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Gerald M. Cross, M.D., FAAFP

Gerald M. Cross, M.D., FAAFP, Veterans Health Administration, Principal Deputy Under Secretary for Health, U.S. Department of Veterans Affairs

Good morning, Mr. Chairman and members of the Subcommittee. Thank you for the opportunity to discuss the reports from VA's Office of the Inspector General (OIG) and the Office of the Medical Inspector (OMI) regarding surgical care provided at the Marion, IL VA Medical Center (VAMC). I am accompanied by Ms. Kate Enchelmayer, Director of Quality Standards, Dr. John Pierce, Veterans Health Administration (VHA) Medical Inspector, Nevin Weaver, VHA's Director of Workforce Management and Consulting, and Paul Hutter, VA's General Counsel. These reports were issued yesterday and I understand the Committee has already received them. As the Committee members know, these investigations yielded troubling news.

Last year, VA provided treatment to almost 5.5 million veterans, the vast majority of whom received exemplary care. The events at Marion represent an unfortunate exception to our established record of high quality care. As part of that care, the VA review process detected the problems at Marion, and our response has been sure and swift. Our Department is committed to continually improving our care to make the VA health care system a model of excellence for health care around the world. VA is determined to do the right thing for our patients and their families.

In that spirit, I will now outline VA's initial response to the problems VA identified at Marion, the conclusions of the two independent investigations, and our subsequent actions.

The Marion VAMC opened in 1942 and now provides care to almost 44,000 veterans annually. The Marion VAMC serves 27 counties in southern Illinois, eight counties in 1 southwestern Indiana, and 17 counties in northwest Kentucky. It is a general medical and surgical hospital that operates 55 acute care beds. The last full survey by the Joint Commission was completed on August 31,2007. There were no major issues identified, and the Marion VAMC was re-accredited.

The National Surgical Quality Improvement Program (NSQIP) gathers aggregate data from surgical outcomes to determine whether there are significant deviations in mortality and morbidity rates for surgical procedures. VA developed NSQIP almost 15 years ago as part of our effort to monitor and improve the quality of surgical care. The American College of Surgeons (ACS) has incorporated its own version and now enrolls new private sector hospitals in the ACS' program. VA's NSQIP feeds back mortality and morbidity data on a quarterly basis to VA Surgical Chiefs, Directors, and VISN CMO's. Beginning in Fiscal Year 2007, the National Director of Surgery of the NSQIP Executive Committee reviews NSQIP information on a quarterly basis. Prior to that time, the information had been reviewed by the board yearly. It was decided that NSQIP would be a better tool if the data were acted upon more frequently. This was reinforced when our NSQIP data was evaluated after the onset of this new timing.

For Fiscal Year 2006 (FY06), there were fewer surgery-related deaths at Marion VAMC than statistically predicted by NSQIP, suggesting surgical performance was acceptable. Questions about the quality of care at Marion first arose in April 2007, when NSQIP data became available to facility leadership at Marion for the first quarter of Fiscal Year 2007 (FY07). The data revealed the number of deaths during and after surgery between October and December 2006 were significantly higher than NSQIP statistically expected.

On April 26, 2007 the 151Quarter FY07 data became available to the facility's parent organization, the VA Heartland Network Office in S1. Louis (VISN 15). In early May, the Network's Chief Medical Officer discussed the data with the Marion director, who agreed to review the data by asking Marion surgeons to conduct additional internal peer reviews. On May 22, the director provided the Chief Medical Officer with the results of the peer reviews conducted by the hospital, which concluded surgical performance was acceptable.

In July 2007, the Network and the facility received NSQIP results from the second quarter of FY07, indicating there had been two additional reportable1deaths between January 1 and March 31. On August 10, the Network learned of four more surgery­related deaths and one of the hospital's three general surgeons notified the Director he intended to resign. The Network initiated additional peer reviews, this time by VA physicians from outside the facility. In addition, they notified the NSQIP executive committee.

On August 15, 2007 the VA NSQIP Executive Committee told Marion they would conduct an urgent site visit. As a result of the findings of their August 29 and 30 visit, NSQIP's Executive Committee recommended suspending major surgeries at the hospital, pending a more comprehensive investigation; the facility director agreed. After NSQIP verbally briefed the Under Secretary for Health, he immediately directed the Office of the Medical Inspector to investigate the situation at Marion.

The Medical Inspector's initial investigation took place on September 5 and 6, and he briefed the Under Secretary on September 10. The Medical Inspector recommended continuing the suspension of major surgeries, due to serious concerns regarding the facility's surgical care capabilities. On the same day, the Under Secretary also requested the Medical Inspector continue its review and asked the Inspector General to begin an independent investigation of its own. VA briefed the staffs of the House and Senate Veterans' Affairs Committees on the Medical Inspector's findings on September 13.

On September 14, a new leadership team took charge of Marion. The Under Secretary reassigned the Hospital Director and Chief of Staff to non-supervisory, restricted 1 Mortality Reportable deaths: All deaths within 30 days including preoperative, intraoperative and other postoperative occurrences prior to death. (American College of Surgeons: National Surgical Quality Improvement Program) administrative duties outside the hospital and placed the Chief of Surgery and an anesthesiologist on administrative leave.

