NRC ISSUES CONFIRMATORY ACTION LETTER TO THE DEPARTMENT OF VETERANS AFFAIRS
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As a result of errors in the prostate cancer treatment program at the Veterans Affairs (VA) Medical Center in Philadelphia, Pa., and suspected errors at other facilities, the Nuclear Regulatory Commission said Wednesday it has issued a confirmatory action letter to the Department of Veteran Affairs National Health Physics Program.

The letter documents the commitments made by the Department of Veterans Affairs to identify and address the problems that have led to medical errors at VA hospitals and to prevent their recurrence. The NRC will verify through inspections that the items in the confirmatory action letter have been successfully completed. The VA will not restart its suspended cancer treatment programs until these commitments have been met.

The Department of Veteran Affairs National Health Physics Program commitments include:

• conducting inspections at all 13 VA hospitals authorized to perform prostate cancer treatments;
• developing and implementing standardized procedures for prostate cancer treatments at all VA hospitals;
• identifying causes of the medical events and implementing corrective actions;
• suspending any prostate cancer treatment program where 20% or more  treatments have been identified as medical events;
• conducting an inspection to confirm that all necessary corrective actions have been taken prior to restarting any suspended cancer treatment program;
• notifying the NRC when program restart is planned;
• conducting an inspection of new prostate cancer treatment programs to confirm they meet the enhanced standards. 

“The health and safety of US veterans are of paramount importance to the Nuclear Regulatory Commission. Facilities that use nuclear materials for medical treatment have a responsibility for administering treatments properly and safely,” said Regional Administrator James Caldwell. “The confirmatory action letter will help us ensure that problems that led to medical errors at VA hospitals are addressed and that actions are taken to prevent their recurrence.”

This issue first came to the NRC’s attention in May  2008, when the Department of Veterans Affairs National Health Physics Program notified the Nuclear Regulatory Commission that the radiation dose delivered to a patient at the Veterans Affairs Medical Center in Philadelphia, PA, to treat prostate cancer was more than 20 percent lower than the prescribed dose.

Prostate cancer treatments involve implanting iodine-125 seeds of a prescribed radiation dose into the patient’s prostate.

The medical center’s review of all other prostate cancer treatments at the facility had identified 92 medical errors out of the total of 116 treatments conducted since the inception of the program in 2002.

In response, the NRC launched a special inspection to examine circumstances that led to multiple medical events during radiation treatments of prostate cancer in VA Philadelphia. Another goal of this inspection was to determine if the problem at the VA Philadelphia medical center exists at other VA facilities with similar programs.

The VA has since told the NRC of additional problems at three of its 12 other facilities: Cincinnati, Ohio, Jackson, Miss., and Washington, D.C.  The VA hospitals at these locations and in Philadelphia suspended their programs. The Department of Veterans Affairs will not resume its prostate treatment programs until its commitments to enhance these programs have been met.

The NRC’s ongoing special inspection is tasked with conducting independent inspections at several Veterans Affairs hospitals; evaluating the response of the Department of Veterans Affairs National Health Physics Program to the medical events and their investigation; and accompanying National Health Physics Program inspectors on inspections of VA hospitals to review their activities. In addition, the Nuclear Regulatory Commission hired an independent medical consultant to examine possible health effects to patients.

The 13 VA hospitals with prostate cancer treatment programs are in: Albany, N.Y., Boston, Mass., Brooklyn, N.Y., Cincinnati, Ohio, Durham, N.C., Jackson, Miss., Los Angeles, Calif., Minneapolis, Minn., Philadelphia, Pa., Richmond, Va., San Francisco, Calif., Seattle, Wash., and Washington, D.C.

The NRC will issue two special inspection reports. One will address the medical events at the Veterans Affairs Medical Center in Philadelphia; the second report will address findings at other VA facilities. The Department of Veterans Affairs National Health Physics Program will submit a letter to the NRC after all the commitments in the confirmatory action letter have been met. Both reports and the VA letter will be available through the NRC RIII Office of Public Affairs and at the NRC web site: http://www.nrc.gov/reading-rm/adams/web-based.html. 

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Thursday, October 16, 2008