Healthcare Inspection Review of Brachytherapy Treatment of Prostate Cancer, Philadelphia, Pennsylvania and Other VA Medical Centers

On May 5, 2008, a patient of Philadelphia, PA VA Medical Center (PVAMC) underwent prostate brachytherapy in treatment for prostate cancer and was inadvertently implanted with radioactive seeds of the wrong strength. This error was discovered seven days later and set in motion a chain of events that ultimately led to suspension of PVAMC’s brachytherapy program and a comprehensive OIG review of prostate brachytherapy as performed at PVAMC as well as elsewhere in VHA. We found that the May 5 wrong seed strength case was an isolated occurrence. However, there were numerous process deficiencies at PVAMC in quality management, information technology, and contracting with the University of Pennsylvania. PVAMC also had numerous NRC regulatory compliance issues. Despite these issues, actual clinical outcomes expressed as recurrence and disease-relapse rates of PVAMC prostate brachytherapy patients appear within the norm. Complication and adverse event rates for the 114-patient PVAMC prostate brachytherapy patient cohort were not excessive. We made five recommendations, all of which VHA’s Under Secretary for Health concurred with: (1) VHA’s National Director of Radiation Oncology Programs should have sufficient resources, to ensure that VHA provides one high quality standard of care for the prostate brachytherapy population. To achieve this end, VHA should standardize, to a practical extent, the privileging, delivery of care, and quality controls for the procedures required to provide this treatment. (2) VHA should take the steps required to ensure that patients who received low radiation doses in the course of brachytherapy be evaluated to ensure that their cancer treatment plan is appropriate. (3) VHA should review the controls that are in place to ensure that VA contracts for healthcare comply with applicable laws and regulations, and where necessary, make the required changes in organization and/or process to bring this contracting effort into compliance. (4) Senior VA leadership should meet with Senior NRC leadership to determine if there is a way forward that will ensure the goals of both organizations are achieved. (5) VHA should work with the OIG to develop a list of documents that should routinely be provided to the OIG when an outside agency is notified of a (possible) untoward medical event.