The State provided the following information via email:
On April 21, 2006, the Radioactive Materials Program of Arkansas Department of Health and Human Services was notified by Central Arkansas Radiation Therapy Institute, ARK-654-BP-12-08, located in Little Rock, of a possible misadministration (medical event), which had been identified during the post-implant CT of a prostate implant patient. Based upon the CT scan, the facility determined that the I-125 seeds had been implanted in the incorrect area. The post-implant treatment plan generated on April 24, 2006, indicated that a dose greater than 50 Rem had been delivered to an unintended area of tissue.
The licensee and Department will continue to investigate this event. A final written report regarding this misadministration (medical event) will be submitted within 15 days.
NRC Region IV was notified of the potential misadministration on April 21, 2006.
- * * UPDATE RECEIVED FROM THE STATE (KIM C. WIEBECK) VIA E-MAIL TO JOE O'HARA ON 5/10/06 AT 0938 * * *
As previously reported, on April 21, 2006 CARTI notified Arkansas Department of Health and Human Services of a misadministration (medical event) that occurred during an I-125 prostate seed implant. The final written report was received on May 9, 2006.
The post-implant dosimetry imaging determined that the 84, I-125 seeds with average activity of 0.219 mCi on March 28, 2006, were misplaced approximately 4 cm inferior to their intended position. The post-implant dose calculation determined that a dose of 108 Gy, which was consistent with the prescribed dose, had been delivered to the incorrect area.
Root cause was determined to be two-fold. First was the inability prior to implant to place a Foley catheter to fill the bladder allowing a clear definition of the base of the prostate gland. Second was the human error in clear delineation of the prostate gland and alignment of the template prior to seed implant.
The patient will require further treatment of the prostate gland via re-implantation in order to deliver the appropriate dose. Any effects from the misadministration (medical event) may not manifest immediately and may be difficult to distinguish from the effects of the external beam IMRT treatment that the patient received prior to the March 2006 implant.
The licensee has implemented a new policy for inexperienced urologists that requires placement of the Foley catheter prior to implanting seeds, thus ensuring clear definition of the base of the prostate and the urethra.
Notified R4DO(Powers) &
NMSS EO(Morell)