Mr. Chairman and Members of the Subcommittee, I am here today to discuss my office’s efforts in overseeing and reporting on the issue of patient safety within the Department of Veterans’ Affairs (VA). The vast majority of Department of Veterans Affairs employees who are engaged in patient care activities are well-trained, dedicated, and compassionate individuals who are devoted to providing high-quality, safe patient care to eligible veterans. We have noted that the Veterans Health Administration (VHA) is aggressively supporting these employees’ efforts by establishing a National Center for Patient Safety (NCPS). In October 1999, the NCPS staff began providing nationwide training for VHA quality managers and senior clinicians on how to critically evaluate and identify the root-causes of serious patient incidents that occur in the course of medical treatment. The root-cause analysis process will ultimately evaluate aggregate patient incident data on events that occur frequently, such as medication errors, patient falls, and suicidal-related events. Once clinicians are able to identify the root-causes of an adverse event, they will be better prepared to formulate measures to reduce the possibility that similar incidents will recur. The initial training will be completed in August of this year, and I understand that the NCPS plans to present similar training once each quarter to ensure that all VHA employees who engage in quality management activities are trained. We salute the VHA employees who strive to provide safe patient care, and we commend the NCPS’ efforts to provide training that should ultimately result in a reduction in the number of adverse patient events.

In spite of VHA employees’ efforts to provide safe patient care, recent Office of Inspector General (OIG) investigations and inspections have uncovered instances in which some health care providers have ignored or circumvented established policies and procedures that have led to direct or potential patient harm. Even more alarmingly, some employees have engaged in criminal behaviors that have seriously harmed some patients, and may have caused other patients’ deaths. The OIG has raised these issues and concerns with the Secretary of Veterans Affairs and with the Acting Under Secretary for Health in several reports and in a report of the deliberations of an OIG Medical Evidence Working Group.

Perhaps the most disconcerting part of our findings and Working Group deliberations is that many of the serious events that occur involve severely debilitated or otherwise compromised patients. It is the caregivers’ responsibility to take extra precautions to protect these patients, because when controls are absent or break down, vulnerable patients can be harmed.

The OIG’s Office of Healthcare Inspections (OHI) is currently completing a report that discusses its findings and conclusions regarding the manner in which VA Medical Center employees assess debilitated and mentally infirmed patients’ levels of risk for eloping or wandering away from the treatment environment. The report also discusses the effectiveness of VHA’s methods to protect high-risk patients, and the effectiveness of patient search procedures. The missing patient data that the report discusses comprises all recorded missing patient episodes that occurred during fiscal years (FY) 1998 and 1999. We initiated this nationwide evaluation because we became aware of a series of tragic events in which patients wandered away from their treatment locales and were later found dead by VA employees or local citizens. Inspectors validated the data, and conducted focused reviews at 11 randomly selected VA Medical Centers during FY 2000. Our work shows that VHA managers are taking the issues of patient elopement and subsequent patient searches seriously, and that several medical center executives have initiated innovative procedures to more strongly protect these patients’ safety, and to reduce the frequency of patient elopements. Nevertheless, my OHI inspectors will make recommendations that are aimed at strengthening protection of these patients nationwide in the forthcoming report.

My staff pointed out in a 1999 report, that VHA employees did not always report serious patient incidents when they occurred, nor did they initiate formal investigative actions. In two separate cases that my inspectors reviewed, severely debilitated patients, whom employees had secured to their beds with the use of soft vest restraint devices, had slipped from their beds. Both patients had apparently been strangled by the soft restraints that had been intended to keep them safe. In another instance, a similarly debilitated patient partially fell out of his bed, and became wedged between the mattress and the siderails, resulting in his apparent suffocation. In two of these three cases, employees who were directly involved in the patients’ care failed to report the incidents to medical center managers, and the events did not become known until other employees reported the incidents to the local media. In the third case, employees reported the incidents, but did not accurately or completely report all of the circumstances surrounding the incident to the investigative panel. The effect of these failures to provide full and open disclosure of patient care incidents severely impedes managers’ ability to fully examine the incidents in order to determine their true causes, and to address and correct those causative factors in order to prevent similar incidents from recurring.

