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Re: Misadministration



Mark L. Richard wrote:

>I've never been thoroughly convinced that the
>regulations regarding misadministrations have actually served as much of a
>deterrent as the NRC (and the politicians who many times pressure the NRC)
>would like to think.  It would be interesting to see if the number of
>misadministrations have changed over the course of several years.  Maybe
>such information has been published.  If anyone out there is aware of such a
>report, I'd be interested.

Such a report exists.  It is SECY-97-037 and can be found at 

http://www.nrc.gov/NRC/COMMISSION/scyindex1997.html

In the "Summary/Conclusion" it states
 
....

"There has not been a significant reduction in the total number of reported
misadministrations, the performance indicator most closely linked to this issue.
While the number of reports of diagnostic misadministrations has been
significantly reduced due to changes in the requirements of what must be
reported, the net number of reported therapy misadministrations remains at
approximately 30 to 40 per year.  However, the distribution of errors that led
to misadministrations, per modality, has changed.  For example, strontium-90 eye
applicator events have increased significantly.  An ongoing investigation
involving eye applicators is expected to add at least two more
misadministrations, each involving multiple patients, to the database.

....

"Many of the above errors that led to a misadministration could have been
prevented by:  (1) redundantly checking the data entry and calculations (QM
Objective 3), or (2) immediately before administering the dose or dosage,
comparing that which was to be administered to the written directive (QM
Objective 4).  Thus, with the exception of equipment failures and certain source
migration/dislodgement events, it would appear that more complete adherence to
meeting the objectives in the QM Rule should reduce the likelihood of a
misadministration."

NRC Information Notice 99-11, which can be found at the following site, provides
a review of 5 recent cases involving the use of I-131.  The first two are not
misadministrations, since the licensees were not informed by the patients they
were pregnant.  

http://www.nrc.gov/NRC/GENACT/GC/IN/1999/index.html


I hope that these and comments by Dr. Carol Marcus will help readers understand
some on the problems in administering radionuclides in medicine.  It is a very
complex and changing technical field that requires a lot of human interactions.
Unfortunately, humans make mistakes.  And as problems are addressed, new ones
arise.  The large issue now seems to be with HDR afterloaders.


-- John 

The comments are mine.

John Jacobus, MS
Health Physicist
National Institutes of Health
Radiation Safety Branch, Building 21
21 Wilson Drive, MSC 6780
Bethesda, MD  20892-6780
Phone: 301-496-5774      Fax: 301-496-3544
jjacobus@exchange.nih.gov (W)
jenday@ix.netcom.com (H)
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