NRC cites VA clinic for radioactive-treatment violations
Source: Inquirer
Published: 11/19/2009 Author: By Josh Goldstein and Marie McCullough
Posted On: November 19, 2009 at 9:54 AM By: Kathy

Inquirer Staff Writers

In the first outside report on its flawed prostate-cancer program, the Philadelphia VA Medical Center was cited for eight apparent violations in using radioactive materials on nearly 100 veterans, federal inspectors have concluded.

The Nuclear Regulatory Commission found that the Philadelphia VA staff failed to evaluate radiation doses or know when to report a mistake, according to the 16-page report obtained yesterday by The Inquirer.

The brachytherapy team, for example, failed to check radiation doses for more than a year because a computer was unplugged from the hospital's network, the report said.

The response to correct the problem was also flawed, the report found. The VA hospital, for example, double-counted one patient, and the true number of veterans who got incorrect radiation doses was 97, not 98 as originally reported.

"We did the best job we could to do a good review," responded Dale Warman, a medical center spokesman. "We provided access to everything and everybody the NRC could possibly have wanted, but perhaps it wasn't as fast as they, or we, would have wished."

The Philadelphia VA has sent eight veterans to Seattle for additional treatment and says its caregivers are closely monitoring all affected patients.

At least five veterans have filed claims with the VA, and more cases are anticipated.

While the Department of Veterans Affairs inspector general continues a separate probe of the troubled program, the NRC report with its findings and promise of future penalties marks an important milestone since the poor care was first discovered internally in May 2008.

The inspection report is a prelude to a Dec. 17 public meeting at which the NRC, which oversees the medical use of radiation, will decide what official action, if any, to take against the VA Medical Center in West Philadelphia.

The facility could face sanctions ranging from a reprimand to a fine of tens of thousands of dollars.

"We hope learning from this experience will prevent such egregious errors in the future," said Mark Satorius, head of the NRC's Region III office in Lisle, Ill., near Chicago, which conducted the review.

Lawmakers who have investigated the scandal said they were surprised by the new documents.

"I am taken aback by the lack of accountability and public leadership confirmed by this report, particularly when viewed in the context of other reports of programs failing to take care of our veterans in Philadelphia," said Rep. Joe Sestak (D., Pa.)

Sen. Arlen Specter (D., Pa.) agreed. "There is no doubt that mistakes were made by the doctors at the VA," he said.

Brachytherapy involves placing radioactive seeds inside the prostate gland to destroy cancerous cells over several months. The treatment is highly effective when done correctly. CAT scans and computer analyses are used to calculate and confirm actual radiation dosages. Amounts far above or below the amount planned must be reported to the patient and to the NRC.

The agency found that the brachytherapy team was not trained to identify such cases.

The VA shut down its brachytherapy program in June 2008. Investigations by both the NRC and the national VA have found a systematic lack of concern for accountability and safety.

The VA's follow-up review was also in disarray; four cases were identified as substandard when they actually were within acceptable ranges; and numerous cases had conflicting dose data in treatment plans.

It wasn't until last month - more than a year after the substandard cases were first identified - that the VA finally provided a full list of overdoses and underdoses delivered to patients' prostates and nearby organs, the NRC report noted.

The VA's internal review of the cases "lacked the rigor and formality required to demonstrate . . . [a] commitment to performance improvements."

Among the individuals faulted in the scandal were Gary Kao, the University of Pennsylvania radiation oncologist who did most of the substandard implants. Kao lost his job at the VA and is on leave from his research position at Penn.

"This latest report highlights the glaring oversights and errors that occurred at the Philadelphia VA," said Rep. John Adler (D., N.J.), a member of the House Veterans Affairs Committee.

Earlier this month, Adler introduced legislation meant to address those failures by requiring in-depth quality reviews of all programs across the VA hospital system that treat fewer than 100 patients in a year. The bill would also require the VA to perform written reports on contractors' performance.

"We hope this report will bring us closer to closure" on the brachytherapy issue, said Citron, the medical center's director. "The objective here is to find out what happened and to take steps to prevent it from happening again."

He added: "The brachytherapy program remains closed, and there are no plans to restart it."


Posted on November 19, 2009 at 9:54 AM by Kathy  

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