VA fined for botched brachytherapy

Ninety-seven radioactive treatment errors will cost the Philadelphia Veteran’s Affairs Medical Center $227,500.

Last Thursday, the VA hospital was fined by the U.S. Nuclear Regulatory Commission for federal code violations while performing a medical procedure using radioactive materials.

The procedure, brachytherapy, is a prostate cancer treatment that uses small radioactive iodine-125 seeds. The seeds are implanted in the prostate to battle cancerous tissue.

The Hospital of the University of Pennsylvania reported on Feb. 25 that it may have committed an error in the treatment of a prostate cancer patient who was undergoing brachytherapy.

According to the report, a new ultrasound unit at HUP used to implant the radioactive seeds in a patient may have malfunctioned, as the seeds were placed “in an appropriate pattern, but outside the intended target.”

“I don’t know of any other issues,” said HUP spokeswoman Susan Phillips, when asked about the possibility of errors with other patients.

Despite complications centering around the procedure at the VA hospital and HUP, NRC spokeswoman Viktoria Mitlyng said implantation errors “are not common.”

“Since 2002, a little over 100 errors of this type have been reported by other hospitals, as opposed to 97 from the Philadelphia VA from 2002 to 2007,” Mitlyng said. “The scale at which it occurred [at the VA hospital] was unprecedented.”

The Feb. 25 report also stated that the Commonwealth of Pennsylvania will coordinate with the NRC to investigate the possible error, noting their ongoing investigation of “pre-April 2008” brachytherapy implants at HUP and at the VA hospital.

The violations at the hospital occurred during patient treatments performed by Gary Kao, then an associate professor of radiology at the School of Medicine. Kao, who was on contract with the VA Medical Center at the time, reportedly botched 97 of 116 procedures investigated by the NRC.

Mitlyng said the fine was the second largest proposed by the NRC for medical mistakes. The largest — $280,000 — was levied in 1996 against hospital owners in Indiana, Pa. and Marlton, N.J., according to The Philadelphia Inquirer.

Mitlyng also emphasized that the numerical dollar amount of the VA hospital’s fine was “not arbitrary.”

“We have a set of rules that allow us to calculate the amount of a fine,” she said. “It is designed to bring attention to certain violations and to make sure the license holder addresses them. We can’t say, ‘this feels like a million to me.’”

The VA Medical Center has not shown any intentions to restart the prostate treatment program, according to Mitlyng. In order to do so, the hospital would have to “show the agency that [it has] addressed all the issues identified, … create a new program of safety controls and have it in place for the NRC to look over,” she said.

Robert Lustig, Penn Med professor and HUP physician who specializes in radiation oncology, wrote in an e-mail that Penn has been using brachytherapy for about 50 years. With proper tumor and patient selection, “it is an integral part of the practice of Radiation Oncology,” he wrote.

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