El NRC amenaza VA con la multa $227.500 para los procedimientos “incorrectos” de Brachytherapy

por Brendon Nafziger, DOTmed News Associate Editor | March 22, 2010
NRC fines VA hospital
in Philadelphia
The U.S. Nuclear Regulatory Commission proposed a nearly quarter of a million dollar fine against the Department of Veterans Affairs for a series of botched radiation therapy procedures for prostate cancer at the Veterans Affairs Medical Center in Philadelphia, PA, the organization announced on Thursday.

The fine, totaling $227,500, is the second largest ever proposed for a medical error, according to the NRC, coming just behind $280,000 fines recommended in cases involving medical radiation overexposure in 1987 and problems with oncology treatments in 1994.

"We feel that with the fine we want to send a strong message. The NRC is not going to tolerate a lack of management, a lack of safety culture or a vast programmatic breakdown," NRC spokeswoman Prema Chandrathil tells DOTmed News.

The NRC, which oversees the use of radiation for medical treatments, began its investigation of the Philadelphia medical center in May 2008 after staff there reported some patients didn't get the appropriate radiation dose during brachytherapy treatments for prostate cancer. In this procedure, tiny radioactive seeds are injected into the prostate, and radiation from the seeds blasts the cancer.

The NRC found that between 2002 and 2008, 97 of 116 procedures performed at the VA hospital were done "incorrectly," with patients not receiving the correct dose or seeds not entering the correct organ, a known risk of the procedure.

In their investigations that led to the fine, the NRC uncovered eight violations at the troubled prostate cancer program, including not having a process in place to verify that patients received the correct treatment and not having proper training of staff on how to report errors, which NRC calls "medical events." According to Chandrathil, the hospital didn't always follow NRC protocols, which require doctors to report to the agency if during a brachytherapy procedure the target organ receives 20 percent less, or more, than the planned dose.

The DVA has 30 days to pay the fine or contest it. According to Chandrathil, at a Washington, D.C. conference in December 2009 when the NRC weighed taking an enforcement action against the DVA, the veterans agency at that time denied seven of the eight violations, but later sent a letter accepting all marks against them.

When contacted by DOTmed News, the DVA wouldn't comment, but instead offered a statement from Richard Citron, the Philadelphia VA hospital's director, admitting that "there were clearly missed opportunities in oversight from 2002 to 2008."