NRC: Meeting Transcript - 05/08/1997 - Meeting with Advisory Committee on Medical Uses of Isotopes (ACMUI)

1
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
*****
MEETING WITH ADVISORY COMMITTEE
ON MEDICAL USES OF ISOTOPES (ACMUI)
*****
PUBLIC MEETING

Nuclear Regulatory Commission
Room 1F-16
White Flint Building 1
11555 Rockville Pike
Rockville, Maryland

Thursday, May 8, 1997

The Commission met in open session, pursuant to
notice, at 9:01 a.m., Shirley A. Jackson, Chairman,
presiding.
COMMISSIONERS PRESENT:
SHIRLEY A. JACKSON, Chairman
KENNETH C. ROGERS, Commissioner
GRETA J. DICUS, Commissioner
EDWARD McGAFFIGAN, JR., Commissioner
NILS J. DIAZ, Commissioner
. 2
STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
ANNETTA VIETTI-COOK, Assistant Secretary
NAOMI ALAZRAKI, M.D.
JUDITH I. BROWN
DANIEL F. FLYNN, M.D.
JOHN GRAHAM
WIL B. NELP, M.D.
JUDITH ANNE STITT, M.D.
DENNIS P. SWANSON, M.S., B.C.N.P.
LOUIS K. WAGNER, Ph.D.
THERESA WALKUP
JEFFREY F. WILLIAMSON, Ph.D.
ANDREW KANG, M.D.

. 3
P R O C E E D I N G S
[9:01 a.m.]
CHAIRMAN JACKSON: Good morning, ladies and
gentlemen.
Today, the NRC's Advisory Committee on the Medical
Uses of Isotopes will provide the Commission with its annual
briefing.
The ACMUI, as its called, last met with the
Commission in May of 1996 to discuss the National Academy of
Sciences report on the Medical Use Program.
In the intervening year, much has occurred that
relates to the medical use program.
Most recently, the Commission directed the staff,
in a March 20, 1997, Staff Requirements Memorandum, to
develop a program for revising 10 CFR Part 35.
Also within that SRM, the Commission directed the
staff to continue to use the Advisory Committee on the
Medical Uses of Isotopes and other professional
organizations and societies in developing regulatory guides
and standards.
Today's presentation provides the Commission with
its first formal briefing since the SRM was issued. We look
forward to hearing from the advisory committee on its views
on achieving the goals of the SRM.
I understand that presentational material is
. 4
available at the entrances to the room.
So, unless my colleagues have any opening
comments, please begin.
Dr. Stitt, are you the lead?
DR. STITT: I think Don Cool is the lead.
CHAIRMAN JACKSON: Okay.
DR. COOL: Good morning.
The Advisory Committee on Medical Uses of Isotopes
is an advisory committee which has been established for a
large number of years, going way back to the time of the
Atomic Energy Commission.
Its function has changed over the course of time a
little bit, as the Commission's involvement in medical
regulation has increased, FDA involved that occurred in the
'70s occurred. So, it has undergone some transitions.
This group provides the staff with advice in a
number of areas in terms of the regulation and guidance
documents that are being developed, some instances of
particular training and experience where some unique
questions come up.
They provide us particular advice on individual
cases, provide us advice and a sounding board, if you will,
for interactions with other Federal agencies, professional
societies, and various groups.
I personally find it very valuable to have these
. 5
folks available to me and my staff in trying to work through
the program.
The chairman for the committee now is Dr. Judith
Stitt from the University of Wisconsin.
The ACMUI met just about a month ago, on April
10th and 11th, and devoted the entirety of that meeting to
the issues associated with the revision of Part 35 and the
questions and things which the Commission had put forward in
the SRM.
That SRM was available to the advisory committee
during that briefing.
And at this point, I'm going to turn it over to
Dr. Stitt to introduce the committee members and the
committee to provide you with their thoughts and views on
the subject.
Dr. Stitt?
DR. STITT: Thank you, Don, and good morning. The
ACMUI is very pleased to be here, to have this opportunity
to meet with the commissioners and to express our opinions
and our ideas regarding radiation medicine.
I'd like to introduce three of our members who are
seated behind me and are not at microphones but are
certainly available for questions.
Theresa Walkup, Certified Medical Dosimetrist and
Radiation Therapist. She's at Mercy Health Care in Oklahoma
. 6
City.
Andrew Kang, who represents the FDA as a member of
our committee.
And Will Nelp, to my far right, who is a Nuclear
Medicine Physician at the University of Washington in
Seattle.
I'd like to ask my committee members to introduce
themselves, starting with Jeff Williamson.
DR. WILLIAMSON: I'm Jeff WIlliamson, a Radiation
Oncology Physicist at Washington University School of
Medicine in St. Louis.
DR. STITT: Dennis?
DR. WILLIAMSON: And good morning.
MR. SWANSON: Good morning. I'm Dennis Swanson,
Nuclear Pharmacist from the University of Pittsburgh.
MR. GRAHAM: John Graham, Director of St. Mary
Hospital, an affiliate of the Beaumont Hospital System.
DR. ALAZRAKI: Naomi Alazraki. I'm a Nuclear
Medicine Physician at Emery University School of Medicine in
Atlanta.
DR. FLYNN: Daniel Flynn, a Radiation Oncologist,
Holy Family Hospital in Massachusetts, also Mass General
Hospital and Harvard Medical School.
DR. STITT: Thank you, committee members.
We view ourselves as the voice of clinical
. 7
medicine. The ACMUI members manage patients, we perform
diagnostic tests, and treat cancer patients with radiation
procedures.
The ACMUI has been working together effectively
for several years and has developed a cohesive style but
with plenty of room for different views.
We are now embarking on a new venture that for us
started just three weeks ago, when we received direction
from the commissioners regarding the IOM report, the
elements of DSI-7, and Part 35 changes.
The ACMUI is here today to discuss an overview of
these issues and to give the commissioners a sense of our
clinical opinion.
I'd like to start with the first slide.
[Slide.]
DR. STITT: Radiation medicine is a small part of
the NRC business. It's also a small part of medicine when
considered as a whole.
Radiation medicine is a safe process in
relationship to the practice of medicine.
We have taken our definition of risk from the
documents that we have been reviewing from the NRC staff.
Risk is related to the probability of error and the severity
of consequences.
CHAIRMAN JACKSON: Let me just ask a question
. 8
question. When you speak of risk, are you referring to the
worker, the patient, or the public?
DR. STITT: I'm referring to it in the sense of
risk as a whole, when you're looking at medical events,
human factors in medicine. So, you could use risk in any of
those particular subcategories.
The risk is going to then change to some degree,
depending on which group of procedures and whether you're
looking at workers, patients, or public, and I think those
all become important in some categories, and we're going to
try to address those as we go through our comments.
One can also think of risk in a little more
simpler term, but that is variation around an expectation,
and you can consider that variation, again, in all the
different walks of life of radiation medicine.
When I think about risk, it's something I do every
day.
I talk to patients about what is the risk of you
having a bowel injury if we proceed with this radiation and
what is the likelihood that radiation treatment to the
pelvis is going to keep cancer at bay versus your chance,
your risk of developing a bowel obstruction as a
consequence?
Next slide, please.
[Slide.]
. 9
DR. STITT: Research in risk and event reporting
for medicine is relatively new. It's been studied for quite
some time in transportation, aviation, and in other
industry, but when you look at the literature for medicine,
it's really quite new.
It's been said that risk or error just simply
doesn't occur in medicine, doctors don't make mistakes, and
so it's really not been the subject of much formal research.
There is a growing body of literature about
medical events of all nature, and there are some small
pockets of research that are actually taking place now in
radiation medicine.
In general, there's a very low incidence of error
in radiation medicine, and this is not even relating error
to consequence or to risk.
We feel that incidence of error is low in all of
the radiation modalities because of the elements listed here
on this slide.
They include voluntary practice patterns, practice
standards among the different groups, staff training
standards for dosimetrists, physicians, physicians, and the
broad quality improvement patterns, programs that exists in
all departments.
In addition, you can look at credentialing and
hospital privileges for those procedures that are performed
. 10
in hospitals.
COMMISSIONER ROGERS: Excuse me. Just before we
leave that slide --
DR. STITT: Sure.
COMMISSIONER ROGERS: The number, 1 times 10 to
the minus 4 -- where does that come from? We've had a lot
of trouble trying to get numbers like that over the years,
and I wondered how you were successful in doing so.
DR. STITT: We did, too. We took it from NRC
materials that we were given.
[Laughter.]
DR. STITT: Jeffrey, do you want to make any
comments?
DR. WILLIAMSON: Well, it's really hard to defend.
I looked at the numbers of misadministrations that
were reported in your evaluation of the QM program, and you
actually had the numbers of procedures there, so I looked at
that. I looked at the IOM report. I ball-parked the number
of procedures that occur over the country and kind of came
up with this number.
COMMISSIONER ROGERS: Well, it's always the
denominator that gives us the problem, not the numerator.
DR. STITT: Correct.
Dan?
DR. FLYNN: I'll give you an example.
. 11
Like maybe 5 or 10 years ago, we estimated the
number of brachytherapy procedures in the United States
between 30 and 50 thousand.
Now, with prostate seed implants, more than 5,000
a year, and HDR brachytherapy, individual procedures, it's
probably closer to 60 to 80 thousand a year.
If you have 8 misadministrations per year and the
denominator is 60 to 80 thousand, that would be 1 to the 10
to the minus 4th. That would be a reasonable estimate.
COMMISSIONER McGAFFIGAN: Could I ask a couple of
questions?
DR. STITT: Please.
COMMISSIONER McGAFFIGAN: Is it possible that NRC
regulation has had something to do with the 1 in 10 to the
minus 4th? I mean, you know, you have a list of --
DR. STITT: You notice we left that one out, but
it comes up every time we have this discussion, and
certainly, the NRC very definitely is of the opinion that
radiation -- that events are lower in radiation medicine
because of the NRC's presence.
CHAIRMAN JACKSON: Let me rephrase the question,
if I may. If NRC removed and replaced its prescriptive
regulatory requirements with performance-based, would the
low incidence of error remain so based upon these other
factors that you talked about?
. 12
DR. STITT: I think that is putting it in a little
bit different context. I think it's one of the real issues.
