The
Kentucky Radiation Health Branch was notified by the U.S. NRC by email on October 4, 2010 of a possible medical event occurring in the Commonwealth. There was no identification of the licensee involved. After extensive research, the Radiation Health Branch identified the licensee where the alleged medical event occurred. During an inspection of the facility, a review of medical documents identified a medical event involving the therapeutic treatment of prostate cancer with
Pd-103 seeds.
The treatment plan called for 100 Pd-103 seeds with an activity of 1.237 mCi per seed. The pretreatment plan of D90=132.78 Gy. The post treatment plan indicated the prostate received a D90=5.18 Gy. The licensee has not acknowledged a medical event. The patient involved has never been notified by the licensee. He was advised of the misadministration by another physician during a second opinion medical evaluation.
Violations have been issued to the licensee. [An] evaluation [by the state] is ongoing.
- * * UPDATE FROM MICHELE GREENWELL TO JOE O'HARA AT 0841 ON 12/15/10 * * *
The following update was received from the Commonwealth via fax:
The written directive had a prescribed dose for Pd-103, 100 Gy, act/seed 1.6 U, number of seeds 100.
Notified R1DO(Holody) and FSME(Villamar).
- * * UPDATE FROM MICHELE GREENWELL TO MARK ABRAMOVITZ ON 7/1/2011 AT 1353 EDT * * *
The Commonwealth of Kentucky performed an inspection of Our Lady of Bellefonte Hospital on 11/30/2010 and found 35 additional cases of medical misadministration during prostate seed implantation by one doctor. The date of the misadministration occurred from 10/3/2001 to 2/24/2009. No written directive for the dose prescribed or delivered was found for 14 of the cases with the remainder of the cases not having the post implant dose recorded. There was no post CT scan on 17 cases, and D90 doses ranged from 0% to 162% of the prescribed dose. The physician was notified on all of these cases however, none of the patients were notified.
Notified the R1DO (Welling) and FSME (Jackson).
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.