ML20062D337
| ML20062D337 | |
| Person / Time | |
|---|---|
| Issue date: | 07/23/1990 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20062D323 | List: |
| References | |
| FRN-55FR1439, FRN-56FR34104, RULE-PR-35 AC65-2-002, AC65-2-2, NUDOCS 9011130121 | |
| Download: ML20062D337 (189) | |
Text
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V Q --- d 4
OFFICIALTRANSCRIPT OF PROCEEDINGS M8D@
U.S. Nuclear Regulatory Commission Tide:
Workshop on Quality Assurance in the Medical Use of Byproduct Material Docket No.
Rockville, Maryland Monday, July 23, 1990 pgg,1 - 187 9011130121 901106 PDR ORQ NREA PNU ANN RIIEY & ASSOCIATES, LTD.
1612 K a. N.W Suke 300 Mahingson, D.C 20006 (202) 293-39 %
1
4 o-I 1
1 2
UNITED STATES NUCLEAR REGULATORY COMMISSION 3
4 l
5 6
7 Workshop on Quality Assurance in the 8
Medical Use of Byproduct Material 9
10 11 12 i
13 Nuclear Regulatory Commission 14 Nicholson Land Building South 15 Conference Room 013 16 5650 Nicholson Lane 17 Rockville, Maryland 18 19-20.
21 MONDAY, JULY 23, 1990 23
-23 24 25 9:47 o' clock a.m.
-e e
2 1
PARTICIPANTS:
i 2
3 J. Telford, NRC 4
S. Bahadur, NRC 5
L. Camper, NRC 6
J. Piccone, NRC 7
D. Wiedeman, NRC 9
E. Kline, NRC 9
M. Lesar, NRC 10 M. Weber, NRC 11 R. Henkin, ACNP 12 N. Alazraki, SNM 13 W.
Briner, SNH 14 V.
Tedio, ACNP/SNM 15 S. Surrel, SNM 16 H. Karagiannis, !!RC 17 K. Morris, ACNP/SNM 18 19 20 21 22 23 24 25-
l 4'
O e
3 1
PROCEEDINGS i
2 (9:47 a.m.)
3 MR. TF.LFORD:
Welcome.
I'm glad to see all of you 4
here today.
We would like to have a roundtable discussion 5
with the representatives from the American College of 6
Nuclear Physicians and the Society of Nuclear Medicine.
7 We have a proposed agenda that we tried to work 8
out.
9 Would anybody like to make a modification to the 10 agenda?
It could be that we are not successful in 11 completing all of the topics today, and if that's the case 12 we'd be willing to meet again.
.I 13 Any suggestions for modifying the agenda?
14 MR. HENKIN:
I suggest that we not treat the 15 agenda too rigidly and that we can skip around and do 16 whatever we like within it.
Is that okay with you?
17 MR. TELFORD:
Sure.
18 For the introductions, what I had in mind was for, i
19 people just to go around the table and t-
-\\ve their names 20 and their affiliation more or less for the record and kind 21 of to break the ice and let everybody get to know one 22 another just a little bit.
23 I suppose I should start.
My name is John 24 Telford.
I am the Section chief of the Rulemaking Section 25 in the Regulation Development Branch, Division of Regulatory
e 4
1 Applications.
2 My job is to sort of be-the team leader for the 3
folks who write tha final ru_e and certainly.was the leader L
i L
4 of the folks that wrote the proposwJ rule, so if you have 5
any questions about the intentions of what we were trying to a
6 accomplish during our discussions of the proposed rule, then 7
please feel free to ask.
8 Why don't we go clockwise.
9.
MR. CAMPER:
I'm Larry Camper.
I am the Section 10 JLeader of the Medical and Academic Section.
11 Our group is responsible for policy development, technicalfguidance and-what have you for the medical and 12 v
,;l 13 academic'uses of. regulatory materials that NRC regulates.
14 We are working closely with John's group in 15 developing the,QA rule.
16 MR. WIEDEMAN:
I am Darrel Wiedeman.
.I am-the
~
,17 Technical Assistant to the Director for the Division of'
18!
Radiation Safety and Safeguards in the NRC Region III gm 19
' Office.
20 I am also_part of the QA Site Team.that is doing 21r the site evaluations.-
.~
'22:
MR. BRINER:
I am Bill' Briner.
I am Chairman of
^
~
the Society of Nuclear Medicine's Committee on Government
.23 24 Relations.
'25-MS. ALAZRAKI:
I am Naomi Alazraki.
I am e
e
et o.
5
.1
. President of the Society of Nuclear Medicine.
2 MR. HENKIN: -Robert Henkin, President of the 3
American College of Nuclear Physicians.
4 MS. SURREL:
Sharon Surrel.
I am the Chairman of 5-the Government Relations Committee, a Tech Section of the m
6 Society of Nuclear Medicine.
7.
MS. FEDIO:
I am Valerie Fedio.
I am with the 8-Washington Office of the ACNP/SNM.
9 MR. KLINE:
I am Ed Kline from Atlanta, the NRC 10 Regional Office there and I am one of the members of the l.1 pilot team.
12' MS. PICCONE:
My name is Josie Piccone, I am-a
'L 13 health' physicist at NRC Region I.
I am also a member of the 14
-QA' team.
~15 MR. BRINER:
Mr. Telford, maybe we'd like to know Le 16-
.who.these folks back here;are too.
.17 MR.1TELFORD:
Certainly.
Let's let them introduce 181 themselves.
191 MS. KARAGIANNIS:
Harriet Karagiannis, health-20:
physicist,, AEOD/NRc.
21 MR.. WEBER:
Mike Weber, Office of the Chairman,
- j. -22 MR.-LESAR:
Mike Lesar, Office of Administration.
23 MR. BAHADUR:
Sher Bahadur, Branch Chief for the
- 24' Regulation Development Branch, the branch that is 7
25 responsible for developing this issue.
u
'o.
6 4
-1 MR. TELFORD:
Okay.
You mentioned that we'd like
.t-2 to maybe skip around.
Would you like to go with the second 3
item next?
-4 MR. HENKIN:
I think perhaps maybe we should have 5
some opening statements of what we are doing.
6 MR. TELFORD:
Good idea.
7 MR. HENKIN:
It's your meeting.
Why don't you 8
' start?
x 9
MR. TELFORD:
Opening statements -- what would you 10 like me to --
11 MR. HENKIN:
Why we're all here -- why arc r all
- 12 '
here?
I' 13 MR. TELFORD:
We are all here to have a roundtable 14; discussion about the proposed rule, the reporting 1
1L5 requirementsfand the regulatory guide and to discuss the 16, aspects of the ACNP or~SNP or-JCAHO programs 1that you feel 17 are recommendable,'that should be in such a proposed rule 18
-for quality assurance or maybe in place of, whatever your 19 particular. recommendation might be, but in' general to have a 20' good. understanding of what we-are.trying to accomplish and 21' how we would go about it and the recommendations that you
'2 2 -
would make.
23 I look at this as'certainly a two-way discussion 24 that we can understand each other's intentions and modes of q
25 operation.
l l
3. e :-
o.
7 1
The way we're going about this, I feel it will be i.
2 educational from both sides or to both sides.
I am looking 3
forward to having this discussion.
4 MR. HENKIN:
I guess I will speak for ACNP.
I 5
will'.)ot endeavor to speak for the Society for Nuclear 6
Medicine.
7 We are somewhat constrained, if you like, in this 8
discussion by.the fact that there is an operative resolution 9
of the American College of Nuclear Physicians which requests 10-the NRC to withdraw this rule.
The underlying assumption to_
11 that resolution is that there is no need for the rule and 12 that'it will in fact not affect the public health and safety 1
13 to have the rule or not have the rule at all.
14 In addition, we believe that the rule, proposed d
15 rule, represents-an intrusion into the practice of medicine i
16' against'the. statements of principle that are formulated by 17 NRC with: regard to intrusion into the practice of medicine.
18-We. understand the rule to represent an effort to 19 reduce misadministrations and that to be its primary 20 endeavor.; It.may have secondary endeavors but that is its 21-primary endeavor.
22
~In regard to that, we have asked before and in a 23 meeting with Chairman Carr were assured that the NRC would 24 in the future-account separately for sealed and unsealed 25
-source administrations because in fact there are entirely
L 8
4 1
different groups of people involved in the use of those 2
different materials.
3' Commissioner Curtis presented to Dr. Holmes, Dr.
b 4
Marcus and myself several years' worth of data on medical 5-misadministrations and asked for our input.
When we 6
reviewed that data which I believe went back as far as 1985, 7
if. memory serves me correctly, we discovered.that the worst
-8 year that we had were about four unsealed source
~9 misadministrations and the best year was about two, so if 10 one-says that the range is zero to six to be relatively 11<
conservative, what we are talking about is a-great' deal of
'12 time, effort and money being spent to produce-a rule that l'
- 13 may affect at a maximum six patients nationwide per year out 14 of ten million administered doses.
< 15 -
That to.us seems. illogical.
16 In addition, in a-situation in which funds for 17-medicine are becoming tighter, we havela Federal budget 18 deficit, a great-deal of funds on both sides are being 19 expended to promote a rule that seems to have little if any e
20 impact.
21 So, with t' hat in mind, we think the first part'of 22 the discussion ought to be whether or not such a rule is 23 necessary before we discuss whether or not what this rule 24 might contain, and we.have yet to receive from anybody a
-g 25
. justification for this rule based upon a maximum.of six
9 1-patients per year who would be affected nationwide.
2 MS. ALAZRAKI On behalf of the Society of Nuclear
-3 Medicine, I would like to say that basically the 12,000 4
physicians, scientists, technologists whom the Society
[
5 represents also feel that quality assurance practice and 6
implementation in the practice of nuclear medicine is 7
ongoing, has been ongoing for many years now with guidance 8
from the JCAHO and from organizations which do audits.
'. 9 For-example the American College of Nuclear 10 Physicians, to assure that the quality-assurance programs
'11 are accomplishing their stated goals, the JCAHO has about a 12 39-year history.in quality assurance.
It does nothing else, i
13' just quality assurance.
14 It has developed over the years and evolved a c
15 program which today I.think most people agree is a fairly 16..
good program,' extremely. comprehensive and for nuclear-17.
medicine per se covers anything that NRC'might be interested 1
q'
'18/
in putting into its rule'.
19 If you' review the JCAHO site inspections, in 20 general nuclear medicine departments do quite well in q
l o
.21 comparison with other medical services in hospitals, so we
'. 2 2 -
feel that quality assurance is being very well practiced in-23 nuclear medicine services aroun$ the country.
We are in j
24 agreement with everything that Dr. Henkin just stated, and I 25' don't want to repeat it, about the misadministration
o o
10 1
situation.
1.
We also feel that there is no need for duplicative 2
3 quality assurance impositions on our practices.
4 What I might say is that it would seem reasonable 5
to us for NRC to be sure that all of its licensees are 6
indeed implementing a quality assurance program in line with 1
7'
-JCAHO or ACNP audits.
8 It might be reasonable for NRC to look into 9:
whether there are.any licensees who are not for one reason 10 or another operating under JCAHO or ACNP-audit guidelines.
11 That is about the only thing that SNM can see is 12 relevant for NRC to do in the area of quality assurance.
l 13-MR. HENKIN:
May I just make one addition?
The 14 American College of Radiology also runs a practice audit 15 program.
16
-MR.-TELFORD:
Two points to clarify:
I assume 17 that your statements are relevant to nuclear medicine 18; diagnostics and nuclear medicine therapy?
19 MR. HENKIN:
Correct.
20
.MR. TELFORD:
Your statements about the nuclear
'21 area don't extend to teletherapy or brachytherapy?
I am-not qualified to comment on 23 teletherapy or brachytherapy.
24 MR. TELFORD:
One other small point is that the 25 objective of the proposed rulemaking is to prevent 1
i
'll i
1 misadministrations, not reduce them.
That's the --
1 2
MR. HENKIN. I think we ought to discuss that.
3 MR. TELFORD:
Okay.
1 4
MR HENKIN:
I think we ought to discuss what it 5
is that one can do to prevent misadministrations and what it t
6 is that you're proposing to do and how that will change 7-anything.
I would like to hear how it will change what is-8 going on now.
9 MR. TELFORD:
Well, we can pick that up whenever 10 you like.
Is there an item on the agenda that that fits s
11-with?
b 12 MR..HENKIN:
I'm trying to understand the thinking' 13 that goes into this rule that, first of all, perceives the 14 problem,.and second of all, believes that it can be L
15~
-corrected--by regulation.
Let me speak to that point, too.
We
~17-have been asking for now for four or five years -
.I expect
- 18 '
it's1a sum total of.that -- for some evidence that any kind 191 of rule or regulation that is apt.to be promoted by the 20 Nuclear Regulatory Commission or any other regulatory body.
J L
21 and that sort of. thing, is going to have any impact whatever 122
-on quality assurance.
23 We also are quite cognizant that you're spending R
L.
24 money for-this in a budget year that is a disaster for the 25 Federal Government.- We're having a disastrous year, too, as
lO;
'e 12 1
far as trying to contain health care costs, rather i
2 unsuccessfully thus far.
To me, it just doesn't make any 3-sense whatever to cause rather large expenditures of public 4
funds from the NRC standpoint and our own funds, in trying 5
to abida a regulation which is not going to be effective for 6
the purpose for which you state.
".7-MR. TELFORD:
I can think of two things that may 8
make it worthwhile to discuss this.
We're both talking 19' about quality assurance, but I'm not sure that we're 10 communicating.
i
- 11 MR. BRINER
That's correct.
We are not sure you.
12' know what. quality assurance in medical practice.is or health I
13 care administration is.
14 MR. TELFORD:
Well, Captain Briner. you may be 15 right.
16 MR. BRINER:
That's one admission I was waiting to-17 hear.
.18 MR. TELFORD:
Does everyone have a' copy of this?
t 19 If we coudl turn to page 1449 of the proposed regulation, 20 and the particular section is 3535, the basic quality 21 assurance program.. This 1s-really the focus of what we're l
22-trying to do.
Now, let me tell you a few things that we're 23 trying to accomplish to --
6 24 It may be that we are using a term that we are 25 familiar with that brings up all sorts of connotations of
13 1
other activities of which we don't really have regulatory j
l~
l 2
force.
But in Section.3535, the opening paragraph says that 3
we would.like each licensee to have a' quality assurance 4
program.-
5 We would like that program to be designed to 6
prevent indirect costs of errors in medical use and that the 7'
objective would be to provide high confidence that errors in 8
medical use would be prevented. -Now, that may be just a 9
euphemism for misadministrations.
I just mention that as --
'10 MR. HENKIN:
I don't know what also it could be~.
11
'MR. TELFORD:
That is the basic g3st, but the L
12 heart of it is the 8, objectives that folled. 'What they
} 13:
basically say'is that, first.of.a31, we would like a nuclear
}
14-physician to decide that;this patient should get byproduct l'
L 15 material'.
~ 16, Second, we:should issue n directive as to what the 17 4 dose --
L18 '
MR. BRINER:
You-already have said.that.and that's 4
192 a-regulation. ~ You say that byproduct material'shall be.used y
L20 only: under :the direction and the order of a licensed-l L
'21' physician.
.Now, why and the world should you establish 3535
.22 all over again tx) make that point, plus the fact-that you 23
.are.not going to prevent errors.
24-MR.-HENKIN:
Letime even amplify on that.
If 25 anything ever intrudes into the practice of medicine, 3535 i
14 1
does.- Most of the rest of what you've got is relatively
,=
2:
benign until you get to-3535 in which you decide that a 3
prescription must be issued in which you decide how review 4
is going to be done for appropriateness.
5 Let me refer you to the corpus Juris Secundum 6
which is the_ contemporary statement of American law as
~7 derived from reported cases.and legislation, Volume 70, 8
1987.- This is under Physicians and Surgeons.
"The practice 9
of medicine as ordinarily or popularly understood., has 10
. relation to the art of preventing, curing or alleviating 11 disease-or pain.
It includes the diagnosing, treating,
.12 operating or prescribing for any human disease, pain, 13-injury,4 deformity or physical condition.- It also includes 11 4' the application and use of medicines and drugs for the 15 purpose-of curing, mitigating or alleviating bodily 16
- diseases, but:it does not wholly depend upon the 17 adminstration of drugs.
18' Therefore,.3535' intrudes directly into the
~
19 practice of medicine as defined in law at the present time.
20 MR.'TELFORD:
You're focusing'on the first 21 objective?
l-l '
22 MR. HENKIN:
I'm focusing on-all of them; the 23 whole thi.ig does.
24 MR. TELFORD:
Okay.
Should I proceed or are-there 25 questions that I should answer?
l
15 1
MS. ALAZRAKI Just to add to that a little bit,
-2' the first one, if you want to focus on that, that's the 3.
first thing we do in any quality assurance program under 4
JCAHO.
We make sure that the study is appropriate to the 5
patient's condition.
I mean, that's exactly, word for word,
-6 practically --
7 MR. TELFORD:
I was attempting to paint sort of a 8
neutral image of what we're trying to accomplish here with 9
3535.
Shall I proceed, or are there questions that you want l
10 me to answer?
i
'll MR. HENKIN:
I would like you to explain why 3535
-12 is not an intrusion into the practice of medicine, because 13; if it'is, it's directly in contradiction to your statement 14 of principles; that you won't intrude into the practice of 15 medicine.
1 <6
'MR. TELFORD:.
I think you're alluding to the 1979
- 17.
Commission Policy Statement.
Then it goes far before that.
"18 It is not our intention to interfere with the practice >of P
19-
~ medicine.
Our intention is to make sure that whatever is 20 directed by the nuclear'physicinn is administered to the L
21 patient.. We have that narrow focus.
- 22.
MR. HENKIM:
That is the practice of medicine.
23 MR. TELFORD:
Okay, if that's the practice of-24-medicine, then that's what we're -- that's our focus, is 25 just that'.
After the authorized user, nuclear physician, 1-l
_ _.. - ~
e 16-1 has_given a directive as to what is to happen, if that 2-happens,-3535 is happy.
If that's an intrusion into 9
3 medicine, so be it.
I
~
4 MR. HENKIN:
3535 prescribes what is to happen.
5 It says " ensure that", " ensure, ensure, ensure and 6
ensure..."
That's a "thou shalt."
Okay, that says that I 7
must practice according to 3535.
That scans that the 8~
practice of medicine is not in my control but in your l
9 control.
'10 LMR. TELFORD:
Excuse me, Dr. Henkin.
There's a 11 very basic misunderstanding that you have.
3535 is a 12-performance-based quality assurance program.
These are 8
- 13 objectives -- these are merely 8 good. things to do that each 14 licensee would design their program to meet these t
15 objectives.
Yo.u can do that any way you like.
l'6 MR. HENKIN:
No sir, I don't agree with you,
-17
- because when you take 35'J5 and turn it around and you 18 -
inspect against 3535, tlese become cite-able things, if you 19
' don't do them.. If you have not satisfied'3535, you are then 20' open to a citation for not having an. adequate quality 211 assurance program.
221
'Therefore; they become a standard of practice.
23 MR. TELFORD:
50t quite.
3535 is a performance 24 based rule.
It says, here, 8 good things to do.
Each 25 license would then propose their own program for their own
j o'
17 1
facility unique setting so that they could meet the 3
'O 2
objectives here in any way that they chose to.
3 Now, what happens after that?
A patient comes in 4
-- you're from an agreement state and so are you Dr.
5 Alatraki and so'are you, Captain, Briner --
6 MR. BRINER:
Half of my practice goes on to the VA
.7 medical center, so I'm under --
)
8 MR. HENKIN:
Mine go there, too.
9 MR..TELFORD:
For the VA hospitals, then you know 10 that the-licensee sends in an application that says how they 11-are likely to meet such a ruling.
The application is
'12.
finally approved and it's really that document which becomes 13 your license. conditions against which you operate.
14 In that document, you have defined'how you will 15' meetJthe objectives of this rule.. It's not --
16'
'MR. HENKIN:. So what you're actually telling.me is 17 that'the license becomes'the conditions of the practice of 18i medicine,-which is exactly whatLwe're saying.
The license
-19 cannot prescribe the practice of medicine.
It can only L20
' prescribe the-safe handling of regulated materials.
121.
.It cannot prescribe 1the practice of medicine..
22
.MR. BRINER:
Can we turn this around:a little bit.-
i, 23 MR. TELFORD:
Excuse me.
Let's -- there's a basic
(
(
24 misunderstanding here.
You're talking about the practice of 25-medicine.
Now, if you disregard the words that are here, l
l
p' 18
~
1 just.for a moment, and let's talk about the intentions of 2
what's in 3535.
4
-3 First of all, it-says, let's make sure that the 4
right directive is given.
Let's -- ideally, let's write it 5
down.
Let's make sure that those that are involved 9
6 understand what's to be done.
Let's make sure that any 7
planing is in accordance with that directive that the ll 8
nuclear physician has given.
Let's make sure that we get 9
the right patient, and then let's finally make sure that the 10.
byproduct material administered is what was in the 11 directive.
12 That's the heart and soul of all of this.
- 1 13 MR. HENKIN:
Which does not exit in regulation.
14 MR. TELFORD:
If you want to allude that to being
?-
15 the practice of medicine --
- 16 MR.zHENKIN:
It is.-
17 MR. TELFORD:. Okay, but that's what this is about.
l l
18 Now, Dr. Briner?
19 MR. BRINER:
There's somebody who doesn't 20 understand what somebody's saying.
I'll turn that right 21 around; you don't understand what we're saying.
We're 22 saying that you, NRC, have no-business in this quality 23 assurance realm of interference because there are 24 professionals out there doing that very thing and people who 25 know what. they're doing and are doing an excellent job with
19 1
doing that.. Now, why try to duplicate -- rather poorly, I t-2 must say -- their efforts?
Why should you do it?
You've 3
not ever explained to me, why should the NRC be getting into 4
this husiness?
5 701. TELFORD:
Well, it is rather basic.
We have a 6
regulatory responsibility to ensure adequate safety of the 7
public, and that includes patients.
8 MR. BRINER:
You have known shown that the public
.9 has been damaged.
10 MR. HENKIN:
What is the risk, what is the hazard 11 you're' protecting against?
What is the damage that_you're
.12 proposing to remedy?-
'I 13 MS. ALAZRAKI:
And what are you going.to do beyond 14-what's alr idy being done with this?
Everything that's here H
t 15 is already being.done.
16 MR. TELFORD:
That's an interesting discussion and 17)
I would like.to get into that at some po' int on the agenda.
18 MR. BRINER:
Let's see how you answer that 19'
_ question, Mr. Telford. TR1y is it that the Nuclear g Regulatory Commission really wants to get into this, you w
lcnow, knowing full well that you disagree that the JCAHO is, L,
21 22 or'is-it'you're feeling that they're an ineffective p
.23 organization?
Is that what you're saying, they're not doing l-24-their job?
25 MR. TELFORD:
In 1979, the commission felt --
o e.
1 20 I
I 1-MR.-BRINER:
Please answer the question.
Are you 2
saying,' by issuing this that they are not doing their jobs i
3 effectively?:
4' HMR. TELFORD:
That's a tough question.
l 5
MR. BRINER:
Because you.are not saying, then 6
we're always going to --
7-MR. TELFORD:
We are saying that, first of all,
[
8 the JCAHO is a voluntary organization.
9 MR. BRINER:
We'll get into that.
10.
MR. HENKIN:
We will talk about that later.
It's j
11 like the Army being voluntary.
12
-MR; TELFORD:-
So, in order to carry out the 1
13 regulatory responsibilities of the Commission, the 14
-Commission:needs a regulation that is mandatory for all 15 licensees.
Now, what's in that regulation is what we'd all-16 like'.to discuss.
j
'17 You're-really basically asking:aEcouple of 18 questions.
One la that', what's the problem that we're.
19 trying to fix, and aecondly, why do we think've'have the --
20-MR. BRINER:
Can it be fixable by what you're
-1 12 1 suggesting?
22 MR. HENKIN:
Is it fixable by regulation, is the 23 second part of that question.
J 24 101. TELFORD:
We think so.
25 MR. HENKIN:
There's a basic rule that goes, one
(
i
^
21 1-
.cannot legislate against stupidity.
Do you have any o
2' evidence to indicate that zero to six misadministrations per
-3 year > result from anything but stupidity?
4' MS. ALAZRAKI:
Accidents.
- 5 MR. TELFORD:
Before we developed this proposed 6~
regulation, We' looked at the misadministrations in the 7
' therapy. range from 1980 through '88, then we developed this 8
proposed regulation.
At the time, JcAHO didn't have quite t-9 the program:they have today, as evidenced by these new l
10:
manuals.that.have just come out.
At the time, the American 11-
. College of Radiology was developing their model quality'
/
12
. assurance program.
There have probably been advances that b
13 various societies have made in the last two years.
L 14 We're interested in finding out what are those L
'15
' good points, but.that's really not the question that you're 116 lasking. 'You're asking -- when we look at the t
L 117 misadministrations, you're asking, what do we see, what are L
i 18 we trying to prevent?-
19 MR. BRINER:
That can be got out by this sort of 20 thing.
It's a~very important second question.if you're part I
21-
'of'that question.
A 122 MR. CAMPER:
Let me point out something to you, if 23 I..may, before you go into-that, John.
When you say that 1
24 these misadministrations occur because of stupidity, we look 25 at the misadministrations that occur and we don't come to
iY e
22 1
the conclusion that.they're'being caused by stupidity.
In
(
-2 may cases, they're being caused by a lack of procedures or a 3
breakdown in procedures.
In many cases, there are 4
procedures in place; they're simply not being followed.
5 The question that we have is, why one looks at 6
JCAH and various procedures that are out that practicing 7
medicine, we still see misadministrations current.
Now your 8
response to that would be, well, misadministrations are 9
insignificant..They're such a small number, the frequency
- 10 of occurrence is so insignificant, that we shouldn't be 11
-bothered about it.
Or you might argue that FRC has no 12 business being in this area.
11 3 The question I would come back to you with is, if indeed there are procedures out that and if indeed there are 14 15.
stillLbreakdowns,rthey're not being caused by stupidity.
L g
- 16-They're being caused lby. procedural error.
What should we do 17 as a regulatory agency that has responsibility in this area,
[
18-what should we.do?,
19' MR. BRINER:
Procedural error or stupidity, I20 whatever, the factLremains that you are not-going to correct t
?
' 21 '.
that by these kinds of regulations.
4 l22 MR. HENKIN:-
In fact, if the proper procedures 23
'already exist and people do not follow them, there is no i
24 regulation in the world that is going to cause them to be 25 followed.
l 1
j c-
.e 23 j
1 When errors occur, they occur for several reasons.
.c 2
.One of them is fatigue.
One of them is overload.
People 3
are overworked.
Another series, as your own evidence 4
documents, of-patient contributions to the era, where the 5
patient identifies himself as the wrong patient, your t
6 regulation is never going to cure that.
7 If the money spent on developing this regulation 8
and. attempting to implement it or spent and directed toward 9
increasing staff available to nuclear medicine, we'd have a 10 greater impact on misadministrations than any regulation 11 ever would because our people are stretched so thin and 12 they're fatigued.-
I 13 I have people that are working 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> a day 14-because I can't have enough staff.
Those people are more 1
s 15' cprone tx) error..
A regulation such as this would not prevent 16 an error of an-over-tired person.
17' MR. WIEDEMAN:
In your examples, because of 11 8 misadministration,.where does misunderstanding fall in?
19-Many times,,you know, misadministrations --
20
'MR.~HENKIN:
Miscommunication or misunderstanding?.
i L
'21 MR. WIEDEMAN:
Both.
The ambiguous, sometimes 22 redui. dant-, terminology that's used in nuclear medicine.
'I R2 3 '
MR. HENKIN:
The regulation doesn't address that, i
24
.first of all.
What does happen from time to time is a 1
25 referring physician will misorder an examination.
The 1
o 1
2
.o 24 1
referring, requesting physician-will order a therapy when, j
l 2
in fact, he doesn't really mean a therapeutic procedure.
3 And that, under JCAHO standards, and under most operating 4
standards, is caught routinely.
Nuclear medicine 5
departments catch that everyday around the country in their i
i 6
review of procedures.
It is very rare for one of these to l
P 7
slip through the system, m
8 The number of times por day that procedures are c
9 questioned in a department such as mine or a department such 10-as Naomi's--- we're on the phone with people all day long
(
11-saying, what did you mean, what did you want, what did you 12-really order. 'That goes on as a routine basis because we
-13 have~to satisfy another standard.
