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. *** END OF DOCUMENT ***

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