Washington D.C., June 15, 2006 - Congressman Mike Bilirakis (R-FL), Chairman of the House Veterans’ Affairs Subcommittee on Oversight and Investigations, today held a hearing on monitoring patient safety at VA Medical Centers (VAMC). This hearing focused on the recent events at the James A. Haley and Togus VA Medical Centers in Tampa, Florida and Augusta, Maine respectively.
In March, Bilirakis released a statement in response to the VA’s IG report which identified failures in patient safety standards at the James A. Haley VA Medical Center. Surgeons at the Haley VAMC implanted an unsterilized cranial plate in a patient in February 2006 and nearly duplicated the mistake a week later. The subcommittee learned of a similar case of improper sterilization of a medical device at the Togus VA Medical Center in Augusta, Maine.
The James Haley Medical Center is the busiest VA hospital in the country serving 148,000 patients, and is one of four "polytrauma" units that specialize in treating injuries caused by improvised explosive devices, common in Iraq.
Testimony on the credentialing and screening of medical personnel and the VAIG Combined Assessment Program Reviews (CAP) from 2004-2006, which evaluated selective operations at some VA medical facilities, was also considered in the hearing.
The following is the text of Congressman Bilirakis’ remarks:
Good morning, ladies and gentleman, and thank you for being here as we discuss an important aspect of healthcare: patient safety. Today, we will discuss oversight of patient safety at Department of Veterans Affairs’ medical facilities. This review of patient safety comes to us, not only as part of the Subcommittee on Oversight and Investigations’ agenda, but in the wake of problems identified at two VA facilities.
Surgeons at the James Haley VA Medical Center in Tampa, Florida, implanted an unsterilized cranial plate in a patient in February 2006 and nearly duplicated the mistake a week later. At another facility in Augusta, Maine, it was determined that a transrectal ultrasound transducer was improperly sterilized and cleaned following medical procedures. It is my understanding that this incident was not a one time occurrence but happened repeatedly over a number of years and that unclear instructions contributed to the sterilization problems.
Thankfully, we are unaware of any patients that were harmed in these incidents. These medical devices and other versions of them are used in VA facilities across the country. The VA had great difficulty identifying the extent of the veteran patient population that may have been exposed to these inadequately sterilized devices. Furthermore, the VA was less than expeditious in notifying this exposed population.
Since these medical devices are not unique to the VA health care system, we have asked the Food and Drug Administration to share with us what it has done to notify the entire U.S. health care delivery system of these patient safety implications.
Not only will we discuss the safety of medical devices that assist in patient care, but we will hear about the proper screening of VA Medical Center employees, to include physician credentialing and privileging. In addition, we will review VA’s policy and safeguards on hiring convicted sex offenders to work in the VA and examine the implications for patient safety and VA employees.
Today, we will hear testimony from Dr. James Bagian (Bay gin), Director for the VA National Center for Patient Safety who is here to discuss the situation of properly handling medical devices in VHA facilities. Dr. Bagian is accompanied by Dr. Lawrence Deyton (Day ton), the Chief Public Health & Environmental Hazards Officer for the Veterans Health Administration.
From the Office of Inspector General, Dr. John Daigh (Day), Assistant Inspector General for Healthcare Inspections, is here to share the IG findings on the medical device situations and on other patient safety issues found at VA Medical Centers.
Additionally, Dr. Daniel Schultz (Shults), Director of the Center for Devices and Radiological Health at the Food and Drug Administration, is here to share FDA procedures on approval of medical devices and how concerns are reported and handled.
Finally, we have Laurie Ekstrand, Director of Health Care for the U.S. Government Accountability Office, to discuss the credentialing and privileging of medical professionals at VHA facilities.
I look forward to hearing the testimony and the answers to Member’s questions.
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