DEPUTY UNDER SECRETARY FOR HEALTH
FOR OPERATIONS AND MANAGEMENT
VETERANS HEALTH ADMINISTRATION
DEPARTMENT OF VETERANS AFFAIRS
COMMITTEE ON VETERANS' AFFAIRS
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
U.S. HOUSE OF REPRESENTATIVES
July 22, 2009
Good morning, Mr. Chairman and members of the Subcommittee. Thank you for the opportunity to discuss the Department of Veterans Affairs’ (VA) enforcement of VA’s brachytherapy program safety standards. I am accompanied today by Dr. Madhulika Agarwal, Chief Officer, Patient Care Services, Veterans Health Administration (VHA); Dr. Michael Hagan, National Director for Radiation Oncology in VHA; E. Lynn McGuire, MS, DABMP, National Health Physics Program Director in the Office of Patient Care Services, VHA, Michael E. Moreland, FACHE, Network Director, VA Healthcare – VISN 4, and Dr. Richard Whittington, a physician at the Philadelphia VA Medical Center (VAMC).
My testimony today will briefly describe brachytherapy, review what happened at the Philadelphia VAMC, explain VA’s enforcement of safety standards for brachytherapy, and discuss the current status of these programs throughout VA. Brachytherapy for prostate cancer is a form of nuclear radiotherapy where small radioactive seeds are implanted in the prostate to destroy cancerous cells. Although risk to healthy tissues in the body is minimal, side effects may occur. Brachytherapy is an appropriate treatment approach for low-risk patients with prostate cancer, but implant quality must be monitored closely in each case and programs performing this procedure must be regularly reviewed.
VA acknowledges that some of the brachytherapy treatments provided at the Philadelphia VAMC did not deliver the intended dose; we regret this occurred. We have notified patients by mail and by telephone and are covering all costs associated with additional tests while continuing to monitor the care of our patients, whether they are seen at VA or private facilities. A review by independent, external physicians and physicists with no involvement in the Philadelphia VAMC’s brachytherapy program examined patient scans, dosages and medical records and discovered that 92 events involving under-dosing or doses to organs other than the treatment site were found that met the definition of a medical event according to the Nuclear Regulatory Commission (NRC). It is important to highlight that the definition of “medical event” does not necessarily mean Veterans were harmed, and experts still debate the long-term impact of this treatment. We are working with NRC on regulatory issues related to prostate brachytherapy, and NRC is refining the definition of “medical event” as it pertains to these procedures. The Philadelphia VAMC’s brachytherapy program has been suspended since June 2008 and will not be reopened until NRC’s concerns have been satisfied and until requirements of the VA’s Radiation Oncology program are met. VA’s National Health Physics Program (NHPP) is responsible for radiation safety oversight through a license issued by NRC and reports to VA’s National Radiation Safety Committee. NHPP has conducted site inspections at all facilities where prostate brachytherapy is performed and when a possible medical event is reported.
Enforcing program safety standards is essential to ensuring patients receive the care they require. VA, as do other health systems, relies on complementary systems of accountability to identify quality problems like these on the system and individual levels. We use multiple internal and external survey and inspection processes (e.g., Joint Commission, American College of Radiology Oncology, American College of Radiology, Nuclear Regulatory Commission, and others); patient satisfaction and complaints; and individual peer review. The deficits in this program at the Philadelphia VAMC went undetected by many of these systems for almost 6 years, and it was only the recognition of potential problems by the staff at the Philadelphia VAMC that eventually led to more in-depth investigation, review and subsequent disclosure to patients and the public.
In November 2008, VA amended the criteria for suspending a prostate brachytherapy program to require immediate suspension of any such program where medical events are discovered for 20 percent or more of patient treatments reviewed or evaluated for regulatory compliance. VA is requiring these reviews use a minimum sample size of 10 recent patient treatments or the total number of patient treatments in the last 3 years, whichever is less, for initial evaluation. If 20 percent or more patient treatments are discovered as medical events, VA requires increasing the sample size to at least 30 or all patient treatments within the last 3 years, whichever is less. If 20 percent or more of the final sample size is confirmed to be medical events, the program must be immediately suspended. Moreover, VA also requires its NHPP to inspect any report of medical events to confirm regulatory compliance and implementation of VHA standard procedures. VA will suspend any prostate brachytherapy program if the results of this inspection indicate significant program deficiencies and program suspension is deemed warranted by the National Radiation Safety Committee in consultation with the Director of the National Radiation Oncology Program and the Principal Deputy Under Secretary for Health.
In response to concerns raised by NRC and to ensure other VAMCs were performing prostate brachytherapy procedures correctly, VA completed inspections by January 2009 of all VA facilities with active programs. VA also developed and implemented standard procedures for prostate brachytherapy programs, addressing quality assurance measures and patient safety. These include the following:
VA clinical standards and procedures are now among the most rigorous in the health care industry.
Regarding future actions to prevent similar situations, VA has asked the American College of Radiology (ACR) to conduct site surveys at each facility performing brachytherapy for prostate cancer. Our goal is 100 percent accreditation of our facilities; nationally in the private sector and VA, only 15 percent of practices are accredited now. Furthermore, each facility performing permanent implant prostate brachytherapy must develop, maintain and implement written procedures based on the American College of Radiology’s “Practice Guidelines for Transperineal Permanent Brachytherapy of Prostate Cancer” and publications by the American Association of Physicists in Medicine. We are also drafting a VHA handbook for radiation oncology.
VA has used the situation in Philadelphia to conduct a comprehensive review of its prostate brachytherapy programs. Fifteen VA facilities have provided prostate implants since 2005, although two, Reno, NV and Birmingham, AL, are currently inactive without plans for resumption. Seven facilities, including Albany, NY, Boston, MA, Brooklyn, NY, Minneapolis, MN, Richmond, VA, San Francisco, CA, and Seattle, WA, are currently active and offering brachytherapy treatments. In our comprehensive review, we found these facilities have provided appropriate treatments. VA’s NHPP has temporarily suspended four programs, including Cincinnati, OH; Washington, DC; Jackson, MS; and Philadelphia because problems were found involving under-dosing. Based upon these reviews, the Cincinnati program was found to be in compliance with VA standards and is in the process of fulfilling national VA requirements for resuming prostate brachytherapy. Complete reviews of the Jackson and Washington programs continue. Problems with the treatments offered at the Philadelphia VAMC were discussed previously. The Durham, NC, VAMC has voluntarily chosen to no longer provide this procedure in-house and is providing this service through a fee-basis agreement with Durham Regional Hospital. The VA Greater Los Angeles Healthcare System in California has elected to pause its program to conduct a review of procedures, with new patients scheduled for July 2009.
Secretary Shinseki and VA’s senior leadership are conducting a top-to-bottom review of the Department and are implementing aggressive actions to ensure the right policies and procedures are in place to protect our Veterans while providing them the highest quality health care possible. It is important that our Veterans and their loved ones have faith and confidence in our medical system and in our system of care. Thank you once again for the opportunity to testify. My colleagues and I are prepared to answer your questions at this time.
U.S. Department of Veterans Affairs - 810 Vermont Avenue, NW - Washington, DC 20420
Reviewed/Updated Date: November 10, 2009