ENS 46528
ENS Event | |
|---|---|
06:00 Jan 10, 2011 | |
| Title | Agreement State Report - Numerous Medical Events from Prostate Brachytherapy |
| Event Description | The following was received from the state via fax;
In July 2010, the Wisconsin Department of Health Services (DHS) sent out an Information Notice to all licensees who perform prostate brachytherapy and asked them to perform a comprehensive review of all prostate brachytherapy cases to determine whether any medical events had occurred. On January 10, 2011, the licensee's Radiation Safely Officer reported the identification of five medical events involving permanent implants of I-125 for prostate brachytherapy where the total dose delivered differs from the prescribed dose by 20% or more. The licensee is identifying a medical event of any case where D90<135 Gy or D90>195 Gy for patients who receive seed implants only. [D90 is a recognized value in the regulatory guidelines and means a dose of 90% to the prostate. Anything outside of the D90 value is considered to be a medical event.] The licensee performed a comprehensive review of all 44 prostate implants performed since August 2003. The licensee's five medical events include one overdose to the prostate and four underdoses to the prostate. All were patients who received seed implants only. No medical events were identified involving doses to other organs or tissue above 0.50 Sv and 50% more than the expected dose. The licensee has notified the referring physicians and will not be notifying the affected patients per DHS 157.72(1)(e). Overdoses (medical event criteria used: D90>195 Gy): 11/13/2008: 199.15 Gy Underdoses (medical event criteria used: D90<135 Gy): 2/9/2007: 100.20 Gy; 11/12/2007: 127.34 Gy; 6/16/2008: 130.12 Gy; and 7/13/2010: 116.16 Gy
This is an update to Event Notification 46528. The licensee recently performed post-implant dosimetry on seven prostate brachytherapy patients whose post-implant dosimetry had never been performed. Evaluation of these seven implants prompted the licensee to report two additional medical events. The medical events involved permanent implants of l-125 for prostate brachytherapy where the total dose delivered to the prostate differs from the prescribed dose by 20% or more. The licensee is in the process of notifying the affected patients and referring physicians. Underdoses (medical event criteria used: D90<135 Gy): 8/22/2005: 102.89 Gy; and 5/8/2006: 126.24 Gy; DHS will send a special inspection team to determine the root cause(s) of these medical events. WI Event Report ID No.: WI 110001 Update Notified FSME(Angela McIntire) and R3DO (Richard Skokowski) 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.
This is a second update to Event Notification 46528. The licensee is retracting an overdose previously reported for a patient who received a permanent prostate implant on November 13, 2008. During a reactive inspection conducted on February 18, 2011, DHS inspectors identified that post-implant dosimetry of prostate brachytherapy implants had not been performed appropriately. Specifically, the licensee's former physics consultant generated post-plans that were not based on the number of I-125 seeds actually implanted in the patients. For the patient in question, the original post-plan was based on an implant of 98 seeds; however, only 76 seeds were actually implanted. The licensee's current physicist generated a new post-plan using the correct number of I-125 seeds and observed a corresponding reduction in dose delivered. The new D90 value for this patient does not meet the licensee's medical event criteria. WI Event Report ID No.: WI 110002, 2nd Update Notified FSME(McIntosh) and R3DO (Dickson) |
| Where | |
|---|---|
| Saint Nicholas Hospital Sheboygen, Wisconsin (NRC Region 3) | |
| License number: | 117-1302-01 |
| Organization: | Wisconsin Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+8.48 h0.353 days <br />0.0505 weeks <br />0.0116 months <br />) | |
| Opened: | Chris Timmerman 14:29 Jan 10, 2011 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Mar 1, 2011 |
| 46528 - NRC Website | |
Saint Nicholas Hospital with Agreement State | |
WEEKMONTHYEARENS 465282011-01-10T06:00:00010 January 2011 06:00:00
[Table view]Agreement State Agreement State Report - Numerous Medical Events from Prostate Brachytherapy 2011-01-10T06:00:00 | |