In levying the fine, the NRC said that an "unprecedented number of medical errors" had been identified at the Veterans Affairs Medical Center (VAMC) in Philadelphia. The VA has 30 days starting on March 17 to either pay the proposed fine or challenge it, according to a statement by the NRC.
The proposed fine is associated with an extensive investigation conducted by the NRC relating to incorrect placement of iodine-125 brachytherapy seeds to treat prostate cancer diagnosed in military veterans at the Philadelphia VAMC from 2002 until 2008, when the program was shut down. Out of 116 procedures performed, 97 were executed incorrectly, according to some reports, although the VA subsequently said that number should be reduced to 19.
The fine is one of the largest ever proposed by the agency for medical errors, according to the NRC. The principal violations, assessed at $208,000, are associated with a lack of written procedures to provide high confidence that each treatment was implemented as prescribed, and also the lack of a procedure to verify that treatments were implemented correctly.
Additional violations, assessed at $19,500, involve the wrong dose of radioactive seeds being ordered and implanted into one patient because no procedure existed to verify correct implementation of treatment. The $19,500 proposed fine also covers an alleged lack of training for staff in the NRC's definition of a medical event. It also covers associated reportability requirements and the failure to report medical events to the NRC no later than the next calendar day.
The NRC learned of some of the problems in May 2008. It subsequently expanded its inspection to other VA facilities offering brachytherapy prostate cancer programs. The NRC reported that it identified some concerns, but they did not reach the level of what it called the "widespread programmatic breakdown that afflicted VA Philadelphia."
In addition, the NRC stated that it found it imperative to make an assessment regarding the National Health Physics Program's effectiveness as a regulator. The results of the inspection of the National Health Physics Program will be documented in a report to be issued later in 2010, and if violations to NRC regulations are identified, the NRC stated that it will take appropriate enforcement actions.
By Cynthia E. Keen
AuntMinnie.com staff writer
March 17, 2010
VA responds to NRC report on brachytherapy violations, January 18, 2010
VA lowers estimate of patients affected by brachytherapy mistakes, December 21, 2009
NRC report cites Philadelphia VA, November 19, 2009
Bill targets QA at VA facilities, November 13, 2009
NY Times story claims treatment errors at VA brachytherapy unit, June 23, 2009
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