The Philadelphia program was shutdown in June 2008 when treatment errors involving the incorrect placement of iodine-125 seeds were discovered. Subsequent investigation identified 98 medical errors out of a total of 116 treatments performed on 114 patients.
The NRC conducted a two-phase investigation. It reviewed circumstances relating to the events, focusing on identifying programmatic weaknesses from July 2008 to February 2009. From June to October 2009, it verified the accuracy of radiation dose calculations provided to the NRC by the Philadelphia VAMC.
The eight violations were associated with:
- Lack of procedures to ensure that each prostate cancer treatment adheres to the written prescription
- Absence of verification tools to ensure that the treatment was delivered as prescribed
- Failure to record the dose received by the patient on the doctors' prescription form
- Failure to verify that all written reports were accurate and complete
- Failure to instruct medical staff in identification and reporting requirements for medical events
- Failure to notify the NRC no later than the next calendar day after the discovery of a medical event
The NRC will hold a conference with the Department of Veterans Affairs in Rockville, MD, on December 17, 2009, to obtain information to assist the NRC in making an enforcement decision.
In its press release, the NRC stated that it will continue inspection efforts with the focus on other VA prostate cancer treatment programs and the National Health Physics Program.
Bill targets QA at VA facilities, November 13, 2009
6 more botched prostate brachytherapy cases at Philly VA, August 18, 2009
Congress eyes safety of VA prostate brachytherapy: Part 2, August 10, 2009
Congress eyes safety of VA prostate brachytherapy: Part 1, August 6, 2008
NY Times story claims treatment errors at VA brachytherapy unit, June 23, 2009
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