Misadministration and the QMP

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>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>
>
>
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>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
>