- 14 We have to satisfy an appropriateness standard 1'
15 that comes out of JCAHo that we are doing something
'16 appropriate to the patient's medical condition and to us, 17-
-that's a greater concern than satisfying your standard-l D
18 because they're going to come around that and we have to 191 have in place screens, monitors, to show that we are R20 providing appropriate medical service to patients and that 21 we're not doing testa that aren't indicated and we're not 22 doing tests'that are inappropriate for the medical L
23 condition.
24 So, as part of that, there exists a system to 25 screen for all of these things already and therapeutic L
1
j -
25 1
- procedures fall into that system because they are procedure.
- i 2-In fact, the-consciousness of nuclear medicine people, of
- 3 therapeutic procedures is so high that most of us require a 4
direct conversation already with the referring physician.
5 We won't take an intermediary order.
1 6
In our lab, for example,.the physician ordering 7-the procedure must speak directly to a nuclear medicine 8
physician if it's a therapeutic procedure and discuss with 9
him why he wants it.
10 MS.,ALAZRAKI:
I can tell you, in our department, 11 I can-give you a. monthly accounting of exactly how many 12 inappropriate orders we got and what they were.
Its in our 13
- minutes for JCAHO purposes.
This is one of,the things'which 14
- is basic to the practice of' nuclear medicine.
It really is 15 practice of medicine, that type of a~ thing.
i
- C 16 MR. TELFORD:
So, you're saying the first three 17-objectives were already met by.your' program.
- 18 MS. ALAZRAKI:
Yes.
And documented.
Just to add 19 a:duplicative administrative burden to redocument this in 1
- 20' terminology and inform that for NRC seems ridiculous.
21 MR. TELFORD:- Let's assume that we could clean up i : 22 the terminology.
I think you're making an assumption that 23-this is duplicative.
Because this is a performance-based 24 rule, you~could in fact propose as part of your application 25 to do exactly what you just said, that you're already doing e
, ~.,,
-.-r--
L l,
26 1
it for JCAHO and meet these three objectives.
- p 2'
MR. BRINER:
Could we turn that around that a 3
little bit.
In Dr. Alatraki's opening statement she made a p
4 remark that surprised even me.
She surprises me every day, 5
but I think she said something to the effect that, even if 6
you want to go ahead in your regs and say a quality t
7 assurance program is in effect at this licensee, and let it 8
go at that, that's within your purview, but don't prescribe 9
what you do in that quality assurance program.
10 MS. ALAZRAKI:
I think it would be perfectly
'11 reasonable-for NRC to note what quality assurance plan the 12 licensee is-operating under and to not that that's an 13 acceptable plan.from NRC's point of view, and to identify
.14 those who don't operate under JCAHO or any of the practice 15:
audit _ plans.
16-MR. BRINER:- We're having at rare moment when I 17.
would disagree with what she said.
Remember when you say 18 that, if you modify that plan after you've made such a 19-statement, you've got to let them know and get an approval.
20
'from.them to do it.
21 MS. ALAZRAKI:
They would have to recognize the I 221 authority of JCAHO'to regulate that.-
23 MR. HENKIN:
That's correct.
Essentially, they 24
-would.have to grant the JCAHO legal status.
25 MS. ALAZRAKI:
Exactly.
o a
37
- 1 MR. TELFORD:
Excuse me.
Could we go off the
.2 record for a minute.
3~
(Discussion off the record.]
4' MR. TELFORD:
Back on the record.
5 MS. ALAZRAKI:
We're on the issue of whether or 6-not NRC can recognize JCAHO or any of the operative 7
verbalizations in terms of if they are quality-assurance 8
activities.
9 MR. TELFORD:
I think there are a couple of 10 alternatives there.
I mean assuming that we could have a Lil discussion of exactly what the JCH recommends, kind of like 12 we have started to have, that basically we feel the first
'13'
- three. objectives have already been met.
We could find out 14 exactly, of: the interest that. we have, how many _ of those are 15 already being. met by JCH, then assuming something could be
'16
. worked out,-then ILean think of=a couple of alternatives.
17l 10t;, HENKIN:
Let's do the following:
Let's say 18 that we do not at the moment drop-our objections to this 19 rule but are willing to discuss with you what-it is JCAHO
.20 does outside the view of this rule.. Okay?
~ 21' MR. TELFORD:
Sure.
.y 122
-MS. ALAZRAKI:
Okay.
123 MR. TELFORD:
I think there is still.a question in-24 my mind about what are the problems we see.
25 MR. HENKIN:
Having read the reports from
1 i
28 1
Commissioner Curtis, I cannot see or imagine how anything in i
2 this rule would have changed any of those instances over the
-3:
past 5 years.
Okay?
There is just nothing that I see that 4
you've done here that would have made a bit of difference in 5.
the documents that commissioner Curtis gave me.
Now, maybe 6
in teletherapy or brachytherapy -- I have no idea -- but not 7
in nuclear medicine.
It wouldn't have changed the outcome 8
of one of those-procedures.
9 Where somebody picks up the wrong vial of 1
10 material, thinking it is the correct vial of material, and 11 mis-administers that material is not going to be changed by-i 12 your regulation, because he believes he has got the right
'13 material and he followed procedures.
'14 MS. SURREL:
It's a human error.
15 MR. TELFORD:
I've got some cases of 1
16 misadministration here that we can discuss.
These are 17 taletherapy, brachytherapy, and nuclear medicine.
l 18.
Let me ask your indulgence, because while you-can 19 say we're only-interested in nuclear medicine, we cannot do.
20-that.
We have to say we are trying to put in a place a 21 program.
22 MR. HENKIN:
Well, I think you could do that by
'23 spreading them into sealed and unsealed sources.
24 MR. TELFORD:
That's a procedural matter.
What 25 I'm talking abcut is I would like you to understand what we
l o
m.
29 1
see from.our point'of view as regulators trying to assure
,1 2
adequate protection of the public from a national 3
perspective.
4 MR.-CAMPER:
Let me add to that, too.
5 It easier for you to say, as practicing nuclear 6
medicine physicians, let us focus only upon nuclear 7
medicine, and we understand that.
But we have a larger area
.8 of responsibility.
9 It's venar interesting.
As I read through all the 10.
documents, over the weekend, that accompanied Dr. Marcus' 11 summary of the comments that were received in the public-a-
12
' comment period, there were a number of reoccurring themes.
3 I
13 One of'them that I was struck by was that, as one goes and 1
'14 looks at the'various institutions of differing size i
15:
.throughout the United States, there are-varying degrees and 16 degradation of quality assurance in these institutions, and i:
-17.
indplaces where there is highly-sophisticatedrmedicine being-it"
- p
'18 practiced,~at t' Dukes and UCLAs and Loyolas, etcetera, s
.19 there is a level of quality assurance, but'it is not the u
L
.20 same level that's occurring in-some of the. community 2 11
' hospitals.
22 MR. HENKIN:
But this is a misunderstanding on
.23 part, too, and that is the type of procedure we r
- 24.
- tice-in a Duke, Loyola, Emory situation is different 25 than what they practice in a community hospital.
The number
I l
c-30 1-of therapeutic iodine procedures in most community hospitals 2;
is nil.=
i
'3 MS. ALAZRAKI Very small.
4 MR. HENKIN:
Okay?
Very, very low compared to a 5
major institution, so that you're talking about a level of 6
practice that's entirely different, as well.
You're talking-7-
about liver scans, bone scans, brain scans, and an 8
occasional, once-a-year therapy patient, perhaps.
There are 9
exceptions to that rule, but they-are some of the better 10 community hospitals that are, in some respects, comparable 11 to some of the university hospitals, and they have the 12 procedures in place to do that.
But when you talk about F
'13f that, I think you have to realize that the level of quality n-14; assurance recognized by JCAHO is appropriate to-the 15-institution that it operates in.
It's a local environmental 16
' question.- It does not prescribe, across the board, the same
-17 thing for everybody,-and in, fact, JCAHO has recognized that-
- 18
+by even.using different inspection teams for. academic.
19
' hospitals an'd'for non-academic hospitals, realizing they 20 thold them to a different standard.
21~
MR. TELFORD:
That's why we.have a performance-
'22 based rule.
-23 MS. ALAZRAKI:
Well, it took JCAHO a long time to 24' evolve into --
25
- MR. HENKIN:
Twenty years.
's ce 31 1
MS. ALAZRAKI:' Twenty years to come up with these
- (,,
2 differences and these nuances in quality assurance.
They 3
are quality assurance experts; you are not.
4 MR. TELFORD:
Would you look at it for at least 5
approaching it as a performance-based rule, so that each 6
facility can tailor their rule to meet the facility needs?
7' MR. HENKIN:
I don't believe it's truly 8
performance-based because of the way you listed your eight 9
criteria.
Performance-based would say you must develop a
-10 rule to assure that there's appropriate operations at your 11 institution, but you've. laid out eight things they must have 12 in'that performance-based rule.
The sort of removes it from 1
13 the category'of a performance-based rule.
It's a sort of 14 hybrid.
15 MR.' TELFORD:
.I get half a point?
16-MR. HENKIN: / Half 6 p;ir.t.
- 17 MR. TELFORD:
All right.
18-MR. HENKIN:
No more.
19 MR. BRINER:- Just so the rest of the people know 20 who the most recent. arrival is, Kris Morris is Director of
'21 the ACNP SNM Washington office.
12 2 Kris, glad you made it.
23 (Slide.)
.j 24 MR. TELFORD:
What I'd like to do refer you to the 25 current requirements that are in 10 CFR, go through some
32 1
recent misadministrations, and tell you some of the reasons i
2 why we think we have a need for a solution to the problem.
m 3
(Slide.)
I 4
MR. TELTORDt Can everybody see these?
5' MR. BRINERt I'll think about them when I go to 6
bed at night.
7 MR. TELFORDt As of April let of this year, the 29 8
agreement-states are now required, as a matter of 9
accountability, to report misadministrations.
Prior to' chat 10 date, they were not required to report these.
These are 11 basically, as you know, six mistakes that you can make, and 12 if you make one of th$se mistakes, you're required to 13 report.
That's all we currently have is a reporting 14 requirements.
l
[
15 So, this is one is for any pharmaceutical or 16 irradiation other than the one intended; this '6s to the 17 wrong patient, number two.
Number three is via route of R
18-administration other than was intended.
Number four is a 1
19
' diagnostic misadministration, where the administered dose j
differs from what was prescribed by 50 percent.
Number five 20 21 is a therapy by radiopharmaceutical such that the 22 administated dose is different than prescribed by 10 23 percent.
And number six is meant to capture teletherapy as i
24 well as brachytherapy, and that's where the administered lL.
25 dose is 10 percent different from what was prescribed.
---_-,a,_m
-.--s---
--_------------w--------x--------------
x--
---a
-m
O l
33 1
Any points of clarity?
t 2
MR. HENKIN:
No, except that we're not really 3
prepared to discuss the last one.
4 (slide.)
5 MR. TELFORD:
First of all, I beg your indulgence 6
on several teletherapy and brachytherapy misadministrations.
7 The primary reason, from your point of view, could be Mr.
8 camper's point that sometimes you see -- it was Mr.
.9 Wiedeman's point, as well.
Sometimes you see a breakdown in 10 what apparently looks like a breakdown in procedures or a 11 misunderstanding of what was supposed to be done.
12 This happ3ned in cumberland, Maryland.. The nature 13 of the misadministration was that 33 patients received the 14 wrong dose.
The problem was that when they changed the 15 cobalt source, they forgot to tell the computer program of 16 the new source information, and as a consequence, 33 17 patients got overdosed, and the actions taken to prevent was
'18 that the licensee is now in an over-check procedure, as well 19 as there has been a change in the physicist.
20 MR. HENKIN:
May I ask you -- since I don't know 21 anything about this, I can ask a-dumb question.
Were any of 22 those patients injured?
Have any of them reported any 23 injury?
24 MR. TELFORD:
I believe in the details of this 25 repott, there was some erythema, but I don't think --
)
o+
e 34 j
1 MR. HENKIN:
They got sunburned?
2 MR. TELFORD:
These 33 patients were --
3 MR. HENKIN:
My limited understanding of 4
radiotherapy is that most; patients, including my father, who 5
underwent radiotherapy at the prescribed dose, gets local
)
6 erythema.
So, what you're telling me is that I can't 7
discuss the merits of the case.
All I want to know is was
)
8 anybody injured?
l 9
MR. TELFORD:
Well, I apologize.
I cannot answer 10 your question, because there were a total of 33 patients 11 involved here, and their amount of overdose was in 12 proportion to the dose they received.
13 MR. HENKIN:
So, we just don't know if anybody was 14 injured.
ll 15 MR. TELFORD:
I don't.
16 MR. HENKIN:
Well, then we, as a group, don't.
17 (Slide.)
18 MR. TELFORD:
This happened in March of '89, and 19 in May is a teletherapy misadministration.
The patient was.
20 administered 100 rads to the brain instead of the floor of 21 the mouth.
This is the wrong site for the kind of problem.
22 The cause is that the names and appearances and even the 23 planning pictures of the two elderly patients were 24 remarkably similar, and the patient requiring the treatme
25-to the lower palate was administered the brain dose instead.
_ - _ ~
o 35 1
In this case, the patient got 100 rads to the t
2 wrong location that the patient didn't need.
The actions 3
take to prevent recurrence was that we now have procedurea 4
which would require that each patient's identify be verified j
5 by a photograph and oral communication or positive 6
identification by a second person.
7 Questions?
1 8
MR. HENKIN:
Again, I'm fascinated.
These are 9
absolutely fascinating things to look at the cure.
The cure
'10 is positive identification by a second person.
Who might 11 that be?
J l
12 MR. TELFORD:
Well, as long as their procedure 13 works, it could be a technician.
14 MR. HENKIN:
Well, sure.
And that, to me, is as
[
15 worthless as anything else, because you have a busy hospital 16 setting and you have people coming down from the nursing 17 floors.
Presumably, the nurse on the floor knows the r
18 patient better than anybody else.
Most of the time, 19 nowadays, they don't know the patient very well at all.
20 So, what you've done is impose -- they have 21 imposed -- to satisfy you, they have created a requirement
~22 that has no meaning.
23 MR. TELFORD:
This procedure was their choice.
24 MR. HENKIN:
Oh, I no, because they had to do l
25 something to make you happy.
. _ = - - -.
36 1
MR. CAMPER:
Well, their previous procedure I
2 obviously didn't work.
3 MR. HENKIN This doesn't guarantee that it won't 4
happen again.
5 Ms. ALAZRAKIt As a matter of fact, even in 6
diagnostic administrations of radiopharmaceuticals, which j
7 again is different from what you are presenting here, since 8
we don't deal with the sealed-source administration of 9
radiation, but in administering radiopharmaceuticals, even 10 diagnostic doses, we have that type of a routine of two l
i 11 people checking.
J 12 MR. TELFORD:
That's good.
We will get to some i
13 nuclear medicine cases in a minute.
14 (Slide.)
15 MR. TELFORD This happened in March of '89 in 16 Indiana.
The patient got 300 rads to 9 sites on the left 17 hip and groin, which should have been to the right hip and 18 groin.
19 Causes were there was the patient -- and that may 20 not be the correct word -- maybe it was a misunderstanding.
21 But that's what's among the licensecu technologies.
L 22 Probable cause is you get an extra 2700 rads to 23 the wrong hip and groin.
And the action taken was they l
24 initiated new procedures to verify treatment cycle.
25 Questions?
e s---
---.-e
.m.--g
_y
,.py,
.w,
.g
-,,+.-g.w--
w e
1 o~
37 1
MS. ALAZRAKI Again this is out of our frame.
Ji 2
That type of an accident happens in surgery all the time.
3 Of course, the consequences there are much more grave.
But 4
the court system takes care.
5 MR. HENKIN:
I can -- I can site a case of one our 6
surgeons who did the wrong-sided carotid endarteractomy, 7
okay; which I think is probably more serious error than any 8
of the errors you're going to present todays and wound up 9
not getting sued for it because he had good relations with 10 the patient.
11 MR. TELFORD:
Off the record, why did he only do 4
12 one side -- I had both.
13 Doctors do recognize that surgery is not our 14 regulatory responsibility.
15 MS. ALAZRAKIt Wait a minute.
16 (Laughter.)
17 MR. HENKIN:
We're trying to set -- we're trying 18 to set for you an environment that says, are you trying to 19.
correct something -- there are grievous errors that occur 20 from time te time in medicine, because of the people 21 involved in medicine, and that not -- everybody_ recognizes 22 that those errors are not all preventable, because they're 23 human errors.
24 And we're trying to set for you a relative scale.
25 You've seemed to have developed the idea that these
38 1
therapeutic misadministrations represent a severe public I
2 hazard, and that you need to take regulatory action to 3
correct that hazard to the public.
4 We are trying to put this into the perspective of 5
the practice of medicine and where these fall as a h~ ard 6
within the practice of medicine, so that you have a frame of 7
reference, as to what it is we're dealing with and how much 8
expenditure of public and institutional funds are 9-appropriate in this setting.
10 MR. TELFORD:
Two comments, if I may?
11 As far as our regulatory responsibility goes for 12 the problem -- it needs to be a problem or a potential 13 problem, for us to become involved.
14 If -- I like your idea of setting a perspective 15 and-I would point out that the proposed rule says it's --
16 it's a performance-based rule and it says, " designed to 17 prevent."
~18 Now, if you wanted to propose a certain threshold, 19 like -- like an acceptable rate.
Like, for instance, the 20 Commission, in the area of reactor safety has said -- almost 21 how safe the plant should be, with the following -- which 22 includes the following statements, not necessarily limited 23 to, but that the cause of death -- or excuse me, probability 24 of a death, due to this reactor, should be a tenth of a 25 percent of all the other causes of death.
And the
O 4
39 1
probability of getting cancer should be a tenth of a percent i
2 of all the sources of cancer -- so it would be --
3 MR. HENKIN:
I find that -- fine, we're below 4
that.
5 MR. TELFORD:
Well, if you wanted to propose that 6
that should be the quantitative design objective, okay, 7
We'll listen.
But, please keep in mind, the rule is just 8
designed to prevent.
And we have -- have a qualitative 9
criteria.
10-If you want to say quantitatively, that's okay, we 11 would like to entertain that discussion.
12 Shall I --- shall I go on?
i 13 MR. HENKIN Yes, please.
14 MR. TELFORD:
Are we missing the point?
15 MR. HENKIN:
No.
I'm not sure what you just said, 16 but qK) on?
17 MR. BRINER:
How did we get into that suggestion?
18-We want it quantitative.
No way.
19 (Laughter.)
20 MR. HENKIN:
That's not what we're saying.
i 21' MR. TELFORD You said you wanted to put it into i
22 perspective -- that there's a certain rate of occurrence --
23
_you know, I'm reading between the lines here, that ought to 24 be acceptable.
25 MR. HENKIN:
Okay, fine.
If we're going to do I
s 40
)
l' that, we should put it into the perspective of the rate of I
2 misadministration of all pharmaceuticals in this country.
3 That rate is approximately 20 percent for 4
nonradioactive drugs.
The rate for radiopharmaceuticals is 5
about.6 percent, if I remember correctly.
That is, in fact 6
-- we would be glad to take that as a -- as a relationship 7
that we can't exceed the rate of misadministration for all 8
pharmaceuticals in the country, and use that one as a 9
standard.
10 IIR. TELFORD:
Unfortunately, we don't have the 11 responsibility for all pharmaceuticals, we only have 12 radiopharmaceuticals.
13 MR. HENKIN:
You just asked me to put it into l
14
.something that -- there -- there's a system for which the i
15 data exists on the rate of misadministration of all 16 nonradioactive drugs for hospital in-patients.
It is about 17 20 percent misadministration, using the definition that 18 differs only slightly from yours, in that they include time.
19 if you don't administer the drug at the correct time, it is 20 misadministerad.
21 In a hospital in-patient as well, that number is 22 20 percent --
between five and 20 percent, depending on the 23 various surveys you read and the skill of the hospital
(
24 populations on those surveys.
25 In that case, why not say that we should be the
-o 1
41 i
same as all pharmaceutical administers, who aret registered I
2 nurses, licensed pharmacists and physicians.
3 You're holding us to a standard that is not a j
4 standard that is part of the practice of medicine.
5 MR. CAMPER:
Well the -- the problem is, of 6
. course, we don't regulate those other areas; and for that 7
matter, we don't know whether 20 percent is acceptable or 8
not.
9 MP. HENKIN:
That's a different issue.
But, we're l
10 talking *. bout what goes on and whether we're being held to a 11 standard that is different from the rest of the practice of 12 medicine.
I 13 To hold us to a reactor safety standard makes no 14 sense.
r 15 MR. TELFORD:
Excuse me, I didn't mean to simply 16 reply that we were going to do any of that, I was merely 17 fishing for suggestions, to see if you wanted to -- if you 18 wanted to put things in perspective and propose a 19 quantitative standard, I'm just_merely saying that we're 20, open for discussion.
~ 21' MR. BRINER:
There's one other difference between 22 what you're talking about -- the 20 percent rate too; and 23 that is that in the majority of those cases, there is 24 demonstrable harm to the patient.
And his note extend to a
(
25 majority --
42 1
MR. HENKIN:
We are talking about drugs that 1
2 includes chemotherapeutic agents, cardiac agents in that 20 3
percent which, it misadministered can kill the patient.
4 We do not have that potential in general and 5
nuclear medicine.
There hasn't been a death from an 6
administered pharmaceutical as a misadministration in 25 or 7
30 years now.
So, that -- we've done a dann good job.
8 (Slide.)
9 MR. TELFORD:
And we agree.
We think you're -- we 10 think the whole industry's doing a very good job.
11 MR. HENKIN:
May I go on?
12 MR. TELFORD:
In July of '89 in Massachusetts, a I
13 patient was administered a dose to the spine, instead of to 14 the right lung.
The cause of misadministration was the 15 technology faile6 to confirm the patient's identify, even 16 though there was an available.
17.
In addition, the technologist failed to recognize 18 the absence of any treatment positioning tattoos, which 19 would have indicated that that was the wrong site.
20 The consequence was that the patient received an.
21 unattended 250 rads to the spine.
The actions taken to 22 prevent recurrence was that the licensees instituted 23 procedures which require that each patient's identity be 24 verified by a photograph.
And in questionable cases, the g
25 physician will verify the patients prior to treatment.
_. ~..
.a 43 1
MR. HENKIN:
Does that make any sense to you, t
2 John, that they apparently had a -- a procedure in place, l
3 with a photograph -- nobody bothered to look at the 4
photograph.
Their cure for the problem is to tell people to 5
look at the photograph.
6 MS. SURREL:
So, you've just proven that you have 7
a procedure in place and by human error they did not follow 8
it.
9 MR. TELFORD:
You've just proven that you've got -
.10
- that you can the procedure there and if it doesn't work --
11 MS. SURREL:
So how, you know, in dealing with --
12 with this particular rule -- how can you put another 8
13 procedure in place and eliminate the mistakes that have been 14
.made.
15 MR. TELFORD:
This rule doesn't put any procedures 16 in place.
This proposed rule says "each licensee should 17 have a quality assurance program, l
18 The procedure that -- procedures that are put into 19 place are up to the licensee to meet their problems.. And L
20 this was -- this licensees choice to do this procedure.
21 MR. HENKIN:
But John, listen.
The licensee had 22 in place, originally --
23 MR. TELFORD:
But, wait a minute -- you're --
24 you're asking, let's see.
You're changing the subject l
?5 really, because this is -- this is not under the conditions 1
. ~...
44 1
of the proposed rule; this is under the current reporting 2
requirements.
3 So, all the licensee has to do here is report.
l 4
Now, when the NRC finds out about it, it naturally asks, 5
what are you going to do to prevent recurrence.
6 So, all I'm showing to you is that we have looked 7
at the recent misadministrations.
We're attempting to find 8
the cause here -- what's the problem and what are the set of 9
problems to be solved.
10 Based on this, I don't think you can draw an 11 inference that these rules would prescribe this same sort of 4
12 action.
1 13 MR. HENKIN:
No.
I can draw --
14 MS. SURREL:
Then how are these rules going to 15 correct those sorts of problems?
16 MR. TELFORD:
That --
17-MR. HENKIN:
This licensee obviously had something 18 in' place, with -- included a photograph.
Okay.
The person 19 didn't follow procedure.
20 The quality assurance program they had in place, 21-likely would have satisfied your draft regulation.
22 What you had,is somebody who broke his 23 institutional rules.
Okay.
Your program won't prevent them 24 from breaking institutional rules.
25 I have institutional rules.
Any time we've had a f
l-
~.
6 o
i 45 l
1 diagnostic misadminsistration, it has always come down to j
i 2.
the same thing -- somebody broke the rules.
Not that they
]
3 didn't know them.
They short circuited the system some how.
4 MS. ALAZRAKI:
The last time that we had a -- a 5
misadministration is a similar situation to this, only in a 6
diagnostic setting.
7 The technologist had just found out that her 8
father had cancer, and didn't want to go home, wanted to stay at work.
And that happened.
That's human error.
9 L
10 I mean, people are going to be upset and 11 distraught and, for whatever circumstance, and those things 12 are going to happen.
Now, you might want to say, no one who l
l i 13 is not mentally fit should be doing this kind of work, but l
l.
'14 that's --
15-MR. HENKIN:
We would be in big trouble.
16 MR. TELFORD:
The NRC can't dictate who and who 17 should not work.
18 MS. ALAZRAKI:
Those things -- those things happen 19 and nobody may know.
20 MR. HENKIN:
Could please skip some of these 21 teletherapy demonstrations.
We really -- I mean, we can sit 22 here and chat about it, but we don't know anything about it.
1 23 MS.~ALAZRAKI:
They're not relevant to us.
l 24 MR. TELFORD:
I thought you were having a very l
25 good time listening to the actions to prevent recurrence.
.~.
6 e
1 46 I
1 1
MR. HEFXIN:
If you want to do that, we can do i
2 that, but it doesn't seem to make much sense to us to do 3
that.
4
[ Slide.)
5 MR. TELFORD:
What I was really endeavoring to do 6
is to show you that -- the kinds of problems we see, the 7
causes we see and -- and the actions that the licensees are 8
suggesting that may be appropriate to fix these problems --
9 these causes, and that we have tried to learn from these --
10 misadministrations; and tried to incorporate those into the 11 proposed regulation.
12 MR. HENKIN:
Can I'-- can I comment that the more 13 you require people to note things and the more that you 14 require them to initial things -- the end result of all of 4
15 that is generally noncompliance with you rules; rather than 16 any effective outcome.
Okay.
17 That what you do and what has been asserted may be L
18 the outcome of implementing this ruim, is to simply create 19-more noncompliance out there in a short-staff situation, or l
20 more' nonsense, where people go back once a month and initial 21 all of them.
22 You know, that -- that doesn't -- that isn't going 23 to fix the nonexistent problem.
24 MR. CAMPER:
That was something else that came up.
25 The problem we have is that if licensees choose not to l
l
e c
47 1
follow the regulations or choose not to follow license t
2 conditions --
/
3 MR. HENKIN:
Or are unable to.
4 MR. CAMPER:
-- or are unable to, as a regulatory 5
agency that is charged with public health and safety, that 6
almost falls on deaf ears.
We can't do anything about the 7
fact that licensees will argurs that we can't comply, or we 8
don't comply, or we don't chaose to comply.
We have an 9
inspection mechanism that dt.als with that.
10 MR. HENKIN:
Your rulemaking, in effect, has a 11 good deal of the force of law.
12 Now, there is a principle in law that says that an l-13 unenforceable law should not be passed, basically.
You 14
,should not make an unenforceable law.
l 15 If you pass a regulation which the majority of 16 people cannot comply with, then you have passed a regulation l
17 that is essentially an unenforceable law.
And the wisdom of 1.
I 18 that regulation must be questioned.
19 MR. CAMPER:
So then you are saying that on the L
20 proposed rule, that the majority cannot comply?
21 MR. HENKIN:
I don't know that.
I'm saying that p.
22 there is a strong suspicion on the part of many people that 23 compliance with that regulation may be quite difficult, in
(
24 may settings.
