NRC fines Phila. VA $227,500 over prostate care

The Philadelphia VA Medical Center was hit with a $227,500 fine by the Nuclear Regulatory Commission yesterday for poor care in a prostate cancer program that resulted in 97 veterans getting incorrect doses of radiation.

The fine levied against the Department of Veterans Affairs was the second largest ever by the NRC against a medical facility. The VA has 30 days to contest the fine.

"The VA Philadelphia had a total breakdown in management oversight, a total breakdown in the program, and a total breakdown in safety culture that resulted in these egregious failures," said Steve Reynolds, director of the division of nuclear material safety for NRC Region III, which oversees the Veterans Health Administration.

The largest NRC fine was $280,000 in 1996 against the owners of hospitals in Indiana, Pa., and Marlton. That case involved the death of a patient.

"Fortunately nobody died here," Reynolds said.

At least not yet.

Between February 2002 and June 2006 - when the prostate brachytherapy program at the Philadelphia VA was shut down - 114 veterans were implanted with dozens of radioactive seeds to kill their cancerous cells.

So far, 11 of those veterans have had recurrences of their cancer, and eight more show signs of a possible return. In addition, nine men sustained radiation injuries to their rectums, according to the VA.

The treatment mistakes led to internal investigations, congressional scrutiny, the NRC probe, a continuing review by the VA's inspector general, and a flood of legal claims.

The VA inspector general is expected to issue its report next month.

"There were clearly missed opportunities in oversight from 2002 to 2008," said Richard S. Citron, the Philadelphia VA director.

"But issues with the brachytherapy program do not reflect the high level of health care offered in Philadelphia or throughout the VA system."

Brachytherapy involves implanting dozens of radioactive seeds inside the prostate gland to destroy cancerous cells over several months. The treatment is highly effective when done correctly.

Records show that the Philadelphia program - which was run by University of Pennsylvania doctors - was deeply flawed from the start, and that doctors and officials repeatedly missed chances to fix it.

On Feb. 3, 2003, for example, the brachytherapy team implanted its ninth patient with 74 radioactive seeds aimed at his prostate. A routine check after the implant showed that 40 of the seeds landed in the bladder.

In a 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.

At least 31 veterans or wives have filed claims seeking a total of $58 million against the VA. Two men have filed federal lawsuits.

This month, Barry Lackro named the VA, radiation oncologist Gary Kao, and Penn in a suit filed in federal court in Philadelphia. His suit stated that in his case, seeds were improperly placed and he got an inadequate dose to his prostate and excessive radiation to his rectum and bladder.

As a result, his "prostate cancer has returned" and "the healthy tissues of Mr. Lackro's rectum and bladder have been damaged by radiation," the complaint alleged.

Several lawmakers who have investigated the problems at the Philadelphia VA yesterday praised the NRC's action.

"Clearly, there was a pattern of outrageous conduct at the Philadelphia VA that truly let down dozens of veterans suffering from prostate cancer," said Rep John Adler (D., N.J.), a member of the House Veterans Affairs Committee.

Sen. Arlen Specter (D., Pa.) said that while the NRC action was one government agency fining another agency, the impact would be broader.

"This kind of fine will be a shot heard around the country," he said. "It is a major embarrassment that tells the world that what went on at the Philadelphia VA Medical Center was outlandish, reprehensible."

Specter's opponent in the Democratic primary in May, Rep. Joe Sestak, said the NRC decision "takes the Philadelphia VA one step further toward addressing and bringing closure to past instances of woefully inadequate care."

And Rep. Phil Roe of Tennessee, the ranking Republican member of the House Veterans Affairs oversight subcommittee, said, "My primary concern is whether the negligence by the Philadelphia VA is indicative of overarching patient safety issues."

Katie Roberts, a spokeswoman for the VA in Washington, said in a statement that the department "continues to take the Philadelphia brachytherapy situation very seriously and has taken every step to correct or mitigate the problem."

While the fine and notice of violation yesterday concluded the NRC's 21-month-long investigation of the VA, Reynolds said that the agency would continue to scrutinize the hospital.

He said that the NRC was investigating whether the National Health Physics Program, which oversees radiation use at all veterans' hospitals, was up to the task.

The NRC yesterday also rejected an effort by the VA to retract 80 of the 97 reported "medical events" - mistakes - in Philadelphia based on a new criteria it devised for what counted as a radiation error.

In January, Gerald Cross, then-acting undersecretary for health at the VA, sent a letter to the NRC seeking to retract the 80 medical events.

"We rejected that totally," Reynolds said yesterday.

But even if the VA had only 17 medical events, Reynolds said, "17 is still a huge number of medical events and a huge programmatic breakdown. Whether 17 or 97, Philadelphia VA failed."