NRC evaluation response

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

As promised here is my response to the Institute of Medicine questions 
regarding the NRC.
                                                September 2, 1994



Kate-Louise Gottfried, J.D. M.S.P.H.
Institute of Medicine
2101 Constitution Ave. N.W.
Washington D.C. 20007

Re:  NRC Medical Use Program

Dear Mx. Gottfried;

     Here are my responses to the specific questions addressed in you mailing. I did poll
the 18 members of the AAPM Radiation Protection Committee, talked with more than a
dozen of my colleagues and put a request for comments regarding your questions on Internet
two bulletin boards. These comments include many but not all of the responses I received,
but they are my opinions.

1. Does the current regulatory structure provide adequate
safeguards to protect the public health and safety? If not how
could things be changed?

     Yes, because the regulatory structure is (or has been, before QMP) incidental to
insuring public health and safety. I believe the regulations are not major factor in protecting
the public health and safety. Professional pride, peer pressure and the legal implications of
errors are more important factors than regulations (probably in that order). 


2a. How does the current regulatory framework (as it applies to
ionizing radiation in medicine) affect the practice of medicine?

     Almost none. I believe the current regulatory framework has little or no effect on the
practice of medicine.

2b. What is your opinion of the revised quality management rule
for misadministrations and the new reporting requirements? 

     My opinion, shared by many of the other respondents, is that the problem is not in
the rule, but the way NRC is enforcing it. If there is a misadministration the NRC acts as if
either:
     a) the institution did not follow their existing QMP, or
     b) the QMP was defective because the misadministration occurred.
In either case the NRC usually decides there was a license violation and the institution is
cited and fined.  

     All the management and regulations in the world can not overcome human nature.
The best we can do is develop reasonable programs to reduce misadministrations to an
acceptable level. If you put a new set of tires on your car every month you would reduce the
already small risk of tire failure, but at a cost most would find unacceptable. 
     Some respondents believe the NRC QMP is not necessary and should be eliminated.
They point out that the NRC's ACMUI said the QMP was unnecessary. This is an example
of the way NRC listens to the user community. They don't. This is probably there is a
review and evaluation of the NRC.


   How would you change it?

      I would require NRC to demonstrate willful neglect or malfeasance before they could
level a fine. That is, to try to change the NRC approach from  police-judge to  teacher-
helper. In medicine we're all trying to help the patient, fines and bad publicity don't help
solve the problem.


   What suggestions would you make regarding tracking/preventing
misadministrations?

     I believe all misadventures, even those below the current NRC thresholds should be
reported to the institution's Radiation Control Committee. 


   Are the NRC's definitions of misadministrations on target?
     Yes, although I would suggest that any wrong patient/wrong isotope should/must be
reported to the institution's radiation safety committee and kept as a matter of record. 


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?

     There is merit in having a national, uniform set of regulations and requirements for
radiation use and protection. Today this is effectively in place because the NRC requires
conformity in agreement state regulations. The Suggested State Regulations promulgated by
the CRCPD essentially mirrors the NRC regulations in part 20 and 35. If there is to be
national "super agency" I would NOT recommend the responsibility rest with NRC. They
have too much of a "radiation police" mentality as evidenced by their "find and fine"
approach to violations. Also there is very little medical expertise in the NRC.

     There would be merit in closing one loop-hole in current regulatory framework. At
the present time there is no regulation of non-byproduct material radiation sources in VA
hospitals. That is, neither x-ray machines nor their operators at a VA hospital are under state
or NRC regulation. This problem could be solved by the VA system without setting up a
super agency. 
     On the other hand a single agency would eliminate conflicts in regulations
promulgated by NRC, EPA, FDA, OSHA, and AOFA (Any Other Federal Agencies). This
might reduce the paperwork burden. In my opinion, shared by everyone I communicated
with, life would be worse with a "super NRC".


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?

     Absolutely not! The risks from radiation exposure are extremely small, a few per
million per rem, and the amount of effort expended in reducing this already small risk could
be better spent in other areas of the country's needs. 


