Critical Warning Signs Missed at Philly VA

Weak Oversight Efforts Fail to Protect Veterans 

Washington, D.C. – On Wednesday, July 22, 2009, the House Veterans’ Affairs Oversight and Investigations Subcommittee, led by Chairman Harry Mitchell (D-AZ), conducted a hearing to evaluate the safety standards of the brachytherapy program administered by the Veterans Health Administration (VHA) at the Department of Veterans Affairs (VA). 

The Subcommittee specifically focused on the procedures and directives currently in place to ensure that veterans receiving brachytherapy, are receiving quality medical care.  Brachytherapy is a form of nuclear radiotherapy to treat prostate cancer where small radioactive seeds are implanted in the prostate to destroy cancerous cells.  The hearing was called to respond to recent reports that veterans did not receive proper treatment at the Philadelphia VA Medical Center (PVAMC), including under dosage and misplacement of the radioactive seeds in the body.    

“Reports of botched prostate cancer procedures, a lack of quality and standard controls in the VA healthcare system and egregious errors in the brachytherapy treatment at the Philadelphia VA Medical Center are unacceptable and wrong,” Chairman Mitchell said.  “While we are disturbed that, perhaps, there was a lack of proper local quality controls and management of these brachytherapy programs, our main concern is that the problems marring the program in Philadelphia could be happening at the other facilities still doing these procedures.”

The main protections that were not in place to protect veterans include lack of peer review among medical and scientific staff, insubstantial oversight that missed critical warning signs of anomalies at PVAMC, and lack of proper patient follow-up.  Further complicating this treatment is the fact that brachytherapy is a relatively new procedure and involves patient risk.  The program has continued to evolve as the medical community learns to better administer the complicated therapy.

The VA’s National Radiation Safety Committee is responsible for patient safety and day-to-day oversight of VA medical procedures using radioactive materials.  The National Health Physics Program (NHPP) acts as the VA’s regulatory organization and is responsible for issuing permits, conducting inspections and event follow-up, investigating incidents, allegations and enforcement.  Additional oversight is conducted by the National Regulatory Commission (NRC), an independent agency that seeks to ensure the adequate protection of those working with radioactive material, as well as the public and the environment, and that the patient receives the radiation dose intended and prescribed by the medical practitioner. 

Representatives from VA testified that problems at PVAMC went undetected for almost six years, until reported by VA staff.  As a result, VA amended the criteria for suspending a brachytherapy program, implemented new training requirements, and has improved its peer review efforts. 

“The tragedy of this incident is that it could have been prevented,” said Bob Filner (D-CA), Chairman of the House Committee on Veterans’ Affairs.  “Oversight protections are in place, but they are not operating effectively across the board.  There is no question that the VA needs to better police itself – on a local level and on a national level.  Investigations into this incident are ongoing and I urge VA leaders to be accountable for the quality of care our veterans receive.”      

Since 2005, fifteen VA Medical Centers have operated brachytherapy programs.  Nine VA programs are approved to provide brachytherapy, although only 7 are active programs that currently offer treatment. 

Witness List

Panel 1:

·       Gary D. Kao, M.D., Ph.D., Associate Professor, Department of Radiation Oncology, University of Pennsylvania
·       Steven M. Hahn, M.D., Henry P. Pancoast Professor and Chair, Department of Radiation Oncology, University of Pennsylvania
·       Michael R. Bieda, M.S., Clinical Chief, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania

Accompanied by:

o       Gregory Desobry, Ph.D., Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania
o       George Lazarescu, Ph.D., Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania

Panel 2:

·       Steven A. Reynolds, Director, Division of Nuclear Materials Safety Region III, United States Nuclear Regulatory Commission

Accompanied by:

o       Charles L. Miller, Ph.D., Director, Office of Federal and State Materials and Environmental Management Programs, United States Nuclear Regulatory Commission

·       W. Robert Lee, M.D., M.S., M.Ed., Professor, Department of Radiation Oncology, Duke University School of Medicine (On behalf of the American Society of Radiation Oncology)
·       Paul M. Schyve, M.D., Senior Vice-President for Health Care Improvement, The Joint Commission

Panel 3:

·       Joseph A. Williams, Jr., RN, BSN, MPM, Assistant Deputy Under Secretary for Health for Operations and Management, Veterans Health Administration, U.S. Department of Veterans Affairs

Accompanied by:

o       Madhulika Agarwal, M.D., MPH, Chief Officer of Patient Care Services, Veterans Health Administration, U.S. Department of Veterans Affairs
o       Michael Hagan, M.D., Ph.D., National Director of Radiation Oncology Services, Veterans Health Administration, U.S. Department of Veterans Affairs
o       E. Lynn McGuire, MS, DABMP, National Health Physics Program Director, Patient Care Services, Veterans Health Administration, U.S. Department of Veterans Affairs

o       Michael E. Moreland, FACHE, Network Director, VA Healthcare – VISN 4, Veterans Health Administration, U.S. Department of Veterans Affairs
o       Richard Whittington, M.D., Staff Physician, Philadelphia VA Medical Center, Veterans Health Administration, U.S. Department of Veterans Affairs
o       Kent E. Wallner, M.D., Chief, Radiation Oncology, Puget Sound Health Care System, Veterans Health Administration, U.S. Department of Veterans Affairs

###

Prepared testimony for the hearing and a link to the webcast from the hearing is available on the internet at this link: http://veterans.house.gov/hearings/hearing.aspx?newsid=438