RE: Medical Misadministration

["Vernig, Peter G." <Peter.Vernig@med.va.gov>]

Barbara and Radsafe,

While a misadministration is not automatically a citation, 
IMO you have about as much chance of evading a citation as you do if you are
pulled over for doing 75 on a 55 stretch of road.  And the NRC has the habit
of multiple citing.  That is you get cited for the misadmin., you get cited
for failure to properly train the person who caused the misadmin. [almost
any citation can be doubled by a failure to properly train], and you may get
cited for allowing a dose to the public [when the wrong patient gets a dose
s/he is public] to exceed 100 mrem/y.  Sometimes the ways of multiplying
things are very creative.  

Please don't get me wrong, I've seen the multiple citation used on a lot of
materials licensees besides medical and I presume it is used in the power
reactor arena too. Generally they are used when there is enforcement action
which is not as certain for a misadministration but is at least very likely.
Generally it is not the fines but the publicity that HURTS and there is
always a press release for enforcement actions.

Anybody out there ever reported a misadministration and not get cited for
it?  The point I was trying to make is the NRC takes misadministrations
SERIOUSLY and they are rarely shrugged off.

The new part 35 proposal renames them "medical events" if the draft
submitted to the commissioners is the same in that respect as the April 30
draft posted on the website.  There was a previous attempt to do something
like that back when I believe the threshold was raised to 20% from 10% and
between 10 and 20% there is something called a "recordable event" that you
need not report but BETTER DOCUMENT ALONG WITH CORRECTIVE ACTION etc.
Anyway the commissioners at that time turned the change down and according
to an NRC rep. they said essentially, "let's call a spade a spade".  Be
interesting to see what they do this time around. But I assure you all
whether it is called a medical event or a misadministration, virtually
everybody takes them seriously and a citation is virtually assured.

BTW for medical types the proposal was supposed to go to the commissioners
this week or even last week.  While not a given, it is probable that an "as
submitted draft will be posted soon after on their web site.

-----Original Message-----
From: BLHamrick@aol.com [mailto:BLHamrick@aol.com]
Sent: Wednesday, August 11, 1999 9:14 AM
To: Multiple recipients of list
Subject: Re: Medical Misadministration


In a message dated 8/11/99 8:05:58 AM Pacific Daylight Time, 
Peter.Vernig@med.va.gov writes:

<< Just like any citation the response requires that the facility say 1] why

it...
 
I think one difference, however, is that the misadministration in and of 
itself is not a violation.  A failure to report it may be a violation if it 
meets the reporting criteria, and there may be citations for failing to 
follow licensed procedures, or (where applicable) the QMP rule, but there is

not a citation for the naked occurrence of the event.

Barbara Hamrick
BLHamrick@aol.com
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