We're going to try to at least address -- talk
around those issues as we go through our report to see if
there's some groundwork, some basis on which to try to
answer that question.
Naomi.
DR. ALAZRAKI: Yes.
I would just interject that I think the medical
community feels that the errors have been low more because
of the training and experience of those working in the field
than because of any prescriptive rules from NRC, and I think
that the experience -- there is some experience that --
that, in the absence of some of these -- and I can't quote
right off the top of my head -- that, in the absence of some
of the prescriptive-nature materials, that the error doesn't
change, that it's basically the bottom-line human error.
COMMISSIONER McGAFFIGAN: Could I ask another
question on voluntary standards? One problem -- the reason
your community -- medical community at large, not radiation
medicine -- ends up on "60 Minutes" with such regularity is
that the -- there are some people who clearly practice
medicine and don't practice it well, and you know, you get
the horror stories.
I was told last year by a fellow who does New York
. 13
City's radiation safety, not just for us but for the whole
city, of a person conducting mammographies who, when they
finally looked at him, almost everything was wrong about
what he was doing, over 100 procedures -- they're just
bogus.
Actions had been taken as a result of that. He
still hadn't been disciplined by the State medical board.
He had moved on to Pennsylvania or something. It was a real
horror story. That one hasn't made "60 Minutes" yet.
But how do you deal with the fact that you have -
- everybody on the other side of the table practices
medicine, practices medicine well, you know that there is an
outlier element of your community that doesn't, and you
know, does regulation or at least the possibility of
enforcement by us or a state body if it's not by-product
material keep those people somewhat honest or at least get
them off the streets?
DR. STITT: Well, a general response to that would
be more like the comments that Stephen Brier made in his
book, Breaking the Vicious Cycle. How can you regulate any
part of life down to the last 10 percent, 5 percent, 1
percent?
So, I mean I think we have to set standards,
whether they're NRC regulations, voluntary standards of
hospitals, or national practice groups, and then try to
. 14
bring practitioners to those standards.
Were you waving your hand?
DR. WILLIAMSON: Well, I guess I could make some
statement. I guess, in my own practice, which focuses
largely on brachytherapy, the Commission's rules and so on
are sort of an overlay that's imposed on top of already
functioning quality assurance program.
You have to remember that brachytherapy in
virtually all departments is a relatively small part of the
practice, and so, we have, in most institutions, a fairly
detailed quality improvement program that encompasses
brachytherapy.
So, we kind of have the NRC standards functioning,
of course, and we have our quality improvement program
functioning, which I'll try and address in my part of the
comments.
It is my opinion that the incidence of errors is
kept low because of the adherence to voluntary standards
rather than compliance with the sort of overlay of
regulations, which I think are a fairly incomplete clinical
quality assurance program.
CHAIRMAN JACKSON: I think, as we go through --
and I think we should move on -- I think we do have to try
to make a distinction between two things.
One is, does the mere existence of regulation
. 15
encourage the creation and lay out some baselines for
effective quality assurance programs of the type you feel
that you have, and the second part has to do with the nature
of the regulations and what they can be or need be if we
assume that there's an affirmative answer to the first,
which is obviously where the Commission, in a certain sense,
is coming down, where one can accomplish and ensure that one
has the right elements in a program to protect patients, the
worker, and the public in a way that's different than the
way we've been doing it to this point.
DR. STITT: We'll continue on with slide three.
[Slide.]
DR. STITT: I think the first comments that we
have made really lead us to the statement that the ACMUI
members have agreed upon, that the low-risk status does
justify and move away from prescriptive regulations and
toward the development of performance-based regulation of
radiation medicine.
So, I think the comments you just made,
Commissioner Jackson, put that side of the table and this
side of the table on a level where we have several things
that we agree upon.
Next slide, please.
CHAIRMAN JACKSON: I haven't made a statement. I
asked a question.
. 16
DR. STITT: What's that?
CHAIRMAN JACKSON: I said I haven't made a
statement relative to prescriptive versus non-prescriptive.
DR. STITT: Okay.
CHAIRMAN JACKSON: I've asked the question, which
is what we'd like to hear from you about.
DR. STITT: Next slide.
[Slide.]
DR. STITT: As we said initially, risk is related
to the probability of error and the potential for the
consequences of those errors.
We, as the ACMUI, have developed a spectrum of
radiation procedures that we have begun to look at from one
end being high-dose-rate brachytherapy, which is a special
form of radioactive isotope therapy, to diagnostic nuclear
medicine, which we feel is at the opposite end of the
spectrum.
CHAIRMAN JACKSON: Where does gamma teletherapy
fit in the spectrum?
DR. STITT: Gamma teletherapy is a specific type
of teletherapy, teletherapy referring to cobalt therapy, and
it should be on this list and is not.
We felt that it resided toward the bottom, around
the level of low-dose-rate brachytherapy and that the gamma
stereotactic really refers to very, very focused multiple
. 17
beams of radioactive cobalt as the teletherapy unit that is
almost exclusively used for treating small brain cancers or
AVM malformations in the brain.
It has a risk that's on the higher end of the
spectrum because it has multiple fields, it's very high
doses, and treatment is given in a single visit.
Dan Flynn will continue with comments on the next
slide.
DR. FLYNN: Next slide, please.
[Slide.]
DR. FLYNN: Again, continuing with the risks and
the potential, I should say, health consequences of
exposure, high-risk procedures, meaning high-risk for health
consequences, would be, for example, exposure to large
numbers -- I should say large numbers of members of the
public to greater than Part 20 limits, deterministic
injuries to staff possible or likely, probable serious
injury to the patient, and health consequences meaning a
low-risk event occurs and it results in a consequence such
as harm to the whole body, harm to a part of the body, like
an organ system, the kidney or the skin, produces symptoms
and injury.
Examples would be, for example, high-dose-rate
accident in Indiana, Pennsylvania, where a source is -- lost
control.
. 18
Not only is the patient severely injured by the
accident, but members of the public could be potentially
seriously injured as this source is out of control for
longer and longer periods of time.
Another example would be in Guyana, Brazil, an
uncontrolled teletherapy cesium-137 source, large numbers of
people, much bigger accident than even Indiana,
Pennsylvania, and with serious consequences.
Next slide.
COMMISSIONER McGAFFIGAN: Could I ask a question
on that slide before we go on? Which Part 20 limits are you
talking about?
Exposure to the public greater than Part 20
limits. Are you talking about the public release limit, the
100-millirem, the patient release, 500 millirem, the
occupational dose?
DR. FLYNN: It's more of a general statement,
meaning if -- large numbers of the public, meaning many
thousands of individuals -- that would be considered a high-
risk procedure if thousands or -- large numbers of the
population would be exposed to a dose that's greater than -
- much greater than the Part 20 limits, for example, such as
in those accidents.
CHAIRMAN JACKSON: Dr. Williamson has a comment.
DR. WILLIAMSON: Yes. This is attempting to
. 19
define risk separately for three separate sub-populations.
So, for general public, we meant large numbers of people
being exposed to even small doses that could have a, you
know, calculable epidemiological impact.
COMMISSIONER McGAFFIGAN: But that's 100 millirem.
DR. WILLIAMSON: That's 100 millirem, roughly. I
guess we took that as -- one could debate it, but --
COMMISSIONER McGAFFIGAN: Right.
DR. WILLIAMSON: -- for purposes of this
discussion, we accepted that.
For members of the staff working with the
radioactive sources, we took the end point to be the
possibility of some injury.
COMMISSIONER McGAFFIGAN: Greater than 5 rems?
DR. WILLIAMSON: No, much greater than that, an
injury, an actual injury, like putting the source in your
pocket and getting a skin burn, a skin erythema, or
something of that nature, not -- I think we would say medium
risk might be for the public where only a relatively small
number of persons could be exposed to an epidemiologically
significant exposure.
COMMISSIONER McGAFFIGAN: So, for the staff, it's
much greater than 5 rems. 50 rems?
DR. WILLIAMSON: Possibly. It would depend on the
end point involved. 50 rem to the whole body, I think,
. 20
would probably be closer.
DR. FLYNN: The staff is also being monitored, and
as radiation workers, of course, we would expect that the
limits on them would be different than the limits on the
public.
COMMISSIONER McGAFFIGAN: Right. The current
limit is 5 rems, isn't it?
DR. WILLIAMSON: Yes.
DR. FLYNN: Yes. 1,250 a quarter.
COMMISSIONER McGAFFIGAN: You're saying, in this
case, it's much higher than 5 rems.
DR. WILLIAMSON: Yes. I'm talking about like an
actual injury, not the possibility of getting cancer 30
years down the line.
CHAIRMAN JACKSON: Please go ahead.
DR. FLYNN: All right. Next slide, please.
[Slide.]
DR. FLYNN: And then these are general statements
now in terms of risk.
Health consequences of exposure, let's say,
medium-risk procedures, members of the public and staff
exposed to less than Part 20 limits, but if we're talking
about very large numbers of the public -- and we'll discuss
the ALARA concept separately -- we certainly wouldn't want
to see unnecessary radiation exposure to large populations
. 21
of people, even if it was below the limits, small numbers of
individual staff or public exposed to greater than Part 20.
An example of medium risk might be teletherapy,
but not teletherapy in the sense of the Guyana, Brazil,
accident, teletherapy in the sense of medical practice.
I think when a source is decommissioned or a
radiation oncology facility is abandoned, like in Guyana,
Brazil, that that's a different issue, handling sources in
transport or sources that have been decommissioned, as
opposed to -- we're talking about medical practice, treating
patients on a daily basis.
Teletherapy would, in my opinion, be in the
medium-risk level.
Whereas in low-risk procedures, exposures to the
public and all staff would be less than Part 20 limits,
would be, for example, diagnostic nuclear medicine, where if
there is a technesium incident of some type, it is unlikely
to result in any harm to the public or staff and it only
involves one patient to which we would not expect any
medical consequence whatsoever and a very low-risk procedure
in that particular isotope.
Next slide.
[Slide.]
DR. FLYNN: Again, risk in radiation medicine --
high-risk procedures, the potential for risk based on the
. 22
health consequence of errors -- that is, for individual
patients or individual staff, we're talking about harm to
the body or part of the body, especially when talking about
patients.
