bob, you alluded to the 10 fact that you have looked at some comparative numbers 11 in other practices of medicine and I would be grateful 12 for seeing those because I think it really helps us to 13 have some perspective here.
I'll be back to you with 14 some detailed questions too.
15 But I would like to thank you - all very 16 much for the effort in putting this together.
I know 17 you did it.under very difficult. and trying-18 circumstances in a very short period of time and I 19 think it givesfus an excellent -- he's laughing at 20 very short period of time.
You can go'to sleep now.
21-It really helps us to deal with these issues.
c
. I'd.like to make a couple 22 CHAIRMAN SELIN:
23 wrap-up remarks, if I might..
i 24 The first is just some background.
.It is 25 true we're talking about a relatively small number of NEAL R. GROSS COURT REPORTERS AND TRANSCRieERS 1323 RHODE ISLANO AVENUE, N.W, (202) 2344433 WASHINGTON, D.C. 20005 (202) 234-4433 l
.,a.
i l
112 4
l 1
therapeutic administrations.
If I figure this out 2
right, it's about 20 per year in the states that we 3
regulate and if it were the case that the number of i
4
- misadministrations, proportional number of licensees,.
i 5
that would be about 60 or so nationwide.
So, just in
[
6 terms of therapeutic administrations, we're not
{
7 talking about a huge problem.
Most specifically, the 8
newspapers have been criticized for scaring people-off 9
meetings.
Nobody should conclude from this that sick i
10 people with cancer should not go to hospitals and get i
11 therapeutic treatment because of the probability of a-12 misadministration.
But.I don't think that was the 13 intention of the articles.
It's not certainly the i
14 intention of our review.
I think we noticed ourselves 15 last summer and the press has certainly sharpened our 16 attention and given some real flesh and bones to some 17 theoretical problems that there are weaknesses in 18 these programs.
We see a lot of; weaknesses in--the-19 control programs and-we see weaknesses or 20 inconsistencies in the-way we regulate these programs.
21 So, the conclusion shouldn't be therapeutic radiation 22 is bad for your health,-but rather there is room for 23 improvement both in the licensee's actions and most 24 particularly in our actions and our relations with the
~25 agreement states.
I-think that's the principal NEAL R. GROSS -
' COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N.W.
i' (202) 234 4433 WASHINGTON, D.C 20005 --
(202) 234-4433.-
l 113 1
conclusion.
2 Then from the presentations that we've had I
3 today, we s9e a range of things to be investigated, 4
places where we need better to determine what the 5
current situation is, places where management changes
=
6 can be made, places where policy questions have to be 7
brought up and most specifically places where we know 8
a lot about what we think the policy is, but we 9
perhaps could learn a
little more about what's i
10 actually happening, the feedback on the empirical l
11 information.
There was a lot of work done.
I sort of 1
12 missed the point as to why it's so funny that it was i
13 done in a short time, but there was a big paper done 14 on a very timely basis that was quite informative. As 4
15 you can see, the Commission is very interested in this 16 work.
You've sparked a lot of discussion, a lot of i
1' 17 speculation, and I hope that your reviews will be able l
18 to systematically go through this speculation and the 19 questions that you put to yourselves and come up with i
20 systematic answers.
Not just one-of these or one of 21 those, but an overall approach that says, "Here's a-22 good approach and therefore here arc how various 23 questions get answered."
l 24 So, we look forward to your work and as 25 affected by the follow-up in the next couple of weeks.
i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON, D C. 20005 (202) 234-4433
1 114 1
So, this is a very good start on what's been a 2
longstanding sort of nagging problem.
3 Thank you very much.
4 MR. BERNERO:
Thank you.
5 (Whereupon, at 4:26 p.m.,
the above-6 entitled matter was concluded.)
7 4
8 9
d j
10 11 12 13 14 15 16 i
17 4
18 19 20 i
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23 l
24 4
25 NEAL R GROSS l
COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
(202) 234 4 33 WASHINGTON. O C. 20005 (202) 234 4433
}-
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i CERTIFICATE OF TRANSCRIBER This is to certify that the attached events of a meeting-
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of the United States Nuclear Regulatory Commission entitled:
IITLE OF MEETING:
BRIEFING ON STATUS'OF MEDICAL USE
!=
ACTIVITIES 4
PLACE OF MEETING:
ROCKVILLE, MARYLAND 1
a DATE OF MEETING:
JANUARY 22, 1993 i
were transcribed by me. I further certify that said transcription i
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is accurate and complete, to the.best of my ability, and that the transcript is a true and' accurate record of the foregoing events..
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