Re: Medical ethics-long soap

["Mike Bohan" <mike.bohan@yale.edu>]

        Reply to:   RE>Medical ethics-long soapbox

Hey Ron,

I just want you to know you really opened up a can of worms here!  I'm now
assuming the top position on the Soapbox and all are forewarned that this post
is looooooonnnnngggg!

I assure you that we Medical HP's understand and use TEDE, TODE, CEDE, etc. just
like the Nuc. Power industry, but we use them for "Occupational Exposures"
because the regulations force them down our throats!  

However, patients are not exposed to occupational radiation, they are given
diagnostic or therapeutic doses, which are exempt from these regulatory
practices.  In medicine, we don't do dosimetry to keep some regulatory type
happy, we do it because we must know the "true and real" (as best we can)
biomedical consequenses to each and every organ, of the treatments  given.

The problem with the beginning of this  thread is that everyone is assuming that
Nuc. Med. or X-ray Techs. should know this information and be able to quote it
to patients off the top of their heads.  Some of the better one's may be able to
do this, but most Techs have to really know a lot of other info first, which is
much more important to their daily job requirements, like anatomy, phamacology,
physiology, phelobotomy, imaging sciences, etc.  Some, but again, not all, 
Radiology Doc's also suffer from the same situations and "shortcomings", but
that why they hire guys like me!!! (Oh Boy!, Thank GOD!)  

If people really need to know what their dose was, they should ask for the
physicist.  Unfortunately, most do not know enough to ask for one in the first
place.  Most Techs. also have 3-4 patient scans waiting when these questions are
asked and do not have the time to run into the hot lab and find the package
insert, or consult an x-ray exposure chart to refresh their memories as to the
standard numbers.  They have even less time to explain what the numbers mean. 
Realize that a full service nuclear medicine program performs more than 40
distinct types of NM studies.  A full service radiology department might be
capable of performing 100's of different types of studies.  See how easy it is
to remember the first 40 numbers on your next cash register receipt?

So it's not really a case of ethics after all.  Any diagnostic study commonly
used has had extensive dosimetric studies performed during the initial FDA
approval process.  If you don't believe me, ask Mike Stabin.  The doses are well
known to the Medical community (physics orientated types) and have been shown to
be "safe and effective".  The medical advantages they provide far outweigh the
radiation risks they incurr.  So the medical people "in the trenches" so to
speak, don't worry about them much, they're more concerned in making sure they
perform a good diagnostic study in the first place so your Doc can diagnose and
hopefully provide a cure to you or your loved ones --- Thank GOD or whomever you
choose, again!.

As to the second part of your question, the NRC through the QMP rule ventured
into the "forbidden zone" in medicine.  They made a rule that caused a "Catch
22" problem in medicine and infringed on medical practice, which in their
Memoranda of Understanding they said they would not do!  

--- Here we go on the WAYBACK machine again!---   

Historically, they created the "MISADMINISRTATION RULE" around about the 1970's.
 I was a little wippersnapper Univ/Med HP tech. in those days, so I don't
remember exactly when.  

The rule required that when a mistake which met certain regulatory criteria,
(not based on actual harm to the patient, I might add!) occurred it had to be
reported to the NRC.  I actually liked the rule, because we had to investigate
what went wrong, fix the problem, report all this to the NRC and give a copy of
the report to the patient unless the referring physician (not the one directly
responsible for the goof!) determined it would be damaging to the patient.  The
NRC said that they would collect the info and use it to inform other licensees
what went wrong and what corrective actions were taken so that other medical
licensees could benefit from and hopefully avoid similar experiences.  

This  actually, I believe, was very effective.  In that every time something was
reported, each hospital (At least, mine did!) would check their programs for
similar vulnerability and the patient had a copy of the investigation so that,
if they felt that they were harmed by the incident, they could take it to their
personal lawyer and both could make lots of money with it!  

The NRC would also sometimes come and follow up the hospital's investigation to
see if there was any additional information to be gained, but the rarely used a
misadministration as the basis for a NOV unless standard licensing requirement
violations contributed to the misadministration.  Since there was a cooperative
relationship and punitive actions didn't happen unless the hospital really
deserved it, most medical licensees weren't bothered by the requirements. 
Patient care was improved, communication lines were open and patients could
easily sue if they suffered from medical malpractice.

However, the the NRC made a major mistake.  The deluded themselves into thinking
they could stop every mistake!  Which is a common regulatory problem, when
regulatory agencies make politically pressured promises they can't keep! (e.g. -
Secretary Pena's (sp?) promise that the FAA and the airline industry were not
going to allow airplanes to crash anymore!  HELLO -- ValueJet!)  

They used the misadministration information collected over more that 15 years to
justify the QMP rule.  And then when the Cleveland Plains Dealer article came
out along with the patient death which occurred at Indiana, Pensylvannia, the
NRC hit the medical licensees similarly to Nuc. Power after "THE CHINA SYNDROME"
and "TMI"!  