The probability of occurrence is low given the
current standards for both the physician, the physicist, the
support staff in terms of education and training, existing
quality improvement in practices, safety, regulations within
the community, and the delivery practices.
The overall risk is low given the current practice
standards, and practice standards normally means
professional societies like the American College of
Radiology, American College of Radiation Oncology, and other
societies, but the process that we're going through in terms
of state licensure, credentialing by the hospital,
privileging by specialists in the field to make sure that,
even though physician is credentialed by the hospital, is
that person's background and education and training
sufficient to perform this procedure, and national
certification boards, which a lot of hospitals now, and
insurance companies, are requiring before they will
reimburse for that procedure, separate from the hospital
privileging process.
I think I'll turn this back to Judy now.
DR. STITT: I'd like to start with the next slide
. 23
and spend some time discussing the Medical Policy Statement.
[Slide.]
DR. STITT: The ACMUI at its most recent meeting
just three weeks ago spent considerable time discussing the
Medical Policy Statement.
We felt this was a very important place to start
our comments regarding Part 35 and DSI-7, because the
Medical Policy Statement really is the foundation for those
other elements.
Number one, the NRC will continue to regulate
medical uses of isotopes as necessary to provide for the
radiation safety of workers and the general public.
Statement number two, which is the next slide --
[Slide.]
DR. STITT: -- and the slides have modifications
and they are named ACMUI modification in that it's in the
lighter font -- the NRC will regulate the radiation safety
of patients only where justified by the risk to patients and
only where voluntary standards or compliance with standards
are inadequate.
Our second point is that assessment of the risks
justifying such regulations will reference comparable risks
and comparable modes of regulation for other types of
medical practice -- for example, anesthesia risk, drug
administration error.
. 24
COMMISSIONER ROGERS: Before you leave it, do you
want to discuss these as we go or -- for example, the use of
the word "only" --
DR. STITT: Uh-huh.
COMMISSIONER ROGERS: What is that intended to
exclude that's a problem right now?
DR. STITT: I think it's intended to be -- to
focus on what is included, potentially, more than what is
excluded.
I think that you could say that that relates back
to low risk of diagnostic procedures -- that is, that only
where justified by risk of patient could allow you then to
say risk from diagnostic procedures, the consequences are so
low that that might not need to be in the regulatory
framework.
Other comments from the committee on policy
statement two?
CHAIRMAN JACKSON: Dr. Williamson.
DR. WILLIAMSON: Well, I think the underlying
concern is that a criterion of risk, like 10 to the minus 6,
10 to the minus 7, or zero, might be imposed, and therefore,
even one incident could be cited to trigger, you know, the
rulemaking process, and I think what we're trying to suggest
is that the baseline for figuring out what an acceptable
risk is for threshold of regulation, you know, ought to be
. 25
somewhat comparable to what happens in other medical
specialties and not orders of magnitude below, you know,
what our colleagues deem acceptable.
COMMISSIONER ROGERS: But that could be the
interpretation of the statement without the "only," and you
know, what I'm trying to get at is there's something that
you felt was going to be accomplished by adding the "only,"
and I'm trying to get at what is that?
CHAIRMAN JACKSON: Mr. Graham?
COMMISSIONER ROGERS: You've already said we're
justifying it by the risk to the patients.
MR. GRAHAM: Right.
And I think part of what the ACMUI has discussed
over the past several meetings is the concept that, as it's
originally defined, as it's originally developed, the
regulation may sound very reasonable, that the Medical
Policy Statement sounds perfectly adequate, but it's over
time, as incidents come up and then additional regulations
are applied and then you get into issues of interpretation
and enforcement in the field, that we want to assure that
the good programs, the majority of the programs out there,
have a system of performance-based initiatives in which
they're working with the NRC and the staff to get better and
yet there are prescriptive regulations that still permit the
winnowing-out of the bad players, who are small in number
. 26
but who, as you say, garner a lot of the press.
Adding the word "only," in the opinion of the
committee, created a perspective of a threshold that you
don't write a regulation when it might help you write a
regulation only where justified by the risk to the patient,
and I think Dr. Stitt's example of diagnostics is a concrete
example of, if there's very low risk to the patient, low
risk to the public, then regulation related to those
diagnostics under a revised policy that has added the word
"only" would probably be revised.
COMMISSIONER McGAFFIGAN: I'll tell you my
frustration with the focus on the Medical Policy Statement
before we redo Part 35 is I think you can -- as Commissioner
Rogers was just suggesting, under the current policy
statement and the staff's intention as expressed in various
papers to you and to us has been that they are going to look
in Part 35, they've been wanting to look for three years in
Part 35 at less prescriptive regulation on diagnostic
medicine, and that's within the spirit of the current policy
statement.
My sense is that what you're trying to do here is
constrain and work on -- you're really working on other
issues through the policy statement when probably the best
use of time is to work on Part 35 and see where you get, you
know, with the staff in addressing your specific issues on
. 27
things like diagnostic medicine.
DR. STITT: I think the committee felt very
strongly about the Medical Policy Statement and that we as a
group reflect so many backgrounds of clinical medicine that
to come up with some sort of idea of where we wanted to
start working on this, we had to see if we even had the same
philosophy background-wise.
We're all clinicians here, we take the Medical
Policy Statement very seriously and feel that that's the
foundation upon which 35 needs to be addressed, and that's
the reason we spent most of our meeting discussing the
Medical Policy Statement.
CHAIRMAN JACKSON: Why don't we go on?
Commissioner Rogers, did you have another comment?
COMMISSIONER ROGERS: Well, I don't want to pursue
it too much, but it does -- I tend to have the same response
that Commissioner McGaffigan had, namely it's really the
implementation of the policy statement that I think is where
you're finding problems, and I still haven't heard anything
that suggest that, with the addition of the word "only,"
there's a clear change in policy.
It's a question of how this policy is implemented
by the regulators, and so, I don't want to pursue it any
further, but so far I haven't heard anything that
illuminates that.
. 28
DR. STITT: The word "only" appears in -- we
haven't made that as an addition, but the second bullet is
also our commentary on statement two, and really the
"only's" -- actually, there are two; one is missing -- only
where justified and only where voluntary standards are
inadequate -- relate to the second bullet that tie this into
risks that are -- that reference comparable risks in other
parts of medicine.
COMMISSIONER ROGERS: So, you really would like to
add a second "only." Is that it?
DR. STITT: The second part of that slide is part
of our modification to statement two.
COMMISSIONER ROGERS: Well, no, but what you just
said now was a second "only" after --
DR. STITT: In the minutes of the ACMUI meeting,
there were two "only's," only where justified and only where
involuntary standards are inadequate, followed by the second
bullet.
COMMISSIONER ROGERS: You're adding a second
"only" to the first bullet. I'm just talking about the
first bullet.
MR. GRAHAM: Yes. I think we're just trying to
clarify which set of slides you have there.
COMMISSIONER ROGERS: Oh, I don't know. I have
one that I got the other day.
. 29
MR. GRAHAM: Okay.
COMMISSIONER ROGERS: Has it changed?
DR. STITT: The minutes of the ACMUI meeting --
COMMISSIONER ROGERS: Oh, yes. I'm sorry.
COMMISSIONER DIAZ: There's another "only" there.
COMMISSIONER ROGERS: Another "only."
DR. COOL: Commissioner Rogers, we apologize.
There was one that was sent up that had that typo, which we
tried to fix.
DR. STITT: Statement three is the next slide.
CHAIRMAN JACKSON: He wants to discuss the second
bullet.
COMMISSIONER ROGERS: The second bullet also, I
think, is a question, and could you just elaborate on that?
It sounds to me as if what you're suggesting here
is that we look at what the risks are for anything else, any
other practices of medicine, and see that what we do with
respect to -- what our expectations are for radiation,
medical radiation areas, would be the same, we would have
about the same results. Is that what you're saying?
DR. STITT: I think what the committee is saying -
- and I'll let this unruly group speak for themselves --
COMMISSIONER ROGERS: In other words, that you
tolerate risks in radiation medicine that are comparable to
the risks that occur in other practices of medicine.
. 30
DR. STITT: Yes.
We think radiation medicine ought to be viewed as
part of a whole. It's a relatively small part of medicine.
Risks, events in medicine are now starting to be reported,
described, and assessed to complete the cycle to decrease
those events in all of medicine, and I think we feel that
radiation medicine shouldn't be kind of sitting out there on
the end of the limb by itself, it ought to be viewed as part
of the practice of medicine in the whole.
Does anyone else have a comment?
COMMISSIONER ROGERS: You know, my concern there
is that our attention to this area is dictated by the Atomic
Energy Act, and I think there is a question about whether
that, in fact, is a point of view that is justified under
that act. That's a question for OGC to look at.
COMMISSIONER DIAZ: I actually share that concern.
It might be that -- the statement is very broad.
It might be that the intent is good, but if you look at the
statement, it says "as comparable." It's just very open,
and it might not be compatible with the way that the we
handle things.
CHAIRMAN JACKSON: I think we need to move on.
[Slide.]
DR. STITT: Let's move to the next slide, which is
the third statement under the Medical Policy Statement, and
. 31
the Medical Policy Statement three is the NRC, and we have
added "will not intrude into medical judgements affecting
patients and into other areas traditionally considered to be
part of the practice of medicine."
CHAIRMAN JACKSON: Do you have a working
definition of what those areas are?
DR. STITT: Certainly, patient-physician
interaction. I think this has specifically come up, and
Jeffrey will probably address this in his section, the
obligation to send a written letter to a patient about an
event that's occurred, most people would feel is an
intrusion into the practice of medicine, and that tends to
come up on a regular basis at ACMUI meetings.
COMMISSIONER McGAFFIGAN: Could I --
DR. STITT: We feel that the risk to the patient
in radiation medicine is probably lower than other areas of
medicine.
This is what you have addressed in statement two
as an area of question, and we feel that there are a variety
of reasons that the risk is quite low, including the many
factors that we've discussed this morning.