The reports of the Inspector General and the Medical Inspector agree that surgical patients were harmed because patients received substandard care at the Marion VAMC. According to the Medical Inspector, out of 7,949 procedures conducted over a period of two years, nine surgical patients died as a result of substandard care. Thirty­four additional patients who had a procedure also received substandard care, which complicated their health issues; while ten of these surgical patients died, the Medical Inspector did not determine that substandard care caused their deaths.

In parallel with the completion of the reports by the Inspector General and the Medical Inspector, VA has conducted checks on the credentials of every member of the hospital's medical staff. One surgeon failed to disclose a previous license and was fired. VA learned about this license, as well as an action against it, during a re­privileging review. The anesthesiologist placed on administrative leave has since resigned. VA has alerted the appropriate licensing authorities about the anesthesiologist and the surgeon who resigned in August. The surgeon who was fired in January is still within a 3D-day appeal period, so VA is unable to make a report until that time has expired. Investigators examined the quality-management program and other concerns raised by employees regarding human resources, labor relations, and the environment of care.

Both the Inspector General and the Medical Inspector identified the same four areas as contributing factors to the decline in Marion's quality of care: facility leadership, quality management, privileging, and credentialing.

The Inspector General concluded significant warning signs were available such that the leadership of the Marion VAMC should have recognized them and intervened before others discovered these problems. According to the Inspector General, much of this information was not disseminated to other VHA managerial entities, including the Network Office in 81. Louis or Central Office in Washington, D.C.

Both reports found that reviews of the quality of care, including the facility's peer reviews, were not complete and thorough. Additionally, trends in patient deaths at the hospital, which VA requires all medical centers to monitor, were not adequately evaluated, preventing the facility from properly addressing these problems in a timely manner.

VA requires that its physicians be credentialed and privileged regularly. This information is verified through the National Practitioner Data Bank, other databases, and additional sources containing information on disciplinary actions taken against a physician's state medical license or a physician's competence.

VA physicians must complete a written request for clinical privileges for review by their supervisor, who considers whether the physician possesses the appropriate professional credentials, training, and work experience to successfully perform the procedures for which they have requested privileges. Every two years, or more frequently if circumstances dictate, supervisors are required to review information on each physician's performance, including surgical complication rates, and to decide whether or not to renew a physician's clinical privileges.

Both the Inspector General and the Medical Inspector found cases where surgeons performed procedures with little or no documentation of their competence. When granting privileges, supervisors did not conduct full evaluations; rather, they relied on privileges granted by a previous, non-VA facility without adequately considering objective measures of past performance and outcomes.

These reports also criticized the facility for permitting surgeries more complex than the facility could accommodate based on its staff and capabilities. There was not adequate staff coverage in areas critical to managing surgical complications, including respiratory therapy, pharmacy, and radiology.

Staff at the Marion facility also failed to pursue adequately questions regarding one surgeon's credentials that arose after the surgeon was hired. This information became available through an alert from the Federation of State Medical Boards.

VA is closely examining each of these areas, not only at Marion but throughout the Department's health care system, to ensure no other facilities share these issues and to prevent them from developing anywhere else. We assembled a work group to review the process by which peer reviews are handled within the Department. Yesterday, the Under Secretary signed a new directive setting forth new requirements on the manner in which physicians will conduct peer reviews at all facilities while calling for external and independent reviews when appropriate.

Similarly, we are reviewing our credentialing and privileging processes, and will increase our vigilance to ensure the information provided by our physicians is valid and complete. Yesterday, VA initiated an Administrative Board of Investigation to review quality of care issues and the conduct of individual employees at Marion. The Board

will consist of senior VA employees from other facilities and networks: three physicians, two human resource specialists, and an information technology expert. The Board is empowered to recommend specific disciplinary actions against individuals. For now, VA is continuing its suspension of major surgeries at Marion.

It is important to note the Inspector General's and the Medical Inspector's reports are based on external peer reviews of the written records of surgical cases in the Department. The staff at Marion has not yet had the opportunity to provide information, but they will be given this opportunity by the Administrative Board.

VA has begun notifying all patients and family members of patients who we believe may have been harmed by the events at the Marion VAMC. We will provide them a thorough and honest assessment of their care, and will offer follow-up assistance as appropriate. We will also help them develop and file, as appropriate, any claims they may have related to improper or insufficient care at the Marion VAMC. A toll-free number has been established for those with questions about the notification process. Marion patients requiring surgery will, as appropriate, either be transferred to the 8t. Louis VA Medical Center or, if 8t. Louis does not have the capacity or the patient cannot travel, VA will contract for care in the community.

Let me close with VA's sincere apologies to all who received substandard care at Marion, to their loved ones, to the Marion community, and to all of America's veterans and their families. We understand our unique role in upholding two sacred trusts ­physicians' responsibility to instill confidence in their patients and provide the best care possible; and our nation's duty to honor and care for those who have served so nobly to defend it. We are determined not only to correct the problems we have uncovered, but to make Marion and all our facilities a model for health care excellence across the country and the world.

Thank you again for the opportunity to appear here today.