25 MR. TELFORD:
But you are aware of the fact that
o 48 1
we are conducting a pilot program, with approxinately 70 t
2 volunteers, and you are aware of the fact that sa have had 3
workshops with those volunteers to discuss with them the 4
proposed 35.35 and the objectives there, and that they have 5
each developed or modified their program to meet 35.35, and 6
that they did so for a 60-day period.
7 And we will also have workshops with those folks 8
to find out their suggestions for how to modify the proposed 9
regulation and to hear about their experiences trying to 10 satisfy this regulation, how much trouble it caused them, 11 how much cost it was, et cetera, et cetera.
12 MR. BRINER:
You just touched a nerve.
13 MR. TELFORD:
Yes.
Cost.
MR. BRINER:
That's part of the public 14 l
15 information, right?
16 MR. *ELFORD:
Yes, sir.
17 MR. BRINER:
How much did it cost NRC to do this, 1
18-and what does it cost the individual people in the pilot 19 study operation?
Do you have any idea how much it cost?
l l
l 20 MR. HENKIN:
Yes, that's a very good question.
21 What has the cost to NRC been to date for this rule, L
22 development of this rule, and for the pilot program?
Do you 23 have any idea?
24 MR. TELFORD:
I have not calculated that.
j 25 MR. BRINER:
I would advise you not to, or you
1 e
o 49 I
will have a sleepless future.
2 MR. TELFORD:
Thank you.
3 (Slide.)
4 MR. TELFORD:
There's a case of misadministration 5
in March of 1990 in Michigan.
This was 3250 rads to the 6
wrong portion of the spine.
Do you think that caused any J
7 harm?
8 MR. HENKIN:
Yes.
And you have te tell me whether 9
this could have been prevented or not.
10 MR. TELFORD:
The cause here was the technologist l
l' 11 didn't consult the treatment chart, didn't consult the 12 directions, and used an anatomical market still present from j
13 prior treatments.
Therefore, the technologist treated the
+
14 incorrect site.
So now they will have a second technologist t
15:
verify the treatment prior to administering the radiation.
16 MR. HENKIN:
You have increased the staffing 1
17 requirements of that institution'with this solution.
18 MR. TELFORD:
Excuse me.
The licensee --
19 MR. HENKIN:
Remember, licensees gives you back i_
20 what they think you want, okay, and what they think you will
-21 accept.
h 22 If the licensee were to give you back, I'm not 23 going to change anything, you wouldn't be very happy with 24 that in general.
You want them to do something.
They've 25 got to do something.
Therefore, what they do is they
, -.,,,.,, +
..-,-...-.,.-..,-..-n
~.--,.-.w,.,--
>+--r
,w
50 1
1 propose to you something that they are going to do to t
2 satisfy you, and somewhere in their system, the cost gets 3
eaten for this, or the staffing requirements are increased, i
4 because you are going to use maybe two-tenths of a person to 5
do this.
6 So that where they had two technologists, let's 1
7 say before, they really need 2.2 people now to do the same 8
patient load.
9 This diminishes the quality of care to patients 10 overall, whether or not you realize that.
And that's the 11 implications of some of this stuff.
12 Especially, and I can't speak to what the sa.itage 13 of radiotherapy technologists is, I know that I am short 2.2 14 staff technologists right now, and that it hurts bad, to be 15 short 2.2 people.
And I cannot legitimately, as a 16 physician, practicing medicine, justify the use of a staff 17
. technologist for medical application that don't affect 18 outcome.
That's a medical judgment.
19
[ Slide.)
20 MR. KLINE:
It is subjective, I guess, as to which 21 institutional costs are incurred by having a double 22 verification or a redundancy.
And it all varies between 23 institutions.
24 MR. HENKIN:
There is still going to be a cost.
25 MR. KLINE:
There is still an associated cost.
e 51 1
sure.
Could be minimal, could be large.
I l
2 MR. HENKIN:
I'm just saying in that case, that 3
might take
.2.
4 MR. KLINE:
The other side of the coin, in the 5
hospital, to have the same mistake occur, if you don't 6
institute some corrective action --
7 MR. HENKIN:
That's a hospital decision, based on 8
its malpractice situation and its environment, that --
9 MR. KLINE:
But that's a regulatory position of l
10 the NRC, that we have to ensure the safety of the public.
11 MR. HENKIN:
But you said to the hospital, and I'm 12 saying what you are doing is getting into the hospital's I
13 management policy, which is not an appropriate place to be.
14 MR. KLINE:
But they have a license.
15 MR. CAMPER:
We're not getting into the hospital 16 management policy.
The hospital will choose a corrective 17 action.that it deems appropriate.
We are looking, though, 18-from a public health and safety standpoint, for corrective 19 action.
You're right.
We do expect to see some adjustment 20 in your program to prevent this type of thing from happening 21 agaits.
We expect it to be satisfactory.
But how they go 22 about doing it, whether it's 1 PTE,. 2 FTE, an 23 administrative clerk doing these kinds of things, is really 24 up to the hospital and the licensee.
We don't get into 25 that.
i 9
52 1
MR. HENKIN:
The point I'm trying to make, Larry, i
2 and it's a point that doesn't seem to be getting through, is
)
3 that many of these are once in a lifetime occurrences for a 4
. technologist.
Having made an error of this type, it is 5
unlikely that person would ever make that error again.
They 6
are so mortified professionally, and feel so inadequate, 7
that the likelihood of repeating the error is nil.
8 So what you do is you introduce a system that says 9
an individual made an error; now we are going to forever 10 modify the system at this particular institution when the il likelihood of that individual or another one at that 12 institution making the error is very small.
13 MR. KLINE:
Would your recourse be to ignore it l
14 and t:o say the system didn't work, but, well, that was --
l 15 MR. HENKIN:
Only if you examine the system and 16 find that in the first place the system was no good.
17 If there was no system in the first place, that 18 would be a justifiable thing; you say well, you didn't.have 19 a system, you should have a system.
20' If in fact they had a reasonable system of some 21 sort, because under your proposed rule, if this occurs, what 22 are you going to do?
You are going to go back and ask them 23 to do the same thing they are doing now; how are you going 24 to change your quality assurance plan to assure this doesn't 25 happen.
It's the same thing.
e 53 1
MS. ALAZRAKI It really depends again upon what t
2 the real incidence of these occurrences are.
And in nuclear 3
medicine, what we've tried to say is that the incidence is 4
so small, that you're not going to improve upon it with 5
regulations or with procedures.
We're already doing the 6
optimum quality assurance, based on JCAHO and other things, 7
that NRC is not going to make any kind of an impact on that 8
in our practices.
9 Now, you are presenting us with a lot of radiation 10 oncology cases, which we are not involved in.
11 MR. CAMPER:
That's a point well made.
And no one 12 would argue that the frequency of occurrences for 13 misadministrations in nuclear medicine is very small.
We 14 won't argue that.
15 Again, as John pointed out earlier, what we are 16 trying to do here, and we ask you to bear with us, is to 17 give you the flavor of the environment that we have to look 18 at.
19 We can't isolate nuclear medicine.
20 MS. ALAZRAKI:
You certainly can.
21 MR. HENKIN:
You certainly can.
22 MS. ALAZRAKI:
It's an entirely different 23 practice, different departments in the hospital, different 24 positions,.different technologists.
It's a totally 25 different department.
And you certainly can isolate it.
4 54 1
MR. HENKIN:
Commissioner Carr agreed to that
(
2 Asolation.
3 MR. CAMPER:
When we look at what is occurring in 4
Lisadministrations across the board, we're saying, at least 5
thun far, that the status quo is no acceptable.
6 MR. HENKIN:
Let me corrtect that question.
How 7
many therapeutic brachytherapy, tuletherapy administration 8
are there per year, nationwide?
)
9 MR. TELFORD:
150,000.
10 MR. HENKIN:
Okay.
150,000.
there were 14 11 misadministrations last year, medical misadministrations, if
~
12 I remember you correctly.
F 13 MR. TELFORD:
14 this year.
12 last year.
14 MR. HENKIN:
12 last year.
Okay.
15 MR. TELFORD:
Which includes brachytherapy, 16 teletherapy, and nuclear medicine.
17 MR. HENKIN:
Okay.
Subtract out the three from 18 lats year that we knew about.
That leaves 11 for 19 radiotherapy out of 150,000.
Now, is that 150,000 patients l'
20 or 150,000 sessions?
21 MR. TELFORD:
Patients.
22 MR. HENKIN:
Patients.
So a session is on the i
23 average of ten per patient, if I remember my radiotherapy l
24 correctly.
25 So you are talking about 1.5 million sessions and
55 1
11 errors.
i 2
MR. TELFORD:
No, no.
You can't multiply all of 3
those numbers.
Some of them are brachytherapy, which is a 4
one-time implant.
5 MR. HENKINt There are obviousi many more than 6
150,000 sessions.
7 MR. TELFORD:
Administrations.
8 MR. HENKIN:
Administrations.
Okay.
There are 9
obviously many more.
We can argue about what the number is.
10 But there were 11 out of that large number.
11 I submit, without knowing a damn thing about 12 teletherapy or brachytherapy, that that is insignificant.
L 13 It falls into your BRC classification.
14 MR. TELFORD:
Be careful.
BRC says 10 millirem 15 per patient.
16 MR. HENKIN:
If you spread it over the public, 17 150,000 exposed people.
18 MR. TELFORD:
If you are going to market something 19 like glow-in-the-dark golf balls or irradiated gemstones or 20 watches, your product, if it is sold to 100 million people 21 collectively, will be more than the 1,000 rem.
But if it is 22 to an individual, like it's a product that is only going to 23 go to a few people, then you *.ook at it on an individual 24 basis, and the increase shovld not be more than 10 millirem 25 per percon to be BRC.
I dtn't think these are BRC.
e 56 1
MR. HENKIN:
I have another dumb question.
And i
2 that is, why don't you let the medical malpractice 3
environment take care of this?
Because this is the greatest 4
disincentive to screwing up that there is.
You can do 5
nothing to a physician or an institution that compares to 6
what one good malpractice suit can do.
7 MR. TELFORD:
Maybe you're right.
We can't sue 8
the physician for $10 million.
We can only pull the 9
license.
10 MR. HENKIN:
And you wouldn't do that anyway, 11 because if you did that, you would render the institution 12 without service to the patients as a whole, and you know you 13 have a policy against doing that.
14 MR. TELFORD:
I think we've already done that this 15 year, in fact, a couple of times.
16-MR. BRINER:
Not for misadministrations.
17 MR. KLINE:
We're looking now at whether or not 18 we're trying to prevent or diminish-the chances, because 19-what is an acceptable rate of misadministrations 20 therapeutically for --
21 MR. HENKIN:
Well, the malpractice report will 12:2 tell you it is zero, because anybody who has a therapeutic 23 misadministration can turn around and sue.
Therefore, 3
they've already got an effective limit, if you like, and it 24-25 says, by the way, there are severe penalties associated with l
1 _. _ _ _ - -. _ _ _ _ _ _ _ - - _ - _ _ -. - _ - _ _ _ - _. - _ _ - - _ - - _ - _ _ -. - - - _.
J
57 1
a therapeutic misadministration.
Those severe penalties may 2
run into the millions of dollars.
3 If you want to look at a disincentive to have a 4
therapeutic misadministration, I suggest that is a very 5
strong disincentive.
6 MR. KLINE:
That is a deterrent, but not a 7_
preventative mechanism.
8 What is an acceptable rate?
What do you submit is 9
an acceptable rate?
10 MR. HENKIN:
There is no such thing as an 11 acceptable rate.
12 MR. KLINE:
That is basically what you are 13 quantitating here.
i 14 MS. ALAZRAKI:
You can't talk about an acceptable 15 rate.
All you can talk about is exceeding, if you can 16 define it, in other words, if there is something procedural 17 above and beyond human error, which you just can't 18 eliminate, no matter what you do.
i 19 MR. BRINER:
I would say it is that range at which 20 we now are in nuclear medicine.
You will not diminish that 21 any more, no matter what you do.
22 MS. ALAZRAKI:
In fact, we believe seriously that 23 by burdening the nuclear medicine community with further l
24 paperwork and regulation, you will endanger the low rate 25 which we have, because of the need to pull personnel off to
58 1
do-this type of administrative paperwork above and beyond I
2 what we are already doing.
And that further endangers 3
mistakes or endangers the possibility of mistakes.
4 MR. KLINE:
Assuming that we institute these 5
asasures, has anyone sat down and looked at the costs in 6
associated personnel and extra time required for the 7
returns.
8 MR. HENKIN:
We have all sorts of estimates on 9
that which have been provided previously.
Your pilot study 10 Will indicate some degree of what that is, but even if it 11 costs only 5-10 percent of personnel time, which I think is 12 a conservative number to talk about --
13:
MR. KLINE:
That's assuming now.
Let's look at 14 maybe one to two percent.
15 MR. HENKIN:
There's no way that it would cost one 16 to two percent.
17 MR. KLINE:
The question is; we don't know, and 18 possibly, part of this pilot study might reveal.
19-MS. ALAZRAKI:
We have to establish that it's 20 going to accomplish anything.
21~
MR. HENKIN:
What is one percent of nuclear --
22 MR. KLINE:
We haven't established that it will, 23 but we haven't conversely, either.
It's an untested rule, 24 that's true, but the argument goes both ways.
You can argue 25 that it's not goina to affect medicine, it's not going to
99 1
help.
How do you know?
I 2
MS. ALAZRAKI Because what we're trying to prevent 3
is already at such a low rate.
4 MR. HENKIN:
I'll tell you how I know.
We have an 5
analogous situation in another medical specialty.
Blood 6
banking ir, regulated and the reporting of misadministered 7
red cells is a reportable item.
8 MS. ALAZRAKI Only deaths.
9 MR. HENKIN:
Causing deaths is a reportable item.
10 Okay, when you take the number of reported 11 misadministrations of red cells leading to death, factor
)
12 that into the total number, you come out with an identical i
13 rate that we have for radiopharmaceutical misadministration, 14
.6 percent.
15 okay, there's a message in here.
The message in 16 here is that while you have humans in the system, you are 17 going to have an ongoing rate of errors.
There seems to ba, 18 at least from two diverse medical specialties, -- the only 19 thing they have in colmnon is a reporting requirement.
The 20 same error rate comes out.
21 Both have stringent procedures in place to assure 22 that misadministrations don't occur.
So that what we're 23 saying is that in blood banking there is a real risk of the 24 mis-- obviously, they've only got to report deaths.
- Yet, 25 they still have misadministr:tions in blood banking.
What
I 4
- n 60 J
1 does that tell you?
it
.l 2
Does it tell you that with all the effort in the e
3 world, you may not be able to -- there's an asyntotic 4
approach to zero.
The asyntotic approach to zero says that 5
you can never hit zero.
The line effectively levels out and t
6 parallels the axis forever.
You may have reached that line 7
at.6 percent.
\\
8 MS. ALAZRAKI:
That's basically the most important i
9 message that we have; that we feel that the 10
- misadministration rate in nuclear medicine is approaching L
- 11
- the human error rate and you're not going to improve on 12 that.
We have instituted quality assurance techniques to K
I
- 13 ensure against misadministration which are excellent, i
14~
MR. TELFORD:
So you're suggesting that
.6 percent i
15 is the --
'16 MR. HENKIN:
As low as reasonably achievable.
17.
MR. TELFORD: -That the regulation should be p
=
- designed 1to acknowledge that each licensee has a rate that's
. 19
.6 percent or below --
j 20 MR. HENKIN:
Mine is much better than.6 percent.
21 MR. TELFORD:
Is that what you're saying?
22 MS. ALAZRAKI:
What we're saying.is there is no 23.
need for NRC to embark upon.any unnecessary duplicative E
24 regulations.
25 MR. TELFORD:
We were going through the iii,ia uhn iiiiiii ia ii ii is i a i e
iini
i
- )
.o 61 1
misadministrations-that we say.
Let's see, that's I:
2 brachytherapy, that's brachytherapy and that's brachytherapy 3
-- that's brachytherapy..Those are nuclear medicine.
4 The reason I bring this case up is because it's 5
probably one of the oldest cases that I've showed you.
It's
~6 1988.
The patient was -- the misadministration was that the 7
patient got 30 millicuries instead of 30 microcuries of I-8 131.
9 The cause, from our point of view, is that the-10 order'from the regular pharmaceutical was verbal and the 11 1 technologist got confused and order 30 millicuries instead i
12 of microcuries and that when the dose arrived, it was not f
13 checked in a dose celibrator because th'is is an agreement 14 state.
This agreement state does not require dose 15-calibrators andLthey used the gamma counter and disregarded 16 the-high count rate.
17 104. HENKIN:
This-might fit-my definition of
_18 stupidity beautifully.-
I mean, here it was clear _ cut 19 information presented to the person that they had the wrong material and they ignored it.
20 21 MS. SURREL:
There was procedure here, okay.
The 22 pharmaceutical was ordered verbally.
Now, the verbal order 23 may have been correct.
You're not stating one way or 24 another whether it was.
I 25 The point was that the person was confused.
In I
l
s c
62 1-fact, there is a procedure and the procedure'in Texas is not i
2 to have a' calibrator, okay?
There is procedure there that 3
was somehow viulated by a human being.
4 MR. TELFORD:
If the order was firm for 30 5
millicuries --
6 MS. SURREL:
This could have just as likely have 7
happened if the order was --
8 MR. BRINER:
That may not be the only error there.
9 Who ordered it to begin with?
10 MR. TELFORD:
The technologist ordered it.
11 MR. BRINER:
Okay, where's you physician?
12 MR. TELFORD:
The nuclear physician had ordered 1
13 the technologist to order 30 microcuries.
14 MR. HENKIN:- You believe that writing this down 1
15 would have changed it?
16 MR. TELFORD:
.I am trying to show you problems.
'17 MS. SURREL:
We are-telling you that a procedure 18:
.in' place may not have changed this particular error.
.19 MR. HENKIN:
There are probably three errors in
'20 this situation.
There are at least three errors in this 21-situation,-okay?
Now, one of those errors would not have 1
'22 been corrected by your regulations because a dose calibrator u-23 is not required in Texas.
7 j
24 Their quality assurance plan wouldn't necessarily 25 have to include a dose calibrator, because their state hf ir., D-
'6 63 1
doesn't require that.
I I
2' MR. TELFORD:
I'll correct you on that, but go 3-ahead.
4' MR. HENKIN:
Well, correct me on it now.
5 MR. TELFORD:
This requirement would be compatible
--6 for all agreement states.
7' MR. HENKIN:
But your quality assurance plan 8
doesn't have to require a dose calibrator.
You could have a 9
quality' assurance plan that doesn't require a dose 10 calibrator.
11 MR. TELFORD:
In the Regulatory Guide which 12 accompanies this, it talks about checking the dose in the
'13, dose calibrator.
L14 MR. HENKIN:
What you're doing is that you're
'15 assuming the authority in the agreement states as well, that 16
.if the agreement states-don't believe,that this is
~
- appropriate, they've still got to do it.
-18 MR. TELFORD:
That's an interesting statement, but 19' we've met with folks from the agreement states, and some I20 agreement states would go further-than this proposed 21 regulation.
i4 '
And they certainly can.
They have 23' the freedom to do that.
.t' 24 MR. TELFORD:
That's exactly right, but what this 25 would envision is that all agreement states would come up to
i 64 1
a-certain level.
1:
2 MR. HENKIN:
Are you implying that the agreement 3
' states are not doing an adequate job right now?
4
'MR. TELFORD:
No, I think you are.
5 MR. HENKIN:
Well, I'm trying to figure out what 6'
you're saying.
7.
MR. CAMPER:- This rule for be an area for
+
i 8
compatibility for agreement states.
9 MR. TELFORD:
It will be.
-10 MS. ALAZRAKI:
In the long term.
11 MR. TELFORD:
It will be a matter of 12 compatibility, i 'l
'13 MR. CAMPER:
In the area of medicine, much of what l
14 we do in'part 3535 does not require compatibility for the l
i
- 7 15' agreement states.
There are.only a couple of 16 misadministrations.
This rule would tme an area of required
- cjc 17 compatibility for all-the agreement states.
U 18 MS. ALAZRAKI:
You have-the capability of doing 9
ll 19 that right now without any kind of quality assurance i
20 program; don't you?
21~
MR. TELFORD:
We can --
22.
MS. ALAZRAKI:
No," inL terms of how the. institution 23 documents a dose.
You don't have that capability?
24
'MR. TELFORD:
Well, the answer is the regulation.
I 25 MR. HENKIN:
No, the answer to most things is not 7-vr w
y m
---a m-
- m--
s n-63 IJ a regulation.
4 2'-
MR. TELFORD:
A mechanism for agreement states is 3
a regulation.
4 MR. CAMPER:
If I understand your question, would 5
ina give a great deal of leeway to the agreement states in g
6
-regulating the use of medicine?
There are very few things 7
that we require strict compatibility for at this point in o'
8 time.
.n s
W 9
MS. ALAZRAKI:
Misadministration is one.
What 10 else?
(
11 MR. TELFORD:
All they have to do is report the What I w's trying'to do was to show you 12 misadministration.
a y.. l o m-13 some causes and'what.the licensee has decided to do so that' g
'14 we can understand the cause and.whether or not you think the 15 actions taken to prevent reoccurrence are'even interesting.
16' MR. BRINER:
Who ordered this to begin with?.
17' MR. TELFORD:
Who ordered what?
18 MR. BRINER:
This thing that: precipitated the 19
' misadministration?
'20 MR. HENKIN:
This wasn't the therapy; dose
,21 initially started out.
It was the non-therapy does, 12 2 therefore, the ordering by the nuclear physician wouldn't t
23 prevent this. error again.
24-MR. BRINER:
That's exactly right.
25 MR. TELFORD:
That's what the state of Texas l
1
b 66 1
decided to do.
2.
MR. HENKIN:
I'm just pointing out to you it's an 3
illogical solution.
4 MR. TELFORD:
I agree with you, and that's why in 5
the proposed regulation, it says that if you're going to 6
order any I-131 procedures, 30 microcuries is the --
7 MR. HENKIN:
What am I going to do with renograms 8
.that are 300,microcuries each, using I-131?
Am I going to 9
have to go through this song and dance before I can do 10 those?
11 MR. TELFORD:
The song and dance that you allude 12 to is for.a therapy procedure, just a written directive.
13 You do not. issue a-written directive for your procedures?
14 MR. HENKIN:
A written directive meaning what?-
15' MR. TELFORD:
Something that you sign and directs 16 lthe technologist to do something?
.17-MR. HENKIN:
Not for an individual patient and not 18 necessarily.
There's a standard dose in the procedure 19;
. manual.
The Joint Commission requires that the physician 20 review'the procedure' manual and initial the procedure manual
.21
~to indicate his approval of that procedure manual.
22 MR. TELFORD:
Good, that's exactly what we have.
23 MR. HENKIN:
Then we don't need it.
24' MR. TELFORD:
Do you issued a verbal directive?
- 25 MR. HENKIN
It depends.
It may not be anything.
___.i-- - - - _ - _. - - _ - - _ _. - - - - -. _ _ _. - -. - _ _. _ - _ _ - - -. - ~ _. _ _ - _. - - _ _ _. _. _ _. - - _ _ _ _ _ -.. _ - - - - - _. -
Di e,
67-1 It may be just okay, that's a renogram, fino.
Everybody
.(-
2-knows what we do with a renogrant it's in the procedure 3'
manual.
4 MS. ALAZRAKI:
The physician checks that the study.
'5 is appropriate for the patient.
That's medical practice.
-6 That the study is. appropriate for the patient.
7.
MR. TELFORD:
How do you do that?
s 8
MS. ALAZRAKI Based on the history.
9 MR. TELFORD:
Do you initial something?
10' MR. HENKIN:
No, not necessarily.
11 MR. TELFORD:
All right.
12' MR. HENKIN:
It varies institution to institution, L
'13 widely.
In our case, we go through the requisitions.and we 14 pull-out those that we have question about; the rest are
- 15 :
handed to'the technical staff.
16 MS.-ALAZRAKI:: What is recorded is any 17 inappropriate-order.
21 8 :
MR. HENKIN:- Right.
19 (Slide.)
20 MR. TELFORD:
The nuclear and procedures we are
! 21; lwell aware of because of the pilot program we're doing.
And 22 I think that they are going to offer us a very good solution J!.
23 here.
f
'24 MR. HENKIN:
The solution is they may all 25
' disappear, because there is a new pharmaceutical approved f,.
fJ
e i
68 1
that will probably replace it.
2 MR. TELFORD:
This has happened in March of 1989 3-in Boston, Massachusetts.
The patient received the wrong 4
radiopharmaceutical.
The patient was to receive I-123; l
5-instead the patient received five millicuries of I-131.
The 6
technologist misunderstood the wording in the notes made by 7
the referring physician in the patient's chart.
This is the 8
referring physician and not the nuclear physician.
And the p
patient got 500 rads.to the thyroid, approximately.
And 9
10 this licensee proposed a new procedure to verify what is to k;f
-11 be done in each diagnostic. step.
-12 So this is just a simple overcheck that they w' b 13 proposed to do.
S 14-MR. HENKIN:
We don't know exactly what they 15:
proposed to do.
But that's'okay.
~16 (Slide.)
17 MR..TELFORD:
This is May of 1989 in Minnesota.
1'
+18 This patient received 30 millicuries instead of 300
.t 19 microcuries.
The technologist misunderstood-the referring l
20-physician's request, what it was, what the pharmaceutical-1 21
~was to be,.and~the patient got 3000 rads to the thyroid, 22 approximately.
And the licensee decided that a new l.
i 23 procedure would be used.
He said that a patient is not to
[
24 be administered without prior approval by the nuclear 25 physician.
The nuclear phy=ician was not in the loop here, i
Ep<
69 l'-
prior to this.
+
2 MR. HENKIN:
Let me make a point about this.
And 3
that is that this hospital's quality assurance probably 4
acted on this as well.
Since it is a 1989 case, they had to 5
have a quality assurance by 1969.
And more than likely, the 6
recommendations of the internal quality assurance group are 7
what you got here.
8 So that somebody, formally, within the hospital, 9
would have reviewed this without a misadministration report 10 to NRC..-And what you got back were the -- just guessing --
11 the recommendations of the-quality assurance group in the 12
. hospital as to what should be done, so that, looking at a 13 1989 date, and that that would function whether or not they 14 had to report it and whether or not you had a plan in place, because they have to deal with those kinds of things.
16' That's their-job.
17 _.
We have a;whole group that does nothing but:
18
-hospital' quality assurance, and that we are constantly 19 prodded to do quality assurance studies within the f-20-department that look at two different things.
We have two 21 levels of. quality assurance studies.
One are administrative 22 issues, such as this.
This is~an administrative issue.
23 Another one, which you can concern yourself with,
,i-24 and is really important, is outcome.
25 MR. BRINER:
That's right.
p r
70 1
-1 (Slide.)
2 MR. TELFORDt-This is a case in October, 1989, 3
4 The patient ten times the prescribed dose.
The 5
cause!was that the referring physician here checked the 6
wrong. box on the form.
This institution at least had a form 7
for ordering doses in diagnostic case, but somebody checked 8
the wrong box and the patient got 100 rems to the thyroid.
9 I realize this. reporting requirement was triggered 10 here, because it was ten times the dose, and in the 11 diagnostic case, 50 percent larger.
This hospital decided 12 to. revise its procedures to require the nuclear medicine and if 13' not the referring physician here.to review and approve the 14-request, and to write the dosage on the referral form, to 11 5 '
get the' nuclear physician into the loop.
116 MR. HENKIN:
Thisiis a very~ interesting hospital.
,17,
.It's a very interesting hospital, because I inspected this 18-hospital as part of a practice inspection program recently.
19 And'they have just been pressured by Joint Commission, they R2 0 '
had no.in-house quality assurance program.
They didn't
-21 have one, despite the size of the institution.
'o 22 Joint Commission turned around on them and said we 23 will not accredit you again until you have a quality t
24:
assurance. program in place.
25 So that this is a demonstration, if you like, of 1
'o
-71 1
the' power of Joint Commission to make this particular 2-hospital, in-nominate at the moment, but well-known, and to 3
say.that Joint Commission can turn the screws on that 4
hospital to force them to put a quality assurance program in 5
place.
6 MS. ALAZRAKI:
It is also a good example of why-7 NRC perhaps should check that all their licensees do have a 8
quality assurance program.
9 MR. TELFORD:
I can't believe you said that.
i.