COMMISSIONER McGAFFIGAN: Again, I'll just suggest
that the current words are "minimize its intrusion into the
medical judgements," etcetera, and "minimize its intrusion,"
I think, recognizes that there's, you know, always going to
. 32
be a balance that has to be struck, we're going to try to
minimize, but "not intrude" is such a blanket statement that
it is surely intended to be used as a stick against us in
any case where any doctor perceives any intrusion into what
their definition is of the normal practice of medicine.
So, I think you're taking a balanced statement
from 1979 and trying to turn it into a stick that the
medical community can use against us.
DR. STITT: Well, it probably reflects the fact
that we're clinicians and practice medicine and think pretty
strongly about these issues.
COMMISSIONER McGAFFIGAN: Okay.
DR. STITT: Let's move on.
I have a series of slides that try to focus in a
little bit more detail on the issues of prescriptive and
performance-based, and this has to do with the issue of
quality improvement and quality assurance.
[Slide.]
DR. STITT: This slide describes quality assurance
which, for any procedure, action is taken only when the
process average exceeds a pre-determined threshold. This
would be very -- this would be a definition of a
prescriptive-based process as we know it.
So, when the process average is under the
threshold, no questions are asked; when the threshold is
. 33
exceeded, there's commonly panic and finger-pointing.
This is not exclusive to our area of medicine at
all. Common examples of traditional l QA
include the number
of C-sections performed at an institution per month,
medication errors, and certainly, radioactive isotope
events.
Next slide.
[Slide.]
DR. STITT: When you look at quality improvement,
the entire output of the process provides a basis for
action, not just occurrences that are deemed unacceptable
because they exceed a certain threshold or specification.
I'd like to move to the next slide, which is a
graphic.
[Slide.]
DR. STITT: So, in the top graph, in the QA
process, there are a number of cases -- and you can see that
on the vertical axis -- that are evaluated by some sort of a
quality measure -- that's on the horizontal axis -- and then
when that threshold is exceeded, some sort of action occurs,
and that's a fairly common description that's used in
manufacturing, business, and in medicine and does describe a
prescriptive-based type of process.
If you look at the second diagram, which describes
the QI approach and a more performance-based approach, cases
. 34
are evaluated also according to a measure, but as you can
see, there are more cases that are being evaluated and acted
upon, and therefore, you're narrowing that curve.
So, there is a shift in the process and a shift
toward the desired direction of quality.
COMMISSIONER McGAFFIGAN: Could I ask, how is that
achieved?
I mean how -- if this approach has been used, how
do you enforce or -- you know, as a -- if you're the head of
the hospital and you want -- you want the whole curve
narrowed, you know, do they get a -- if you're the head of
the hospital, do you get a monthly report as to whether --
whether things are narrowing and then hold the department
head responsible if they aren't and, you know, ultimately
fire them or -- I mean how do you -- how do you --
DR. STITT: One issue -- and we'll be getting to
enforcement, and I think that is a key, and it's -- this is
not a knee-jerk. This is a continuum. It goes on and on
and on. And I was hoping our hospital administrator might
perk up and contribute.
This is actually a process that JCHO has
encouraged for some time and that you find most institutions
applying on a broad hospital or out -- now out-patient
clinics are starting to come under this JCHO type of
process.
. 35
So, John, why don't you make some comments?
MR. GRAHAM: Let me give one -- one simple example
of how we've converted over the past 10 years from quality
assurance to quality improvement, going back to that real
simple example of Caesarean-section rate, and then the
related event is the attempt, the goal to have a vaginal
delivery for later births wherever possible, and under
quality assurance, we would track the Caesarean-section rate
of a physician.
Those that truly were outliers, we would send a
letter to; the chairman would talk to them. It had very
little potential affect on practice in a lot of cases.
It was only where it was a very large dramatic
variance from the entire group that it became so obvious
that we could take some sanctioned action against that
individual.
Under quality improvement, we developed a review
of the process of how you would take care of that patient in
their second delivery, where you're trying to encourage a
vaginal delivery, and identify the concerns that had kept
practitioners from using the approach -- the time it took to
try to educate the mother on getting ready for that attempt
-- set up a process with the nursing staff and others that
would collaborate so that it became much easier in the
overall process to achieve the goal of that vaginal delivery
. 36
in the second birth, and all of the statistics moved in the
right direction, the C-section rate went down, the V-vac
rate went up, because we focused on the process, we
identified where the problems were in the system, defined
the resources that could improve that process, and without
ever going after anyone, all of the numbers simply moved in
the right direction.
It became easier from a system and a process
standpoint to try to achieve the right outcome than to do it
the old way.
CHAIRMAN JACKSON: I think Dr. Flynn wanted to
make a comment.
DR. FLYNN: A radiation medicine example would be
-- and this is also an example of compliance with voluntary
standards by professional societies -- you know, weekly
chart rounds where the radiation physicians get together and
present cases and show up the films, weekly checks of the
patients under treatment, weekly checks of the dose
calculations by the physicist, usually a second physicist or
a second dosimetrist other than the one who initially did
the calculation.
But for example, in port filming -- port filming
is whereby a patient is under treatment and we actually take
a film of the treatment beam to make sure the patient hasn't
-- see how compliant the patient is in not moving, how good
. 37
the technologists are in setting up the fields and
everything.
Now, if we do port films, let's say -- let's say a
practice may choose to do port films once a week. They see
that the prostate cancer patients with very stable setups
are not moving.
So, the outcome would be that, with all these
films that we're looking at, there is no real deviation
seen, but with the -- so, instead of doing the port films on
those patients every week, it might be every other week.
But on the other hand, the Hodgkin's disease
patient, the setup is complex. There a patient may move or
cough, and so, those port films, instead of being done once
a week, they may be done twice a week.
So, therefore, you are focusing medicine in a
cost-effective means on the more error-prone measures of
outcome and less focus on the less error-prone procedures.
That would be an example of what we actually do today and
what most practices do. That's just one example.
DR. STITT: I think one of the points that we
would like to make is that this -- these two graphics do
describe the QA versus us QI type of performance.
The QI is performance-based type of process. It's
something that actually goes on in hospitals on a routine
basis; this is not research that we've pulled from
. 38
something.
So, I just want to make it known that this is
something that we're already doing. This may be a way to
shift radiation medicine into a process that we're already
familiar with.
COMMISSIONER McGAFFIGAN: You said you're going to
get back to enforcement?
DR. STITT: Yes. That's coming up.
COMMISSIONER McGAFFIGAN: So, is this enforceable?
I mean the statistics that were talked about earlier.
Instead of enforcing against the outlier, can you enforce
against the whole licensee improving practice, and if that's
--
DR. STITT: I think so. Most of us are hospital-
based, some or all of our practices.
In order to maintain accreditation for our staff
privileges, for the hospitals that we work in to maintain
accreditation with JCHO, we're obligated to be able to show
that we can work within these boundaries.
Well, I'm going to turn it over to Jeff
Williamson, who's going to address more of those issues, and
we'll start with our favorite slide of all.
Next slide, please.
[Slide.]
DR. WILLIAMSON: Well, we thought this would be a
. 39
good lead-in to the two topics that I want to address.
One is just to review our committee's concerns
with what we understand to be the current regulatory
approach, especially as it pertains to patient safety as an
end point and especially in those areas where continuing
regulation -- i.e., the high-risk procedures -- seems
likely.
The government-by-yo-yo is kind of -- is an
amusing analogy, of course, coined by our previous chairman,
Dr. Siegel, and what he's getting at is the consequences of
letting the course of rulemaking be charted by single very
low-likelihood events.
The consequences I've sort of listed on this next
slide.
I think the -- you know, one major result is that
you wind up, when you look at the totality of regulations
formed in this way, without regard to principles of
coherence and completeness and without looking at the place
of these events that drive the process in the whole spectrum
of potential risks, one winds up with a kind of a quality-
improvement fragment that's a very sort of unbalanced and
distorted sort of mirror image of what we do every day in
clinical practice.
I think two characteristics that it has is that
there are a lot of detailed prescriptive rules on some
. 40
things that are not very important, and other things that
are very important are left unmentioned by the regulations.
A good example might be the excruciatingly
detailed regulations regarding quality assurance of dose
calibrators used to measure source strength of diagnostic
radiopharmaceuticals, whereas the calibration of low dose-
rate brachytherapy sources, to my knowledge, is not
mentioned anywhere in the regulations or even in the
guidance, and brachytherapy is an area where trying to
deliver the dose accurately to the patient is, you know,
much more important to clinical outcome, I believe you could
argue, than it is in diagnostic nuclear medicine.
I think not only in terms of content but style,
too -- this is really maybe the -- a major point we're
trying to get across is -- is that what we have is basically
a set of relatively rigid rule-governed prescriptive things
we're supposed to do that are supposed to be applied no
matter what the circumstances are, and that's just not how
effective functioning quality improvement works in radiation
oncology.
Most of our -- the guidance provided by, for
example, the AAPM emphasizes the process of adopting and
adapting general guidelines to the specific needs of each
individual clinical practice.
I think another example I could give -- one might
. 41
consider requirements in our license that we have vendor-
supplied training for our HDR unit every year. Well, how
useful is this, one could ask.
I think for a facility that has a very high
frequency of procedures, has a lot of experience using the
unit, frequently it's probably a waste of time.
In a practice that has a very low frequency of
procedures, the annual training is probably woefully
inadequate, and some sort of program, ideally, needs to be
set up in order to maintain the competence of the care-
givers.
Where exactly this line should be drawn is very
difficult. It really boils down to a clinical judgement on
somebody's part.
In this particular instance, which is a technical
question, it would have to be answered by the physicist; he
would be the responsible person for determining this.
I think another example of QI versus QA is, if
there is some sort of an event, maybe not even a
misadministration but just some concern about the overall
delivery process, I think just simply slapping another rule
like, uh-oh, better have a second person now come and check
the treatment plan if you're concerned about the accuracy of
computer treatment planning -- I think, in fact, what we
would do is look over the whole process and decide among a
. 42
number of different alternatives to try and improve the
overall quality of treatment planning.
Some possibilities that we would consider would be
more intensive training, perhaps, increased physicist
supervision of the dosimetrist in certain types of cases,
maybe improved forms for capturing the data that's needed to
drive the treatment planning process in a clearer and more
accurate form.
So, it's not necessarily adding another sort of
formal feedback loop. It's not like we're workers at some
machine where we do the same actions all the time.