5. Are your patient informed about the potential risks associated
with medical procedures involving ionizing radiation?
     If yes, how?
     If no, why not?

     Yes in radiation therapy and in some cases regarding ionic contrast media. No, in
general radiation exposure cases because the hazards from radiation are so small they are not
a concern. At UNMH any discussion of risk with the patient includes obtaining a written
informed consent.

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?

     No, Before about 1960 there were essentially no regulations. Few if any patients were
injured by standard medical practices in use at the time. The primary concern of medical
professionals is the welfare of their patients. This was true before radiation regulations were
in place and would be true even if all regulations about radiation were eliminated. 


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?

     I believe a professional organization such as ACR or AAPM should develop
guidelines for QA programs with oversight of the programs the responsibility of JCAHO. I
do not believe any federal should devise the programs. Federal agencies have a tendency to
require all programs to fit under a single umbrella. The "one size fits all" regulation
mentality is not realistic. Different programs have different characteristics and requirements
for their QA programs.


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?

     We have a continuous QA improvement program patterned on the requirements of
JCAHO. We developed it using our in-house expertise. Most other respondents I talked with
reported the same situation. Their QM/QA programs were developed by the individual
departments because the members of the department have the required expertise. 


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?

I wasn't aware of the provisions of this act regarding accreditation of training programs. I
expect we do adhere to the standards because New Mexico has a law requiring all individuals
administering x-rays to humans to either, a) be a licensed health care professional, or b) be
registered with the state. The latter requirement means the technologists must have passed the
national registry examination. These state requirements are 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?

There is already a complete working mechanism for the review, accreditation and periodic
re-review of education programs for radiologic technologists, and radiation therapists. All
that would be necessary is to require all individuals using ionizing radiation for medical uses
to either be a licensed health care professional or a graduate of an accredited program. I do
not believe a duplicate program should be set up to compete with one which is working quite
well at the present time. 


11. How 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? 

     First and most important; training and accreditation programs can never prove
competence. At the University of New Mexico new users are trained and work under the
supervision of experienced users. All medical users of radiation at UNMH are required to
attend an annual one hour in-service course on radiation protection, radiation biology, and
regulations and to pass a written test in order to be authorized to use radiation on humans.
Everyone, including the Chairman of the Radiology department takes the course and must
pass the test.  The state of California requires training and licensing of individuals using
medical radiation including fluoroscopy. I believe there is a need for a national requirement
similar to California's
     At UNMH new technologies are adopted by one or a few interested users who attend
short courses and seminars to be trained in the application of the technology. These
individuals return to train others interested in using the technology. 

12. What are your other concerns regarding the regulation of
ionizing radiation in medicine?

My primary concern is that we are expending national resources in an effort which over-
regulates radiation. We are attempting to reduce a small risk, while ignoring other more
serious risks. The harm inflicted on patients by radioisotope misadministrations is minuscule
compared to the harm caused by the misadministration of non-radioactive pharmaceuticals. 
If we spent the same amount of money and effort currently expended on overregulation of
radiation to reduce either drunk driving or to improve prenatal maternal care the nation's
health and welfare would be improved.
                       Summary of Comments
                   By Charles A. Kelsey, Ph.D.
                          AAPM Liaison


The risks to human health from radiation in medicine are known and are very small. 

The cost of regulation of radiation in medicine is high and the benefits are low. Radiation in
medicine is over-regulated when the amount of risk to public health is considered. Regulation
cannot eliminate human error. 

The creation, (or assignment of responsibility to) a single agency might simplify paperwork
and reporting requirements but is fraught with possible disadvantages. The primary
disadvantage is that the agency would expand and extend existing regulations thus increasing
the paperwork required from institutions and individuals using medical radiation. 

If a single agency is chosen it should not be the NRC. 

Thank you for allowing me to respond to your questions and comment on your study. 



Charles A. Kelsey, Ph.D. F.A.C.R.

Chair, AAPM Radiation Protection Committee



Assume the usual disclaimer is placed here
Charles A. Kelsey
Radiology Department
University of New Mexico
Albuquerque NM 87111