Re: Evaluation of NRC

[tdc@ehssun.lbl.gov (Ted M. de Castro)]

I can only comments on SOME of these questions.  Basically this looks like a
"more of the same" of what we have been "ratcheting" up for a while and the
concept that government can fix anything and that training and acceditation
can indicate or prove competence.

These comments are only regarding diagnostic x-ray and reflect my work as a
private consultant in that area.

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

yes

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

Many elements enforce good practice and therefore promote safety and
quality.  Others are governmental attempts to push things into a "one size
fits all" normalization scheme - or for total documentation.  The latter
elements increases cost and paper!


>>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?

No

>>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?

Compared to the regulatory framework of other risks in our lives and in the
industrial environment - ABSOLUTELY NOT.  Radiation risks are treated far
far more conservatively than other risks where the immediate cause and
effect are within the realm of human perception and trivial understanding.

>>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?

Some have - many others just increase cost and paper.

>>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?

NONE OF THE ABOVE!!!  They should review QA programs devised by the user
from the perspective of how it relates to that facility and if the safety
shows it to have been effective.  NOT relative to elements of some
universally devised program.

I would really worry about an agency devised QA program.

BUT supplying "sample programs" and guidelines - or maintaining a library of
good effective programs others have devised (and are willing to share) would
be an EXCELLENT idea ------ just so long as they do NOT become de facto
standards or "essential elements".


>>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?

While I would NEVER suggest that untrained personnel should do this
work - no amount of training can PREVENT errors or make a sloppy lax
person meticulous.

Likewise no amount of testing/credentialing can PROVE that person is
competent.

Indeed these things often focus the attention on the training/testing
system and NOT the profession.  ie.  passing the test IS competence
and therefore training and study is focused only on the test and the
testing environment.


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

In diagnostic radiology - over emphasis on global uniformity and
subjective assessment of radiographs of phantoms, and a de-emphasis of
the underlying physics and mechanics that make the tool a stable
instrument.