A great deal of clinical judgement is needed to
keep this system going, and as a clinical physicist, much of
my time is spent, really, in designing and overseeing a
process and trying to make the standard deviation be as
small as possible.
I think another really major concern is the way
enforcement is done.
I think most of us would agree that the end points
mentioned in the regulations are good common sense things
and they're incorporated in virtually all voluntary
standards, but what really is upsetting and, I think,
somewhat counterproductive is the adversarial and punitive
enforcement attitude.
The emphasis is on -- during inspections, to this
. 43
day, at least in our institution, at least remains on
isolated errors and paperwork violations, really, whether or
not they are truly representative or descriptive of the
overall quality of our program and whether or not these
particular paperwork violations, which they are, often, have
any real clinical significance.
So, it's sort -- when you make a very rigid rule-
based system that relies on sort of automatic fixed
punishments, you know, that does not rely -- or leaves out
clinical judgement, I think you maybe, we would submit, wind
up with something that is not a productive use of either the
agency's resources or our time either.
CHAIRMAN JACKSON: Let me ask you a question about
this.
DR. WILLIAMSON: Sure.
CHAIRMAN JACKSON: You talk about future patient
safety regulations, and your second bullet suggests that --
encourage the acceptance of voluntary practice standards,
and with many voluntary standards available to
practitioners, how should the NRC determine which ones are
acceptable?
DR. WILLIAMSON: Well, I was going to try and
address that.
CHAIRMAN JACKSON: Okay. Well, when you do that -
-
. 44
DR. WILLIAMSON: Okay. Yes. I will --
CHAIRMAN JACKSON: -- address the following, also.
DR. WILLIAMSON: Yes. I will try to do that.
It's not a simple answer.
CHAIRMAN JACKSON: That's right.
DR. WILLIAMSON: Yes.
CHAIRMAN JACKSON: And there are many industry
standards that are actually broad guidelines, that, in fact,
require the user or allow the user to modify or tailor those
guidelines to his or her economic or staffing situation, and
so, to what extent should NRC allow flexibility in
interpreting or making a choice?
DR. WILLIAMSON: I'll try to give an answer. I
guess, at this point, I would say there are, you know,
really three directions maybe the Commission could go in
terms of what to do about patient safety in so-called high-
risk procedure areas.
One would be to maybe accept the modification
we've suggested or accept the implications of our modified
Medical Policy Statement, which suggests that things really
work quite well by themselves, that the community really has
an intensive significant commitment to this type of quality
improvement program, as evidenced by our overall good record
in unregulated parts of radiation, or at least unevenly
regulated parts of radiation medicine.
. 45
I think a second option would be to persist with a
similar sort of model, which is the threshold-driven, rule-
based, punishment-based type of system.
CHAIRMAN JACKSON: Better get to the third.
DR. WILLIAMSON: Okay.
Well, the third -- okay -- I think would be to put
aside this whole model of rigid rule-based prescriptions and
-- and accept, I think, that clinical judgement and
flexibility really are critical elements of a functioning
quality improvement process, and if you could come up with a
system of writing regulations and enforcing them that was
consistent with the actual way most of the community
practices quality improvement, I think a lot of the sort of
dissonance would go away.
CHAIRMAN JACKSON: But that still begs the
question of how does one decide which voluntary standards
are acceptable, and how does one decide how to bound
flexibility, and what does flexibility mean?
DR. WILLIAMSON: Okay.
CHAIRMAN JACKSON: Then I'm going to defer to
Commissioner Dicus.
DR. WILLIAMSON: All right. Okay.
Well, I will -- our suggestion is to go to some
type of a system that's more of an overall score-card, like
an accreditation process of each practice, that that should
. 46
be the enforcement mechanism, rather than punishment related
to detailed infractions of prescriptive regulations or even
detailed -- even individual treatment errors, there should
be a credentialing or accreditation process to which each
practice is subjected to periodically, and I think it would
be helpful if we had slide 17.
CHAIRMAN JACKSON: Let me let Commissioner Dicus -
- I think she had a question.
DR. WILLIAMSON: Okay. I'm sorry.
COMMISSIONER DICUS: Let me pursue the enforcement
policy a little bit with you, and I'll be as brief as
possible, just a little bit of discussion.
I think you're going to touch on a couple of
things I'm bringing up, but -- and I am familiar with
accreditation processes from my previous life in the State
of Arkansas, and they have a different goal than perhaps the
regulatory process, and so, we have to be a little careful
there when we try to make these kinds of comparisons, but
one of my theories about enforcement policy is basically, in
a perfect world or a better world, an enforcement policy
should be a very positive process, one that, in effect,
encourages, even promotes better performance, a better way
of doing business, but also has an element of it that will
address the outliers, the 10, 5, 1 percent that you
mentioned that don't -- that fall outside the framework.
. 47
Given that, given some of the things that you're
talking about here and, I think, a couple of things you're
going to go into, what I see missing -- I like the idea of
QI. That's a positive process. You have that, you have
accreditation.
But what is missing, in my view, is the transition
and the metrics to really show how we make a positive
enforcement policy work, and my question, then, to the
advisory committee is, are you prepared to be able to give
us some very definitive advice on how we make that
transition and what those transition steps are?
It's not an easy thing to do, and we have to go
from the words to the reality, and so, I'm asking -- give us
a little bit of feedback on that.
CHAIRMAN JACKSON: Don't everyone speak at once.
[Laughter.]
DR. STITT: We love to give you advice. That's
one thing we're good at, and certainly, that would be --
COMMISSIONER DICUS: I mean something very
definitive.
DR. STITT: That would be part of our continuing
discussions as a committee. We have tremendous work that
has to be done, and I think what we need is what you're
saying.
You're telling us what you would like to hear from
. 48
us, and so, that -- what we're putting forth here are some
ideas, and you're responding back, and I don't happen to
have a list in my pocket, but certainly we can move toward
that.
DR. WILLIAMSON: I'll try to give some examples as
I go through my last slide.
CHAIRMAN JACKSON: Commissioner McGaffigan.
COMMISSIONER McGAFFIGAN: I want to go back --
actually, this may help, it may not -- to the example you
gave.
Your license at the moment requires you to provide
vendor-supplied training for an HDR unit annually. If we
went performance-based, say, and your license instead said,
you know, in your case, you believe you don't need it at
all, because your unit uses the device.
How does an NRC staffer -- and other units, you
said, might -- you know, that use them infrequently -- might
need it much more frequently.
Do you want us, in writing licenses, instead of to
say annually, to say, in your case, not at all, and in
another case, you know, three times a year, or do you want
us to say you will get vendor-supplied training on an
adequate basis in your clinical judgement, and then how do
we enforce against --
One exercise you might go through in terms of
. 49
bringing this down to details is each of you look at your
licenses and tell us what -- tell Don Cool what your license
really should look like and what -- and what it is that --
that he could do, then, to enforce that new license you --
you propose.
But in this particular case, you know -- because
if we start doing it, you know, we'll be into clinical
judgement all the time as to whether adequately, you know,
you took advantage of vendor-supplied training.
DR. WILLIAMSON: Well, you raise a really good
general question. If you're going to get into the swamp and
swim with us, you have to learn to swim with us, I guess.
CHAIRMAN JACKSON: I think what the commissioner
is suggesting is an exercise, which you say you're going to
be taking this up in ensuing meetings, is that, you know, at
some point the rubber has to meet the road.
DR. WILLIAMSON: Yes, exactly.
CHAIRMAN JACKSON: And you could do this exercise,
not a Gdanken experiment, to look at a license and how it
would be --
DR. WILLIAMSON: Yes.
CHAIRMAN JACKSON: -- modified and how it would be
enforced against -- okay -- because if the enforcement is
against a given doctor's judgement as to what is adequate,
then you're basically saying we predicate our regulatory
. 50
action on the judgement of that person to whom -- you know -
- or the institution that hires that person, to whom we're
giving the license, and so, that's an interesting concept.
DR. WILLIAMSON: Okay.
CHAIRMAN JACKSON: So, I think it's more than a
Gdanken experiment that he's talking about.
So, why don't we move along?
DR. WILLIAMSON: Okay. Okay.
Now, the -- could I have the next slide, please,
the next one?
[Slide.]
DR. WILLIAMSON: Well, to continue -- and maybe
this is a really good example -- I think, to have a
accreditation-based system, you first have to decide what
the end points of it are, what indicators are going to be
looked at, what sorts of things is this process going to
attempt to see that are available in every practice.
As a mechanism, I would suggest close
collaboration with the professional organizations that are
in the business of attempting to set and codify voluntary
standards of practice.
I think the practices that have to be developed
maybe fall into three categories.
I think that there are safety standards for --
similar to -- perhaps qualitatively similar to those in the
. 51
present regulations for handling and storing and
inventorying sources and so on, designed to promote safety
of staff and public.
There are essential resources that must be
available for any staff or practice to be up to standards.
These include not only equipment, such as quality assurance
equipment, but appropriately-trained and credentialed staff
for handling the kinds of procedures that are done.
This is sort of the really sticky end point, which
is these specific quality improvement elements, which are
agreed upon are appropriate to be in a accreditation-based
regulatory system -- I guess we'd take Commissioner
McGaffigan's example -- probably a good end point it would
be reasonable to consider would be there has to be some sort
of a program which is deemed adequate for ensuring the
competency of all staff members using critical treatment
delivery equipment -- the treatment planning system, the
treatment delivery unit -- and how do you compensate in your
individual practice if you have only a few procedures each
year to ensure that you maintain competence in that?
The site visit would be, basically, is that a good
answer?
Do professionals in the field agree that this is a
reasonable approach that this institution has put together
in order to assure a minimum -- minimal state of competence
. 52
in using the devices which are essential to doing treatment
accurately.
So, this is kind of the example.
If I could go to the next slide.
[Slide.]
DR. WILLIAMSON: It's qualitative. It relies on
the judgement of some kind of a team -- outside team of
experts that comes and visits each institution.
So, this is what this slide attempts to do, is
inspections would function like an accreditation site visit.
It might helpful to incorporate some clinical professionals
as outside reviewers in this periodic process.
Next slide, please.
[Slide.]
DR. WILLIAMSON: I think it would be helpful to
study other models of accreditation.