They quickly passed the QMP rule which was in the proposed stage at the time,
without almost any industry or state support, I might add.  The QMP rule
basically required each hospital to create a program to ensure that mistakes
"COULD NEVER HAPPEN"!  After the rule was in place, whenever a misadministration
was reported, the NRC would send out a "HIT SQUAD" to investigate.  They always
would issue a NOV usually with fines for Severity III or higher violations,
because either the QMP program was deficient (because it allowed the incident to
occur) or you didn't follow your QMP program in the first place! (this is the
"CATCH 22"!).  

While this was bad enough, the NRC couldn't resist playing their hole card ---
namely "PRESS RELEASES".  This really drove the hospitals up the wall!!!   

The one thing hospitals and doctors depend on most is their credibility and
respect within their surrounding communities.   This is because TRUST (Something
regulatory types all too often --- forget!!!, although mostly because of
political pressures --- so don't flame me on this one!) is so important in the
patient/physician relationship.   When the news of a misadministration would hit
the local news media, not only the reputations of the people involved were
trashed, but the institution as a whole suffered greatly.

The additional effect of the QMP rule, lest I forget, was that the Doc's went
crazy trying to find ways to avoid vulnerability to NRC sanctions.  They
modified their prescription practices in many ways that were not always in the
best interest of good medicine.  I won't go into to it, but it really warped the
whole process and they avoided starting anything new or experimental because of
the above mentioned risks and sanctions.

Much to its credit, the medical industry didn't fold under the pressure, they
decided to get even!!!  They hoodwinked the NRC and Congress into ordering an
National Academy of Sciences/Institue of Medicine review of the NRC impact on
medicine.  Of course, since the review committee was heavily composed of
physicians and other medical types they decided the NRC was politically
corrupted and was making more trouble than they were worth.   So they
recommended that the NRC should "GET LOST". (Surprise!!!   Surprise???)  

The IOM committee recommended that medical uses should be transferred to the
states so that they only have to deal with state rather than national political
pressures.  Frankly, I liked it better back when I was a little wippersnapper,
but the NRC "Threw the baby out with the bathwater" and "We can't go home
again".  So we'll see what happens, "It ain't over 'till it's over" and
"Anything can happpen in this crazy mixed up world we live in".  But I will say,
this is great stuff, and you Nuc. Power types need to get one of those ol' NAS
committees going too!

Well, the day is late, my beard has grown long, my feet are hurting from
standing on this damn soapbox for so long and the wife is calling me to COME
HOME! again!

All I've got to say as I step off this soapbox is "John Tolan, you old goat,
where are you when we need you"!!!  You lucky retired old curmugeon (sp?).  I
really miss that guy!  Can't you guys down in Missouri get him a computer and a
net connection so he can join in on this fun!!!???

As usual, all disclaimers apply and if I flamed anyone, Excuseeee ME!,  I just
had to vent my spleen!    

<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><
Michael J. Bohan, RSO   |  e-mail: mike.bohan@yale.edu
Yale-New Haven Hospital |    Tele: (203) 785-2950
Radiological Physics    |     FAX: (203) 737-4252
20 York St. - WWW 204   |    As usual, everything I say may be plausibly
New Haven, CT    06504  |    denied at my employer's convenience ...
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--------------------------------------
Date: 28/06/96 10:43 AM
To: Mike Bohan
From: RONALD GOODWIN
     Michael - we nuc power types do believe you med people have ethics.  We 
     just do not understand why TEDE and CEDE seem to be so foreign.  In 
     recent postings I have seen long and complex debates on dose at point 
     of entry, at target organ, etc. ad nauseum, on radpharm doses.  Now, 
     would the NRC allow a nuc power plant to get into heavy debate on dose 
     to nose, mouth, larynx, esophagus, lung, alveoli (sp?), etc. if one of 
     the nuc workers breathed a millicurie or two?  Nope - give em the dose 
     to the whole body, the lung, and committed fifty year.  Thats what we 
     would have to do.  So, from all I have read lately the question of 
     ethics has never really risen, however, I can not understand the 
     complexity of dose reconstruction that seems to be so difficult for 
     nuke med techs and M.D.s to work out.
     
     Please, enlighten me.  In our work on developing regulations for human uses

     of ram, we (the state of Ohio) find that each dose of radpharm comes with 
     instructions, including doses, or so our nuclear pharmacies tell us, as 
     does 10CFR35.  Yet, I also read the medical family as a whole wants to be 
     de-regulated.  I want to know why?  Is there such a thing as red gammas 
     (nuclear power plant radiation) and green gammas (nuclear medicine) or does

     the nuclear medicine family just have better PR?
     
     Thanks for reading this.  I eagerly await your answer.
     
     Ron Goodwin
     Senior Health Physicist
     and 27 yr. Nuke at NPPs
     Bureau of Radiation Protection
     Ohio