ENS 46529
ENS Event | |
|---|---|
06:00 Jan 10, 2011 | |
| Title | Agreement State Report - Prostate Brachytherapy Misdosing |
| Event Description | The following information was received from the State of Wisconsin via fax:
On January 10, 2011, the licensee's Radiation Safety Officer reported the identification of ten 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. During a recent routine inspection, Department of Health Services inspectors determined that the licensee was not reviewing prostate brachytherapy cases against medical event criteria. The licensee is identifying as a medical event any case where D90<135 Gy or D90>195 Gy for patients who receive seed implants only, and D90<100 Gy or D90>145 Gy for patients who receive seed implants in conjunction with external beam therapy (combined therapy). The licensee performed a comprehensive review of all 82 prostate implants performed since August 2003. The licensee's ten medical events include six overdoses to the prostate and four underdoses to the prostate. 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). Overdoses (medical event criteria used - D90>195 Gy): 12/23/2003: 204.95 Gy; 10/27/2004: 160.49 Gy {combined therapy, medical event criteria used - D90>145 Gy}; 1/20/2006: 211.23 Gy; 6/14/2006: 207.03 Gy; 9/5/2007: 205.7 Gy; and 10/17/2007: 210.47 Gy. Underdoses (medical event criteria used - D90<135 Gy): 9/26/2003: 123.03 Gy; 10/31/2003: 116.78 Gy; 1/14/2004: 126.73 Gy; and 3/31/2009: 123.74 Gy. DHS will send a special inspection team to determine the root cause(s) of these medical events on February 2, 2011.
This is an update to Event Notification 46529. On January 31, 2011, the licensee retracted one medical event for a prostate brachytherapy patient treated on 3/31/2009 based on refined post-implant dosimetry. Further updates will be made through NMED. DHS will send a special inspection team on February 3 2011. " 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. |
| Where | |
|---|---|
| St. Vincent Hospital Green Bay, Wisconsin (NRC Region 3) | |
| License number: | 009-1303-01 |
| 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: | Pete Snyder |
| Last Updated: | Feb 1, 2011 |
| 46529 - NRC Website | |
St. Vincent Hospital with Agreement State | |
WEEKMONTHYEARENS 469492011-05-15T05:00:00015 May 2011 05:00:00
[Table view]Agreement State Agreement State Report - Medical Events Involving Use of Savi Brachytherapy Applicators ENS 465292011-01-10T06:00:00010 January 2011 06:00:00 Agreement State Agreement State Report - Prostate Brachytherapy Misdosing ENS 432882007-04-04T05:00:0004 April 2007 05:00:00 Agreement State Improper Applicator Length Leads to Wrong Dose 2011-05-15T05:00:00 | |