In a dramatic about-face, the Philadelphia VA Medical Center has acknowledged that its troubled prostate cancer program violated federal radiation rules meant to protect patients from harm.
Just last month, Philadelphia VA officials disputed the finding of a Nuclear Regulatory Commission investigation that the hospital committed eight safety violations in its prostate brachytherapy program.
They did so despite an internal Department of Veterans Affairs review showing that 97 of 114 prostate cancer patients treated over six years at the hospital received incorrect doses of radiation.
Yesterday, Gerald Cross, acting undersecretary for health at the VA, changed course.
"I accept the violations," he wrote in a 12-page letter detailing the agency's latest position.
Cross said the failure by Philadelphia VA staff to identify and report the poor quality of treatments was "perplexing" and showed "a lack of safety culture."
Changes in the VA's position during the 19-month investigation bother Steve Reynolds, director of the division of nuclear material safety for NRC Region III, which oversees the Veterans Health Administration.
"If you look at the facts of the situation, they had major problems at VA Philadelphia," Reynolds said. "The doctors, the medical physicists, the radiation safety officer, the radiation safety committee - they weren't doing their jobs as we expected them to do."
Reynolds also said this was the first time in his more than 20-year career that a licensee had reversed its position after an enforcement conference.
Now, he said, the nuclear agency must resolve the conflict between what Philadelphia VA officials initially said last month and what the VA's Cross now says.
"This is no longer as clear-cut," he said. "They made it more complicated."
Still, Reynolds said the NRC would issue its enforcement action - ranging from a reprimand to a fine up to $500,000 - in the next several months.
Prostate brachytherapy involves implanting dozens of tiny radioactive seeds into the acorn-size gland to kill cancerous cells.
The Philadelphia VA treated 114 veterans with brachytherapy from 2002 to 2008, when problems were discovered and the program was shut down.
So far, 11 of the veterans have had recurrences of their cancer, and eight show signs of a possible return. In addition, nine of the men sustained radiation injuries to their rectums, according to the VA's latest information.
The treatment mistakes led to internal investigations, congressional scrutiny, the NRC probe, an ongoing review by the VA's inspector general, and a flood of legal claims.
Up to December, 31 veterans or wives have filed claims seeking a total of $58 million against the VA, according to records obtained by The Inquirer through a Freedom of Information Act request.
Several lawmakers who have investigated the cases said the VA responses were anemic. The lead physician lost his VA job when the program closed. Another physician accepted a three-day suspension, and a radiation safety employee received a letter of reprimand in her personnel file.
In his letter, Cross supported the VA's staff in one area. He reiterated the VA's intention to withdraw 78 of the 97 cases as reportable events worthy of concern.
However, even using new criteria to evaluate mistakes, as the VA proposes, would leave the Philadelphia hospital with 19 bad implants - a still-troubling 17 percent of cases.
Records show that the Philadelphia VA's program was deeply flawed from its earliest patients, and that doctors and officials repeatedly missed chances to correct it.
On Feb. 3, 2003, for example, the brachytherapy team implanted its ninth patient, planning to put 74 radioactive seeds into his prostate. A routine check after the implant showed that 40 of the seeds landed in the bladder.
In another case in 2005, 45 of the 90 seeds implanted in an 86-year-old veteran were put in his bladder and had to be extracted.
Some seeds ended up near the rectum, and the patient reported significant pain in urination, records showed. He was one of eight Philadelphia patients whom the VA sent to Seattle last year for reimplantation.
Both cases were reported to the NRC, which did not deem them to be violations.
In December, the VA used those earlier NRC findings as evidence that its radiation policies were not flawed.
The NRC's Reynolds rejected that. "It is troubling when a licensee says, 'Hey, you inspected me years ago and didn't find a problem; therefore, we must be OK,' " Reynolds said. "In this case, they just took it out of context."
An NRC report in November found the VA had committed eight apparent violations.
Those included failure to train staff on how to identify and report bad implants, a lack of procedures to ensure safe implants, and not reporting mistakes as quickly or fully as required.
But in December, at the NRC's predecision conference, the mood grew contentious when Joel Maslow, chairman of the Philadelphia VA's radiation safety committee, rejected seven of the eight apparent violations.
Maslow noted that the NRC had not found violations in the 2003 or 2005 cases, and said the medical center had found documents showing that the staff had been properly trained to identify and report medical events.
He said that the hospital had reported problems to the NRC, albeit months or years afterward.
"We reported what we knew when we knew it," he testified last month.
In a statement yesterday, Maslow defended his testimony as "valid and based on factual information." But he added, the VA's new "consolidated response is more complete and clearly the best way forward."
The VA's reversal yesterday also undermined testimony by Mary Moore, the medical center's radiation safety officer. Moore told the NRC that the brachytherapy program's staff had gotten training and that documents proved that fact.
But "the records do not support a conclusion that training documents were adequate," Cross wrote.
In a statement yesterday, Moore did not address those concerns. "I am committed to continue strengthening our program to ensure a safe environment for our patients and staff," she said.
Other observers said the VA hospital needed to acknowledge problems in its performance to move forward.
"It is about time for the Philadelphia VA to accept their outrageous mistakes in the treatment of our local veterans," said U.S. Rep. John Adler (D., N.J.), a member of the Veterans Affairs Committee. "Now, the Philadelphia VA is going to have to work hard to convince the thousands of brave men and women in our area, who served our country, that the hospital is getting back on the right track."
Medical center director Richard Citron said that is what he and his staff were trying to do.
In a statement, Citron said, "This was a terrible situation, and we are not happy if even one veteran did not receive the level of care he earned and deserves."
No comments:
Post a Comment