10 MS. ALAZRAKI:
A quality assurance program such as 11 JCAHO, I mean, every licensee should have some quality 12 assurance program, and you should recognize that JCAHO's 1
13
-quality-assurance program is a better one that you are probably going to be able to devise, and'already in place, 14 15 and if not in' place with any licensee,.they should get it in
' 16 ;
place.
?17 MR. TELFORD: ' Gee,LI think we all agree with-that.
p p
18-MS. ALAZRAKI:
Not an NRC program, but the JCAHO-t-
.19 program.
20 MR.-TELFORD:
Well, we haven't gotten to n.
~. 21
-discussing form yet.
L f
22 MS. ALAZRAKI:
We've been discussing that.
Thic's l
123 what we're doing.
j '
24
[ Slide.]
25 MR.-TELFORD:
This is the case in Arizona in 4
e e-
~
e
.o.
72 1
November of.1989 that everybody is probably familiar with
.c 2-where the patient got 100 millicuries instead of 100-4 3
microcuries.
Thera were several causes.
4 The order for the radiopharmaceutical was verbal.
- 5 In fact,~I think it was changed once, also verbally.
The 6'
dose was not measured in the dose calibrator, even though 7
Arizona, as an agreement state requires that.
There was
- 8 miscommunication between to technologists.
9 One technologist says the dose-has arrived, just L
10
.give it to the patient; the other technologist assumed that
'll-everything else had been done, without checking the packing 12 slips'and checking the dose calibrator, et cetera.
-13 The horrible consequence, no doubt, was that the
-14'
' patient's thyroid was destroyed.
The state here suspended
'15 the use of1I-131 until the licensee could show how these 16 types of misadministrations'could be prevented.
On a 1.
.17 :
subsequent day they allowed them to use up to 100 L
=18 ;
microcuries without state approval.
L'
-19 MR. HENKIN:- Let me make some comments on it.
- 20 Number-one, classic stupidity.
I mean,: just y
L 1 21
< classical stupidity.
They violated the state's. regulations.
- w
- 22 They violated good practice regulations.
L L,
23 How come nobody noticed that this container
-24 ~
weighed a ton when they went to lift it up?
I mean, you q
25 know, you get 100 microcuries of iodine, the shielding is h
- 4 73
,1 considerably different_than 100= mil 11 curies of iodine.
2
.It never triggered'in anybody's brain that this n
L3 thing that weighed a ton might not be the right thing.
4 So what you got is a lot of folks who were real 5
stupid.
And again, I submit, you cannot legislate against
- 6-stupidity.
7-MS. SURREL:
And again, I submit to you there is
- .-(
8-procedure there.
Procedure was just not followed.
9 (Slide.]
10 MR. TELFORD:
Okay.
Well, unfortunately, you 11 know, we have this regulatory responsibility to ensure 1.11 b j 12.
adequate safety of the public.
And when we see cases like 13 thi's,.and they go on and on, we don't have the option to w
i f'
14 say, well the agreement state or the licensee has a 15 procedure in place,-therefore everything is all'right.
16:
_These cases keep recurring.
17 MR.-HENKIN:
And they;are going to, forever and m,la, P ' ' '
- 18 ever and ever.
19-MR. CAMPER: -That can-be the case.
And we here 20 this again and again and again. -But let me'just emphasize 21-that, at least at'this point in time, the frequency of J22 occurrence of the major misadministrations is not acceptable
~23
.to the Commission.
24 MR. HENKIN:
Three per year?
25' MS. ALAZRAKI:
Out of 10 million administrations?
- f 74 1
Come on.
2 MR. CAMPER:
The point is, we would not be here 3
going.through this drill and having this discussing if it 4-was acceptable to the Commission.
5 MS. ALAZRAKI:
That is totally unrealistic.
6 That's unacceptable and unrealistic.
7 701. HENKIN:
That exceeds the standard of practice 8
for every area of medicine, for most industrial applications 9
of anything.
1 10-HMR. CAMPER:
That could certainly be the case, and 11-your argument has merit.
But I'm just simply saying, to 12 look at where we are now, the frequency of occurrence is --
13 MR. HENKIN:
Are you-telling us we need to go back 14 and meet with the Commissioners about this again?
15 MR. TELFORD:
All we're saying, you're saying to 16 us, the rate-is low.
'17 MR. BRINER:
We are saying to you the rate is as t
18 low as it can be.
19-
'MS. ALAZRAKI:
As low as reasonably achievable.
'20 MR. TELFORD:- I appreciate your opinion.
I won't l-2 11 say this is establist.ed fact, because.the data is somewhat a F
H22 little soft, both or exactly.how many administrations were 23' given or exactly how many misadministrations really llp 24 occurred.
I mean, today is a little soft.
j i
~25 But let's take it as an assumption that the rate 1'
l 1
75 1
is very low.
Okay?
And we could argue, I mean we could I-2 debate that the rate of misadministrations are apparently 7
3 low.
ButLwhat we're seeing is that there's a problem out 4
there.
Something is broken.
5 MR. HENKIN:
How is it broken?
6 MR. TELFORD:
Well, here is a case of it being i
7 broken.
November, 1989, Kuakini Medical Center, Honolulu, 8
the wrong patient received a therapeutic dose of 9 9
millicuries of I-131.
Now, I'm sorry guys, but we've got
. 10 the responsibility of assuring adequate safety for these 11 patients.
12 Do you want me not'to try?
13 MR. HENKIN:
You've tried.
14 MS. ALAZRAKI:
You've tried.
15 MR. TELFORD:
No, we haven't.
No, we haven't.
We 16 have not tried at all.
. 17 MS. ALAZRAKI:
How are you going to improve upon v
l1 18-the current JCAHO quality assurance program?
I didn't say we were.
We haven't l
20
_gotten to that point yet.
217 As a' matter of fact, I have a very interesting i
- 22 example'of a JCH program that you sent in.
And with your 23 permission, I would like to hand it out and I would like to r
24 talk about this JCH program, because that is on the agenda.
25 And I would like to share with you, or we would like to 1.
l-
76
-l' share with you what we see of that nrogram that is on paper.
- 2' Now, it could be that you are doing much more in 3~
your actual practice than.what is on paper.
4 MS. ALAZRAKI:' Let me say that what JCAHO wants on 51 paper at the time that that was written was one indicator in 6
the professional, and we do many more than just one 7
indicator.
If you had the year's minutes from our meetings, 8
which JCAHO inspects when they come, you would see that 9
there are many.more indicators than one.
And one indicator 10 on appropriateness.
]
11-MR. TELFORD:
But, see, I would like to understand 12 exactly in detail, as a one to one comparison of what the
~
objectives that we have are, what of those are already being 13 14 met by what JCAHO-requires today?
' 15 ~
See, it could be that that is a great boon for us, r
16 because we have.a couple of alternative. ways to incorporate 17.
their requirements,'or indeed we may be, just in theory we 4
18 could say,.if you are JCAHO certified, it could be that you
- 19 are exempt from the requirements as stated in our rule for 20.
' nuclear medicine diagnostics.
21 101. BRINER:
Let's get.the terminology there; it's 22 accredited, not certified.
23 MR. TELFORD.
I stand corrected, Captain Briner.
)
24 tm. BRINFR:
All right.
If you're in the quality 25 assurance busines s, you ought to know what the terms are L
l' Ii:
l
I k-k
- bi e
b i
t p
+
77 L
F
' 11 that we go by.
ci 2 MR. TELFORD:
You are correct.
ei:
=
- 3 MR. BRINER:
All right.
C 4
MR. TELFORD:
In this case, the cause was the
-5~
technologist called the patient.
Patient B responded and 4
q,,
6 received the I-131 dose, instead of Patient-A.
1 7
Did I get that right?
- (
~
,1 8
MR. HENKIN:
Well, it doesn't matter.
We got the
- 1) +',
'9 message.
J' 10:
MR. TELFORD:
Okay.
The wrong patient responded.
j
'A *, The-patient was to receive 20 millicuries of technetium for
?,
- '!e M 12 a bone scan, but because it got the wrong patient, then the
- - (@. ;
13:
patient got the 9,000 rads to the thyroid.
j!
14-This licensee proposed that they would have a 15 single technologist.who has'the' responsibility for gi74 16
~ recognizing patients -- to;do so prior to therapy; and to 1 Iih w
'17 handle all: aspects of Iodine-131.
h h
' 18 Also they'll have the patient ar.d the physician
- i 19'
.and'the technologist sign the therapy worksheet, prior to y
- 2 0 '-
' treatment, i
21 This'is what they proposed.
And I've shown you a 22 variety of these; and they're all -- they're all kind of 23 different.
24 MR. HENKIN:
Can I comment on this one too?
25 MR. TELFORD:
Sure.
y c.
78 1
MR. HENKIN:
Because this one's fascinating.
2 Because we almost had a diagnostic misadministration 3
recently that paralleled this; and it was caught only by
'4 accident, because somebody was very alert.
5 MR. TELFORD:
Okay.
6 MR. HENKIN:
We had a patient coming in for a bone 7
scan.
We had another patient coming in for a hepatobiliary
,8 study.
Okay.
9 The lady for the hepatobiliary study was delayed.
10 Her -- the machine to do her on was not available and she 11 had to wait in the waiting room for a while.
She saw a 12 number of people-going ahead of her for studies.
So, the I
13 next name-that was called out, she responded to.
14 Okay, she responded to that name because she felt L
'15 she was losing her place'in line,.okay.
And she got all the 16 way back to the hot lab, when the technologist picked up the 17 requisition, he realized that this patient was probably not 18-69 years old, the way-it's stated on the requisition -- she 19 looked more of about 35 years old.
And he started to 20 question what was going on.
L 21-But, in fact, if he hadn't looked at the age --
22 this lady kept swearing she was the other person, because 23 she was losing her place in line and all these other people
.p 24 were going ahead of her.
25 So the causes are not always within the nuclear 1
o 79 l-medicine staff for these errors.
-2 (Slide.)
3 MR. TELFORD:
Well, that was a very good action 4
that the technologist took.
5 MR.-HENKIN:
But, no quality assurance program in 6
the world would mandate that.
That's a smart person, that's 7
all.
You just got a smart person in there, who had the time 8
to look at the requisition that day.
9 If I have to devote people to administrative 10 actions,-I-may not have the time to be reading the fine 11 print on every requisition.
x 12 MR. WIEDERMAN:
If I remember, at Loyola issues a 13
-little plastic card to all out-patients, and I assume.
14-MR. HENKIN:
They do not necessarily have that 15" card on the first visit -- that's -- most of our people --
<16
'many of our people are single visit for diagnosis only.
+17 They are not in the Loyola system.
That card is not always 18 issued on the first visit.
It sometimes comes in the mail, 19 subsequently.
20 But that -- you knott, this is this question that's 21 been raised'-- should we check driver's licenses.
Well, if 22 you believe driver's licenses -- that -- we have a lot of 17 23 year-old kids with forged driver's licenses that say they're 3_
24 21, okay, for obvious reasons -- that any of this 25 documentation is, first of all, a tremendous burden, and
o 80 1L second of all, the only time you really get concerned is 2-when the patient cannot identify himself -- he's comatose, 3
okay, lor you have a question as to the patient's mental t
4 ability, and he's not banded.
S' A hospital -- all hospital in-patients are r
)
6 supposed to be banded.
From time to time there's one who m
t.
7:
isn't banded.
Our standing rule is that if they patient 4
8 isn't banded and cannot identify himself, someone from the 9.
nursing service must come and identify that patient'and band q
.10 him on the spot.
11 But, I describe to you situations in which 12 misadministrations occur, that are not the fault of nuclear I
13 medicine's staff and would not be preventable.
We almost 14 had a diagnostic misadministration because this lady wasn't 151 going to!1ose her place in line.
-16 MR. WIEDERMAN:
Now, in your. institution, doctor, 17 I' assume you examine each one of your -- your therapy.
i 18 patients?-
19 MR. HENKIN:
One of us -- one of us would speak to i
and. meet with each one of the therapy patients, that's 20 t
21 correct.
22 MR. WIEDERMAN:
And then a dose:is given that day?
23 MR. HENKIN:
It's given -- well, it doesn't 24 matter, there's always a physician present when the dose is 1:
25 given.
It may not be given'that day, but whenever the dose
(
g e.
m 81 i~"
1-is_given, there would be a physician present.
L 2-MR. WIEDERMAN:
So, you have sort of a -- a e
i 3-redundant system in place-already?
4 MR. HENKIN:
Yes, and I don't think we differ --
f
'5 MR. WIEDERMAN:
Since you not only have your 6
' technologist --
7 MR. WIEDERMAN:
-- that much from most 8
institutions in how it's done.
You know, that I think that 9
most of the time, somebody meets with-the patient and 10.
discusses the therapy with the patient.
Because that's the 11 way.you' don't'get sued, is to discuss the therapy.
12 MR. WIEDERMAN:
I totally agree 100 percent; but i
I 11 3 )
what we're finding is a lot of institutions out there -- the 14' physician doesn't even'see -- the nuclear physician doesn't
- 15 even-see the patient.
16 MR. HENKIN:
That'needs to'be. addressed by 2
17 somebody other than NRC, however,'because that's an issue of 18 quality of practice -- quality of medical care.
That's-not b
19 necessarily an NRC issue, that's an issue that deals-with
.20-quality of medical care as such.
1<
21?
MR. KLINE:
But, if the wrong' patient is given the.
22 wrong --
23 MR. HENKIN:
The physician could still give it to f
24 the wrong patient.
25 I will point out to you, at the hospital that we
i 82 l
l 11 talked-about a few minutes ago, whose name we wouldn't cite
/-
2
-- a physician misadministered a dose to a patient.
t p
3 MR. BRINER:
That's one of-the rounds that can go 4
wrong.
.But still -- there's still a number of different 5
. mechanisms that could be prevented by simple checks.
6-I think, * 'lat the point is here is that a lot of 7
facilities are doing it -- like yourself.
I believe you 8
probably had a very good quality assurance program; but can 9
you speak for the moral majority, or are there others out I
10 there that are as good as your quality assurance program at
! 11; detecting these errors as they come through the front door?
- 12' MR. HENKIN:
The quality assurance program is 13'
'related to the type of practice the institution has.
That's p
14
.really what Joint Commission does -- it relates it.
.15
-And when it comes through nuclear medicine, one of
'16
- the question they ask you is=about therapeutic procedures.
17-They always ask about therapeutic procedures.
1 18-And they actually ask questions far more extensive 19 than NRC asks.
They want'to know how you go.about
-20 evaluating patients for therapy.
They want to know how you 21
. follow up your therapy patients to see that the doses you're i;
22 using are, in' fact, the appropriate doses that you may be I
23 prescribing them.
l+
24 You're only saying we have to prescribe them.
I 25' Joint Commission wants to know we're prescribing the right
83 7
1 does, and that we some how are following_up our therapy V
'21 patients to see that we're having an appropriate effect on 3
those patience.
4 MR. KLINE:
Okay.
So, you're looking at longevity 5
-,and you're looking-at recurrence --
6 MR. HENKIN:
We -- we have our people come back 7
for a-year, if_they will.
But you can't force them to come-8 back.
9 MR. KLINE:
But see, now we're getting into 10 something different.
We don't look at that end, because 11 we're not into clinical medical sense.
12 MR. HENKIN:
But, they are far more extensive in 13 what they ask for.
14 MR. KLINE:. Yes.
-I realize what you're saying.
' 15 '
Yes, they do go further.
16 But, we're just simply looking at the preventative
.17 measures.
And, believe it or not, there are, I would
.18 speculate, just as:you might speculate the opposite, a lot
~19 of hospitals that don't have-these sort'of checks in place.
20 Now, how do you assume.that they have-them in 21 place,-and how do you assume that they.do have a good 22 quality assurance program?
23 MR. WIEDERMAN:
That's the Joint Commission's 24
-function.
That's what they're out there for.
What about
'25
'the outpatient, private practice patients?
S.
t 84 l'
MR. HENKIN:
I think we have to discuss that as a 1
2 separate topic.
Because they don't have to compose 3
anything, except their licensees.
4 MS. ALAZRAKI Accept if they're licensees of e
5 yvors, you can ask them to comply with JCAHO, as a quality 5
6 assurance --
b 7
MR. HENKIN:
There is an increase.
8-MR. WIEDERMAN:
You're saying, we should ask the 9
private practice but we shouldn't ask the hospitals?
10 MS. ALAZRAKI:
No.
You can require it of all your s
11 licensees, as long as we're hooked up with a quality 12 assurance,Jor appropriate --
'13 MR. HENKIN:
Or hove them present other acceptable 14 evidence that is discussable as to other acceptable 15
. evidences.but there's nothing that stops Joint Commission 1 <6 from inspecting out-patient facilities, okay.
And, in fact, 17
.if-the reimbursement trends continue the way they are --
118 MS. ALAZRAKI:
They will.
19 MR. HENKIN:
-- it's probably going to be required' 20 any way, so that down the road, it's Medicare who's probably 21' going to require that at some' point.- They require it now 22-for in-patient facility.
23
[ Slide.)
.g~
24 MR. TELFORD:
We looked at misadministrations from We see a lot of mistakes being made.
I 25 1980 to date.
85 1
MR. HENKIN:
You see some mistakes.
1 2
MR. TELFORD - Our reaction is, we'd like to try to
-3 prevent these misadministrations.. In fact, the exact j
4 reaction that Dr. Alazraki had, was that everybody should-5 have a quality. assurance program, everybody should be trying A
16 to prevent.
4 1
=7 MR. HENKIN:
No, we don't argue wit.h that.
8-MR. TELFORD:
That -- that's our b Asic intent, 9
we'd like to prevent.
10 Now, if you want to discuss how to do that, let's
= 11-do that.- But, basically, we'd like to prevent --
f.
c12 MR. HENKIN:
The question is --
I 13' MR. TELFORD:
-- the errors in medical use.
W 14 MR. HENKIN:
-- whose job is it to prevent?
(in 15
.That's what the bottom line is.
116 MR.-TELFORD:
Whose job?
p, L17I MR. HENKIN:
We believe that is a function.of the-
'18 practice of medicine -- to' prevent: medical errors.. No other
- l
- .
L,
- 19:
. Federal regulatory agency.is involved in the prevention of L'
20-medical practice errors.
This is a technology statement.
- 22 MR. HENKIN
It's a medical -- I read you -- do
'.23 you want to hear the definition of a medical practice?
y 24 MR. TELFORD:
Okay..
It's a medical error.
25 MR. HENKIN:
It's a medical practice error.
l l!
t -
y y l
86 li MR. TELFORD:
It's a medical practice error.
v
<2 MR. HENKIN:
Again, I will take the-analogy I took 3
with you in a private discussion.
If I'm an internist and I g
-4 run a private office and I do no nuclear medicine, I' n not 5-
. licensed by the NRC --
6.
MR. TELFORD:
Okay.
'7 MR.'HENKIN:
-- however, I have a nurse working 8'
for me in that office and she give B-12 injections to 9
patients, common thing that happens in a private office 10 setting for an internist.
111-If she aisadministers B-12, or gives son.ething c
12-other than B-12 in the injection; what Federal agency is-l t
' 13
~ interested or responsible 6/ that?
14-MS. ALAZRAKI:
None.
15 ;-
MR. HENKIN:
None.
16
-Whose head is it on?
Mine.
It's my medical 17-practice.
Everybody in that practice I am responsible for.
L 18 I-will be sued if any of them do anything stupid, criminal 19, or anything else.' So that is no difference in a nuclear 20 medicine practice.
1 :-
21 The people-who work in that practice, in the 22 hospital.I am responsible for. legally.
It is my practice, 1
23 as if it were an internist private office practice.
And we l7 24-do not believe there is anything in Federal law that i
4 25-cntitles you to get into a medical practice.
And that is
s
-t 87 1
what you're doing.
I 2-We come back to the very beginning.
The internist
- 9 i
- who misadministers a drug.in his office, no matter what it 3
4 is, the FDA has no right to go in there and do anything with 5
it.
Neither do you have any right to involve yourself in a i
6
-- the practice of medicine.
7 And that's what we're talking about.
No matter 8
what the merits may be, we can argue over the merits.
9 MR. TELFORD:
Let's say that -- it's not you, 10 because you have a --
i 11 MR. HENKIN:
No, no.
Let's say it=is me.
12 MR. TELFORD:
Let's say -- let's say -- while you i
131 say it's -- where's the nearest you know what?
I need to 14.
take a pit stop here.
15 MR. HENKIN:
We'll go off the record a minute.
16
_(Brief recess.)
17 MS. ALAZRAKI:
Except their licensees.
18 MR. TELFORD:
Back on the record.
19 Let's continue.
I'd like to finish with this line 20 because I'm going to, respond to your question of need.
Then
. :21 '
we can break for lunch and come back and perhaps fruitfully
- i L22 get into a discussion of what the JCAH0' requires.
23 The first point here was that we see these
]
12 4 misadministrations and we have the reaction that Dr.
25 Alazraki had, that we think everybody should have a quality
e 88 1
assurance program and should try to prevent and not only 4
2 that, it's our regulatory responsibility to make sure that 3
adequate safety is provided for members of the public
)
4 including patients.
5 Now what we see is that we're -- the total 6
collective "we" here including the NRC and the agreement 7
states which comprises something like 2,000 facilities for 8
NRc and 4000 facilities for agreement states is that we seem 9
to be going around one at a time and we see one problem like 10 a teletherapy problem at hospital number one, a 11 brachytherapy problem at hospital number two, and then we 12 see a nuclear medicine therapy problem at hospital number 13 three, then we-see a patient identity problem in hospital 14 number four, so we can iterate through our 6,000 facilities, 15 one's for teletherapy, one's for brachytherapy, one's for 16 nuclear medicine, one's for patient identity, we could go 17' around that loop 24,000 times, which seems to be an
[
18 inefficient way to proceed.
19 Rather, we would like to have a generic solution, 20 to have a performance based set of requirements that in part i
L 21 could be driven by JCAHO, indeed maybe should incorporate 22 everything there that is worthwhile but we favor a generic 23 solution.- That is another need for rulemaking.
24~
Thirdly, we would like to bring all the licensees 25-up to the same minimum sufficient level of standards.
It
(
l
e e
l 89 i
l 1
could be that because 79 percent of hospitals belong to JCAH 2
that they are already up to a certain level of standard and 3
it could be that it turns out that the final rule could be i
4 nothing of an impact to those folks to speak of because they 5
already have JCAH requirements in place, but there are those 6
out there that don't have those same minimum sufficient
'7 levels, so that is the third need for the rule.
8 I am sure you have some coms nts to make.
9 MS. ALAZRAKIt When you say a generic solution, do 10 you mean sealed sources, unsealed sources?
Do you mean --
11 what are you talking about?
12 MR. TELFORD:
Generic solution means one solution 13
-- the form is for everyone, like --
14 MR. HENKIN:
One size fits all.
15 MR. TELFORD:
One size fits all.
It's in this 16 case a regulation that's --
17 MS. ALAZRAKIt And "one size fits all" could be 18 JCAHO type of quality assurance compliance would be 19 acceptable.
20-MR. TELFORD:
The JCAHO type requirements could be 21 included in that generic solution as being applicable to i
22 nuclear medicine diagnostics.
23 MS. ALAZRAKIt As opposed to radiation therapy 24 or --
25 MR. TELFORD:
As opposed to what we have invented w
so-w-e*e
+, -
i*---v h
p p
er,es
__,m,-u,_
e 90 1
so far.
2 MS. ALAZRAKIt Okay.
3 MR. HENKIN I don't think I am prepared to 4
comment on that as a solution at the moment.
It is 5
certainly one of the viable solutions is to say that 6
compliance with JCAHO will satisfy NRC.
That is certainly a 7
potentially viable solution, okay.
8 Whether it is the best solution is another 9
question.
10 We have yet to deal with the issue that is at the 11 heart of this and that is whether or not you have gone 12 beyond the limits of the Atomic Energy Commission Act and 13 whether you have gone beyond the statements of consideration 14 in terms of involvement in the practice of medicine and that 15 I think is an issue that is key to all of this, whether or 16 not it is JCAHO or anything else.
17 MR. CAMPER:
Let me make a comment about that and 18 certainly we're not prepared at this moment in time to 19 answer that question.
That is a question that would have to 20 involve the office of General Counsel obviously and things 21 like that.
22 What I would rather do though is try to focus upon 23 where I think we are now and that is, as you and I 24 discussed, Dr. Henkin, after the meeting that this 25 rulemaking has a history.
There have been some steps that
O' t
91 1
have been taken along the way including the fact that the 2
medical community asked the commission to pursue a 3
performance-based rulemaking, which it is doing, that asked 4
the commission to conduct a pilot program, which it is 5
doing.
6 I think to try to be as constructive as possible 7
for today's meeting we should focus upon or draw attention 8
as to whether or not the JCAHO criteria will address our 9
needs.
10 We also should focus upon whether or not the idea 11 and the possibility of categorizing nuclear medicine and 12 brachytherapy and teletherapy in some separate fashion is i
13 the best way to go.
14 We start getting into the argument of whether or 15 not the rule is necessary.
Are we invading the practice of 16 medicine and so forth and so on.
17 You are entering into a different area, a 18 different arena than I think we are capable of dealing with 19 here today.
Our primary focus, and John can correct me if i
l 20 I'm wrong, is to try to take a look at given where it is 1
21-today in the history of the rulemaking process thus far, to 22 what exter', in what fashion can we take a look at existing 23.
programs out there and see if they will work.
l (-
24 As John pointed out earlier, we would like to go 25 through one of these JCAHO programs and try to compare and
j 92 1
contrast how it relates to what we are specifically asking b
L 2
for.
3 Another thing I think is very important is to try 4
to get back to the point -- your earlier comments about 5
35.35 and the eight objectives and the language in those 6
eight objectives and in trying to draw some clarification as 7'
to what we can do if anything to wordsmith, if you will, 8
those objectives so that they address your concerns about 9
invading the practice of medicine while at the same time 10 trying to address our concerns about a performance-based 11 quality assurance program.
12 I think that would be more constructive.
i 13 I am not sure we are really in a position to 14 answer the question --
15 MR. TELFORD:
Well, we could discuss these.
Dr.
16 Henkin is alluding to the 1979 Commission policy statement.
17 MR. HENKIN:
We can further than that.
18 MR. TELFORD:
We can discuss those.
I mean that's_
l 19 really the basis for --
20 MR. HENKIN:
Well, if you're. telling me that you 21 aeed a ruling from the Office of General Counsel on whether 22 or not you're within your bounds in terms of the statements 23 of consideration, I think that's reasonable, okay?
i 24 I think by the same token we would have to obtain i
25 a legal opinion in that situation as well because that
'I
_M
l s
93 1
becomes a legal proceeding then and I think that is a very, i
2 very key th!ng to decide because in a way you are setting 3
precedent for Faderal regulatory agencies and this is what 4
worries us -- so that you need to understand why we are so 5
concerned about this topic as to whether or not you are 6
within the bounds of your regulatory authority to do so.
7 MR. CAMPER:
Let's go off the record for a minute.
8 (Discussion off the record.)
9 NR. TELFORD:
Let's go back on the record.
Let me 10 see if I understand your question correctly, Dr. Henkin.
11 I think you are alluding to the 1979 Commission 12 policy statement, in fact Item 3, which says "The NRC will
'I 13 minimize intrusion into medical judgments affecting patients 14 and into other arean traditionally considered to be a part i
15 and a practice of medicine."
l 16 This statement says that the NRC will minimize l
17 intrusion.
18 MR. HENKIN:
That's correct.
19 MR. TELFORD:
But the first one says that the NRC 20 will continue to regulate the medical uses of radioisotopes 21-as necessary to provide for the radiation safety of workers 22 and the general public, so it says it will continue to l
23 regulate all medical uses and the second statement is that i
24 the NRC will regulate the radiation safety of patients where 25 justified by the risk to the patient and where voluntary 1
94 1
standards or compliance with these standards are inadequate.
I 2
MR. HENKIN:
There is also a statement that you 3
have made any number of times as an agency on the record 4
which basically says that you are interested only in the 5
safe handling of materials, okay, the storage and handling 6
of active materials safely.
7 This again goes well beyond that and it goes to j
8 the point of prescribing things that are already prescribed i
9 by medical -- by parts of the medical practice, that there 10 are at least three groups that are involved in quality l
11 assurance in nuclear medicine at the present time.
