Re: "Violation" Policy for Nuclear Med. and Radiation Oncology

[fegallag@uci.edu (Frank E. Gallagher, III)]

> how many deviations are acceptable in the clinical use
>areas (i.e. nuclear medicine & radiation therapy) before some type
>of "escalated enforcement" (to use an NRC term) is warranted.  Does
>anyone out there have such a policy or any ideas?  We would like to
>hear your opinions.  In return, we would be happy to share our
>policy with anyone interested.

We recently revised our policy for dealing with repeat items of
noncompliance found during routine radiation safety surveys.  The same
policy applies to human uses in medicine as well as biomedical research.  An
earlier version of the policy had been in effect for about 4 years.

We assign points for repeat deficiencies found during consecutive surveys,
with the number of points determined by the number of times the citation has
previously appeared on consecutive reports (e.g., an item of noncompliance
found during 4 surveys in a row would have 3 points {for 3 previous surveys}
assigned on the 4th survey report).  Excessive radiation and/or
contamination not corrected in a timely manner counts for 2 points for each
consecutive previous survey with the same problem.  The points are summed
for the survey and "enhanced" action is taken as follows:

1-2 points: A special notice is included in the survey report  from the
technician

3-4 points: The RSO or Sr. HP visits the Responsible P.I. (RPI) to discuss
the issues of repeat noncompliance and a warning memo from the RSO or Sr. HP
is sent along with the survey report from the technician

5-6 points: A short suspension of the "permit" (we call them RUA's) is given
and the RPI. is required to send a memo to the Chair of the Radiation Safety
Committee requesting reinstatement of the RUA. The RPI must appear at the
next meeting of the Committee, but the RUA is typically reinstated well
before the meeting.  We have had perhaps a half dozen short suspensions in
the last 4 years.

7+ points: A long suspension of the RUA is given for at least 30 days, and
the RUA is not reinstated until after a discussion with the RPI at a meeting
of the RSC, which may be longer than 30 days.  We have not had any long
suspensions as yet.

By limiting "points" to repeat items of noncompliance, we do not need to
calculate them very often.  We have more problems with labs having a one or
two repeat deficiciencies, than with labs having a lot of "new" deficiencies.
    

Frank E. Gallagher, III, CHP
RSO, Univ. of California, Irvine, 92717-2725
Voice: (714) 824-6904; Fax: (714) 824-8539
E-mail: fegallag@uci.edu