There's the American College of Radiology
Accreditation program, which is functioning for radiation
oncology.
There's the Mammography Quality Standards Act,
which functions somewhat as sort of score-card of overall
institutional performance in providing mammography services
and, at least ideally, doesn't hit on people for isolated
infractions but, you know, presumably, is designed to bring
that group of outliers, that 10 or 15 percent, try to
. 53
encourage them to stay closer to the mean.
It looks at the end point being, you know, overall
conformance with the appropriate quality improvement
standards.
I think maybe calibrating this process against a
random sample of institutions might be a good way to garner
experience and decide the details of where cutoffs should
be.
Thank you.
DR. STITT: Dennis Swanson will continue.
MR. SWANSON: Yes. I've been asked to address
misadministration medical event reporting.
Next slide, please.
[Slide.]
MR. SWANSON: At the outset, let me state that the
commissioners did ask the ACMUI to provide input on the use
of terminology "misadministration" versus "medical event,"
and you'll see that this slide has listed "isotope event."
The ACMUI has not come to any agreement on what
terminology should be used, and certainly, "isotope event"
is not the final ACMUI terminology.
My personal thoughts on it is that the actual
terminology used is probably not nearly as important as the
mechanism by which we go about doing event reporting. So,
I'm just going to refer to these as events at this point in
. 54
time.
The ACMUI has come to some agreement, though, on
key points related to event reporting.
The first of these is that there is a need to
dissociate the reporting of isolated events from actual or
perceived punitive actions, and we feel that one mechanism
to approach this -- and I'll come back to this a little bit
later on -- is to address reporting at a local level, for
example, have regulations that require reporting to the RSO
or to the licensee rather than reporting on a national
level.
That will take some of the perception of punitive
action away from it, I think.
CHAIRMAN JACKSON: Let me ask you a question about
that.
MR. SWANSON: Sure.
CHAIRMAN JACKSON: With this focus at the local
rather than the NRC level, then to whom should an NRC
licensee report, and how will the NRC be made aware of
events that affect its overall mandate to protect public
health and safety?
MR. SWANSON: Well, certainly, the reporting at
the local level is not necessarily in lieu of a central
reporting program, and I'll come back to that later on.
When the NRC, in the agreement states, conducted
. 55
inspection processes, they certainly have the right to look
at the adverse events reporting at the local level and can
make judgements at that local level as to were these events
appropriately responded to.
They also, I think, would have the opportunity to
identify what are potential problem programs and then, with
the assistance of consultants, can actually make the final
determination of are these or are these not problem
programs.
Reporting at the local level -- I mean you still
have your inspection processes in place -- doesn't preclude
the NRC from ascertaining that that process is taking place.
I'll come back to central reporting program in my
next slide.
CHAIRMAN JACKSON: I'm also interested in how the
NRC would be made available of events that have generic
implications.
MR. SWANSON: Let me come back to that one in the
central reporting program, which is in the slide down the
road here, okay?
Other key points.
There's certainly a need to dissociate the
reporting of events from the patient notification
requirements. This gets a little bit into the quality
management rule.
. 56
As Dr. Stitt said earlier, while the ACMUI
recognizes the concerns related to patient notification,
patient notification falls into practice of medicine, and
really, I think this is beginning to intrude into the
practice of medicine.
COMMISSIONER McGAFFIGAN: So, you would have no
requirements on patient notification?
MR. SWANSON: Patient notification is taking place
at the institutional level. It's part of the patient-
physician interaction.
I think that that's an area that the NRC has
gotten itself in particular trouble with with the quality
management rule in general, if you read the comments of the
community.
Third point. There is a need to simplify and
harmonize the definitions of isotope events. The current
definitions of events, medical misadministration events, are
far too complex, far too confusing.
I as a practitioner, when I'm giving presentations
on this or discussing this, I have to go back and review the
rules every time.
They're very complex definitions, far too complex,
and I would personally feel that many of the violations of
the quality management rule that have been documented are
probably due to just simply the complexity and the confusion
. 57
surrounding the definitions.
There is also a need to harmonize the definition.
Another factor contributing to the complexity is the
difference between state definitions and NRC definitions.
I come from Pennsylvania, which is an NRC state.
Our state regulations governing accelerator-produced
materials have a totally different set of definitions for
misadministrations.
It's already confusing to begin with, and then add
a different set of confusion on top of it, it's almost
unwieldy to deal with.
Also, when we're talking about harmonization, I
think you need to look at, you know, how does the rest of
medicine define misadministration medical event reporting,
and it's something that we need to take a look at as we
evolve these definitions.
Next slide, please.
[Slide.]
MR. SWANSON: As a possible approach in defining
the definitions, a couple of points that we need to consider
-- if technical data is desired, if that's what we're going
after, then we need to define the technical criteria
independent of clinical effects.
If what we're trying to go after are patient
sequelae data, then we need to define our terminology in
. 58
terms of clinical findings and come to some decision on
that.
Next slide, please.
[Slide.]
MR. SWANSON: Some possible approaches to this --
as I mentioned earlier, I think we need to look at the
development of a performance-based regulation that addresses
reporting at the local level, required reporting to the
licensee, to the RSOs.
As I said earlier, I still think that this will
allow the NRC in agreement states to review medical event
reports, the fact that they're taking place. It will allow
the NRC and agreement states to identify potentially problem
programs.
With regard to centralized reporting, I think --
it's a personal comment; I don't think the ACMUI has come to
total agreement on this -- I think there is a need for
centralized reporting of misadministration, because if we're
ever going to be looking for trends or causes of these
events, we need more data that what we'd see at a given
institution.
This has actually been a problem with event
reporting in medicine in general, is that this information
has tended to remain sequestered within the individual
institutions, and thereby, the word doesn't get out, and
. 59
people aren't aware of problems that other institutions are
having.
CHAIRMAN JACKSON: I just wish to point out that,
you know, in addition to what you just said -- you were
talking a minute ago about harmonizing the definitions of
"isotope event" and you talked about the difficulties within
a statement between what the agreement state program
required versus -- you know, for what it covers versus NRC,
but yet, you know, you stress, you know, having local
reporting, and you know, is that an oxymoron, that somehow
you want harmonization and consistent definitions and so
forth, but you want very tailored ways, localized ways of
reporting events.
I mean it seems to me that, therein, you offer the
opportunity for different definitions to propagate into the
mix.
MR. SWANSON: Well, I think what I'm talking about
about simplification and harmonization of the definitions -
- there probably needs to be somewhere within the new
regulations a simplified definition of events with reporting
at the local level based upon those regulatory definitions.
At least that's my perception of how -- my personal
perception of how that would happen.
I don't think it would be wise to allow each
institution to define its own definitions of
. 60
misadministrations or events, because then you would end up
with the scenario that you're describing, a very mixed bag
of reporting.
CHAIRMAN JACKSON: I think Commissioner McGaffigan
has a comment.
COMMISSIONER McGAFFIGAN: I'll just tell you that
the word "voluntary" under voluntary central reporting --
I'm not sure I even buy the notion that you wouldn't -- the
reporting at the local level, but voluntary central
reporting just strikes me that we're going to end up --
people with good records may voluntarily share their --
share their data, and people with bad records can
voluntarily not share their data, and you just said the
medical community as a whole has had a problem, not just in
this area, knowing what's going on, you don't have good
databases.
Are your insurance companies sort of forcing non-
voluntary reporting and better databases for their own uses
to decide what insurance rates to charge you, or how does
all that work?
MR. SWANSON: Well, first of all, I haven't gotten
to that yet, and I think the introduction to that will
probably address some of your concerns.
I think that, when it comes to centralized
reporting, one of the things that's missing now is that
. 61
there has to be a clearly defined purpose for the central
reporting of medical events, and you know, I might be so
radical as to suggest that that purpose may be a cooperative
effort of the medical community and the NRC to identify
possible causes of events and to document their prevalence.
That ought to be the approach that we're taking if we're
working together on this.
COMMISSIONER McGAFFIGAN: Right.
MR. SWANSON: Okay? That's not happening. Right
now, it's viewed as punitive -- okay? -- and it's based upon
isolated events. You have a requirement for reporting only
high-consequence events. You've collected minimal amounts
of data. It's absolutely serving no purpose, period.
Now, I'm all for central reporting personally --
and I'm speaking personally -- if that's the purpose of the
central reporting. I'm 100-percent in favor of it. Okay?
To get to that, though, you've got to take the
punitive -- the perceived punitive actions out of this, and
that means it needs to be a voluntary, anonymous reporting
system, and I can give you some models that work very well.
You can look at the pilot event reporting of the
Federal aviation people, the FAA. It works very nicely.
It's a voluntary, anonymous reporting system.
If you want to know what happens in traditional
medicine now, there's a voluntary reporting system. It's
. 62
called the Medical Errors Reporting Program, takes place
through the United States Pharmacopeia Convention,
Incorporated.
It's a voluntary, anonymous reporting program.
The USP is an independent agency. For your information,
it's an agency responsible for setting drug standards and
has been and is the only agency -- it's one of the oldest
agencies in the country.
It's a voluntary, anonymous reporting program for
the central collection of information on medical errors for
the purpose, as I stated, to identify the possible causes of
those errors and to document their prevalence. That's what
we need to get to if we're truly going --
COMMISSIONER McGAFFIGAN: How does this deal with
the 10 to 15 percent or 1 percent -- why would somebody who
is not practicing medicine well submit this information
anonymously? Is this another doctor turning in a doctor who
they think is not --
MR. SWANSON: No. It's a voluntary reporting
program.
Again, you know, I think you're going to have to
seek the endorsement of the professional organizations, the
practice standards to participate in this program, very
important that you get a buy-in of the professional
community in doing it, and I think that's easy to do if you
. 63
have that stated purpose up front.
Let me ask you the question. What makes you think
a regulation is going to make somebody report it? Why do
you think a bad person -- isolate a bad person -- will
report an event just because a regulation requires it?
COMMISSIONER McGAFFIGAN: I suspect that isolated
bad person will get -- I hope get caught and enforced
against, having not done it.
CHAIRMAN JACKSON: And if it affects the license
of the facility, others have a shared interest.
COMMISSIONER McGAFFIGAN: Right.
