GovernmentExecutive.com

The Nuclear Regulatory Commission on Nov. 17 found the Philadelphia Veterans Affairs Medical Center in violation of multiple regulations regarding the surgical placement of radiation seeds in the treatment of prostate cancer patients.

The findings resulted from a special inspection NRC conducted at the medical center after a physicist there determined a prostate cancer patient had received an incorrect radiation dose in May 2008. That discovery triggered multiple investigations by NRC and VA, which ultimately identified 98 medical errors out of 116 treatments for 114 veterans at the Philadelphia center between 2002 and 2008.

All the patients were undergoing brachytherapy, a complicated treatment that involves implanting iodine-125 seeds in the prostate to destroy cancer cells. Dozens of patients were found to have seeds erroneously implanted in other organs. VA suspended the center's program in June 2008.

"My professional medical opinion is that the prior brachytherapy program did not remotely meet current medical standards," said Dr. Ronald Goans, the medical consultant NRC hired to examine the records and health outcomes of prostate cancer patients treated at the center.

Goans extensively analyzed the records of 30 patients who were most seriously underdosed or overdosed and found a number experienced symptoms that could be related to the errors, including inflammation and damage to the colon, rectal bleeding and in at least one case, a recurrence of cancer.

In his report to NRC, Goans said the program's past performance "is quite puzzling and shows considerable inconsistency in seed placement."

Brachytherapy at the Philadelphia VA center was performed under a contract with the University of Pennsylvania School of Medicine, and many of the errors were found in surgeries performed by Dr. Gary Kao, a radiation oncologist at the university who played a key role in implementing the center's brachytherapy program in 2002. In June 2008, Kao suspended his clinical practice at the school's request, according Dr. Stephen Hahn, chairman of the university's radiation oncology department, in a statement submitted to the House Veterans' Affairs Committee in July.

The NRC inspection found that the Philadelphia center lacked adequate procedures to ensure patients received treatments according to the physician's prescription and failed to instruct personnel in reporting requirements for medical events. Inspectors also cited the center for incomplete record-keeping and failing to notify NRC no later than the next calendar day after discovery of a medical event.

NRC is considering a range of enforcement actions against the Philadelphia medical center, from a notice of violations to thousands of dollars in fines. Regulators are scheduled to meet with VA officials on Dec. 17 to discuss the issue further. Any enforcement decisions likely will be made early next year, said NRC spokeswoman Viktoria Mitlyng.

Despite the program's shortcomings, Goans praised staff at the center for their efforts to address the problems: "I continue to be impressed with the efforts of the current VA oncology department staff and would not foresee a recurrence of the situation seen in the time frame 2002 to 2008.