12 Therefore, okay, this is already part of the practice of 8
13 medicine because the medical groups themselves are involved 14 in it.
15 It brings it in as part of the practice of 1
16 medicine.
It's a standard of practice.
L 17 If you look at ACNP's manuals, those things are j
18 labelled standards, okay, therefore my argument rests on the 19 fact that you are in fact extending your intrusion into the 20 practice of medicine where such organizations already exist 21 and I think you can make a very interesting case for whether 22 or not you ought to be there and'I would hate to see it come 23 to that but the feelings of the professional societies and 24 the professions are very, very strong in this area because 25 it sets a precedent for Federal regulatory agencies to t
i
~
95 1
regulate the actions of individual physicians.
That is not 2
an acceptable precedent.
3 MR. TELFORD:
I think your point is in part on 4
number two, where it says voluntary standards would be used 5
unless they are found to be inadequate.
6 MR. HENKIN:
Now we have some question as to who 7
can judge adequacy of medical standards.
You have no 8
physicians, no nurses in your employ.
How can you judge 9
medical standards?
10 MR. TELFORD:
This doesn't necessarily say we are 11 going to judge medical standards.
12 I think the key phrase in number one, one of the i
13 key phrases, is medical use.
Medical use is a term defined 14 in 10 CFR 35.2, which says roughly that it is the 15 administration of byproduct material or the radiation 16 therefrom to patients in the practice of medicine, so that 17 when.the commission's policy statement says that it will 18 continue to regulate the medical uses of radioisotopes, that 19 is very specific.
20 MR. HENKIN This is not a medical use that you're 21 regulating.
These are areas outside the direct use, okay?
22 You are not regulating -- I mean if you want to 23 talk about regulating the use that's one thing.
This is not 24 regulating the use.
This is administrative procedures not g
25 directly related but indirectly related to use.
4
- ~ - - _. ~. -
-.--____.____.:--xxx__=_,--=x_._.-
___n--_=-
r 96 1
MR. KLINEt But if it's a use of materials to be I
i.
2 regulated, a function of misadministrations --
3 MR. HENKIN:
We're back to misadministrations i
4 again.
That is a place we don't want to be.
We want to 5
talk about this is the abstract.
i 6
If we talk about aisadministrations you get into a 7
whole other numbers game that I think is very difficult for 8
you to justify.
9 MR. KLINE:
But your statement that we regulate 10 only the safe handling of material, this seems somewhat il contradictory with current regulations that we have.
j 12 MR. HENKIN:
I think you guys have never decided 13 what it is --
14 MR. KLINE:
Okay, so now we're going back to rules 15 that are already in effect, you are saying --
16 MR. TELFORD:
Well, we have decided and it is 17 medical use, as defined in 35.2.
18 MR. HENKIN:
I submit that we need to sit down 19 with the Commissioners and we need to discuss with the 20 commissioners exactly what their direction is for this l
21 because obviously there is conflicting direction for what is
'22 to be done.
23 MR. TELFORD:
Not on our part.
24 MR. HENKIN:
We view that -- okay, at one point 25 they are telling you to stay as much as possible out of the
e I
97 1
practice of medicine but you're interpreting another part to f
2 say that you need to be involved here, in this which is a 3
medical practice area.
4 MR. TELFORD:
It says minimize intrusion into 5
medical judgments.
6 MR. HENKIN:
This is judgment.
It is all 7
judgment.
Quality assurance is completely judgment.
There 8
is no right and no wrong in quality assurance.
It is all a 9
call.
10 It is a baseball umpire.
11 MR. TELFORD:
It seems to us that if you're 12 talking about medical use and the nuclear physician decides j
13 that a patient should get 30 millicuries of I-131, that's 14 exactly what should happen.
That patient should receive 15
_that dose, that isotope.
16 MR. HENKINt And it's his responsibility to see 17 -
that occurs and nobody else's.
18 MR. TELFORD:
If that happens, then the safety of 191 that patient has been adequately assured.
So we're really 20 after the same goal.
21 MR. HENilN:
Let me give you the other part of the 22 coin.
In my practice, I use a drug called Adenosine to 23 enhance the quality of myocardial profusion studies.
It's a 24 dangerous drugt it can cause complete heart block.
I 25 prescribe it at the dose of 140 micrograms per kilogram per
e
-e 98 i
1 minute for 6 minutes.
What paid federal agency is 2
rssponsible for seeing that drug is given at that rate in my i
3 practice?
There is none.
There need be none.
It is my 4
responsibility to see that that occurs.
5 My medical license in the state of Illinois, has 6
described again in here as to what a licensed physician is 7
and what the responsibilities of a licensed physician are, j
8 and I use that drug in conjunction with a radioactive drug.
9 I can do far more damage with that drug -- I can kiiA lo somebody with that drug.
I can't kill him with the 11 concomitant radioactive drug.
12 MR. XLINE:
But.that decision on the quantity to
(
13 use --
14 MR. HENKIN:
Is mine.
15 MR. KLINEt That's correct.
16 MR. HENKIN:
And I have to see that it's executed 17 properly.
18 MR. KLINE:
Are there not a lot of variables that i
19 you have to consider before you would determine the quantity 20 of that drug to use?
21 MR. HENKIN:
No. As a matter of fact, I give the 22 same dose to everybody.
23 (Laughter.)
24 MR. KLINE:
You give the same dose to everybody.
25 Okay.
'k-o 1
99 1
MS. ALAZRAKIt That would be under his purview.
LI 2
MR. HENKIN:
But I could change it on any patient 3
I want to change it on.
It's a prescription I've written, a 4
standing order, if you like, in the department that says --
5 MR. TELFORD:
How about the by-product material?
6 MR. HENKIN:
A by-product material is often 7
changed.
It's more often changed than --
8 MR. TELFORD:
Not a by-product material.
9 MR. HENKIN We're not using a by-product material 10 for this, but we could very shortly.
If the FDA gets its 11 act together and approves cardiolite, it could be used in 12 conjunction with cardiolite.
I 13 MR. BRINER:
You ought to tell them also the 14 half time of that non-radioactive drug you're talking about.
15-MR. HENKIN:
It's ten seconds, eight seconds, 16 something like that.
17 MS. ALAZRAKI:
Very short.
18 MR BRINER:
You're not going to catch him in an 19 error very' quickly, very often.
20' MR. HENKIN:
You see, the parallel I'm trying to 21-draw, that I'm using at the same time a radioactive urug and 22 a non-radioactive drug, both of which I am responsible for.
23 The drug that is potentially lethal, I nsed deal with no 24.
federal agency on.
I could kill somebody with that drug and 25 it's not the responsibility of a federal agency to stop me.
- D o
i 100 1
And it is part of the practice of medicine, as I am licensed 2
by the state of Illinois to practice medicine.
3 MS. ALAZRAKI However, if you did kill someone or 4
hurt someone with the non-radioactive drug, it would come 1
5 under the quality assurance program in review, and that is 6
the control.
i 7
MR. HENKIN:
Even if I didn't -- as a matter of l
8 fact, the Pharmacy and Therapeutics committee of the
)
9 hospital approves r.y use of that drug in that application in 10 that does.
11 MS. ALAZRAKI:
Well, the hospital altogether --
-12 MR. TELFORD:
Well, I'm sorry, Dr. Henkin, but I t
i 13 think we're involved.
I mean, the guidance that --
14 MR. HENKIN:
Well, then we have a basic 15 disagreement and I'm not sure there's much more to talk 16 about because to talk further would be deemed an endorsement t
17 of what you're doing and we don't endorse.it, l
18-MR. TELFORD:
You made the suggestion earlier that s
l 19
-- which I agree with, that we could just assume that, you l
20 know, we set those objections or concerns aside for a i
21 moment.
22 MR. HENKIN:
But they keep coming back.
They keep L
23 resurfacing.
1 g
24 MR. TELFORD:
Not to bury them, but just to set 25 them aside so that we can discuss in detail what JCAM would
b 101 1
require.
I 2
MR. HENKIN:
We can discuss what JCAHO does and 3
what its requirements are, but I don't see this as 4
applicable to the rest of this discussion simply because you 5
are starting from a place that we cannot accept.
6 MR. CAMPER:
Let me address that.
Let me, if I 7
can, so we can come to some conclusion on this point at this 8
moment in time, try to characterize what I think I hear you 1
9 saying.
It goes something like this.
10 On April 7, 1988, members of the medical 11 community, including several members of the ACNUI, briefed 12 the Commission on their concerns regarding the 1987 proposed I-13 rule.
They stated that a performance-based rule should be 14 promulgated rather than a prescriptive rule.
They also 15 suggested a pilot program would be useful for determining 16 whether the proposed QA steps would interfere with clinical 17 practice.
18 MR. HENKIN:
I think that's a mischaracterization 19 of what happened.
What happened was there was total 20 objection to any rule of any sort, and vory much, as at this 21-
-meeting, that's why we refuse to make the same mistake 22 again,.because it was taken out of context as to what the 23 medical community said.
3 The medical community seid there's no need for any 24 25 rule.
And NRC said there's going to be a rule.
Well, we
b
.e 102 i
said if there's going to be a rule it should be performance-
'2 based.
But that has been taken out of context.
It is not a 3
correct interpretation, and I think Bill was involved.
4 MR. BRINER:
That's right.
)
5 MR. CAMPER:
So then, at this point you're saying 6
that the medical community still questions the need for a 7
performance-based rule.
l 8
MR. HENKIN:
We don't question it.
We know 9
there's no need for a --
10
.MR. TELFORD:
You mean, the nuclear medicine i
11 community.
12 MR. HENKIN:
ANCP and SNM.
If you know of others, 13 that's fine.
14 MR. TELFORD:
Well, for instance, the American 15 College'of Radiology and others.
' 16 MR. HENKIN:
Have they endorsed this rule?
17 MR. TELFORD:
I don't want to put words in their l
18 mouth.
We have met with them.
We do not hear similar 19 statements from --
- 20 MR. HENKIN:
The American College of Radiology 21 doesn't really represent nuclear medicine.
22 MR. TELFORD:
I didn't say that.
23 MR. CAMPER:
That's a result of my statement, the 24 medical community.
It looks like we're drawing a 25 clarification as to what we're calling the medical n
, e
.w-
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1 o
103 1
community.
That's a very good point.
2 MS. ALAZRAXI:
When you talk about the American 3
College of Radiology, that concerns both the sealed source 4
and unsealed source administrations.
5 MR. CAMPER:
Despite this position at this point 6
in time, despite the fact that you believe that this Federal 7
Register notice does not adequately characterize the 8
proceedings of 1988, can we, would f.t be worthwhile to set 9
that aside for the time being and look at what to what l
10 extent the JCAH criteria would address our concern.
11 MR. HENKIN:
I think we can talk about that.
I 12 just don't want it in any way taken out of context the way i
13 that was to say that we recommended the use of JCAHO 14 criteria.
That is not at all what we're recommending.
I 15 MR. TELFORD:
If we characterize it as offering 16 you the opportunity to educate us as to what a program would 17 look like if it were following JCAH so that we could then L
18 compare it to the objectives that we're trying to achiet3, 19 we could-either understand how to do that better or how to 20 change ours so that we could be more in alignment.
21' MR. HENKIN:
We could discuss what it is that 22.
JCAHO does and how it does it.
Yes, I think that is a fair 23 discussion to occur so you understand what it is Joint p
24 Commission does.
25 MR. BRINER:
Beyond that, with the exception of
.. _ - = _ _
eo-104 1
you referencing JCAHO as an appropriate way to effect a i
2 quality assurance program, I don't want you to infer from 3
our discussion the fact that you should present a mirror 4
image of JCAHO.
That's not what we're saying.
We're simply 5
saying you don't belong in this quality assurance business, 6
period.
7 MR. CAMPER:
As we look at JCAHO, I think two 8
things would be useful.
One would be, we try to, as John j
9 alluded to earlier, take a program and the specific line l
l 10 items and compare how they do relate to our eight major 11 objectives, also with come consideration in that regard for t
12 the accreditation manual.
i 13 Then, the other thing that I have some concerns l
14 about is enforceability.
Can we discuss that first?
That's 16-the easiest one to address.
17 MR. TELFORD:
Do we want to break for lunch at 18 some point?
19 MS. ALAZRAKI:
Yes, at some point.
I 20 MR. TELFORD:
Would anybody object to breaking for 21 lunch. It's about 12:20.
22 MR. BRINER:
Let me ask you this, how much longer 23 do you think this is going to take?
24 MR. TELFORD:
Until about 5:00.
9 25 MR. BRINER:
I don't think it's going to take that 1
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105 1
long.
4 2
MR. TELFORD:
Or as long as you're willing to stay 3
and discuss with us.
4 MR. HENKIN:
Well, we will stay as long as there's 5
a productive discussion going on.
6 MR. TELFORD:
I would really like to get through 7
most of these items on the agenda.
I think there's a lot of 8
fruitful areas there to discuss and I think you all could 9
give us a really good insight into what you think should 10 happen or how to change these things or how to improve them 11 from your point of view, and by golly, we all came a long 12 way to come here today.
We have people from Chicago, a 13 person from Atlanta and a person from the philadelphia area.
14 We all came here in earnest to engage in a good 15 roundtable discussion, and we truthfully want to learn from 16 you.
17 MR. HENKIN:
We're very willing to discuss with 18.
you how these other things work and what they do.
I don't 19 think that -- we have no problem with discussing these other 20' programs that exist and how they operate, what they're 21 designed to do.
I think that's fine.
22 MR. TELFORD:
Does that mean you don't want to 23 discuss the other items on the agenda?
1 24 MR. HENKIN:
I'm not sure.
I don't know what I 25 want to say about insight from comments.
I mean, you've got
y 0
106 i
l 1
comments --
i 2
MR. TELFORD:
That was your idea.
3 MR. HENKIN:
Well, you've got the comments on the 4
comments now from Dr. Marcus.
I'm not sure you we can do 5
much more than the comments on the comments.
6 MR. TELFORD:
How about Item 47 7
MR. HENKIN:
I think we've been discussing 35.35 8
extensively.
9 MR. TELFORD:
We haven't discussed i' in detail.
10 Maybe after we've discussed this, maybe after we've 11 discussed where the JCAM facility operation might look like, 12 then we could compare it to the 35.35 objectives.
t 13 MR. CAMPER:
I think that's extremely important, 14 just to try to get a comparison that's close to be a line 15
. item-by-line item as possible.
We have a great deal of 16 interest in your comments at the ASMUI meeting as to whether 27 or not'JCAHO would address the nuclear medicine component.
L 18 I think we all recognize the ceachytherapy and teletherapy 19 pose certain problems.
20 MR. TELFORD:
Great.
It's about 12:25.
Should we 21 break for lunch and come back in an hour?
Is that 22 acceptable to everybody?
Let's take a break and go off the 1
23 record.
24 (Whereupon, at 12:25 o' clock p.m. the meeting was 1
25 recessed for lunch, to reconvene at 1:25 p.m.)
107 1
AFTERNOON SESSION I
2 (2:13 p.m.)
3 MR. TELFORD Shall we resume.
This afternoon, 4
first thing, let me propose that we take an example program 5
that supposedly meets JCAHO requirements, use this as a 6
discussion vthicle to do a couple things.
7 One would be so that we could learn what would be 8
required of any licensee if they were following JCAHO to the 9
extent of our interest of making sure the patient gets the 10 dose as directed.
11 And secondly, to compare it to the objectives that 12 we have -- this would be on page 1449 of this handout.
- Now, 4
13 does everybody have one of these?
Captain, Briner, do you 14 have one of these?
15 MR. BRINER:
Yes.
16 MR. TELFORD:
We would like to understand what 17 procedures would come into play if a licensee were following 18 the JCAHO quality assurance program.
How would you like to 19 proceed?
Would you like to discuss the plan or would you 20
.like us to discuss the plan?
21 MS. ALAZRAKIt Let me just point out, since I know 22 this plan, that the JCAHo quality assurance programs involve 23 mandatory monthly meetings at which time each indicator or 24 point of any incident which has happened over thi past month 25 is reviewed in some detail so that the minutes of the
_.m,
,m,.,... ~, _... -.. -..
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A O
108 1
monthly meeting are a part of the program.
I 2
The indicators change from time to time so that 3
this is a bunch of indicators that you have here for a 4
specific time period and you may find different indicators 5
several months later in the plan.
6 It's a dynamic program, in other words.
It 7
doesn't remain static, so that while what you have here is 8
some indicators from one point in time, you cannot really --
9 you don't have everything to evaluate the total scope of the l
10 program, which would include the procedure manuals, the 11 appropriateness journals which we keep, the minutes, and 12 probably even more documentation than is included in all of
(
13 those items.
14 MR. TELFORD:
Okay.
Could we go through these?
15 I'll take the first one -- to offer diagnostic and 16 therapeutic procedures, which are both useful to the i
17 referring clinician and regarded as appropriate by tb' 18-medical community.
19 The-indicator that you spoke of is r-3 ally some 20-action step that needs to be taken, and this one is to 21 monitor requisitions in order to judge the appropriateness 22 of requested procedures.
23 And then criteria stated in this book, in the 4
" data and reviews" column, says the resident is to review 24 25-every requisition and resolve any questions regarding
,o e
109 1
possible inappropriateness prior to commencing procedure.
(
2 So we would look at this and say that the 3
intentions here seem to be to have a procedure which ensures 4
that the correct procedures is about to happen and you have 5
a physician under the supervision of a nuclear facility, an 6
authorized user, to review the referral prior to administra-7 tion.
6 I think that's one of the ones that we would be in 9
agreement with as something very similar to an objective 10 that we would have.
11 MR. WIEDEMAN:
In my review of this it appears 12 that this first one would satisfy the objective no. 1 of I.
13 35.35.
14 MS. ALAZRAKI Well that would satisfy thac 15 objective.
This is a practice of medicine indicator.
16 MR. WIEDEMAN:
Well the indicator being monitored 17 to requisitions in order to --
i 18 MS. ALAZRAKI:
Appropriateness.
19 MR. WIEDEMAN:
Appropriateness, yes.
20 MR. TELFORD:
And, Darrell, would it also perhaps 21 satisfy the one where depending upon if they have the 22 resident somehow initial or somehow indicate that the review 23 happened, wouldn't that be the same as having the authorized 24 user direct this --
25 MR. WIEDEMAN:
As they're working under the
e 110 i
supervision of the authorized user?
j 4
2 MR. TELFORD:
Yes, directed this -- well, is it a 3
diagnostic or therapeutic?
This one step may cover more 4
than one.
5 MS. PICCONE:
Does JCAHO require that all 6
requisitions be reviewed, or is that the way you have 7
interpreted it?
8 MS. ALAZRAKI Well, what they require is that we l
9 ensure appropriateness.
10 MR. HENKIN:
Well, there are two JCAHO documents, 11 and I think you can't confuse them.
One is their quality 12 assurance manual, one is their accreditation manual.
The 13 accreditation manual can be viewed to similar Part 35 in 14 terms of its effect, and it's a "thou shalts" and you've got 15 to do all those "thou shalts" to get accredited so that you 16 can't divorce these two, because whether or not you have a 17 quality assurance program in place, you still would have to 18 comply with everything in this nuclear medicine section in 19 the accreditation manual.
20 MR. TELFORD:
Does the accreditation manual 21 require that all requisitions or referrals be reviewed?
22 MR. HENKIN:
Well, hold on a second and I'll give 23 that to you.
24 MS. ALAZRAKI t I'm not sure that they actually say
(
25 that.
They do want you to show them how you ensure i
O 111 1
appropriateness of the studies.
I'm not sure that they 2
spell that out.
3 MR. HENKIN:
There is something in here that deals 4
with it.
I didn't underline it so I need to go through it 5
for a second.
6 MR. WIEDEMAN:
It is right before standard.
J 7
MR. HENKIN:
A planned and systematic process for 8
monitoring and evaluating the quality and appropriateness of 9
nuclear medicine services.
10 MS. ALAZRAKI:
Yes, so this is the process that we 11 use.
And that's a medical question, 12 MR. HENKIN:
That's required characteristics under 13 the first section.
Now you see you have to grade yourself 14 and then.the inspector has to grade you as well as to 15 whether you've done that.
16 MR. BRINER:
Why don't you explain about'the 17 accreditation manual has standards, and that happens to be 18 under standard no.
1, NM.1, and the required characteristics 19 under that standard listed, and this happens to be 1.3.9, y
20 and all of these things have to be there in order to satisfy 21 that standard.
22 MR. TELFORD:
Well let's look at the second 23 function -- to offer procedures and render diagnostic 24 interpretations in a timely manner so as to assist the 25 medical treatment of the patient.
And the indicator is
4a 112 1
monitor the interval between the completion of procedures o
2 and the distribution of the final reports.
3 The review is, timeliness data will be gathered 4
from a randon sample of not less than 10 percent of all 5
diagnostic procedures performed in each month.
The average 6
monthly value will be reported and compared to the threshold 7
value.
8 So the intent here is to make sure that the 9
reports are delivered in a timely manner.
Is that true?
10 MS. ALAZRAKI:
Yes.
11 MR. TELFORD:
Okay, this is an area that we will 12 not delve into.
13 MS. ALAZRAKI Right.
14 MR. TELFORD:
So while this may be something of 15 interest to JCAHO, we would not delve into this.
16 MS. ALAZRAKI:
And then again, this is just one 17 indicator which comes under this function at one point in 18 time, but actually over the course of two years we may have 19 four different indicators that would come under this 20 function at different times.
21 MR. TELFORD:
The other indicator under that same 22 function is to monitor the scheduling delay for routine 23 outpatient bone scans.
.t.
24 MS. ALAZRAKI:
As an example.
25 MR. TELFORD:
As an example?
13 113 1
MS. ALAZRAKI:
Because it's a procedure that we do J
t 2
a lot of.
3 MR. TELFORD:
Okay.
4 MS. ALAZRAKI So there's a good indicator of what 5
the scheduling delays are.
6 MR. TELFORD:
All right, so we found --
1 7
MR. HENKIN:
I would also refer vea to the ACNP 8
inspector's manual, the 1988 edition, page 15, in which we 9
have principals -- we don't call them standards, but they 10 have the same effect in terms of practice accreditation --
11 and in 1-10 it says, The nuclear medicine physician shall 12 be responsible for the quality and safaty of all procedures 0
13 perforned at his direction.
This responsibility includes 14 assuring that the staff, under his direction, are properly 15 trained and competent to perform each procedure in which 16 they are' directed to participate.
Only the responsible t
17 nuclear medicine physician shall delegate responsibility to I
18 other persons to perform patient care tasks."
19 MR. TELFORD:
Does JCAHO have a similar 20' requirement?
21 MR. HENKIN:
They make safety the responsibility 22-of the physician as well.
23 MR. TELFORD:
How about FERT?
This basically says 24 that the people under your direction have to understand what 25 they're about to do before they do it, and it's the
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responsibility of the nuclear physician to ensure that.
I i
2 MR. HENKIN:
Okay, well here, NM.1.13 out of 3
JCAHO, where "T.esponsibilities of the director of ths 4
diagnostic ar,d/or therapeutic nuclear medicine department /
5 service which may be appropriately delegated include, but j
6 need not be limited to, the following," and they go through 7
half a page.
8 MR. TELFORD:
All right.
9 MR. HENKIN:
" Approaching the process or processes 10 for determining the qualifications and competence of 11 department / service personnel who are not independent 12 practitioners and who provide patient care services."
i 13 That's NM 1.3.3.
So, I think that that does cover that i
14 question.
l l
15 MR. TELFORD:
Where's the one about making sure-16 that people understand?
t 17 MR. HENKIN:
Qualifications and competence.
18 MR. TELFORD:
Okay.
I am not sure that -- what do 19 you want beyond qualifications and competence?
l' 20 MR. HENKIN:
Oh, Well, it's the language in 1-10 l:
l 21 under ACNP.
22 MR. TELFORD:
ACNP is considerably wordier '~
m 23 JCAHO.
.24 (Laughter.)
25 MR. HENKIN:
That's okay.
_ _. _.. _.. ~.. _.. -,, _ _ _ -.. _. _,...... ~..... _
]
1 115 1
MR. TELFORD:
Once again, 1-10, in my t-2 interpretation, would meet the objective of 35.35 number 4, i
3 objective number four, " Assured current medical use -- no, 4
no.
I'm sorry.
Not that one.
It would be five.
5 MR. HENKIN:
Well, four is pretty close.
6 MR. BRINER:
Now, you've got 1.3.7, too, which 7.
says " Developing comprehensive safety rules in cooperation 8
with the hospital's safety committee and the hospital's 9
radiation safety committee if one exists."
10 MR. WIEDEMAN:
It's the end of number four.
t 11 is understood by the responsible individuals."
of course, 12 that's how the institution would implement that particular t
13 objective.
Training, qualifications.
14 MR. BRINER:
Now, if you want to go back to NM.4 L
l 15 under Standards, how do you know that something is being 16 looked at after the: fact?
In that standard, it says, "As R
17 part of the hospital's quality assurance program.
" the 18 hospital's quality assurance program, I'll emphasize, i
L 19 the validity and appropriateness of diagnostic and/or therapeutic nuclear medicine services are monitored and 20
~
21 evaluated in accordance with certain standards under the QA 22 manual that can be picked up that way."
That's Standard No.
1 23
'NM 24, saying that the hospital itself is looking at --
24 MR. TELFORD:
Where in this program does it g
25 address things like the training?
~
.c 116 l
1 MS. ALAZRAKI:
Okay.
That comes under the q
2 hospital's QA program, which we are part of, but it's not in I
i 3
here.
4-MR. TELFORD:
Okay.
5 MS. ALAZRAKI:
But the hospital credentials and 6
authorizes every physician.
I 7.
MR.-TELFORD:
Let me ask -- does it say that the 8;
technologists have to be traf i<ed and understand the clinical l
.9' procedures manual and trained in the procedures they're 10' about to do.
So, that's covered elsewhere.
- ll-MS. ALAZRAKI:
Right.
12L MR. TELFORD:
Okay.
V lO 13 '
MR.'HENKIN:. Basically, it requires that a job 14 description exists for everybody, okay, that's out there, 15-
'and-.that the job description be appropriate to the tasks 16.
uitdartaken..
l 17l MS. ALAZRAKI:, And that the credentials of the 18 individual be' appropriate for.the-job.
19 MR. TELFORD:: Shall we go to page two?
f 120 MR. HENKIN:
I. guess I had one more I wanted to h
h 21, read you?out of'here.
We lost it for a'second.
NM 3.1 on
.2 2 -
page 123, " Requests / referrals-for diagnostic and/or 23-monitoring'and/or radionuclide therapy procedures include h
24 the study or studies requested and appropriate data to aid i
25 in the peiformance of the procedure requested."
1 1
/~ -
i 117 1
MR. TELFORD:
Which one is that?
c 2
MR. HENKIN:
NM 3.1 in the JCAHO.
3 MR. TELFORD:
Thanks.
What effect does that have 4
in the department?
What does that bring about?
5 MR. HENKIN:
That's addressing your issue of
,i, 6
. making sure there's appropriate therapy and appropriate 7
supervision of therapy, okay,-and that the studies be 8
reviewed.
That's a good deal of what you've been talking 9
about.
10 MR. BRINER:
And it goes back to the standard on 11 the-previous page, NM.3, where, " Reports of consultations, q
' nterpretations of diagnostic studies and redionuclide
\\
i 12 i
13
. therapy procedures are included in a patient's medical 14 records."
15 MR. TELFORD:- Okay.
f 16 MR. HENKIN:
Now, again, I think one of the things 17-you have to realize is that JCAHO requires the hospital to
-18 identify the privileges that every physician has.
19 MS. ALAZRAKI:
Exactly.
20 MR.-HENKIN:
For example, I'm credentialed by the
'21 hospital to perform diagnostic and therapeutic nuclear 22 medicine procedures.
I am not credentialed to perform 23 radiotherapy with sealed sources, for example, even if I 24 might so qualify, or diagnostic radiology.
The hospital 25 does not accredit me to do that.
n.
118 1
When you look here, it's discussing the fact that t-2' only individuals with delineated clinical privileges to-i 3
perform and/or interpret diagnostic and/or monitoring 4
procedures and supervise radionuclide nuclide therapy 5
procedures authenticate reports.
That refers back to the l
6 first page, describing what JCAHO thinks a nuclear medicine
)
7-physician should be who is supervising the department, which n
i 8
are considerably'more stringent standards than NRC has, as i
9 it turns out~.
