Part 21 Report - 1996-220

 
 

ACCESSION #: 9603050336



Beaumont

William Beaumont Hospital

Royal Oak



                                             November 22, 1995



U. S. Nuclear Regulatory Commission

Region III

Office of Inspection and Compliance

801 Warrenville Road

Lisle, Illinois 60532-4351



SUBJECT: Potential Reportable Item (10 CFR Part 21.21)



A potential reportable item as regulated by 10 CFR Part 21.21,

"Notification of failure to comply or existence of a defect in its

evaluation", was identified on January 16, 1995.  Two I-125 seeds (out of

one batch of 202 seeds) ordered for calibration purposes were assayed on

the wrong dose calibrator setting by the manufacturer.  The

"Certification for Secondary I-125 Seed Standard" for the two "secondary"

seeds listed a calibrated activity that was 38% lower than the actual

activity.  The "Certification of I-125 Sealed Sources for Medical Uses"

for the 200 seeds (intended for patient treatment) was correct.  The

manufacturer was notified of the error, the seeds were returned to the

manufacturer, and two correctly assayed "Secondary I-125 Seed Standards

and Certificates" were sent to us on January 18, 1995.



All records pertaining to our investigation of this incident and the

applicable Calibration Certificates were given to the NRC inspectors, Mr.

Mark Mitchell and Mr. John Jones, during the inspection (October 25-27,

1995).



Although the two incorrectly assayed I-125 seeds were not intended for

medical administration, patient dose calculations were performed.  The

dose to a hypothetical patient was calculated for an ocular implant (I-

125 eye plaque) with and without the two incorrectly assayed I-125 seeds.

These dose calculations were also given to the NRC during the inspection

(dated October 25-27, 1995).



To obtain any other information regarding this incident, please contact

the NRC at 708-829-9500.



Sincerely,



Cheryl Culver Schultz, M.S.

Radiation Safety Officer



CC.  Darlene Fink-Bennett, M.D.

     Larry A.  Randolph

     Alvaro Martinez, M.D.

     Purushottam Sharma, M.S.



3601 West Thirteen Mile Road  Royal Oak, Michigan 48073-6769

(313) 551-5000



          VHA.  Member of Voluntary Hospitals of America, Inc.



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