Representatives of the Philadelphia Veterans Affairs (VA) Medical Center have rejected claims by the Nuclear Regulatory Commission (NRC) that the center committed eight regulatory violations in connection with a series of brachytherapy treatments for prostate cancer in which patients received incorrect radiation doses.
Although contrite, Philadelphia VA Medical Center officials vigorously defended the center against the NRC charges during a predecisional enforcement conference held last Thursday at NRC headquarters in Rockville, Md. During that conference VA officials also claimed that the number of patients adversely affected by faulty brachytherapy procedures had been overstated.
The VA originally reported that between February 2002 and June 2008 it had given incorrect radiation doses to 97 of 114 veterans implanted with tiny radioactive seeds to destroy their cancer. Last week Michael Hagan, the VA's national director of radiation oncology, told NRC officials that the VA had overstated the number of patients who actually underwent procedures that could be described as “medical events,” and that a new assessment critiera developed by a panel of experts put together by the VA in the fall actually put the number at 19, instead of 97.
Steven A. Reynolds, director of nuclear-materials safety for NRC's Region III, which has led the agency's investigation, said he found the presentation of this new criteria “troubling.”
"We’ve struggled with getting consistent information from you on what’s a medical event and what’s not,” said Reynolds. “Now you’re coming here again with a new criteria from a new panel–next week are you going to come with another new criteria?”
Hagan said the expert panel consisted of some of the leading names in radiation oncology and had been put together to solve the same problem that Reynolds had described. “The application of a criteria was changing on a monthly basis,” he said, “[S]o we needed to bring clarity to this. Our interest was to bring in those scholars who had a track record in brachytherapy that was undeniable. I have no interest in having a second panel and a second set of criteria. We will apply these only if the undersecretary (of the Department of Veterans Affairs) signs that these are the VHA’s criteria."
In addition to presenting evidence that the number of medical events had been overstated, the VA also argued that it had not violated NRC regulations as charged by the commission. The NRC had identified eight apparent violations, including 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 a medical event.
During the meeting Joel Maslow, chairman of the Philadelphia VA's radiation safety committee, said the VA concurs with just one of NRC charges—the violation involving a failure to record the dose received by a patient on a doctor’s prescription form—and refuted the other seven.
Reynolds said he found the VA’s rejection of the charges—particularly those relating to instructing personnel in identifying and reporting requirements for medical events—“confusing.” He reminded VA officials that in a 2008 response to the National Health Physics Program inspection the center concurred that medical personnel involved in the brachytherapy program did not receive formal training about the regulatory requirements to report medical events.
“I hope you appreciate where I’m coming from,” said Reynolds. “We’ve been going through this for 18 months. We’ve been hearing from your staff one thing—your own responses to your own internal NHPP--and you come here today and it's different. Again, that’s why I’m surprised.”
“As this process has unfolded we’ve asked ourselves questions about how we could have missed this or that, and how some of these errors could have occurred,” said Philadelphia Medical Center director Richard Citron in response. “And we’ve dug deeper and into our files and uncovered some new information."
The VA has until Jan. 15 to submit documentation to the NRC in support of its arguments regarding