10' MS. ALAZRAKI:
That's right.
They require Board
^11-certification for the director of a nuclear medicine-12 department,-either ABNM or ABR Nuclear Radiology Special
'~
13 Competence..
I' 14
)m. HENKIN:
And in 1.2.1.
q
- 15 MR. TELFORD:
Could we go to page two of this 16 plan?
The first item is -- the function is "To perform each-17 procedure in such~a way as to optimize the quality of the s
The indicator.is to
-18 diagnostic information available.
19' monitor the accurate preparation and administration of all 20 radiopharmaceuticals."
The review says to be reviewed and 2 11 summarized: monthly.
So, I take that to mean that there's a 22 report that's issued monthly as to what was administered?
23 MS. ALAZRAKI:
Exactly.
Right.
24 MR. TELFORD:
Okay.
Tnat the correct isotope, 25 chemical form, dose, etcetera --
l t
119
)
1 MS. ALAZRAKI:
Well, what's reported is any 2
deviation from the correct isotope.
3 MR. TELFORD:
Okay.
So, you identify any 4
deviations --
5 MS. ALAZRAKI:
Although, in our records, you could i-6
_go through and find every radiopharmaceutical that you want i
7.
which has been administered during the month.
8 MR. TELFORD:
So, your records would indicate --
9 MS. ALAZRAKI:
But the minutes will reflect --
10 MR. TELFORD:
-.what was directed.
.j 11 MS ALAZRAKI:
Exactly.
.12 MR. TELFORD:
What was supposed to have been given 1
13 in terms of dose, chemical form, physical form, isotope, 14 etcetera.
15 MS '. ALAZRAKI:
No.
The minutes won't --
j 16 MR. TELFORD:
No, the directives.
17-MS. ALAZRAKI:
Right.
18 MR. TELFORD:
Your records..
L19 MS. ALAZRAKI:
Right.
20.
MR. TELFORD:
But the minutes talk about 12 1 identifying'any deviations --
j 22 MS. ALAZRAKI:
Any deviations, because otherwise, 23.
our minutes would be 70 pages long.
)
'24 MR. TELFORD:
-- that were not according to the 25' directives which were in the record.
i
N n
s 120
-l' MS. ALAZRAKI:
Right.
2 NR. TELFORD:
Okay.
Well, that's exactly what 3
we've got in Number 7.
" Ensure that any unintended 4
deviations from a prescription or a diagnostic referral to 5
the clinical procedures manual is identified and evaluated."
6 But you issue a report monthly.
Who signs the report?
7 MS. ALAZRAKI:
We issue the minutes monthly, and I 8
' sign the minutes.
9 MR. TELFORD:
Okay.
Authorized user, nuclear 10 physician signs minutes.
Okay.
11' This other indicator here of " Monitor.the 12 performance of all imaging and CAT instrumentation through
'n 13-routine quality control testing," snd then the review is l14 daily or weekly or monthly.
You want to'be within five
. '15 percent of a mean for uniformity.
This is really equipment
'161 quality.
17 MS. ALAZRAKI:
This is quality control.
11B MR. TELFORD:- Of equipment, right?
19 MS.'ALAZRAKI:
It's quality control..
20
.MR. TELFORD:
Make sure that the camera is
-21 flooded, and all that?
.22 MS. ALAZRAKI:
Right.
23 MR. TELFORD:
Okay.
Well, the first item on this 24 page, the reporting of what was actually administered, that 25-certainly is in accord or in concert with one of the
,a i
s a
121 1
objections, whereas the second one of equipment quality, we
.t i 2
haven't gotten into that.
With any luck, we won't.
3 MS. ALAZRAKI Right.
4 MR. KLINE:
Lot me comment also on the second page-5 of the annual quality assurance plan.
Your data and review 6
mentions to be reviewed and summarized monthly.
You're 7
somewhat-indicating that this one criteria is audited
- 8 monthly.
'So, you're falling into part of Item 8, though
=9 this is focused only in this one area.
10 MS. ALAZRAKI:
What -- item 8?
- 11
' ICR. KLINE:
Item 8 of 35.35, where they talk about 12 a compreher. dive audit, though this is not comprehensive, but 1
il 13 this is one aspect-of an audit. 'So,.you're starting to i
I-14' address that issue, also, when you specify a time 11nterval, 15-which is satisfying that 35.35. (8) (b) (1).
Do you see that, i
16 where_thsyTeall out a procedure for. conducting an audit at
' 17 '
Lintervals no greater.than twelve months-to verify compliance l
18 of.all aspects of the quality assurance program.
19; This is part of what you're doing here, though pi 20 it's'not maybe a comprehensive audit.
I think the latitude L
21 F is that'if you have other examplestin here -- no doubt, you L
L r
' 22-do, where you talk about quarterly and some other things --
> 23 these also can fall into that, and it does become 12 4 comprehensive in that sense, again addressing these elements
+
25
-- the intent is to address each of the one through seven
+
r
1 122 1
elements in this comprehensive review, assuming that the i.
2 seven elements are met in the existing JCAHO guideline in 3
this example that you brought forth.
4 MR. TELFORD:,What Ed is saying that the proposed 5
35.35 envisions an annual audit to allow the licensee to
.c 6
review their program to see if it's still adequate.
7 MR. BRINER:
No, no.
It's up to you.
You can do 8
as many as you want, but once every twelve months.
9 MS. ALAZRAKI:
Well, the way the quality assurance 10
-program works, at least in our institution, I mean in 11 addition to the one-month minutes, there is a quarterly 12 review which is done by the hospital QA committee.
I 13
.MR. CAMPER:
When we look at nuclear medicine 14 services ~and we see the various standards, this is all E15 encompassing in-that it would address brachytherapy --
16' MS. ALAZRAKI:
We have nothing to do with 17 brachytherapy and nothing to'do with teletherapy.
Unsealed 18
- sources.
Unsealed sources.
'19?
MR. CAMPER: ~Is there a section similar --
i L
20 MR. HENKIN:
Yes.
I have never looked.at it but I I
' 21 :
know it exists.
'It exists for every hospital service L
22 department.
L 23 MR. CAMPER:. I have the same problem.
I've not i
24
.seen one on brachytherapy.
25 MS. ALAZRAKI:
I have never seen one either, l
123 1
frankly.
.I ~
'2 MR. KLINE:
The Quarterly Review by the Quality 3
Assurance. Committee usually involves that, so you have 4
somewhat --
5 MR. HENKIN:
That is a hospital-wide effort.
.6 MR. KLINE:
-- somewhat of an audit function in 7
that sense --
l 8
MR. HENKIN:
Each department's quality assurance 9
report is brought before the hospital-wide quality assurance 10 committee usually at a ~uarterly meeting.
If you have got 11 three reports they may lump'them together as one but they 12 will present each departrant's quality assurance efforts, l'
13~
'MR. CAMPER:
Does the JCAM have a' requirement as 14' relates to' time interval for a comprehensive audit?
h 15 MR. HENKIN:
It's an ongoing process in the JCHO's 16
. view.
It-is not one that is done once a year.
It's a 17 continuing process.
18 MR. TELFORD:
Monthly and quarterly.
19-MS.. ALAZRAKI:
Monthly and quarterly, right.
t
-.201 MR. HENKIN:
They want to see that you are-l 21 consistently-reviewing quality assurance, not that you do it 22 once a year or just before their inspection.
They don't buy 23 that.
.24' MR.-TELFORD:
Okay, could we go to page 3?
L 25 The function is to report the findings of each
=
=.
- i s.
124 1~
procedure in an accurate and consistent manner.
The 2
indicator is to manitor the interobserver variability for 3-three phase bone studies and SPECT Thallium studies.
4 The review is these results will be summarized 5
quarterly.
Any individual whose interpretations exhibit a 6-pattern of both consistence and significant nonagreement' 7
will undergo structured re-education.
8 This is to make sure that the people that are 9
reading the films are doing so correctly.
This'is-an area 10-that we would not get into because this truly is medical 11 judgment.
12:
MS..ALAZRAKI:
Right.
"h 13 MR. HENKIN:
It-is an area that the joint-14
_ commission may be backing out of too.
-They've got a lot of t
L 15-
-trouble with this.
16 MR. TELFORD:
The next function is to provide a l
17 safe environment for patients and staff.
.18-The indicator-is monitor staff compliance with 19 Universal Precautions Policy and Infectious Control' i
20 procedures.
21.
The review is supervisors will report all o,
22 deviations from this policy.
23 The results will be summarized on a monthly basis.
24 Corrective actions will be undertaken for each deviation.
25 MS. ALAZRAKI:
So you have to look at the minutes L
g, 125
- 1
- to see whether there have been any deviations.
Basically V
2 the Infection control procedures are well documented in the 3
hospital quality assurance plan and the university 4'
precautions policy is also well documented, so the details 5=
of that are in other documents 6-MR. TELFORD:
Your first indicator is infectious-7 diseases --
8 MS. ALAZRAKI:
Infection control.
9 MR. TELFORD:- Infection control, excuse me.
The 10 second indicator is monitor staff radiation exposure and the 11 review is whole body exposures will be measured by film 12:
badge not to exceed 160 millirems per month and exposures 13-measured by TLD not to exceed 5.5 rems per month.
Data to 14 be summarized monthly.
15 This is an area that of course the Commission is
-16 involved, interested in, but it is from Part 20, not from 17 Part 35.
18 Your third indicator under that same function 19 would be= monitor the~ laboratory and patient areas to
'2 0 -
determine the presence of radioactive contamination.
21 The review;is any readings which exceed either 22 three times background level or twice the previous reading 23 will require the initiation of immediate corrective action, i
24 Again that is a Part 20 requirement and not a Part 25-35 requirement.
l
~
126
)
l' Okay, page 4.
Page 4 doesn't have any functions, e
2=
-Are-these continuations --
y 3-MS. ALAZRAKI:
Continuations, right.
J 4
MR. TELFORD:
We are continuing the function to 5
provide a safe environment for patients and staff.
j 6
Okay,-the first indicator is monitor staff 7
compl'iance-with EUH requirements for an annual BCLS CPR BL recertification, so that's outside of Part 35 interests.
9 The second one on this page is monitor the l10 readiness'of the emergency resuscitation equipment.
- Again,
, Lil '
.that is outside of Part 35 considerations.
12 The third indicator =is-monitor staff radiation N
13 exposure and thyroid'. radiation burden due to participation 14' in the therapeutic administration of Iodine-31 for treatment 15 of Graves Disease or Thyroid Cancer.
16-The ' review there :is corrective action will be 17' initiated whenever a bioassay measurement exceeds 24 18
.microcuries.- Results will be summarized monthly.
g a. -
19 So,this is for safety of workers and-it's really 20-
.not a'Part 35.
- 21.
It is a Part 35?
22 MR. WIEDEMAN:
Yes.
Whenever they do CA therapy
'23 ey have to do a bioassay.
s-24 MS. ALAZRAKI:
Right, right.
p 25 MR. TELFORD:
It's part of 35 but not 35.35.
127 1
MR. WIEDEMAN:
Right, that's correct.
(
2-MR. TELFORD:
Okay, thank you, Darrell.
Keep me 3
honest.
4 There is one more page, which is the addendum.
5 The function is for implementation during March.
6 The indicator is monitor the time interval for the 7
completion of all diagnostic reports in order to identify 8
any outliers which require more than seven days for 9
comp.etion and distribution.
10 The review is all outliers identified by.this
'll, monitor will be reviewed for patterns of similarity with 12-
. regard to report generation and verification process.
1 L
13-This is --
o 14 MR. BRINER: _They will be involved at six o' clock 15 in the morning every morning until they are not outliers 16.
.anymore.
17 MR. TELFORD:- This.is to ensure timely reports, 18
_ timely diagnostic reports.-
19 MS. ALAZRAKI:
Yes.
20 MR. TELFORD:
So this would be-outside'35.35 so 121 after'we review this plan then we find two sets of function 22-indicatorLreview that apply to --
23-MS. ALAZRAKI:
Well, probably most of the others 24 would fall under these functions, except you didn't 25 specifically identify them.
.--..-t i
124
-l' MR. HENKIN:
Some.of th0 others are required by lt 2-the accreditation manual anyway.
4 3
MS. ALAZRAKI:
Right.
4 MR. HENKIN:
So they don't fall into the plan.
If 5
you look at --
6; MR. TELFORD:
Let's go to the eight objectives of 7-
-35.35.
8 Let me tell-you which ones we have already picked 9
up so.far.
10-MR. HENKIN:
You're here to tell us the ones we 11
.have to worry about.
c 12 LMR. TELFORD:' Maybe you have done that well.
13-
'That would be good.
14 Number one is ensure that any medical uses 15 indicated'for;the patient's medical condition.
You have T
16
.taken' care of=that one in this plan.
17 Two, ensure priority in medical _use,-that a
- 18-
. prescription is made-for any therapy. procedure, any 19; diagnostic or any pharmaceutical procedure involving more 2(L
.than 30.microcuries of 10-125 or_IO-131.
21 Let's go off the record a minute.
22' (Discussion off the record.)
23 MR. TELFORD:
Number two then is probably covered.
24 MR. HENKIN:
One and two are both covered.
125 MS. PICCONE:
I don't understand how that's
129 1
covered.
[
2.-
MR.-TELFORD:
Okay.
3 MS. PICCONE:
This is one institution's quality 4
assurance. plan.
5 MS. ALAZRAKI:
Correct.
-6 MS. PICCONE:
This is their response to JCAHO and 7
- the.ir response to their function is to review every 8
requisition.- The hospital down the street can review ten --
9 MR. BRINER:
This is what we are talking about.
10.
-right'now, this one program. -That's all we're asked to 11 evaluate..
12 MR. HENKIN:
All he's doing is he's_just doing i
- 13 that one.
14=
MS. PICCONE:
Not JCAHO in general.-
15 MR. TELFORD:
No, we're taking this program.as an 16-examplefof what a program _would look like if it were 17; following JCAHO.
Given that there is~some variability among 18' programs that'would follow JCAHO --
'19 MS. PICCONE:
That's just my point.
To. follow 20 JCAHO, you don't need to do this.
Is that correct?
21' MS. ALAZRAKI:
Well,_you need to satisfy all of 22
~this.
.23 MS. PICCONE:
But you can satisfy it by --
~
'24-MS. ALAZRAKI:
-- by some other approach.
25 MS. PICCONE:
By looking at ten requisitions'a 1
130 1
month?
2 MR. HENKIN:
I think the point of the JCAHO plan 3
is that institutions identify those areas that represent 4
potential problems for them and that is what they are L
5, supposed to monitor.
6 In other words, if you don't have a problem in a 7
given area, JCAHO isn't asking you to monitor that.
They 8
are asking you to identify the areas of particular problem 9
that,you think you have got at your institution and monitor 10 those areas.
'll For example, many institutions have problems 12
-distributing radiology and nuclear medicine reports -- just I
~ 13
'the physical distribution, so there is an area that they i
- 14 included in their quality assurance plan because they know
.15 Lthey have got a potential problem with that and they are 116 monitoring it.
17-If they have never had a therapeutic 18 misadministration, would it be appropriate for them to be 19 monitoring therapeutic misadministrations?
-.20-MR. TELFORD:
Let me ask the question like this.
i21 This: plan says that this is-for both diagnostic and f22 therapeutic ~ procedures.
~
. L It has the same review function, that is to have a
^23 124 resident review every requisition.
25 Do you in fact do something different for therapy A
131 1
procedures that is a little bit over and above what.you 7
2 would do for diagnostic procedures?
3 Ms. ALAZRAKI Well, the appropriateness is the 4
same thing,.whether it is therapy or diagnosis.
You 5
establish the appropriateness and the attending physician is 6'
more involved in every therapeutic administration than in 7
.the diagnostic administrations.
8; MR. HENKIN:
The answer to that is it depends on 9
the hospital,.that in a teaching hospital considerably more
^
.10-time goes into a therapeutic procedure-because you are 11 trying to teach the resident how you evaluate the dose, how 12-you evaluate the patient, et cetera, et cetera, and the d'
13
- opportunity for teaching that is-considerably less than on 14 the diagnostic procedures.
15 If you look at the~ data.that just was received i
16' Elast week from the Tsaio Report, the RBRVS Time Effort l.
y
- 17 Report, he. concludes about four hours'of physician time go 18 into a therapeutic nuclear medicine procedure by survey.
19 Th'at is data he collected by survey.
I.think I am quoting l
20 that right.
It's about four hours that -- across the board, h
p' f210 Now there is no way four hours goes into most:
U 22' diagnosticLprocedures so.the answer is there is an order of s
fr 23f magnitude difference in the therapeutic procedure according l'
y
!;l
~24 to;Tsaio's measurement.
The average physician time, if I
'25 remember correctly -- I'm sorry this is in the record -- but R
I
'o 132 ui i
somewhere between 20 and 40 minutes for a diagnostic L
2 procedures depending on some of the procedures but it is L
3-about:four hours for a therapeutic procedures.
4 MR. TELFORD:
So what you're really saying is --
-5 MR. WIEDEMAN:
What you got away with.
You at
~6 least have to call the drugstore, don't you, to tell the
-7 pharmacist you're going to send Joe Blow down to --
8 KR. HENKIN:
Sure.
But in essence I've called the 9
drugstore by prescribing for a bone scan that you are to use o
10 20 millicuries of 39 MDP, unless it was a child.
In the R11 case _of a child, use the following computation method to ll 12' compute the dose.
That's my prescription.
13 MR. 1ELFORD:
Okay, and that's in the manual?
14 MR. HENKIN:
That's in the manual, yes.
Can you believe it, we're agreeing?
'16 Objective'3 is merely, first of all, recognizing the way 17 business is done and incorporating those procedures --
18 MR..HENKIN:
Can you read objective 3 again?
.19
'ER. TELFORD:
And it's even in accordance with 20
'JCAHO.
35.35, this is for diagnostics that prior to, medical
~
21-use you have aEreferral, oral; prescription if you like, and L,-
'2 2, it's made l'or any diagnostic procedure.
Now, the reason b
L 23 that I know that the vast majority.of hospitals operate on L
[F 24 oral directives and referrals is that our proposed H2 5 regulations envision a written referral.
i
133 4
1 Now, when I conducted five workshops with 70 1
l 2
licensees, let me tell you how many times I heard, we don't 1
3 do business that way.
Our folks were referred by the phone.
L 4-Only military hospitals.
5 MR. HENKIN:
Well I agree with you, I think that's 6
'.a correct statement.
It happens not to be the way we work,.
7 but it happens to be a correct statement, that most 8
outpatient referrals are by telephone, thet is correct.
- 9 MR. TELFORD:
Yes.
i
.101 MR. BRINER:
But somewhere in the record of that 11 patient at that institution there better damn well be an 12 order signed by a physician.
13' MS. ALAZRAKI:
Oh, yes, there's an order on a 14?
chart somewhere.
-15 MR. BRINER:
On a chLrt.-
'j 16 MR. TELFORD:
When is it signed?
I 17 MR. HENKIN:
It may actually be in our case, for
'18 example,- if you come from outside our system, if you're not 19-
.part of the Loyola system as a patient, you come with a 20 prescription blank from your doctor for!the test, okay, l21 which gets stapled in as part of your medical record.
22 In the internal system, there's an order sheet in 23 the patient's chart on which the physician order the test.
And then there's another sheet he has to sign his name on 24
'25 that's transmitted to nuclear medicine and made part of the
134
_i l
1 l'
. permanent record.
So that most~of your scheduling is done j
-(:
2 orally.
At some point there's usually a piece of paper that 3
shows up.
4 MR. TELFORD:
After the fact.
5-MR. HENKIN:
After the fact.
I 6
MR. TELFORD:
Okay.
In this plan we have a 7
resident reviewing every requisition, whether it's o-8 diagnostic or therapeutic.
We're paying a little more 9
attention to therapy, quite a bit more to therapy, in our.
'10 objectives here, objective 2, to endeavor to get the 11-adthorized user in the loop.
12 In 3, it's clear that'sometimes:the authorized 13 user is notLin the loop.
But in this plan, how do we l-p 14<
. distinguish between what happens for diagnostics and what 15 happens for therapy,-because clearly we're looking for a 16 littlel bit more.
l L
~17 MS. ALAZRAKI:
Well, in fact, no therapy is ever-L 18 done withr2t the. certified physician being involved.
That L
/
19; gjust doesn't happen.
1a 20-MR. TELFORD:
Okay.
l L21 MS. ALAZRAKI:
A resident physician would never j
l 22 institute a' therapy in nuclear medicine without having 23 discussed it or consulted or involved the nuclear physician.
3 24 MR. TELFORD:
Is that an unwritten requirement?
25 MR. HENKIN:
That's what called " stupid" again,
- r. :
135 because any attending physician'that permits resident 1
- l. O h
2 physicians to initiate therapy procedures on his own is 3
crazy andlself-destructive.
4-MS. ALAZRAKI:
Well that's practice of medicine.
5 70s. TELFORD:
Therefore, there is a practice that 6
you do,: hut it's not here, so am I to correctly conclude 7
that it's not required by JCAHO?
8 MR. HENYJN; Yes, JCAHO permits us to delegate 9
within the department certain things.
And if you look, you 10.
can delegate certain things.
.I could delegate to a resident
~
,11 the therapeutic procedure if I so desired.
i
'12 MR. TELFORD:
Or does 2.2.3 cover it?
1 13' MR. HENKIN:
Yes, that simply requires my 14 c.
L aupervision, it doesn't require me to-be. personally,
_15 physically involved -- rather, it requires me to be
- 16~
,; personally involved but not physically involved.
And very i
17.
commonly, that's the way the case in, that the resident sits 18
'down with the' attending physician, they talk ~about the
'19 apatient,. look at. the lab tests, decide what they're going tx) -
20 do'with it, and the resident goes off and does it.
21-MR. TELFORD:
Part 35 would allow the same. thing,
.I, 22 because it says the authorized user or any physician under 23
.the supervision of an authorized user.
24 MR. HENKIN:
What you're proving to me is we don't 4
'25 need Part'35 because-it's all here in JCAHO already.
,._ii
- s 136
^1' MR. TELFORD:
So you either have the first three g
2 or something very close. MR. HENKIN:
Okay.
4 MR. TELFORD:
And I'm giving credit for some 5
procedures which are not in the plan.
6 MR. HENKIN:
Okay.
)
7
.MR. TELFORD - Item 4 in the objectives -- ensure 8
prior to medical use that either you have a diagnostic 9
referral and a clinical procedures manual oc the
- 10 prescription,.as understood by responsible individual.
Of
- 1 11 course you have the diagnostic referral for the diagnostic i2 case, you have.the prescription for the therapy case, z
d 13' So in no. 4 we have seen a lot of cases and 14' misadmit.istrations where there was miscommunication or 15 people-just didn't understand,-sort of a-lack of supervision
- 16
.or a lack of something.
17 MS. ALAZRAKIt I> don't know whether it was a lack 18
'of supervision.
What we said was-in those misadministra-19 tions was it was human error.
20-MR. HENKIN: 'That they didn't understand what was 21 said to them.
22 MR. WIEDEMAN:
Or they couldn't read the doctor's 23 handwriting.
24 MR. HENKIN:
Or they couldn't read or they didn't 25-
-know.
I think we agree that there is miscommunication at q
l i
in i
i ii i i
i ii i
ii i-in
.i iiiii=n ir
- - i i
.- o - -
a 137 times among all medical personnel and among all people.
1 6
. e're having some of it today.
And that people say one W
2-3 thing and another person hears something else.
The game 4
that gets played is called telephone, and we whisper in 5
somebody's ear and it goes around the table and you see what 6
comes out at the other and of the table, if it's anything 7
like what went in the first ear.
8' But thst is a well-known phenomenon and that is 9
like talking to your children.
How many times do you say 10 the same thing to.your-enildren before they finally get what 11; you're saying?
- 12 MS. ALAZRAKI:
But that is not a usual event.
13 LThat is a rare deviation.
14 MR. HENKIN:
That's right.
15 MR._TELFORD:
Well, I didn't want to put words in l 16 -
. your mouth.
What,I was really trying to say was, when we 17
~1ooked'at the misadministrations we saw examples or 18 miscommunication and lack of understanding, et cetera.
19 Therefore,-our intention was to.have an objective that ought a
20;
_to be part of a performance-based program th.t that issue or
- 21'
'those corcerns be addressed.
I didn't say that I see it-in-22 this example program.
23 MR. BRINER:
That comes under NM.2 for the q
24 standard.
The standard says there are policies and 25 procedures to assure effective management, safety, proper-i
L# -
138 1-performance,-equipment, effective communication, and quality
_(-
2' controlLin increments as far as service.
3 MR. TELFORD:. Effective communication, which one 4
is that?
5 MR.-HENK!d NN.2 as a standard.
6 MR. 'tELFORD:
Oh, NM.2 standard.
7 MR. BRINER:
And you look under that and --
8
.MR..TELFORD:
How about 2.2.4?
9 MR. BRINER:.That's it.
There are policies and 10 procedures for the preparation of patients for diagnostic or 11 therapeutic procedures.
12 3GR. HENKIN:
I think even.7 would fit in-there, 13 the preparation, administration of diagnostic agents.
14 MR. TELFORD:
How-does that fit?
15 MR. HENKIN:
Well, that's the really the key to-16 some ofLyour misadministration questions.
How'do.-you 17.
prepare'and-administer the stuff you give?
It says you've 18 got-to have written procedures for that, they're requiring a 19 Written procedure for that.
20 MR. TELFORD:
The other clinical procedures 21 manual?
22 MR. HENKIN: ;Yes,'it's part of the clinical
-23 procedures manual.
24 MS. ALAZRAKI:
Right, procedures manual.
25 MR. HENKIN:
How you reconstitute a kit, how you
ie
'4-139 l-identify'a patient.
1 2
MR. TELFORD:
So you would be instructing the 3
technologists in making sure that they understand all those 4-procedures and can carry them out appropriately?
S' MR. HENKIN:
That's right.
6 MR. TELFORD:
So if you took all of those, NM.2,-
l -.
7 2.2.4, 2.2.7, then you would get --
8 MR. BRINER:
The sua totalfof that you'd have 9
the --
R10 -
MR. TELFORD:
Objective no. 47 ll' MR. BRINER:. That's right.
L L
'12 '
MR. TELFORD:. Okay.
L I
13' MR. HENKIN:
I think 5 is covered by,the same-
'14 thing, it's the same group,5I-think, covers 5.
p.
4 11-MR. TELFORD:
To make sure that the= medical use in 16 accordance with either the referral or the prescription.
I t
11 7 -
should say the referral and'the manual because they work 11.
together.
Well'now this doesn't speak to communication as.
8 l'
19-much as it speaks to.what's actually done.-
For therapy,.
l H20 then, maybe 2.2.3-speaks to --
12 1 MR. BRINER:
-Okay, NM.2.2, 10.1.3.
l-22 MR. TELFORD:
10.1.3, okay.
-23 MR. BRINER:
Identity of recipient, identity of L
24 radionuclide activity of radionuclide administered and date.
25 MR. TELFORD:
Okay, who does that?
140 1-MR. HENKIN:
Maintenance of records, that it I-2=
allows me to decide who's going to maintain those records 3-and how the records are going to kept.
4 MR. TELFORD:
I don't mean to quibble, but 5
objective 5 says " prior to medical use."
No, I'm sorry, I'm 6
wrong, it just says-make sure that the medical use in 7
accordance with.
So, it's not prior to.
I stand corrected.
8 MR. HENKIN:
Let me point out that --
9 MR.' TELFORD:
So you would say the record --
.10 MR. HENKIN:
You don't do these records 11 retrospectively, because you can't.
I don't know of any 12.
. physicians who will administer a dose that hasn't been
- 13' calibrated, and that to calibrate the dose, the dose slip
-14 has-the patient's identity on it, it has the date, it has
'15.
'the nuclide and it has.the amount, in a minimum, some of 16 them have more than that.
But'that's the minimum that we'd 17l
- fin'd on a dose sheet'in any nuclear laboratory, and like I-1 18L
-said, they nay have more, they may have much more than that.
19 depending-on how they're organized, but that's certainly-the 20 minimum.
-21 MR. TELFORD:
Does it have the chemical form here?
22 MR. HENKIN:
Does it have the chemical form?
The 23 dose sheet normally would have the chemical form.
p 24 MS. ALAZRAKI:
Yes, it would.
