RE: Civil Penalty for Medical Violation

[carol marcus <csmarcus@ucla.edu>]

At 01:02 PM 7/20/00 -0500, you wrote:
>Group and Dr. Marcus,
>
>I share some of Dr. Marcus' concerns, not quite as vigorously.
>
>But did I miss something in the revised Part 35?  While I found it VERY FAR
>FROM PERFECT, most changes seemed to me, to at least be in the right
>direction.
>
>	Some improvements:
>
>ALARA is taken out, as is the Quality Management Program [for non-medical
>types a program for therapy and almost all uses of I-131that requires a lot
>of paper work and annual reviews] well mostly the written program and
>reviews are omitted most of the paper remains.  NRC no longer tells us what
>meters we must have or how to calibrate them.  The ten half life rule is
>also dispensed with.  [Don't worry we still have to survey at background
>before releasing.]
>
>	One thing IMO that was not fixed:	
>
>A doctor qualified as an authorized user of the lowest category [ophthalmic
>use of Sr-90] having as little as 24 hours of training can be appointed as
>RSO while a professional HP either needs a board certification or 200 hours
>of specified training and one year of medical HP experience. 
>
>	Something that could lead to a lot of confusion:
>
>The general training experience scheme which says board certification by an
>approved [by NRC] board that requires the stated amount of training and
>experience to sit the exam.  I expect it to be a problem, as boards staffed
>by volunteers [CHP & NRRPT] may find it difficult or cumbersome to change
>their eligibility requirements and seek approval from the NRC.  The
>mechanics of getting that approval are of course not included in the
>regulation.
>
>I share your disappointment with the NUREG 1556 guidance documents.  They
>have mostly the same rules [and recommendations] as recommendations that we
>have seen for years and years.  I have read the decon action level sections
>in several very carefully.  Alas I haven't read even the medical one
>carefully in detail, although I have reviewed most of it.  I would tend to
>ascribe it more to bureaucratic inertia and one hand not knowing what the
>other was up to with possibly some foot dragging thrown in.
>
>Which brings up a point.  This also speaks perhaps to your comment regarding
>the "secret" regulations of license conditions. 
>
>Guidance documents ARE NOT REGULATION unless we let them be!  You do not
>have to accept NRC guidance when it doesn't make sense.  I contested 4 fix
>it "suggestions" the last time I submitted a license application.  The best
>example was the dosimetry guidance; Monthly badges for all exposed to photon
>radiation and monthly rings for anybody handling photon emitting isotopes
>[PERIOD] no qualifiers of any kind.  Taken to the extreme everybody would
>have badges because of background and virtually everybody would need rings,
>if you start looking at what NORM is around.  [That bizarre guidance existed
>in several Reg Guides but I did not see it in the NUREG on medical use.]  I
>prevailed in all four of my objections, the license reviewer did not even
>try a second time s/he simply issued the license based on my filing without
>comment.
>
>It is extremely valuable to have good guidance documents such as ANSI 13.12
>to provide support when you decide that you do not want to accept NRC
>guidance.
>
>And one trick or tip.  Do not hesitate to copy a model procedure and change
>just a few words or even just one ["and" to "or"] to make it easier to live
>with.  The use of mounds of material which may inhibit close examination can
>work the other way also !-}>
>
>Any opinions expressed are mine alone and do not necessarily represent those
>of the Denver VA Medical Center, The Department of Veterans Affairs, or the
>U.S. Government.
>
>Peter G. Vernig                
>Radiation Safety Officer, VA Medical Center, 1055 Clermont St. Denver, CO
>80220, ATTN; RSO MS 115
>303-399-8020 ext. 2447, peter.vernig@med.va.gov [alternate
>vernig.peter@forum.va.gov] Fax 303-393-5026 [8 - 4:30 MT service] Alternate
>Fax 303-377-5686
>
>"...whatever is true, whatever is noble, whatever is right,, whatever is
>pure, whatever is lovely, whatever is admirable, if anything is found to be
>excellent or praiseworthy, let your mind dwell on these things."    Paul
>
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Dear Peter:

ALARA was taken out because it is already required by Part 20.  We gained
nothing.  The Q/M Rule is still there, and applied to diagnostic as well as
therapeutic.  Other material, like the halflives for decay, are in Part 20
so they were taken out of Part 35 but we still have them.  Don't kid
yourself about the license conditions.  THE NEW LICENSING POLICY MAKES THEM
NON-NEGOTIABLE.  White Flint will send you a license that THEY want to send
you.  If you don't accept it in 30 days, you don't practice nuclear
medicine.  Period.  That is one reason why I am so upset at the "Clandestine
Licensing Manifesto".  The licensing NUREGS are now REGS.

Ciao, Carol

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