Re: NRC evaluation

[charles a kelsey <ckel@unm.edu>]

I applologize for not including my name and address in the original 
posting, I'm still new to the information highway and am still learning.
I'm:
	Charles Kelsey
	Radiology Dept
	Univ New Mexico
	Albuquerque NM


I will post my response to the IOM questions under the heading "NRC 
Evaluation"


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 Medicaland Health 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 Physics 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.

Thank for your help and comments

Charles Kelsey