25-MR. TELFORD:
This says --
e t
141 L
1 MR. HENKIN:
Identity of recipient right on the 2L form.
.3 MR. TELFORD:
What?
4 4
MR. HENKIN:
It says identity of recipient,
'5 identify of radionuclide, activity of radionuclide.
6 Identity to me is chemical form.
I mean it's not I-131, but-7 sodium iodide.
g 8
MS. ALAZRAKI:
I think that's fairly standard on 9
-those records.
9
- 10 MR. HENKIN:
That would be pretty standard in most 11 places..
U
.All right, so you would say that 12-
.30t. TELFORD:
l'
'because;JCAHO requires the records of what was' administered,
<13' 14 then you have objective 5.
r E15 -
MR. HENKIN:..Now that's-a contemporary record,
.16.
that's: made at the time ~ you're, doj ng it because there's no
. wayfto do it after the time you do.it.
17 g
18 MR. CAMPER:
Allow me to pick up what I think I
'19 hear, I think, going on and the point you're trying to 20-making.
Is it ' fair to say that the JCAH program is a
~21
' performance-based program?-
22l
-MR.~HENKIN:
Absolutely.
-23 MR. CAMPER:
Then to look at'a particular example 24
'of any given institution it's going to show you how that 25 institution has approached a standard.
i
- ~
a
1:
-d Q-142 11 MR. HENKIN:
Correct.
r 2.
MR.-CAMPER:
Okay.
It seems then that the thing 3
that'would.be very useful to the Commission would be an 4
analysis where each of the eight objectives were lorked at 5
separately and the standard and the required characteristic 6
were identified and linked to each objective.
7 MR. HENKIN:
That's-what we're doing here.
t 8:
MR. CAMPER:
What we're doing is we're stepping r.
9; through one example.
10
- MR. HENKIN:
I'd like to do that --
11, MR. CAMPER:
What I'm suggesting-is, as we proceed 12 ffrom this point forward, it.the ACNP'and-the SNM-are willing 13 to do it, if someone could go through and take each of the 14.
' objectives.--
',h' oL, 151 MS. ALAZRAKI:
We could do it right now.
16:
MR. CAMPER:
But I mean in something that we could 17.
use, in written. form.
18 MR. TELFORD:
If we could-do that, it will be on 191 the record.
h 20:
MR. CAMPER:
Are we really going to now go through D
21-every one of these and take every standard and identify it 22 uin a' fashion that we'll have something to work with in the.
23 future?.
'r
'241 MR. TELFORD:
That is a good question.
I mean, l
25 let's give it a go here and then resolve the completeness
)
1 I
_ -,. - ~ -
ab o
143 1
theorem when we get done.
1 2
MR. BRINER:
I think it might be more beneficial 3
Eto us for you to tell us what is not met by that standard,
'4 what's missing, that we've been going ovar this thing 40 5
ways from Sunday here today.
6 MR. TELFORD:
Let's do it this way.
I can tell l
\\
7 you what we're trying to do here --
8 MR. BRINER:
Look at JCAHO, and you tell us what 9
is missing and, I don't think you can do it --
i 10 MR. HENKIN:
Dr. Alazraki's plan conforms to 11 JCAHO.
How many. items in your group of eight did it miss 12 on?- And, are those covered in other parts of the JCAHO-1 h
13 requirements?-
14 MS. ALAZRAKI:
Yes, because it's over a period of 7.
_15-several-years.we will cover everything ultimately.
16 MR. TELFORD:
Okay.
Let's step through them.
l 17-MR WIEDFMAN:
The plan we're talking about is i
18 just this plan, and not that.
19.
MS. ALAZRAKI:
That's what it's based on.
20-MR. HENKIN:
What I'm saying is.they be viewed t-l 21 together --
'22
-)GR. TELFORD:
Okay.
So that we are talking about i
23 tvih of these.
c 24 MR. HENKIN:
-- because no matter what's in your 25 quality assurance plan, you have to conform with everything l
e 144 1
in the accreditation plan.
i i
2 MS. ALAZRAKI Right.
3 MR. HENKIN:
And we're going to use the ACNP.
4 MR. TELFORD:
Well, ACNP is much more extensive 5
than JCAHO.
i 6
MR. WIEDEMAN:
The point I'm trying to get across 7
is what has been -- you know, unofficially, what are we 8
considering as being submitted to the NRC for evaluation?
9 Is it this plan?
Is it a combination of both of these?
10 MR. HENKIN:
The plan was a sample.
11 MS. ALAZRAKI:
Also, you have to understand that 12 what you have here is not the whole plan.
The hospital has i
13 a whole QA plan which impacts nuclear medicine as well.
14 It's just that on a monthly basis, we don't review the I:
15 credentials of every physiciant we don't review job 16 descriptions for every --
17 MR. WIEDEMAN:
Sure.
18 MS. ALAZRAKI
'And there are a host of other 19' things that you would find if you w nt through the whole 20-hospital manual.
21-MR. BRINER:
If you want a document that is 22 functionality at the majority of hospitals, we'll say, in 23 this country, JCAHO is it.
ACNP is not, because how many l,
24 hospitals --
25 MR. HENKIN:
I can't even tell you otf the top of i
w
-s--w---v-w-re>w,.
---,,-n--r-
--s--
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.,~---.-:.--w e,---,w-eemve--v e-r m-,*---w-*-e v
w<,
o
a 145 1
sy head.
2 MR. BRINERt But JCAHO is widely used throughout 3
the hospital *,4ustry.
4 MS. ALAZRAKIt The other thing is that JCAHO over 5
a period of many years has evolved in understanding of and 6
now is getting to the point of being able to deal with the 7
tremendous variation in hospital nuclear medicine 8
structures.
In other words, there are teaching hospitals, 9
there are community hospitals, there are military hospitals, 10 VA hospitals.
They all have different routines, different 11 missions in a sense, other than the core of patient care, 12-and that all impacts on what is reasonable to do in a i
13 quality assurance program.
14 MR. TELFORD:
What drives the hospital to have its 15 quality assuranca program?
j 16 MS. ALAZRAKI JCAHO.
I i
17 MR. TELFORD:
Okay.
We're doing Item 1 under the 18 objective, Objective No. 1.
It looks like you're doing it.
19 Item 2-really says that you should have a 20 prescription for --
21 MR. BRINER:
Okay.
Let's stop right there.
How l
22 do you define a prescription, because there's a very precise 23 definition under the law.
24 MR. TELFORD:
Well, we defined it in the proposed i
25 rule as being a written directive.
\\
146 1
MR. HENKIN:
That's not the way the law defines 2
it.
3 MR. BRINER:
That's not the way the law defines 4
it.
5 MR. HENKIN:
The law defines a prescription as the 6
direction of a remedy or remedies for disease.
7 MR. TELFORD:
I'm guilty.
I'm guilty.
Hang me.
8 MR. BRINER:
That is not meant to be facetious.
9 It's typical of someone writing regulations in an area where 10 they really aren't well informed about --
11 MS. ALAZRAKI:
On a day-to-day practice.
12 MR. TELFORD:
For the purposes of discussion, i-13 could we think of this as a written directive?
14 MR. BRINER:
No.
15 MR. HENKIN:
No, because it isn't always a written 16 directive, and it need not be a written directi7e.
17
-MR. TELFORD:
Okay.
How can we describe this?
18 MR. HENKIN:
I think the way the law describes it 19 is quite nice.
20-MR TELFORD:
Okay.
21 MR. HENKIN:
A prescription is a direction of a 22
' remedy or remedies for disease.
It's a physician direction 23 to somebody to do something.
Prescriptions can be for i
24 procedures, they can be for pharmaceuticals, they can be for 25 any one of a number of things.
-p e
147 1
MR. TELFORD:
Okay.
We are talking about a
(
2 therapy case here, so the physician in the casa you've 3
quoted analogously would be an authorized user, a nuclear 4
physician?
5 MR. HENKIN:
I presume so.
6 MR. TELFORD:
Can we use that as our working 7
discussion level definition?
8 MR. HENKINt Okay.
You've got an authorized user 9-who wants to decide how to treat somebody.
10 MR. TELFORD:
Okay.
So, he or she either writes 11 it down or verbally directs it.
12 MR. HENKIN:
Okay.
I 13 MR. TELFORD:
Is that acceptable?
14 MR. HENKIN:
That's fine.
15 MR. BRINER:
That's fine.
16 MR. TELFORD:
Okay.
Objective No. 2 would like 17 the authorized user to direct that the therapy be performed 18 or brachytherapy procedure -- excuse me -- teletherapy, 19 brachytherapy or nuclear medicine therapy if it involves 20 more than 30 microcuries.
21 MR. HENKIN:
I think that JCAHO NM 3.2 deals with 22 that.
23 MR. TELFORD:
NM 3.2.
I was going to point out 24 what our Objective 2 tries to do, and then Objective 3, and
.g 25 then look at how the example plar. that we have does anything q
.o e
148 1
different, okay?
So, Objective 2, then, gets the authorized i
2 user into being the director, into being the issuer of the 3
prescription as you've defined it.
objective 3 deals with 4
diagnostic referrals.
So, it envisions that a referral 5
comes in, the referral agrees with the clinical procedures 6
manual, and the referral could be from a non-nuclear
?
physician, and that happens before a diagnostic procedure is 8
done or a prescription is issued.
9 MR. HENKIN:
Okay.
A clinical procedures manual 10 will not normally contain the indications for a procedure; 11 it will contain the procedure to be followed to carry out 12 the procedure because the decision on whether or not a I
13-physician is appropriate is a physician decision that is not l
14 prescribed in a procedure manual.
A procedure manual is l
15 what it says it is -- ft's a how-to.
It's a cook book.
16-MR. TELFORD:
Yes, but didn't we do that back in 17 Objectivu 1?
18 MR. HENKIN:
Not in the procedure manual, though.
19 MR. TELFORD:
I didn't mean to imply that. The
'20 referral comes in, and it says " bone scan."
21 MR. HENKIN:
Fine.
Somebody (4ecides that's 22 appropriate.
23 MR. TELFORD:
And this referral is from a GP, a i
24 non-nuclear physician.
25 MS. ALAZRAKI:
Correct.
l' l
L
k o
149 1
MR. TELFORD:
It comes to your department.
Your i
2 technologist then, using objective No.
3, would say, " Bone j
3 scan.
It's in the clinical procedures manual.
The patient 4
is here; it's the correct patient."
The technologist will 5
handle the patient and do whatever the clinical procedures j
6 manual says, which, incidently, was approved by the 7
authorized user, which is what you said, and then carry out 8
the study based on their training and the procedure 9
described in the manual.
So, that's what's really 10 envisioned by 2 and 3.
11 In objective 2, we have envisioned that the 12 authorized user, the nuclear physician, would be directly 1
13 involved to issue the prescription as you've defined it; 14 whereas in 3, it more or less recognizes the way that 15 diagnostic procedures are practiced in a majority of the 16 hospitals, with the nuclear physician not being directly 17 involved to issue a prescription or give any directions for 18 the diagnostic casar whereas in your plan --
19 MR. HENKIN:
I'd like to see the evidence 20 documenting that nuclear physicians are not involved in the 21 therapy patients.. I want to see somebody show me numbers 22 and data that says that's the case, because, for one thing, 23 they're in violation of JCAHO, and they're in violacion of i
24 good medical practice.
25 That may happen from time to time.
I'm not saying
10 l
150 1
it doesn't happen.
I want to see that it happens in
-1 2
overwhelming numbers, justifiable to being fixed.
3 MR. TELFORD:
Your first point that it's in 4
violation of JCAHO?
5 MR. HENKIN:
Yes.
It says here in NM 2.2.3 --
6 MR. TELFORD:
Wait a minute.
Let me find it.
7-Two-point-two-point-three.
8 MR. HENKIN:
Page 121.
The prescribing of nuclear 9
medicine, radionuclide therapy, and the sapervision of the 10 cost of therapy by a qualified physician, and that's the 11 written policy and --
12 MS. ALAZRAKI:
That's therapy.
13 MR. TELFORD:
That's therapy.
We're talking 14 diagnostics.
15 MR. HENKIN:
I thought we were talking 16 diagnostics.
17 MR. TELFORD:
No, sir.
18 MS ALAZRAKI There was a mix-up there.
19 MR. TELFORD:
In Objective 3, it's just for 20 diagnostics.
21 MR. HENKIN:
Okay.
Try 2.2.4.
22 MR. TELFORD:
Okay.
23
( Laughter. )
24 MR. TELFORD:
Do you want to read it for me?
i 25 MR. HENKIN:
The scheduling of and instruction and 1
yh 151 1
procedures for the preparation of patients for diagnostic or J
I i
2 therapeutic procedures.
3 MR. TELFORD:
What does it mean?
What does it 4
say?
5 MR. HENKIN:
It means that we are supposed to 6
provide instruction to our people how to prepare patients 7
and how to do diagnostic and therapeutic procedures.
8 MR. TELFORD:
Okay.
You could do that via a 9
clinical procedures manual, couldn't you.
10 MR. HENKIN:
You could that in any number of ways.
11 This gives you the freedom to do it; it's just telling you 12 you've got to do it.
I 13 MR. TELFORD:
Okay.
That's directly in accord 14 with what I described.
15 MR. HENKIN:
Right.
The patient arrives from the GP to 17 your. department to have a bone scan.
You've compljed with 18 2.2.4 of scheduling and instructing the technologist via the 19 clinical procedures manual.
The nuclear physician does not.
20 necessarily have to be directly in the loop to issue a 21 prescription-using your definition in order for the 22 diagnostic procedure to be carried out by the technologist.
23 That's all we're saying, is that that's the practice --
24 excuse me -- the business is done --
25 MR. HENKIN:
And that is the practice of medicine.
'o 158 1
MR. TELFORDt Fine.
No disagreement.
2 MR. HENKIN:
That if a physician -- I mean, if I 3
call Walgren's and order tetracycline for a patient and 4
never give -- I'm not required to give Walgren's a written 5
prescription.
Except for a narcotic, Walgren's need not 6
have a written prescription.
They'll just take my verbal 7
order, and when the patient comes in, they'll hand him his 8
bottle of pills, and I don't have to follow it up with a 9
written prescription.
10 You have to do it right when the patient in 11 standing there.
12
-MR. TELFORD:
Then yoc would say likewise that 13 objective No.
6, to make sure you 1: ave got the right patient 14 is --
15 MR. HENKIN:
It's also in there.
16 MR. TELFORD:
-- 2.2.10.1.3.
17 MR. HENKIN:
Yes.
18 MR. TELFORD:
Is that correct?
19 MR. HENKIN:
Sounds good.
20 MR. TELFORD:
Okay, we're up to objective No. 7 21 then, ensure that any unintended deviation from either 22 referral in the manual or the prescription is identified and 23 evaluated.
We saw that in the example program.
24 MR. HENKIN:
That's NM.4 actually in the JCAHO.
25 It says as part of the hospital's quality assurance program l
e s
153 1
the quality and appropriateness of diagnostic and/or i
2 therapeutic nuclear are monitored and evaluated in 3
accordance with a whole bunch of other standards that they 4
got in other places but basically that says that you have to 5
identify things that go wrong in your system.
6 MR. TELFORD:
Okay, and that's why this plan has 7
that particular objective covered on page 2 of the monthly 8
reports, as stated in the meeting minutes, to report any 9
deviations and report those monthly and that's signed by the i
10 nuclear physician.
11 MR. HENKIN:
Most hospitals have at the present 12 time as part of their quality assurance program an incident 1
13 reporting system for all misadministrations that occur in i
14 the hospital, diagnostic or standard therapeutic drugs, and 15 those are all reviewed by the quality assurance group 16 looking for systematic errors.
17 MR. BRINER:
When the patient slips in the 18' hospital.
19-MS. ALAZRAKI Right, that's an incident.
l 20 MR. HENKIN:
That gets reviewed to see whether the 21 hospital is salting its front steps correctly in the winter 22 and things of that sort.
That all is part of the same 23 system.
24 And No. 8 thank god we don't have to deal with, 25 right?
. ~ _
r.
154 1
MR. TELFORD:
No. 8 applies to teletherapy and 2
brachytherapy and is not your concern.
3 MR. HENKIN That's right.
When were these 4
issued?
5 MR. BRINERt These are issued yearly.
This is the 6
1990 version.
7 MR. TELFORD:
How much of a change from '897 8
MR. HENKIN:
Not much.
9 MR. BRINER:
Not a great deal.
i i
10 MR. HENKIN:
Not very much change from '89 The 11 last big change was mid '80s, okay, but their word' 12 changes a little bit from year to year but the ba
- outline I
13 stays pretty much the same.
14 They haven't changed much actually since '86,
'85, 15 something like that.
16 There was a big change around '85 and then 17 trickled changes after that.
1 18 MR. TELFORD:
You said that ACNP -- did you say l
19 something like more rigorous --
20 MR. HENKIN:
I said wordier is what I said.
I 21 MR. TELFORD:
Wordier?
I 22 MR. HENKIN:
Yes.
We take 15 or 20 pages to say 23 what they say in a smaller number of pages but we are L;
24 directing, first of all, we are directino it specifically at 25 a number of patient-related issues in nuclear medicine as
^O 155 1
well that are of interest to you and I think you shov.1d look
\\
2 at that to see what it says.
i 3
Anybody who goes through a JCAHO order would mere 4
than satisfy anything you -- I mean an ACNP order would more 5
than satisfy anything in your draft because we are far more l
6 extensive than even JCAHO is, but we are a purely voluntary 7
system.
8 I think this question of JCAHO being voluntary is 9
a little bit confusing.
You must volunteer for a JCAHO 10 inspection if you want to be reimbursed for your hospital's 11 bills.
If you do not have JCAHO accreditation, no third 12 party insurance company will pay you, so in that regard it's I
13 a voluntary system.
However you volunteer to go out of 14 business if you don't volunteer for the system, so that r
15 while technically it's voluntary, in fact it is anything but 16 voluntary.
I 17 MR. WIEDEMAN:
How about VA hospitals?
18 MR. HENKIN:
They are now under JCAHO.
19 MS. ALAZRAKI:
VA has multiple -- I mean more so, 20 more than JCAHO.
They have their own internal audit 21
' programs which touch -- which do quality assurance too.
VA 22 also is on JCAHO.
23 MR. TELFORD:
We have been through this example 24 program.
We have touched on some of these requirements as l
-25 they were applicable to our objectives.
n 156 1
It turns out that this program embellished by some 2
of the-hospitals' QA programs and embellished by the 3
requirements of JCAHO, although not written here, have to be 4
complied with because they are enforced by JCAHO.
5 Taking all of that, the eight objectives are met 6
so the question is what would you change?
7 MR. HENKIN:
I would leave it alone.
JCAHO is 8
doing'a wonderful job.
Why change anything?
9 MR. TELFORD:
JCAHO is doing a good job.
Let's 10 take that as a given but if we were going to evaluate these 11 objectives and say would we modify any of these, would we 12 delete any of these, would we retain any of these?
13 MR. BRINER:
Why?
I keep going back to why would 14 you want to do that?
15 MR. TELFORD:
Let me see if I understand this 16 correctly, Captain Briner.
17 You would way merely somehow endorse JCAH program.
18 Let everybody comply with that.
19 MS. ALAZRAKI:
That is what we would recommend.
20' MR. TELFORD:
Why pick out only eight of the ones 21 that you are-already complying with?
Let people be 22 accredited by JCAH and grant them an exemption in nuclear 23 medicine for any regulations we might have.
24 MR. HENKIN:
I still have a problem with that.
25 You are granting them an exemption for something you 6
s
i 157 1
shouldn't be regulating in the first place.
I 2
I think you should feel comfortable that you don't 3
have a problem because the joint commission is already doing 4
all of this and as a matter of fact takes a little more 5
every year that it's doing.
6 Every year it adds another layer to their system, 7
partly as the demanda of the general public to assure that 8
there is quality health care overall and that as a result of 9
that there is already an accrediting body in place that is 10 doing the job.
11 Therefore, there isn't a need for anybody to even 12 lay down a regulation that says you have to conform with 13 joint commission because you have conform with joint 14 commission anyway.
15 Now if you want to discuss anything, and I am not 16 sure I am competent to discuss it, you may want to discuss 17 whether or not you have a role in free-standing operations 18 that are not joint commission accredited.
- 19 MS. ALAZRAKI:
Or licensees that are not joint 20 commission accredited.
21 MR. CAMPER:
And/or hospitals that are not JC 22 accredited.
23 MR. HENKIN:
I think you will not find any with 24 nuclear medicine departments who are not JCAHO accredited.
25 Those that are not JCAHO accredited tend to be
158 I
long-term psychiatric facilities --
f 2
MS. ALAZRAKI That's right.
3 MR. HENKIN:
-- things of that type that don't 4
provide these services on site.
5 I would be very surprised to see any NRC licensees 6
in that group of 21 percent or so that don't comply to 7
JCAHO.
8 They are usually a very special type of hospital, 9
drug rehabilitation or alcoholism, something like that that 10 fall outside the standard acute care hospital setting.
11 I strongly recommend that you not stir up this 12 hornet's nest because what we are trying to do is reassure I'
13 you that in fact everything you want to have done is already 14 being done and at times a good deal more than what you want 15 to have done is being done.
16 MR. BRINER:
People don't understand how to 17-approach this problem.
18 MR. TELFORD:
I understand, so that if the L
19 Commission needs an enforceable regulation in this area that 20 it's highly relying on what the JCAH program.
Okay.
21 MR. CAMPER:
Do you have any thoughts on the 22 onforceability of JCAHO as it relates to NRC's ente cement?
23 MR. HENKIN:
It's enforced differently, okay, than 4
24 you would enforce.
They do use a citation system, but their l
25 penalty system is different than yours.
1
159 1
The ultimate JCAHO penalty --
1 2-MR. BRINER:
I think he means how can they enforce 3
it ~~
4 MR. CAMPER:
Let us operate under the assumption 5
for a moment that we go through with the rule and that rule 6
contains language similar to what you're saying but some 7
clause that would say that this criteria can be met by a 8
hospital demonstrating that it has a JCAHO approved quality 9
assurance program, okay?
10 MR. HENKIN:
Well, JCAHO accredited.
11 MR. CAMPER:
Fine, accredited program.
How do we, 12 how does the NRC then enforce?
J 13 MR. HENKIN:
Well I would do it if I were you, I'd 14 do it by license condition, i
15 MR. TELFORD:
That's how you license, how you set-16 t,;em up to give them the business license to operate, but L
i'- how do we --
I L
18 MR. HENKIN:
You've got to mail in a copy of your-19-JCAHO letter.
That is easy enough to do.
20.
MR. TELFORD:
Okay, so you would let JCAH inspect 21-the hospital --
22 MR. HENKIN:
Sure, of course.
They're doing it l
23 anyway.
l 24' MR. TELFORD:
You'd put a copy of the JCAHO 25 inspection report.
I
- wy--w-
-,w y
,--,-_rm-
,-wy.*-*---g
-m-yv
.c.
160 1
MR. HENKIN:
Well, they send a letter of i
2 accreditation to the hospital.
That is what you've got to, i
3 if you want to do anything with it, which I still don't 4
think you ought to do, but if you want to do anything with 5
it, at the time you renew your license please enclose a copy 6
of your most recent JCAHO accreditation certificate.
7 It's actually a thing you put on a wall and it 8
tells you for how long this hospital is accredited, from
)
9 what date to what date.
10 MR. TELFORD:
Okay.
11 MR. HENKIN:
And they don't accredit now for i
12 longer than three years.
I 13' MS. ALAZRAKI Three years.
14 MR. HENKIN:
Three years maximum accreditation, I 15 think, before they come back, which is about the maximum 16 inspection interval that you guys can run, if I remember i.
17 correctly, right?
18 MR. TELFORD:
So if the hospital had some mistake 19 they made that we felt shouldn't have been made, then we 20
- might could cite them for that against the JCAHO --
21 MR. HENKIN:
You can always cite them for doing 22 something evil.
I mean there is nothing that stops you.
23 If they have broken your regulations anyplace, you
(
24
'can go ahead and cite them.
That doesn't prevent you from l
25 citing them.
l:
.a 161 1
MR. TELFORD:
But we have to have a regulation 1
i 2
'that we can cite them against.
3 MR. HENKIN:
You have got loads of them right r-4' You cite people for therapeutic misadministrations, right?
5 Haven't people been fined for therapeutic 6
misadministrations?
7 MR. WIEDEMAN:
No, just for not reporting the 8
misadministration.
9 MR. HENKIN:
I think that's reasonable but I don't j
10 think you need to fine them for that or cite them for that 11 because they are going to be cited for that by JCAHo, which 12 must make=its reports public, by the way.
i 13 MR. TELFORD:
Okay.
This leads us to the 14' diagnostic reporting requirements which is a backhanded way 15 of defining misedministration.
.16 I mean look at how in 10 CFR 35.2 currently it 17 says if you make one of these six mistakes you have a
.18 misadministration.
If your diagnostic administration were 19' 50 percent different from what was directed, you have a 20 misadministration.
c
-21 Remember?
l 22 MR. HENKIN:
I vaguely reqwmber.
g i
i 23 MR. TELFORD:
So that is a way.of defining what a 24 misadministration is, is by the finding of what should be 25 reported.
1.
l-
a 162 1
That is the way it's done.
2 MR. HENKIN You have got that in the regs now, 3
right?
4 MR. TELFORD:
Okay, would you like to look at the 5
proposed reporting requirements --
6 MR. HENKIN:
Sure.
Why not?
7 MR. TELFORD:
-- for diagnostics because some 8
changes have been proposed.
9 That is in this handout, here, page 1442.
10 Everybody have this one?
11 MR. HENKIN 35.33.
12 MR. TELFORD:
35.33.
These are for what's here i
13 called diagnostic events or misadministrations -- oh, I'm 14 sorry.
I gave you the wrong page.
l l
l' 15 Let's go to 1447.
That's the preamble that I 16~
referred you to previously.
.17 The section is marked 35.33.
l.
18-Revised to read as follows:
Under the paragraph y
l 19 (a) these are events.
20 (1) is any diagnostic medical use not authorized
'21 in the license.
That's just something you shouldn't be 22 doing.
Maybe you don't have the license to handle that kind 23 of material or something -- it's really outside your i
24 license.
25 (2) would be any diagnostic medical use without a
.o 163
.1 prescription or referral.
2 Does that ever occur?
3' MR. HENKIN:
I would hope not.
4 MS. ALAZRAKI Not prescriptions as we've defined 5
it here.
I-6 MR. TELFORD:
This is really a diagnostic case so 7
the diagnostic referral is probably the most operative.
8 MR. HENKIN I can't conceive of a situation 9
except, well -- it would still be referrals.
10 MR. WIEDEMAN:
I can envision a referring 11 physician would call you and say, Dr._Henkin, I have got a 12 possible pulmonary embolism,'I'm sending her down right
~I-13 away.
14 MR. HENKIN:
I don't think that's covered in this.
15 MR. BRINERt Here again, your terminology is 16 confusing -- diagnostic misadministration and soinewhere I 17 see creeping into it the wrong treatment is given.
18.
MR. TELFORD:
We are on (a) (2).
19 MR. HENKIN:
A diagnostic medical use without a 20 prescription or a diagnostic referral.
Again, you are 1
-treading into the practice of medicine because diagnostic 2
22 referral encompasses what?
What is a diagnostic referral?
23 MS. ALAZRAKI Let me give you an example where it j
j 24 is really the practice of medicine but it might not fit in l
25 what you have said here.
That is, say we do -- let's see,
= _____ _ ___-_ __-_ _____-_--_-___-______-_
e 164 1
a good one -- let's say we do a MIBG scan and we find an i
2 abnormality which might be associated with a particular kind 3
of tumor and it is very hard to localize that abnormality 4
without injecting a renal agent to see where the kidneys are 5
and if this is really in the adrenals or where it is, so we 6
would go ahead as part of the examination.
All we have been 7
asked to do is an MIBG scan to identify a tumor.
We would 8
go ahead and inject the renal agent to localize.
We do that i
9 all the time.
10 We consider it part, a legitimate part of the MIBG 11 exam but we' don't do it in every patient.
We only do it 12 when we feel it is indicated but it would not be a separate I
13 so-called referral oJ prescription for that renal injection.
14 MR. TELFORD:
It's directly from the authorized 15 user.
16-MS. ALAZRAKIt That's correct.
It's all medical 17 judgment.
