Re: Misadministration and the QMP

[Frank Bloe <bloe@en.com>]

Were the assay results of the iodine dose not compared against the
intended dose as it was ordered from the supplier?  If not, why not?
If so, why did not the assay of the iodine show the 20% discrepancy from
the information provided with the dose from the supplier?

I think the answer is both 1 and 2.  Just my thoughts.  Regards.
-----------------------------

Chris Alston wrote:
> 
> >Content-Disposition: inline
> >Date:         Fri, 1 May 1998 10:08:27 -1000
> >Reply-To: Medical Physics Mailing List <MEDPHYS@LISTS.WAYNE.EDU>
> >Sender: Medical Physics Listserver <medphys@lists.wayne.edu>
> >From: SCOTT DUBE <SDUBE@QUEENS.ORG>
> >Subject:      Misadministration and the QMP
> >To: Multiple recipients of list MEDPHYS <MEDPHYS@LISTS.WAYNE.EDU>
> >
> >
> >         ** Mail from Medphys Listserver **
> >If you reply to this message, it will be posted on Medphys for all the
> >subscribers to review ...
> >
> >
> >Once again I approach the altar of MEDPHYS in search of sage counsel.
> >Consider the following hypothetical situation:
> >
> >A Nuclear Medicine patient was intended to receive a 29 mCi dose of NaI
> >for hyperthyroidism.  The Authorized User filled out the Written Directive
> >as required.  The Nuclear Medicine Technologist prepared the dose
> >based on this Written Directive.  The patient identity was confirmed by
> >two methods.  The dose was administered as directed.  The Nuclear
> >Medicine Technologist made the Written Record as required.  It was an
> >textbook case.
> >
> >However, unbeknownst to all, the calibration of dose calibrator for that
> >particular isotope on that particular day was erroneous by more than
> >20%.  (It is not important how that occurred.)  Therefore, the event is
> >undeniably a misadministration.
> >
> >Here are my questions:
> >
> >1.   Would this be a violation of 10 CFR 35.32 as a failure of the QMP to
> >assure that byproduct material will be administered as directed by the
> >authorized user because the accuracy requirement of the dose
> >calibrator is implicit in the QMP requirements?
> >
> >2.   Or instead, would this be a violation of 10 CFR 35.50, which
> >addresses the accuracy requirement of the dose calibrator explicitly?
> >
> >All comments are welcome.
> >
> >sdube@queens.org
> >