RE: REALLY an NRC EVENT??

["Perrero, Daren" <Perrero@idns.state.il.us>]

In this particular case the licensee has, IMHO, provided information that is
of great value to the regulated community.  Just enough detail has been
provided such that if you are familiar with the source you will recognize
that it is a device used in part of an ongoing clinical trial to determine
the efficacy of intravascular radiation therapy immediately following
angioplasty in a procedure which the FDA has determined to be of
"significant risk".  The notification may be premature, but given its use,
if I was the RSO, I would opt for conservatism as well.

I will say, however, based on my understanding of the device, the
containment safety systems involved should prevent the spread of significant
contamination in the cardiac-cath lab.

Daren Perrero
Health Physicist
perrero@idns.state.il.us



-----Original Message-----
From: dkosloff1 [mailto:dkosloff1@email.msn.com]
Sent: Monday, July 31, 2000 10:40 PM
To: Multiple recipients of list
Subject: Re: REALLY an NRC EVENT??


The licensee determines if their event is required by NRC rules to be
reported.  Licensees may
also decide that they have information, not required to be reported,  that
may be of interest to other licensees.  They may then make a "voluntary" or
"information only" report.  My experience is with power reactors, I do not
have
a CFR with me and there are specific reporting requirements for materials
and SNM licensees.  When making a required report, the applicable CFR
reporting requirement is included.  I did not see any cited requirement in
the report.  A voluntary report is not a report of an NRC event unless the
licensee has made an error and reported a real event with a voluntary
report.    In other words, if a licensee is unsure of an event and tries to
cover itself by making a voluntary report, it doesn't work;  they cannot
comply with the reporting requirements for a real reportable event with a
voluntary report.  For power reactors, that is discussed in NUREG-1022.
Since this was a phone call, technically speaking, it was a "notification"
instead of a "report".

Don Kosloff dkosloff1@email.msn.com
2910 Main St.
Perry OH 44081

----- Original Message -----
From: <ptyree@cisusinc.com>
To: "Multiple recipients of list" <radsafe@romulus.ehs.uiuc.edu>
Sent: Monday, July 31, 2000 2:58 PM
Subject: REALLY an NRC EVENT??


>
>
>
> RADSAFERS - DO YOU KNOW?....
>
> Q:What is the intented purpose of an "INFORMATION ONLY" Event Report?
> Q:Does the following event No.37197 seem to you to serve any useful
purpose?




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