The U.S. Nuclear Regulatory Commission has proposed a $227,500 fine against the Department of Veterans Affairs (VA) for violations of NRC regulations associated with an “unprecedented number of medical errors” identified at the Philadelphia VA Medical Center.
The errors involved the incorrect placement of iodine-125 seeds used to treat prostate cancer. Out of 116 procedures performed between 2002 and 2008, 97 were executed incorrectly.
“This substantial fine emphasizes the high significance of violations at the Philadelphia VA Medical Center that resulted in close to 100 of our nation’s veterans receiving substandard treatments,” said Mark Satorius, regional administrator for the NRC’s Region III office in Lisle, Ill. “The lack of management oversight, the lack of safety culture to ensure patients are treated safely, the potential consequences to the veterans who came to this facility and the sheer number of medical events show the gravity of these violations.”
NRC said this is “one of the largest fines” it has “ever proposed for medical errors.” The principal violations, assessed at $208,000, are associated with the lack of written procedures to provide high confidence that each treatment was implemented as prescribed and the lack of a procedure to verify that the treatment was implemented correctly. Additional violations, assessed at $19,500, involve the wrong dose of radioactive seeds being ordered and implanted into a patient on May 5, 2008, because no procedure existed to verify correct implementation of treatment; the lack of training in the NRC’s definition of a medical event and associated reportability requirements; and the failure to report medical events to the NRC no later than the next calendar day.
Although contrite, Philadelphia VA Medical Center officials vigorously defended the center against the NRC charges during a predecisional enforcement conference held in December 2009 at NRC headquarters in Rockville, Md. During that conference VA officials claimed that the number of patients adversely affected by faulty brachytherapy procedures had been overstated.
When the medical errors came to light in May 2008, the commission said it dedicated a team of inspectors to conduct extensive inspections to determine how 97 of 116 treatments could have been executed incorrectly. In addition, the NRC hired an independent medical consultant to assess the impact of medical errors on patients. NRC inspectors determined a widespread programmatic breakdown had occurred within the cancer treatment program at Philadelphia VA Medical Center.