There are several theories as to why employees don’t report serious patient care events when they occur. One of these theories is that employees fear the potentially career-threatening disciplinary actions that managers may impose on individuals who have been implicated in such events. Another theory suggests that caregivers are themselves so devastated or embarrassed by the consequences of a possibly careless act, that they may attempt to hide the fact that the incident occurred, or obscure the surrounding circumstances in order to shift the blame from themselves. Whatever the reason for employees not fully and openly disclosing such events, VHA managers, need to continue to emphasize this very important issue, and encourage employees to report each incident that occurs.

A series of untoward patient care events that involved alleged criminal actions on the part of certain caregivers led the OIG to develop suggested procedures for VHA managers and clinicians to follow to immediately secure evidence and preserve potential crime scenes when patients die suddenly or unexpectedly. To this end, in the summer of 1999, the IG convened a panel of OIG and external experts to review the related problems and to develop suggested guidelines that VHA managers could follow to strengthen law enforcement officers’ ability to properly and effectively investigate possible criminal patient care activities, and to pursue prosecutions when such action is indicated. In our report dated November 22, 1999, we advised that VHA needed to focus on its procedures for reporting incidents of sudden, unexpected deaths, and on preserving evidence that is indispensable to determining what actually happened to the patients in these incidents. We also advised that VA personnel do not always consider as potential crime scenes the areas in which sudden, unexpected deaths or other serious patient incidents occurred. The lack of appreciation of this factor’s significance has impeded VA’s ability to answer the basic question of "what happened?"

VHA managers and General Counsel also need to clarify the standards as to when sudden, unexpected deaths must be reported to law enforcement authorities, and to update and clarify law enforcement jurisdictional issues so that managers and employees will know without delay what agency to contact while the potential evidence is fresh. Finally, we informed the Secretary and Acting Under Secretary for Health that VA needs to review its regulations and policy as to whether the VA can compel an autopsy and associated scientific/medical tests in the event of a possible homicide, suicide, unexpectedly fatal illness, or unexplained deaths. VA’s autopsy regulation is silent on the issue of obtaining an autopsy when the family refuses consent. Under the current regulation, there is no guarantee that clinicians can perform forensic autopsies when patients die suddenly and/or unexpectedly, because the facility Director’s discretion to order an autopsy is limited to only those rare occasions of abandoned bodies or in which families fail to respond after a patient’s death. We provided the Secretary with three other Federal statutes that might serve as models for changing this VA regulation. We also provided the Secretary and the Acting Under Secretary for Health with recommendations to aid employees in doing a better job of identifying, reporting, and preserving evidence in all cases of sudden, unexpected patient deaths in VA facilities. The Acting Under Secretary informed us that VHA has created a work group to address these issues.

In October 1999, my office initiated cyclic reviews of VA medical facility operations entitled Combined Assessment Program (CAP) reviews. In the course of conducting these CAP reviews, OIG healthcare inspectors and auditors systematically evaluate the effectiveness and comprehensiveness of the facility’s quality management activities and patient safety assessment procedures. In addition, healthcare inspectors examine a range of health care activities that test controls that managers have established to ensure that all patients are receiving safe and appropriate patient care. Several CAP reviews have identified staffing shortages or staff distribution irregularities that have the potential to threaten the delivery of safe and adequate patient care, and in each of these cases, managers have ensured us that they would address and correct these problems. Inspectors and auditors have also identified issues in which local clinicians had stopped making required evaluative visits to contract community nursing homes and State Veterans Homes. Instead, they were simply reviewing other agency reports as a basis for ensuring that veterans who the facility had placed on contract care were receiving safe and appropriate care. We advised local managers of the VA requirement to conduct these inspections, and in each case, they indicated that they would do so. During future CAP reviews, we plan to examine the medical centers’ and affiliated Universities’ procedures for conducting pre-employment evaluations and certifying prospective employees. We also plan to test the NCPS’ success as part of the CAP reviews, by evaluating employees’ performance and actions taken on root-cause analyses, and their success in evaluating aggregate patient incident data on frequently occurring events.

Mr. Chairman, this completes my statement. I will be pleased to answer any questions that you or the Members of the Subcommittee may have on this subject matter.