18 MR. HENKIN:
Why is it -- I_ don't know what this 19 issue of a diagnostic referral means in here.
l 20 MR. TELFORD:
that is the patient that comes from 21 the outpatient.
22 MR. WIEDEMAN:
I know of a case where they were 23 cited for this particular part -- any diagnostic medical use 24 without a prescription or a diagnostic referral.
25 This was a VA hospital.
A technologist's sister's
O 165 1-been diagnosed with some kind of a bone disease and so she 1
2 had her sister come in in the middle of the night and the 3
technologist injected her sister and did the bone scan and 4
then she left the scans on the doctor's desk and normally in 5
a VA hospital you don't see too many female patients -- at 6
least this one -- and that was when the doctor said now wait 7
a minute, who is this woman.
She said, well, that was my 8
sister.
He says, well, who ordered this scan and found out 9
a physician did not order that particular scan.
10 MR. HENKIN:
And why is NRC concerned about that?
11 MR. WIEDEMAN:
Because it was a use --
12 MR. HENKIN:
Why is NRC concerned about that 13 clinical scenario?
14 MR. WIEDEMAN:
Because it met the definition of a 15 misadministration.
16 MR. HENKIN:
Okay, should you be concerned about
' 17 that clinical scenario?
Was the patient exposed to an 18 amount of radiation that was judged to be harmful?
19 MR. CAMPER:
No, but by definition it was a 20 misadministration therefore we are concerned under the 21 current --
22 MR. HENKIN:
We could open up this issue of 23 diagnostic misadministrations, which I don't think we want 24 to do.
I think the wording here is very confusing.
25 MR. BRINER:
Let's go down to (b).
um a
166 1
MR. TELFORD:
We will get to it.
Let me alleviate 2
the confusion, Dr. HenKin.
The prescription is What Comes 3
from the authorized user.
4 MR. HENKIN:
If you just ended it at prescription, 5
what would the problem be?
6 MR. TELFORD:
The referral comes from the non-7 nuclear 8
MR. HENKIN:
That is part of the practice of 9
medicine that you are not in.
Let me say that if in fact 10 his situation would be covered because there war no 11 prescription -- if you ended it right here after the word J
12
" prescription" what's the difference, because it's that I
13 diagnostic referral that muddies this sentence up 14 considerably.
{
15-MS. ALAZRAKI:
That's true.
16 MR. BRINER:
I don't want to discuss this any 17 further.
18 MR. TELFORD:
I don't quite understand how it
'19 muddies it up.
20 MR. BRINER:
Diagnostic misadministration was not 211 something we really wanted'to discuss today.
22 MR. HENKIN:
I think I agree with Bill and by the 23 way I would point out that your definitions of terms of 24 diagnostic referral means a written request dated and signed l
25 by a physician before a diagnostic medical use.
i 0
+
167 1
You just told us that's not what it means at all 2
in the other section.
You just said oral, verbal, 3
everything was fine.
4 Here you defined it differently.
5 MS. SURREL:
The definition says a written 6
request.
7 MR. TELFORD:
I just told you that.
I told you 8
that ten minutes ago, that the referral was a written 9
directive signed by a ner.-nuclear physician.
Prescription 10 is --
11 MR. HENKIN:
That's what your people have told you 12 too, that that is all oral.
13 MR. TELFORD:
Wait, wait, wait. We are operating 14 under.the guise that your definition of prescription was
/~
15 okay for the purpose of discussion, that we would recognize 16 your definition of prescription, that it's a written or oral 17 directive given by a nuclear physician.
That's the 18 applicable case.
19' I told you that the reason that I knew about all l
20 of the diagnostic patients being handled under oral 21 referrals was all of the folks in the pilot program, so we I
L 22-are quite aware that even though we stated what we thought 23 was the-ideal case is to have written directives, be it for j
24 diagnostic cases or therapy cases, that is not the real 25 world.
'O 168 1
That is not the way things are so I said granted t
2' that we'll look at this example program --
3 MR. HENKIN:
I as more confused now than when we 4
started.
5 MR. BRINER:
While we're on this thing I wanted to 6
bring tc your attention where you again make a terrible 7
mistake in your use of terminology.
8 We're talking about diagnostic medical uses, 9
right, under (b) (1).
Any diagnostic medical use other than 10 the one stated in the prescription or the diagnostic 11 referral in the clinical procedures manual, incorrect 12 medical use would include treatment.
I 13 MR. TELFORD:
Okay.
14' MR. BRINER:
And I use the term " treatment" with 15 disdain because there again you imply there is a bad effect 16 that will occur to this patient if something like this 17 happens and nothing could be further from the truth.
18
'That's not treatment.
19 MR. TELFORD:
What is it?
20 MR. BRINER:
Treatment infar: a therapeutic 21:
procedure of some sort.
22 MR. TELFORD:
The sentence says incorrect medical 23 use.
Now " medical use" --
24 MR. HENKIN:
That is malpractice by definition.
25 You are not capable of judging malpractice.
That is the I
o e
169 1
definition of malpractice.
2 MS. ALAZRAKI:
Incorrect medical use.
j 1
3 MR. CAMPER:
Were these points the trouble that 4
you're expressing with the definition addressed in your 5
comments?
6 MR. BRINER:
I can't even remember.
I don't even 7
remember anymore.
)
8-MR. HENKIN:
We certainly did address the issues 9
of written prescriptions and written diagnostic referrals i
1
.10 but these things are 'way out of line in terms of how they 11 fit in tl.a practice of medicine.
12 MR. TELFORD:
Would you believe this is currently i'
~ 13 covered under 35.27 14 MR. HENKIN:
These definitions are in 35.2?
15 MR. TELFORD:
Well, the same. things, diagnostic 16 misadministration is in 35.2.
17 MR. HENKIN:
But we aren't real happy with some of 18 the -- we've never been happy with the diagnostic 19 misadministration.
We've never been able to get anywhere 20 with it, that's all.
We were not happy with that from Day 21 1.
22 MR. BRINER:
That's right.
"23 MR. TELFORD:
Would you bear with me here just for 24 a minute on this sentence.
25 MR. BRINER:
What sentence?
l L
...~.
a.
170 1
MR. TELFORD:
icur sentence, incorrect medical i
2 use.
Medical use is a defined term.
3 MR. BRINER:
Okay.
4 MR. TELFORD:
So that means the administration of 5
byproduct material or the radiation therefrom, so we have 6
incorrect, some sort of incorrect medical use.
7 MR. BRINER:
But in a sentence where in exceptions 8
you are dealing with diagnostic misadministrations, 9
treatment should not ever appear.
Dottom line.
Period.
10 End of comment.
11 MR. TELFORD:
Okay, let's take out the word 12
" treatment" then for our discussion.
13 MR. BRINER:
Why not take out diagnostic 14-misadministrations? That's what we advised you to do years 15 ago.
16 MR. HEdKIN:
That solves the problem i
-17 MR. TELFORD:
Could we address these one at a L
18-time?
I am perfectly willing to entertain that.
19 We'll go back to the sentence:
Incorrect medical 20 use.
i 21 MR. BRINER:
We are not getting anywhere.
We've 22 reached an impasse.
23' MR. TELFORD:
Hang for on a minute. Hang on for a 24 minute.
25 I don't know, if the sentence said incorrect 1'
_.-.~_- - - -
- #4 0
171 1
medical use would include -- skip treatment --
2 MR. BRINER No.
I am not buying off on any part 3
of this section.
4 MR. TELFORD:
I didn't ask you to buy off on it, S
sir.
I just asked you to consider the sentence in some way 6
to repair it.
j 7
You bought up an objection to the sentence.
I was 1
8 trying to look for a solution.
9 MR. HENKIN:
We don't want to repair it.
We want 10 it all to go away because it is inappropriate.
11 It's an inappropriate -- I mean we have agreed to 12 play along on this therapeutic misadministration question i
13 and to discuss this issue, all these issues revolving around l
14 therapeutic misadministrations.
Diagnostic l-15 misadministrations are of no consequence to anyone, l
16-therefore it isn't worth the time to discuss them.
17 MR. TELFORD:
Okay.
Let me rephrase -- let me put l
18 the other question in.
i 19 How would you declare a threshold or structure a 20 reporting requirement for_either a diagnostic case or an I-l 21 131 case --
22 MR. HENKIN:
Why don't you talk to tha state of 23 Illinois.
They have some very interesting draft regulations 24 for what it is that d8.agnostically would have-to be reported 25 and I can't remember all of them offhand, but I think one of
,,_,-m
4
? L L
9 172 q
1 them is that in a diagnostic situation you'd have to be in
.1, 2S
- error by 500 percent-before you had to report anything to l
m 3
' anybody.
4' MR. TELFORD:
This is a diagnostic case?
5 MR. HENKIN:
Yes.
1 6
MR. TELFORD:
Typically like technetium.
7
- MR. HENKIN:
Typically like anything -- they E 81 regulate accelerator products as-well, so you have to
- ' remember that that includes their accelerator products as
-10
- well, s
,11 I don't remember the details of 14: of that but I 12 am,sure you.can get it from Kathy Allen at IDNS, a copy of y
p
'13 :
wiiat IDNS has' talked'about.
J E
' 14 "
MR.-TELFORD:
Okay.
1 o
15:
MR..HENKIN:
It is something the medical community 16-in Illinois has not-found terribly objectionable but sc
[i
- 17f,
- apparently the agreement-states folksihave had a little E'
118 1
- problem with -- but.it is a much more reasonable-situation l
19J ehat says you'have.to make a flagrant-error before you have p
V or to report it to anybody.
1 j
20; I
L*
' 21L MR. TELFORLa So something like the --
L 22 MS.EALAZRAKI:- Something like-a death from a i
E
- 23 transfusion.
u.
s D,
24 MR. TELFORD:
-- the medical use as administered 25:,
is 500 percent different from --
e,Ji+e re--
w
-e--
- - +
s>
e 173 1
MR. HENKIN:
I-don't remember all the details and 4
2 I don't really want to quote tho.no details because I don't
.3 remember them but I'm sure you can get it from the Illinois 4
Department of Nuclear Safety, a copy of what they have been 5
kicking around as a draft document.
6 MR. TELFORD:
Do you feel there should be.som6 7
threshold in terms of a dose to the patient like X rem 8
effective dose equivalent, in addition to the 500 percent or 9
is that sufficient?
10 MS. ALAZRAKI:
I know that the percent is --
11.
MR. BRINER:
500 percent of what?
12
-MS. ALAZRAKI:
-- of the prescribed dose,-the I
13-indicated dose.
14 MR. HENKIN:
I mean all they are trying to get at, 15 and I think the thing we.would not object to, is the report
'16 of a. flagrant error.
7ne stuff we have got now is nonsense s.
- 17
and has-no. meaning,-oNay, to anybody.
~18 MR. TELFORD:
Currently in 35.2 it says 50 percent o
- 19,
'different for diagnostics and if you get the wrong patient, 20 et cetera.
21 MR. HENKIN:
I don't want to discuss how to 22' rewrite the regulation.
23 MR. TELFORD:
Could you define " flagrant" for me?
24-MR. HENKIN:
I can define flagrant as a gross 25 error.
That's all I'll say.
o
i 9
174 l'
MR. BRINERt I would have great difficulty in 2
providing you any advice on diagnostic misadministration.
j
{
3 MR. TELFORD:
Okay, let's go to therapy then.
i i
4 MR. BRINER:
We have just been talking about 5
therapy all day long.
6 MR. TELFORD:
How about I-1317 Would you like to i
w i
7 see criteria there for if the dose, the whole body dose or 8
thyroid dose exceeds certain specifications then it should v
~9?
be' reported?
1 10 MR. HENKIN:
I think-you guys are in the wrong 11 business, collecting this material, because first of all it 1
- 12 leads you to do inappropriate things like'this quality i
13-assurance rule, the draft quality assurance rule, because 14 you draw incorrect conclusions from the data you have 15i collected because you~ con't know how to analyze that data.
"16:
That is problem one.
L
.17 Problem two is that I don't, I believe that these 18.:
are, issues that are addressed within the medical community 1
19:
'and belong to the medical community to address.
-20 They are our' responsibility to address, not to
- 1 21 1 defend, to address the issue of how we train our people
'22 appropriately and I mean the specialty boards and the 23 nuclear medicine technology-certifying board certify people 1
.24 to practice' nuclear medicine in the various levels they 1
=25 practice at.
M k
175 2
l1' It is the responsibility of those folks to see
)
'(
2 that people are appropriately trained.
It is the
]
3 responsibility of physicians to see that their practices are 4
.run properly, okay, and I come back to the same set of 5.
issues again.
6 I don't know why NRC thinks it has a role that no 7
other Federal agency has in the practice of medicine --
t 8
because FDA regulates pharmaceuticals does not give it a 9
role of the right to get into physician offices.
L 10 NR. TFTEORD:
If we would accept the JCAHC 11-accreditation, then that would be all right?
t
,12 MR. HENKIN:
Nol-I don't say for a minute that's LF 13 all'right.
You said that!
' 14
.I think you have no business in this at all!
<15 Your question.to us earlier this afternoon is can 16 we discuss-the JCAHO program and what it does.
17' The answer-to that is yes.
However, the 18 stipulation. we placed on that is that was outside the 19 discussion of a quality assurance rule.
.20 MR. CAMPER:- So that translates into, you are
.)
- 21'
- saying that requiring JCAHO certification -- accreditation, o
22 excuse me -- accreditation would not be sufficient to
'23 address our concern, would not be a satisfactory means to 24 address our concern --
25 MR. HENKIN:
It is an inappropriate thing for you
- .1
~
.~.
le.
176 1
to be involved in this at all.
Therefore we certainly can't
'l 2
endorse JCAHO or anything else as a standard for something 3
that is inappropriate in the first place.
4 MR. TELFORD:
We were talking about reporting 5
requirements.
Now what you are saying is don't do anything.
6 If'we do nothing, then the current requirements 7
remain, that are currently in 35.2, which is a diagnostic 8
administration and it's 50 percent different from what's i
9 prescribed and in radiopharmaceutical therapy a 10 percent 10 different.
s 11 MR. HENKIN:
What you have got written out there "12-makes no sense right now.
If you are going to use those 13 definitions to define a misadministration reporting system, 14
-theyfare no good.
They have got to be reworked.
15 They don't make any sense in. terms of the practice
'16J of medicine.
i 17-MS.-ALAZRAKI:
Our basic premise is that what we 18' started with earlier'this morning is-that your reason for i
19 wanting to get into this is the misadministration problem.
20 We say the misadministration problem is really not
-21' a non-problem because the occurrence of:those 221
-misadministrations as you have defined them approaches what z
23 we consider human error, that no additional procedural
~24 modification is going to be able to impact that, that-also 25-in addition to the fact that it is not of any impact to try
- n 5.-
d 177 1-to do anything about misadministration because it's a non-2 problem that you are getting involved in-practice of 1
medicine, whien of course we-are not prepared to accept as a E
4 regulatory agency.
5 So we are stymied here I think.
6 MR. TELFORD:
So is Dr. Henkin's point is that we 7
don't have the legal authority to do this and Dr. Alazraki's 8~
point is that we shouldn't be trying to reduce or prevent 9
misadministrations beyond the current --
E l
10 MS. ALAZRAKI:
Diagnostic, right.
11:
MR. BRINER:
I think we're at the point where 12 nothing.can be done to further reduce it.
That is the 13.
problem.'
14 MR. CAMPER:
Let me ask you this.
Given that 15 there is currently'a m'isadministration defined in Part 35, 4 <
0:
16-
- and: drawing your attention back to the April the 7th, 1988
-17 meeting, at which it was expressed that the definition of s18 the term misadministration is unclear and the related 19 reporting requirements are confusing, is'there anything that 12 0 -
we can do at-this point in tile constructively as we look-
. 21i at and: talk about the definitions that are now set fortn in
- n. m y
22.
the proposed rule?
23 We seem to have come to an impasse as it relates 24 to any additional constructive dialogue about those 25 definitions as now defined.
v
,---w
-, - - + -.
,n a
178 1
MR. BRINER:
We have about diagnostic
-2 misadministration.
We're at a point where --
3 MR. HENKIN:
I indicated to Mr. Telford on the 4=
telephone when we talked about this meeting that we were not 5
prepared to d'scuss the issue of diagnostic 6'
misadministration because there is just in our minds no 7-justification for any of it and -- do what you want with it 8'
sort of-situation that we are going to oppose it.
t1 9
We are going to continue to oppose it.
We believe 10 it is unjustified.
We believe it has resulted in no benefit 111.
to anyone.
12 MR. TELFORD:
Larry's question is can we have a 1
.13.
constructive dialogue about that?
If we do nothing than --
14 currently, 10 CFR has 50-percent difference.
'15 MR. HENKIN:- The only constructive dialogue --
16 km. TELFORD:
Should it be left there?
17 MR. HENKIN:
-- is to consider removing the 18 reporting requirements completely.
If that's what you want 19; to talk about, we'll'be glad to talk about it.
Revising 20 diagnostic misadministration reporting in any other way is
?
21.
not something we're' going to talk about, 22.
MR. TELFORD:
Okay.
What would be my basis for e
23 removing the reporting requirement?
24 MR. HENKIN:
That you have demonstrated they're 25 not a danger in the public health and safety.
Your own data l
l T
^'
n s.
179 1-has demonstrated that.
You've got the data that shows that 2
the diagnostic misadministrations in this country do not l
3 represent a danger to public health and safety.
4 MR. TELFORD:
Oh, okay.
Just the diagnostic ones,.
5' not the ones that result.in the therapy range, like the I-6 131 misadministrations.
7 MR. : HENKIN:
I could --
8 MR TELFORD:
Like the Arizona case, for instance.
'9 The lady lost her thyroid.
i
-10 MR. HENKIN:
Are we talking about diagnostics or 11 therapeutics?
We keep getting mixed up.
12 MR. BRINER: ' Undoubtedly, here on Rockville Pike I'
13!
today,'someone nearly got killed'by an automobile.
Has that
~14 been sufficient reason for Montgomery County to ban or to
.e
.15 -
~ indicate that only so many cars-per unit of time can go by-16
-here on Rockville Pike?- How far_do you think they'd get
-17 with that?
About as far as you're going to get with a L181 diagnostic misadministration conversation today.
19 MR. TELFORD:
How about therapy misadministrations
)
{
_20' then, not diagnostic?
21 ~
MR. BRINER:
What are we talking-about?
We've 22 been talking about therapy most of the day.
What are we g
23-rehashing it-for?
24 MR. CAMPER:
We're talking strictly about therapy 25 here.
i e
n.
n n
~-
ll n:
s 180 l'
MR. HENKIN:
I thought that's where we were, 2
Iodine-131 misadministrations.
3 MR. CAMPER:
We're talking about diagnostic K
4 nuclear medicine and segregating that into brachytherapy and l'
5 teletherapy, s
i-6
~MR.
BRINER:
Yes.
But most of the discussion 7
today centered around the therapeutic use of radionuclides-8 in other sealed sources.-
9 It's getting close to the time where it's going to i
10 take us 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> to get back into town, and I'm not about to 111-have that happen.
v 12 MR. TELFORD:
Io there a time that you would like h
13 to --
~14 -
MR. BRINER: -Half at: hour.
15-MR. TELFORD:
-- adjourn the meeting?
16 MR. BRINER:
Yes.- A half ~an hour is okay.
17 MR. HENKIN:
I don't think we're getting anywhere
- 18.
on'this topic.
19 MR. BRINER:
Absolutely not.
- 20.
MR. HENKIN:
The only statement we can make on 21-diagnostic misadministrations is that they won't present
-22 more hazard-to the public health and safety.
Since that is 23 the case, there should be no reporting requirement for them.
J.
24.
Anything other than that doesn't fit reality.
25 MR. BRINER:
That is something we've said
-._~
Es 181 1
repetitively for years.
So, it's not coming as any i
2 surprise.
3' MR. CAMPER:
Okay.
Can I make one different 4
point, then?
l 5
We've spent a fair amount of time talking about 6.
the utilization of JCAHO accreditation.as an alternative to 7.
our proposed QA Rule 35.35 for diagnostic nuclear medicine.
8' MR. HENKIN:
Well, I don't think that's exactly p
9 what we discussed.
What we discussed is whether JCAHO L
10 accreditation _ accomplishes the'same goals that your proposed 11 rule would accomplish.
' 12-MR. CAMPER:
Let'me phrace it differently.
t
,h
'13 If we'were to consider using JCH' accreditation 4
14
. standards to satisfy the concerns that we have expressed in 15 the-eight objectives in 35.35, as proposed, would it be --
f16
,would.ACNP or SNM. consider preparing'an analysis or a brief.
L
!17-description categorizing each of=these eight objectives.and j
L18 then identifying the standard and the part of_the 19 accreditation manual that applies?
20 MR. HENKIN:
Want my gut reaction?
L 21' My gut reaction is no,'because we're' opposed to 22'
.the' entire thing in concept.
That's my gut reaction.
Okay?
l l
23-And that :is that we've spent the entire' afternoon 1
pe Lp.
~2 4 demonstrating that JCAHO does what you wanted done.
1 25 Therefore, there is no need for you to do anything more.
L i
L
-~
7 A 1
h 182
- 1-But to consider going ahead now means that you're going to 1
2
-put into place something that's already there, and it makes p
3-no sense at all.
And I, for one, am not adverse to going 4
back to the commissioners and asking them why we're going to 5
do this.-
6 Why is this going to happen?. Because we had a 7
Very productive discussion, Dr. Holmes, Dr. Marcus, and I, i
8 in February, with the commissioners.
I think we got the l
9 furthest along with them we've ever gotten.
They were 10
. receptive.- They were willing to discuss.
And I think they=
'll understood the-issues better than I ever hoped for them to 12 understand the issues.
But now I think it'may be I
13
. appropriate to go back and say, in place of that, maybe it 14 hasn't trickled down from their level, that they understood 15 that'-- where we were and the allocation of resources and 16 things of that sort.
- 1.
17:
I don't see that that's occurring here, that
,18 you're talking about another system layered on top of 19 something else, even if you refer to JCAHO, and all of your 20
' goals are currently being met.
.21 MR. TELFORD:
Well, we're looking.for'an 22 enforceable regulation, and we need to --
23' KR. HENKIN:
Do you want to fine somebody?
124 MR. TELFORD:
Pardon me?
4-25 MR. HENKIN:
Do you want to fine somebody?
Is
W 183 j
l 1-that the goal of this?
2 MR. TELFORD:~ Well, it may be true that the JCAHO 3'
requirements apply to the vast majority of hospitals and j
4 facilities, but a few kind of slip through.
5 MR. HENKIN:
Could you prepara an analysis on how 6
many NRC licensees are not JCAHO accredited?
7 MS.-ALAZRAKI:
That would be worthwhile.
Fine out 8
how many there are, and then we could respond to that.
9 MR. HENKIN: 'How many NRC licensees,ons 10 institutions, are not JCAHO accredited?
11 MR.-TELFORD:. Well, we could consider doing that.
12
'There would be a few that would not be JCAHO accredited, and I
-13 ~
we would'need some sort of enforceable regulation to bring
?
14 those folks up to the minimum -.some minimum sufficient L15 standards.
E16 MR.-BRINER:
Well, let's see who they are and what 17 you're. talking about.
18 MR. TELFORD:
And then we would have to achieve 11 9 some sort of equality between those folks-and the ones that E
-20 are JCAHO accredited.
But to'date -- the ACNP and SNM sent l
21 inta petition, or a resolution -- excuse me -- to have -- to R
(
H22
' propose that the quality assurance rulemaking be withdrawn.
E L
23 RMR. HENKIN:
Correct.
i l'
24
.!CR. BRINER:
It still stands.
25 MR. TELFORD:
The response you received in a memo l
' 'i -
j 184
-1 dated, I think, February of '89, which said that that o'
-2 resolution would be considered among all the other public
-3~
_cmmments during the period in which the other public 4
comments or all the public comments would be evaluated, o
_5-The Commission has given us no change in
' direction.
6 7
MR. HENKIN:
Then I think we should go back to the 8-Commission.
l 9
MR. TELFORD:
The staff is operating under what's l-t :
10 called a si'aff requirements memorandum, dated December 21st 1
11 Lof '89,-in which we are to conduct--,have'the public-
- r
,12 comment period, conduct a pilot program, and prepare a final 13' rule to be delivered to the Commission in March of '91.
So, 14-that's the directive that we're under.
'15 MR. HENKIN:
You understand that we are operating
..y 16 cunder directives, as_well, and our directives are to'see i
17 that-this program is withdrawn, no matter what it-takes.
- 18 '
MR. TELFORD:
You're entitled to that opinion.
19:
MR. h??NKIN:- It is not an opinion.
We are 20:
responsible-to our organizations.
We.have been given a 21'
' directive, a-direct directive to see that this. program is 22_
withdrawn, not to see that it's modified, not to see C
23
_anything else, to see.that it is withdrawn.
24 MR.'TELFORD:
In spite of all that, I think the 25 discussion today has been helpful to me and certainly u
i i
.v 185 1
educational about the JCAH requirements and the example 1
2 program and how these meet or, at least, almost meet or, in 3
fact,-meet the end objectives that we have in the proposed
~
4' regulation.
I thought today's discussion was very helpful.
5 We seem to have come to an impasse over reporting 6
requirements.
You have given us the suggestion that we talk
- 7 to the State of Illinois; we will do that.
We know Kathy,
'8 and she was at the workshop that we had.
We will make that 9
inquiry to find out what they are proposing for diagnostic I
~ 10; reportingLrequirements.
We would like to seek your advice 11' and advice-of others as to how'those.ought to be changed, 12 because.ifJwe do nothing, then the current requirements
-13 stand.
14 MR.-BRINER:- For'the moment.
15 MR. TELFORD:
The medical community made the 16' suggestion at'the Commission meeting in '88 to change the
'17 definition of'" misadministration."- So, we're trying.
918' MR. HENKIN: LIf I remember, they also made the 19 suggestion that the whole thing be: dropped, too.
'20 MR. TELFORD: 'Woll, the directive that we got was 4
21.
Ito'look into rewriting the definition of 22
" misadministration."
23 HMS. ALAZRAKI:
You can rewrite it to exclude-24~
diagnostic.
- 2 5.
MR. TELFORD:
That would make you happy.
Right?
G w
186
- l' Okay.
i 2
MS. ALAZRAKI:
That would make sense.
3 The other which perhaps we have discussed that u
l-4~
seems reasonable to me is for NRC to look into how many and i
5 if there are licensees who are not under some QA program, 6
nothing to do with NRC.
L 7-MR. TELFORD:
Licensees not covered under JCAH?
8 MS. ALAZRAKI If there are any.
9 MR. HENKIN:
Or other practice audit programs.
10-There'are>two other practice audit programs out there.
L.
~
MR. TELFORD: 'Which are?
p
'11-
,12 MR. HENKIN:
ACNP and American College.of 2
1
.13 Radiology.
- 14 MR. TELFORD:.Okay.
15 MS.1ALAZRAKI:
Consider redefining 116'
'" misadministration" to betjust therapeutic; eliminate W
17) diagnostic.
l
'18-MR.-TELFORD:
Okay.
19 Would-anybody like to have any closing remarks?
20-MR. HENKIN:
I think-we've made.them all day-long.
4 u:
121 MS.-ALAZRAKI:
We've=mada. closing remarks.
,~22 MR. TELFORD:
Does anybody here want to make any i~
23 closing remarks?.
24
- [No response. ]
4 25 im. TELFORD:
Okay.
4
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I 187 1
Well, thank you all for coming.
I truly found it.
2-helpful.
3'
--Lot the meeting stand adjourned.
.4 (Whereupon, at 3:57 p.m.,
the meeting was 5-concluded.)
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IL REPORTER'S CERTIFICATE 1
This is to certify that.the attached proceed-ings before the United States Nuclear Regulatory Commission in the matter oft i
l NAME OF PROCEEDING:
Workshop on Quality Assuratice in I
the Medical Use of Byproduct DOCKET NUMBER:
Material P
PLACE OF PROCEEDING: Rockville, Maryland were held as h'erein appears, and that this is theEoriginal transcript thereof for the' file of the United States Nuclear Regulatory Commission taken by.me and~thereafter. reduced'to typewriting by me or under.the direction of the court report '
ing company, and that the transcript is a true and accurate. record.of the foregoing proceedings.
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l-Official-Reporter Ann.Riley & Associates, Ltd.
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