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Evaluation of NRC
Forwarded-from: MIKEG
1. Regarding number 3 only (the Nuclear Medicine Community has had
very high levels of heartburn regarding the QA rules in general, Carol
Marcus at UCLA has been the spokesperson on this issue in the past),
there had been some speculation even before John Villforth retired
from the FDA (CDRH fomer BRH) and Bob Alexander retired from the
NRC (Code 8, Occupational Health) that the machine generated sources
under 21CFR (also includes non-ionizing sources as was noted in
this forum a week or so ago) might move under the NRC umbrella. This
concept was to improve the "efficiency" and "consistancy" in applications
of Standards for Radiation Protection for byproduct and machine sources
of radiation.
2. It seems to me that the concept is still alive and may be building
momentum thanks to the human experimentation issue. That does not
mean that a super-agency couldn't happen that would combine all the old
FRC radiation protection regulatory issues presently handled by FDA,
EPA and NRC. Of course, Agreement States such as California already
are doing this by combining machine sources regulation in one branch
and byproduct material in another branch of the State Department of
Radiological Health (which use common dose limits from Title 17 of
the California Code of Regulations).
3. The other issues are particularly important to medical physicists
and medical institution RSOs (the RSO usually gets to monitor the
adequacy of the enormous increase in documentation that the QA rules
entail). But the Journal of Nuclear Medicine (SNM Newsline) has had
a lot of discussion on this over the last few years and the arguments
don't seem to have changed a great deal. I look forward to animated
discussion!
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The opions expressed above are | The opinions above also do not
those of the author alone and do | represent those of US Department
not represent those of the | of Defense, Defense Nuclear
Stanford University or the US | Agency, US Navy, Metropolitan
Department of Energy. | Edison, Porter Consultants, etc.
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From: charles a kelsey <ckel@unm.edu>
To: Multiple recipients of list <radsafe@romulus.ehs.uiuc.edu>
Subject: Evaluation of NRC
X-Listserver-Version: 6.0 -- UNIX ListServer by Anastasios Kotsikonas
X-Comment: Radiation Safety Distribution List
Help!
I am the AAPM liaison to the Institute of Medicine Review and
Evaluation of the Medical Use Program of the Nuclear Regulatory
Commission and am asking the Medical Physics community for help.
NOTE THAT QUESTION NUMBER THREE ASKS IF YOU WANT A SUPER FEDERAL
RADIATION AGENCY!
The IOM wants answers and comments to and on the following
questions:
1. Does the current regulatory structure provide adequate
safeguards to protect the public health and safety? If not how
could things be changed?
2a. How does the current regulatory framework (as it applies to
ionizing radiation in medicine) affect the practice of medicine?
2b. What is your opinion of the revised quality management rule
for misadministrations and the new reporting requirements?
How would you change it?
What suggestions would you make regarding tracking/preventing
misadministrations?
Are the NRC's definitions of misadministrations on target?
3. Under the Atomic Energy Act of 1954 as amended the NRC
currently only regulates reactor produced byproduct material. Do
you believe the Atomic Energy Act should be amended to require
uniform regulation of all ionizing radiation used in medicine
under a single Federal agency?
If so, which agency, an existing one (ie NRC, FDA) or a new
one. What role should this agency have vis-a-vis the state?
4 Do you believe that the current regulatory framework pertaining
to the medical uses of ionizing radiation reflects the actual
risks associated with the various diagnostic and therapeutic
applications?
5. Are your patient informed about the potential risks associated
with medical procedures involving ionizing radiation?
If yes, how?
If no, why not?
6. In your experience, has the evolution of radiation protection
standards helped to improve patient safety and welfare? Has it
influenced staff safety and welfare?
7. Who should bear the ultimate responsibility for devising
appropriate quality assurance programs? Professional Associations
such as JCAHO, ACR, AAPM, etc? State Agencies, Federal Agencies?
8. If applicable, what kind of QA program do you have in place?
Upon whose expertise did you rely when devising it? How is it
working?
9 The 1981 Consumer-Patient Radiation Health Safety Act provides
minimum standards by which the Federal Government for the
accreditation of education programs for persons who administer
radiologic procedures and for the certification of such persons.
Do you adhere to these standards? Are they effective?
10 What, if any Federal agency should be responsible for
establishing educations standards for accreditation regarding the
medical use of ionizing radiation? NRC? FDA? Other? How should
the quality of the education programs be judged? What criteria
should be applied?
11. ow are personnel under authorized users supervised/trained in
your facilities? How should they be? How are users trained in
applications of new technology? What kind of ongoing training is
provided? Should re-certification be by test or evidence of
continued education?
12. What are your other concerns regarding the regulation of
ionizing radiation in medicine?
If ever there was a time to influence how the NRC interacts with
Medical and Health Phhysics this is it. Please send me your comments via this
Internet address or directly to me at ckel@unm.edu The
drop dead deadline is Sept 3, 1994.I know this is short notice but I just
learned aabout this BB.