The Nuclear Regulatory Commission (NRC), in a report issued last week, charged the Philadelphia Veterans Affairs (VA) Medical Center with eight violations relating to a series of bungled brachytherapy treatments for prostate cancer in which 98 men received incorrect radiation doses.
The errors involved the incorrect placement of iodine-125 seeds used to treat prostate cancer. In a review of its prostate cancer treatments, the Philadelphia VA Medical Center had previously determined that it had made those 98 errors during 116 treatments conducted on 114 veterans between 2002 and 2008.
“The health and safety of U.S. veterans are of paramount importance to the agency,” said Mark Satorius, regional administrator for NRC Region III Office, in Lisle, Ill., in a statement accompanying the release of the report. “The NRC mounted a comprehensive special inspection to determine what went wrong at VA Philadelphia. We discovered an absence of safety checks and balances. They must be in place to ensure safe and quality care for patients.”
The NRC identified eight apparent violations. These violations included a failure to develop adequate written procedures that would have “provided high confidence” that each treatment adhered to the written prescription; an absence of any verification the treatment was delivered as prescribed; a failure to instruct personnel in identifying and reporting requirements for medical events; a failure to record the dose received by a patient on the doctors’ prescription form; a failure to ensure the accuracy of written reports; and a failure to notify the NRC no later than the next calendar day after the medical event.
“The NRC expects licensees who use nuclear materials in medicine to do so responsibly. We hope learning from this experience will prevent such egregious errors in the future,” Satorius said.
The commission has been investigating the prostate cancer treatment problems at the Philadelphia VA Medical Center ever since it because aware that patients there had received radiation deliveries that were either 20 percent higher or lower than prescribed doses or were delivered to the wrong area.
The NRC said that it had hired a medical consultant who reviewed dose records and other data of 39 of the patients involved and had determined that several of those patients had experienced symptoms that could be related to the medical errors in their treatment, including inflammation and damage to the lower parts of the colon, rectal bleeding and recurrence of cancer.
The NRC and the Department of Veterans Affairs will hold a predecisional enforcement conference on Dec. 17 in Rockville, Md., at which the NRC will gather information it will use in taking any action against the VA.