CHAIRMAN JACKSON: But I don't think we're here to
debate that issue here.
MR. SWANSON: You asked for specific issues and
how you might go about doing this. You can have a
performance-based regulation that basically addresses people
participating in this voluntary reporting program.
Go on to the next slide, please.
[Slide.]
MR. SWANSON: We're talking about philosophies
here, a little bit about ALARA. ALARA started out as a
philosophy and has gradually evolved into a requirement, and
the ACMUI believes that ALARA needs to be a philosophy.
I think here is another area that the NRC can
actually become actively involved in this philosophy.
. 64
At the last meeting we had with the commissioners,
one of the statements I made was I can never understand --
the NRC goes out and sees a lot of these practices and you
report the bad things, but we don't see the good things
reported.
Here is where the NRC could actually become
involved in the ALARA program and letting other people know
good things that are happening out there, as a philosophy.
Next slide, please.
[Slide.]
MR. SWANSON: Quality management program.
As per the commissioner's directive that appears
in the SRM through the NRC medical program staff, the ACMUI
concurs that the useful regulatory end points of the quality
management rule are written treatment prescription, review
of dose calculations, identification of the patient.
We feel that the quality management regulatory end
point should be performance-based and not prescriptive.
I don't care to be cited, for example, if my
physicians initial the written prescription rather than sign
it, doesn't make a whole lot of sense -- okay? -- and
certainly the quality management rule with these end points
should focus on the higher-risk procedures, which they do
not.
DR. STITT: We have two final speakers.
. 65
Dr. Alazraki?
DR. ALAZRAKI: Could I have the next slide,
please?
[Slide.]
DR. ALAZRAKI: I'm going to address the NRC and
medical expertise.
I've been a practicing physician in nuclear
medicine for the past 25, 26 years, and over that period of
time, I've witnessed a very painful and sometimes tumultuous
relationship between the NRC and the medical community.
Many of the problems can be distilled down to a
lack of involvement of the medical community, medical
practitioners, in the regulatory process over the years and
also a mind-set of punitive consequences for transgressions
which are frequently the result of the human element in
practicing medicine, and therefore, the ACMUI encourages an
enhanced level of medical and clinical input into the
regulatory process.
Several years ago, about seven or so years ago,
the NRC initiated the Medical Fellows Program. Currently,
although there are two slots, only one is filled by Dr.
Myron Pollycove, a nuclear medicine physician.
Now, we think it's very important that medical
personnel be incorporated into the rulemaking process at the
NRC level and that the role of the medical fellows perhaps
. 66
be enhanced.
We feel that not only nuclear medicine physicians
but radiation oncology physicians, clinical physicists, and
nuclear pharmacists should all somehow be incorporated as
medical fellows and active in the fundamental process which
NRC is now about to embark upon of the revision of
regulations.
Further, perhaps a jump, but even further, even
though the ACMUI appreciates and is aware that the
commissioners take in account the advice of the ACMUI, the
medical community is probably not going to be truly
satisfied until one of its own, someone involved, who has
been involved in the daily medical decision-making process
and the care of patients, is on the Commission, even though
the activity of the Commission, we understand, only a very
small --
CHAIRMAN JACKSON: On the Commission or on the NRC
staff?
DR. ALAZRAKI: No, on the Commission.
CHAIRMAN JACKSON: Then you should go to the White
House.
[Laughter.]
DR. ALAZRAKI: I'd be very happy to.
But you know, even though the activities of the
Commission, probably only a very small part relate to
. 67
medical issues, what the Commission does greatly affects the
activities in the clinical areas of nuclear medicine and
radiation oncology, particularly, and so, we feel that there
is perhaps an appropriate rationale for that stand.
Could I have the next slide, please?
[Slide.]
COMMISSIONER McGAFFIGAN: Could I ask a question?
CHAIRMAN JACKSON: Please.
COMMISSIONER McGAFFIGAN: On that last slide, the
fellows program, you understand the conflict of interest and
salary problems that we get into in trying to recruit
fellows from your community.
The highest salary I think that can be offered is
$123,000, which oftentimes isn't very attractive, unless
somebody comes in under the inter-governmental personnel
act, which means people working at state university medical
centers or universities, you know, can come in and get paid
whatever they're currently getting paid, but then you still
have conflict-of-interest issues that arise. Have you
thought those through?
DR. ALAZRAKI: This is problematic, we're aware of
that, and every other agency which tries to do the same sort
of thing -- the FDA and at NIH, in particular -- faces those
problems.
There are ways around that or there are ways, I
. 68
think, particularly if you deal with people on sabbatical
leaves, where these things can be dealt with, and we would
encourage that the people who come in under this program be
people who are really actively involved in medical practice
or medical care, and so, they can't be removed for many
years; they have to be current people who really understand
what's going on in the current environment in the medical
community.
The medical program in Part 35, as you're all
aware, the changes are going to be considerable, the
deliberations and discussions and the consensus building,
and the staff is, I think, embarking on a -- or planning to
embark on a program which would involve consensus building
through sessions that they would -- briefings they would
hold around the country and solicit commentary.
However, when they go back to their room to write
the regulations, those are -- somehow become distant and,
therefore, very important that not only the Medical Fellows
Program but perhaps even the ACMUI be involved at the level
of the writing of regulations.
ACMUI will be problematic, we're aware of that,
but I think that we probably would be willing to make some
sacrifices to help as much as we can, time permitting
because of our -- getting harder and harder in the medical
world to find time to do voluntary work such as this because
. 69
of the pressures of reimbursement and the pressures that are
on us.
CHAIRMAN JACKSON: We're doing voluntary work,
too.
[Laughter.]
DR. ALAZRAKI: Okay.
So, encourage active input from the regulated
medical users -- that's what we've been talking about with
the fellows program, with the ACMUI, with the -- also, the
professional societies.
Just as we've been talking -- both Dennis and
Jeffrey were talking in the past about the programs of the
professional societies. They're also volunteers.
But there you have groups who want to contribute
meaningfully in the types of programs that you need to have,
and frankly, I think that's your best way right now, in the
absence of one of you who's really been in the medical
practitional world.
That's your best way of effectively instituting
good programs which will be satisfactory to the users and
also do what you need to do in your regulatory mission.
The Society of Nuclear Medicine, the American
College of Nuclear Physicians, the Radiation Oncology
Groups, and the American College of Radiology all can help
in putting together those types of programs for you, and
. 70
then there will not be the same question of intrusion into
the practice of medicine, and any quality improvement
program can be viewed as an intrusion into the practice of
medicine.
DR. STITT: John Graham is our final speaker, to
summarize.
MR. GRAHAM: On a bright note, we're done with the
slides, so I'll try to keep this brief.
In summary, the Advisory Committee on the Medical
Use of Isotopes concurs with the Nuclear Regulatory
Commission's preliminary position supporting a combination
of two options -- to continue the ongoing program with
improvements, which is option two, and to decrease oversight
of low-risk activities with continued emphasis on high-risk
activities, which was option three.
The advisory committee supports the definition of
risk as presented by the International Commission on
Radiological Protection in Publication 60.
Risk is the product of the probability that an
event occurs and some measure of the potential loss or
consequences associated with that event.
Within the context of this definition and based on
the NRC's documentation of abnormal events and
misadministrations, the actual history of risk from the
medical use of isotopes has been very low.
. 71
Radiation medicine, in a relationship to the
entire practice of medicine, is low risk. The actual
history of low risk has been a result of standards,
policies, and procedures that have been voluntarily
developed by medical practitioners.
The advisory committee believes the most efficient
and effective control of risk will be achieved from working
with the provider community to further refine those
standards, policies, and procedures.
The actual history of low risk also is a result of
a portion of the regulations that have been established by
the Nuclear Regulatory Commission.
There are areas of radiation medicine that need
more surveillance than others for the protection of public
safety. The advisory committee is committed to working with
the NRC to establish these required regulations.
The advisory committee recommends reconsideration
of the Medical Policy Statement of 1979. Every action taken
by the NRC on the medical side and every discussion that we
have at the ACMUI should be influenced and guided by the
Medical Policy Statement.
The advisory committee is encouraged by the
Commission's commitment as stated in the Staff Requirements
Memorandum for the Materials Medical Oversight to support
the use of the ACMUI and professional medical organizations
. 72
and societies in developing regulatory guidelines and
standards.
The ACMUI represents a focused clinical background
and a medical perspective that can support the Commission's
responsibility for the public health and safety.
The ACMUI encourages an increased medical
perspective through addition of a radiation medicine
practitioner to the NRC staff and increased utilization of
medical fellows within all of the practical constraints that
you identified, Commissioner McGaffigan.
Medical representation within the NRC also could
evaluate minor incidents and medically rationalize the
enforcement process to avoid some of the reactionary
response that is so vocally presented at some of the
meetings that we attend.
The advisory committee looks forward to having an
opportunity to work with the commissioners, the staff of the
NRC, medical professionals, and the general public to revise
10 CFR Part 35.
As discussed in the Staff Requirements Memorandum
for Materials Medical Oversight, we agree that revision of
Part 35 should emphasize high-risk activities, which was
item one in the summary of that memorandum.
We support the development of performance-based
initiatives for activities where failure to meet the
. 73
performance criteria results in tolerable conditions for
which appropriate corrective action will be taken in
referenced items two, three, and four of that memorandum.
We support revision of Part 35 to safely introduce
new treatment modalities to the American public as quickly
as possible while considering the public safety, which was
listed in item five.
We recommend that the Quality Management Program
should be revised or revoked as a rule since we have not
efficacy from the program.
We recommend an emphasis on quality improvement of
the processes in the systems, with prescriptive regulations
only applied when absolutely necessary, in addressing item
six.
We concur with the concept of collaborating with
professional organizations to develop practice standards
within Part 35. We want to emphasize the role of training
and experience in referencing available industrial guidance
and standards, as stated in item seven.
We support the concept of a rulemaking process
that creates more opportunity for input from potentially
affected parties but that is more efficient for timely
completion of the process, as outlined in item number eight.
In conclusion, the ACMUI is prepared to work with
the Commission and the staff of the NRC to review 10 CFR
. 74
Part 35.
You have deliberated on this issue for a few
years. There has been a strategic assessment initiative,
public comments, the IOM report, and recommendations from
the ACMUI.
