PNO-I-97-011, on 970214,misadministration Involving Diagnostic Dose of I-131 Occurred.Referring Physician Reportedly Decided Not to Inform Patient,Because of Patient Advanced Age & Medical Condition
| ML20134L764 | |
| Person / Time | |
|---|---|
| Site: | 03008184 |
| Issue date: | 02/18/1997 |
| From: | Dwyer J, Shanbaky M, Tara Weidner NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| PNO-I-97-011, PNO-I-97-11, NUDOCS 9702190274 | |
| Download: ML20134L764 (1) | |
. _ _ _ _ . . _ _ _
. Fsbrucry 18, 1997 1 ,
PREL%, . .Y iKrnnCATION OF synsu OR iTaur=f- OCCUun nCE PNO-I-97-011 1 Thio preliminary notification constitutes EARLY notice of events of POSSIBLE ccfoty or public interest significance. The information is as initially I recoived without verification or evaluation, and is basically all that is j known by Region I staff in King of Prussia, Pennsylvania on this date.
- Facility . Licensee Emeraency Classification i Nonocur Medical Center Notification of Unusual Event Moncoar Medical Center Alert 70 Lincoln Way East Site Area Emergency
- _Jocnotte, Pennsylvania 15644 General Emergency Deckets
- 03008184 License No: 37-14870-01 X Not Applicable i
} Subjects MISADMINISTRATION INVOLVING A DIAGNOSTIC DOSE OF IODINE-131 4 At i3:40 p.m. on February 14, 1997, the licensee notified the NRC j Operations Center that, on February 12, 1997, a misadministration j cccurred at their facility when a patient received an 88 microcurie (uci) j dono of iodine-131 (I-131) and only 12 uCi of I-131 was prescribed. This j cycnt resulted in a misa& ministration because: (1) it involved the
- caministration of a radiopharmaceutical dosage of greater than 30 uCi of
] codium iodide I-131; (2) the administered dosage differed from the
{ proceribed dosage by more than 20 percent of the prescribed dosage; and i (3) the difference between the administered dosage and the prescribed i doccge exceeded 30 uCi.
l Tha licensee reported that their staff technologist ordered a 12 uci dose of I-131 from a commercial radiopharmacy on February 11 but that on February 12, the radiopharmacy delivered an 88 uCi dose. The licensee ctated that the 88 uCi dose was properly labeled by the radiopharmacy and wac assayed in the dose calibrator by a temporary technologist prior to
! patient administration, but that the temporary technologist did not 1 quzotion the lack of a written directive for a dose exceeding 30 uCi of
- codium iodide I-131. The licensee said that no written directive was-
! prepared by the physician because their Quality Management Program and l NRC regulations do not require a written directive when the prescribed j dodege of sodium iodide I-131 is less than 30 uCi. The misadministration j w o identified by the staff technologist on February 14, 1997, t
Tho licensee stated that the patient's referring physician was informed s of the misadministration by the prescribing physician. The referring
[ physician reportedly decided not to inform the patient because of the
- pnticut's advanced age and medical condition. The licensee will submit a rcport of misadministration to NRC within the required 15 days. Region I will perform a special inspection to review the misadministration.
. Tha Commonwealth of Pennsylvania has been notified. The Region I Office j of Public Affairs is prepared to respond to media inquiries.
Thio information is current as of 10:00 a.m. on February 18, 1997.
i Centcct: Tara Weidner James P. Dwyer Mohamed Shanbaky
, (610)337-5272 (610)337-5309 (610)337-5209
)
I 9702190274 970218 1 1 PDR 1h2 \
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