VA responds to NRC report on brachytherapy violations

The U.S. Department of Veterans Affairs has responded to a report issued by the U.S. Nuclear Regulatory Commission (NRC) on treatment errors in the prostate cancer brachytherapy program at the Philadelphia Veterans Affairs Medical Center (VAMC) between 2002 and 2008.

The VA acknowledged that many of the shortcomings cited in the report were indeed violations, according to a January 14 letter and 10-page document by Dr. Gerald Cross, acting undersecretary for health for the Veterans Health Administration (VHA) of Washington, DC. However, Cross stated that the VHA took exception to a violation related to submitting written reports within a 15-day time frame, as well as to a violation citing the Philadelphia VAMC's failure to properly complete a written directive.

The prostate cancer brachytherapy program at the Philadelphia VAMC was shut down 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.

However, at an NRC hearing held at VA headquarters in Rockville, MD, on December 17, the VA announced that it had reduced the number of patients affected by medical errors from 98 to 19. In his letter, Cross advised Steven A. Reynolds, director of the NRC's division of nuclear materials safety region III, that the VHA would submit a proposal no later than January 29 to retract approximately three-fourths of previously reported medical events.

The VA's revision is based on a review of the medical events using new criteria developed from the NRC Advisory Committee on the Medical Uses of Isotopes 2005 recommendations, according to Cross.

"Our review of the previously reported medical events under these new criteria better reflects the overall effectiveness of our brachytherapy treatments, since the ongoing reviews by clinical experts have not identified an overall increased rate of adverse outcomes for the patients," Cross wrote.

Nonetheless, 31 veterans or their wives have filed claims totaling $58 million against the VA, according to records obtained in November by the Philadelphia Inquirer through a Freedom of Information Act request.

The NRC is expected to issue violations and any penalties within the next four to six weeks, based on statements made during the December 17 hearing.

By Cynthia E. Keen staff writer
January 18, 2010

Related Reading

VA lowers estimate of patients affected by brachytherapy mistakes, December 21, 2009

NRC report cites Philadelphia VA, November 19, 2009

Congress eyes safety of VA prostate brachytherapy: Part 1, August 6, 2009

NY Times story claims treatment errors at VA brachytherapy unit, June 23, 2009

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