Event Notification Report for March 14, 2008

FITNESS FOR DUTY REPORT

A non-licensed employee supervisor had a confirmed positive for an illegal substance during a random fitness-for-duty test. The employee's access to the protected areas was suspended. Contact the Headquarters Operations Officer for additional details.

The licensee notified the NRC Resident Inspector and Greg Hansen in Region III.

POSSIBLE MEDICAL EVENT - LEAKING BRACHYTHERAPY SEEDS

"Description: Three patients were scheduled for transperineal permanent prostate seed brachytherapy implantations on March 14, 2008. Three separate packages of seeds in preloaded needles were received; surveys showed no surface contamination or contamination outside the inner sterile containers. On March 14, 2006, after 12 of 106 seeds were implanted in the first patient, a survey meter showed a small amount of radioactive contamination on the inside of the sterile packaging. This implantation was stopped. The survey meter showed contamination on the tips of three of the four needles that had been used, the greatest being 5000 cpm (420 Bq if an efficiency of 20% is assumed). This patient was administered stable iodine to block his thyroid in case of a leaking seed. The seed vendor was notified by telephone.

"To determine if the remaining patients should be implanted, the remaining two packages of seeds were opened and the interiors of the sterile packaging were surveyed. No contamination was found. An implant procedure was performed on the second patient. At the end of the procedure, the used needles were surveyed. A survey meter showed contamination on the tips of two of the needles; it was about 1000 cpm (83 Bq if an efficiency of 20% is assumed) on each. The seed vendor was again notified by telephone. A urine bioassay of this patient showed no radioactivity.

"Implantation of the third patient was cancelled.

"The needles of preloaded seeds were supplied by Best Medical International. The seeds contained I-125 and were Best Model 2301. The three batches of seeds were Lot Numbers 23017, 23019, and 23018 (not implanted).

"At this time, it is uncertain whether any seeds were leaking. A possibility is that the contents of the sterile packages were contaminated by the vendor, but no seeds were leaking.

"Effect on Patients: The VA is still evaluating this event. At this time, no adverse effects to the patients are expected.

"Patient notification: The permittee is in the process of ensuring that the referring physicians and patients were notified.

"We will notify the NRC Project Manager, Cassandra Frasier, of NRC Region III.

A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

AGREEMENT STATE - LEAKING IODINE- 125 PROSTATE SEEDS

"Licensee identified 7 leaking Iodine-125 leftover prostate seeds from two patient doses: 3/11/08, 4 seeds. 3/12/08, 3 seeds. Patients were recalled, but showed no iodine uptake. Licensee phoned [state radiation protection officials]."

Seeds are approximately 0.3 micro Curies each.

Mills Pharmaceuticals (Core oncology-Oklahoma City) manufactures the seed sources. They are then sent to Medtech Diagnostic Services, Ft Meyers, Florida. Medtech loads the seeds into cartridges and sterilizes order. Medtech then sends the loaded cartridges to Carolinas Medical Center.

The state, licensee, and manufacturer are working together to determine where the seeds got damaged, whether at manufacturing, loading, or unloading.

"Incident Number 08-12."

* * * UPDATE FROM GERALD SPATE TO JOE O'HARA AT 1055 ON 3/20/08 * * *

The state called to correct an editorial error on the original report. The seed activity is 0.36 milli Curies vice 0.3 micro Curies.

Notified R1DO(Perry) and FSME(Burgess).