The Philadelphia Veteran Affairs Medical Center was found to have committed eight apparent rule violations in connection with the use of radioactive iodine pellets to treat prostate cancer, a U.S. Nuclear Regulatory Commission Review announced Tuesday.
The violations occurred during patient treatments performed by Gary Kao, an associate professor of radiology with the School of Medicine. Then on contract with the VA Medical Center, Kao was found to have botched 97 of 116 procedures investigated by the NRC.
In the investigated procedures, radioactive iodine-125 seeds that were intended to be injected into the prostate to combat cancer were frequently misplaced, the NRC reported. Patients received up to 20 percent more or less radiation in the prostate than originally intended. Radioactive seeds elsewhere in their bodies damaged their bladders, rectums and other internal organs, the investigation found.
The NRC attributes the violations to a lack of procedures to ensure adherence to predetermined treatment plans, to report errors as they occur and to verify all written reports.
Kao and other VA doctors were able to avoid reporting these incidents as mistakes through a technicality that allowed doctors to alter treatment plans while still in the operating room.
Penn Med declined to comment on the NRC’s decision, saying only that Kao has been on leave since June.
An information-gathering conference on the VA’s response to the mistakes is scheduled for Dec. 17, according to NRC representative Viktoria Mitlyng. The NRC is expected to reach a decision on appropriate punitive measures a month or two after the hearing. Punitive actions could range from a notice of violation to fines.
Mitlyng emphasized that Kao should not bear full responsibility for the malpractice.
“What we’re looking at is why this was allowed to happen and what needs to be done so it doesn’t happen again,” Mitlyng said. “There were issues with oversight [and] procedures.”
She emphasized that the violations indicated “gross programmatic failures” that allowed Kao to make mistakes unnoticed.
The NRC Review follows an investigation that began in July 2008, and Congressional hearings this past July.
The agency is also conducting an investigation into the use of radioactive iodine pellets to treat prostate cancer at other VA hospitals and other clinical locations. A complete report on the state of the other programs is expected sometime in the next six months.
“All of these facilities and other medical programs that use nuclear materials,” Mitlyng said, “we entrust ... with great responsibility towards their patients, people who are already not well, and with our work on the VA, we want to make sure that such egregious errors don’t happen again.”
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