We believe that, with open communication and
feedback from the Commission and staff, the ACMUI can
contribute to the public safety and improve the environment
for the practice of radiation medicine.
CHAIRMAN JACKSON: Thank you.
DR. STITT: I just wanted to thank my committee,
who has put in all sorts of time, late at night, during
weekends, and to a man and woman, every single individual
has contributed.
So, thank you very much for everything that you
have done.
And thank you, the commissioners, for the
opportunity for us to be here today.
CHAIRMAN JACKSON: Dr. Cool, I have one question
for you. Do you have a patients' rights advocate on the
committee?
DR. COOL: Yes, there is, at this time, a
patients' rights advocate. Ms. Judith Brown was not able to
be in attendance today.
That is one of the positions which will be coming
. 75
open come this October. Ms. Brown will have been on the
committee for six years, which is the maximum length, and
that is one of the positions which has currently been
advertised in the Federal Register for replacement.
CHAIRMAN JACKSON: Okay.
Any final comments?
Commissioner Rogers?
COMMISSIONER ROGERS: Yes. There's two points
that -- I don't know how far we can get into them today, but
I'm just going to raise them with you.
The first is, how is NRC to determine when an
isolated event is truly an isolated event? That's a matter
of concern to us.
You have emphasized very much in your presentation
that there's been too much focus on isolated events.
That's probably true, but how, from the standpoint
of a -- of responsible stewardship point of view, is NRC to
be able to determine objectively or find out on some
objective basis when an isolated event is truly an isolated
event and not evidence of something broader?
The second one is really the question that's
somewhat connected to this, and that is, should there be a
threshold for required corrective actions?
In reading your -- looking over your slide
material and trying to understand, you know, what you were
. 76
thinking about, it seemed to me that basically you were
rejecting the idea that there should be a threshold for any
kind of required corrective actions, and I think that's a
very fundamental point that somehow is going to have to get
thrashed out, because if there is no threshold, then I think
-- and a well-defined threshold for required corrective
actions -- how do you deal with the situation which is
really -- has a significant root cause that just never gets
dealt with?
So, those are the two points which I'd like to
throw out at you. I don't expect answers right now, but it
does seem to me that these are points that you really have
to think about, because they're very fundamental to the
whole thing.
The other point I'll just touch on, and that is
terminology. I would ask you and the NRC staff to try to be
as clear as possible on terminology.
When you talk about quality assurance in your
slides, you're really talking about what we would call
quality control, not quality assurance, and I know that
these terms sound and seem as if they mean the same thing.
To us, they do not mean the same thing. There's a
significant difference between quality control and quality
assurance.
In brief, quality assurance relates to the
. 77
demonstration that you have done everything that is
reasonable, when challenged, after you've, in fact, done the
right thing, and quality control relates to the processes
that lead you to determine what is the right thing to do.
So, there's a distinct difference there, and when
you talk about quality assurance and we talk about quality
assurance, maybe we ought to make sure we are talking about
the same thing, because you know, it's very, very easy to
carry on endless discussions and debates when, in fact, you
mean something different by the same words.
So, I would just simply point out to you that
there may be a little problem here of terminology and an
understanding of what we mean when we're talking about
quality assurance. Certainly, in the reactor area, it's
very clearly different from what you've outlined here as QA.
So, I would just say, try to make sure that
terminology is not an impediment to -- a misinterpretation
of terminology is not an impediment to progress.
CHAIRMAN JACKSON: Commissioner Dicus.
COMMISSIONER DICUS: I have a question just for
information purposes.
To your knowledge -- and it's on patient
notification -- is our rule on patient notification, to your
knowledge, the only rule related to medicine by a Federal
agency or a state agency or government or law, for that
. 78
matter, requiring patient notification? Does anyone know?
DR. STITT: I'll answer for myself. To my
knowledge, that is correct.
I think that some of the basic problems are those
of communications. The QA would be a standard medical
process, and we're not reactor people, and I think that's
why there is a lot of difficulty in trying to communicate.
If an individual received the wrong medication,
the standard process of dealing with that is formal, it's
institutional, it's written, but there's no Federal
regulation that requires you to write a letter to the
patient.
The patient has to be discussed. You have to fill
out the appropriate hospital form. It's reviewed by the QA
committee and becomes part of the hospital or clinic's
annual report in that particular area.
CHAIRMAN JACKSON: But it doesn't necessarily
trigger an automatic notification of the patient.
DR. STITT: No. The patients may have that
discussed, but there's nothing that's in the form of --
CHAIRMAN JACKSON: It may or it may not be
discussed.
COMMISSIONER McGAFFIGAN: Is this true for the
mammography act? I thought that, in the mammography act,
there was some requirement for patient notification.
. 79
DR. STITT: That's the notification of results of
the mammograms.
CHAIRMAN JACKSON: Commissioner Diaz.
COMMISSIONER DIAZ: I personally agree that, you
know, we need to look at this on a risk basis. I think we
realize that the low risk -- it should be relatively clear.
I do have a concern when we're talking about
assessments of risk and trying to make assessments of risk
in nuclear medicine comparable to other areas in medicine.
Although it was a long time ago, I did work for
hospitals and I did perform as a physicist, and I saw so
many differences between these places that I've always kept
the concern that what we are trying to do is to minimize the
risk to the public. I'm sure you want to do the same thing.
However, to compare to the risk in medicine -- I
have a serious concern that that is probably not definable,
because there are many procedures in medicine that are very
high-risk, and we certainly don't want to elevate the risk
from nuclear medicine, especially diagnostics, although, you
know, therapeutical procedures are different, to some of the
same kind of risk that are associated with some of the
medical procedures, and I'm a little bit concerned that
we're trying to say we are taking this risk field in nuclear
medicine and comparing it to other fields in medicine, and I
don't think that that will fly very far. I'm sorry.
. 80
I see that as a distinct, you know, for me, a
philosophical difference. I would like to keep them in a
playing field that is more quantitative, because we have a
way of quantifying it and maintain it in a more controllable
manner than many other processes in medicine.
CHAIRMAN JACKSON: Commissioner McGaffigan.
COMMISSIONER McGAFFIGAN: I'd again like to ask a
point of information.
The rule on patient notification says that you
have to notify the patient unless the referring physician
personally informs the licensee either that he will inform
the individual or that, based on medical judgement, telling
the individual would be harmful.
Does that occur, where people use clinical
judgement and say no, we won't, and is that enough of an
effort to allow clinical judgement to get into the
notification process?
DR. STITT: Yes, it does occur where clinicians
make a decision.
DR. FLYNN: I've had a number of instances,
looking at about 50 or 60 misadministrations as a medical
consultant for the NRC, whereby the radiation oncologist
notifies the referring physician, the referring physician
says I don't want my patient notified.
The referring physician has no idea what NRC
. 81
regulations are. They have no idea.
And oftentimes, then, the radiation oncologist
reminds the referring physician that they have this
regulation, and then it may be that the patient is -- harm
won't be brought to the patient, but the patient may be
elderly, and whatever you tell them in the nursing home
would be confusing to them, you tell their next of kin that
some minor event occurred, and some of the referring
physicians believe it brings on a psychosis and a radiation
phobia, a psychosis of some minor event that they're
required to report.
So, it comes into problems with how do you deal
with the referring physician if the referring physician is
adamant about the patient not knowing.
So, there's some --
CHAIRMAN JACKSON: It strikes me that the
regulation has that escape hatch.
DR. WILLIAMSON: It does not have that escape
hatch.
We had a case where a 10th of a centigrade was
given to the wrong site because of a minor machine
malfunction, which, since there's no lower threshold for
wrong site, this minor technical error was required to be
reported to the patient.
The physician and referring physician did not want
. 82
to report it to the physician and we had extensive
discussions with your general counsel, and we were forced to
report it, to sort of pick out one of the patient's
relatives or friends.
So, as the law reads now, you have to report it to
somebody.
If you, on medical judgement, decline to report it
to the patient, you must then put yourself in the position,
as physician, of violating the patient's confidentiality and
sort of picking out some friend, associate, or relative. I
think the word in the law is "guardian," but it's very
broadly interpreted.
COMMISSIONER McGAFFIGAN: This gets down to my
earlier point. I think you all have to deal with the words
in the regulations and your words in your licenses, and we
have to get beyond philosophy in the next year --
CHAIRMAN JACKSON: That's right.
COMMISSIONER McGAFFIGAN: -- to rulemaking, and I
appreciate the last speaker's commitment to do that, but
that's --
CHAIRMAN JACKSON: That's where the rubber meets
the road.
COMMISSIONER McGAFFIGAN: -- where the rubber
meets the road, right.
CHAIRMAN JACKSON: And on that note, I'd like to
. 83
thank each member of the committee for today's briefing.
It's clear that you've devoted many long hours of
thought and consideration to this matter, obviously, in and
out of the committee meetings.
And the issue of NRC's regulatory role in the
medical use of by-product material is not a simple or a
trivial one, and the Commission didn't arrive at its recent
decision lightly on this matter.
And the advisory committee's views will be of
tremendous benefit to the Commission and the staff as we
work to revise the program.
And we'll, of course, always give serious
consideration to the views expressed here today, as the
staff reviews the program -- its program for completing the
revision of 10 CFR Part 35.
And building on what Commissioner McGaffigan said,
the Commission would appreciate a more direct and focused
look at possible revisions to 10 CFR Part 35, including test
cases -- I mean you can take any suggestion or think of your
own -- in order to advance the decision-making on this
issue.
And as you do that, it's important to address a
number of the questions that you've heard put to you today
by the Commission, because it's what we are thinking about,
and it's going to inform our decision-making.
. 84
And so, those two elements of giving a more direct
and focused look at possible revisions to Part 35 and, in
the process, addressing the questions or types of questions
that you have heard put to you today are how you can be of
the best help to us as we review the staff's activities on
revising Part 35, because that's where we're going.
We're a regulatory agency, and we're focusing on
that, and so, unless there are further comments, we're
adjourned.
Thank you.
[Whereupon, at 10:51 a.m., the meeting was
adjourned.]

				Search Options
Index \| Site Map \| FAQ \| Facility Info \| Reading Rm \| New \| Help \| Glossary \| Contact Us