JAMES P. BAGIAN, M.D., P.E.
DIRECTOR, NATIONAL CENTER FOR PATIENT SAFETY
VETERANS HEALTH ADMINISTRATION
DEPARTMENT OF VETERANS' AFFAIRS
COMMITTEE ON WAYS AND MEANS
SUBCOMMITTEE ON HEALTH
March 7, 2002
Madame Chairwoman and Members of the Committee, I am pleased to be here today to discuss the significant challenge of improving the safety of health care delivery and particularly the approach that VA is taking to address this problem.
Inadequate patient safety is a critical worldwide problem in healthcare. In the U.S., estimates of the lives lost due to factors related to patient safety exceed that of the lives lost due to motor vehicle accidents, breast cancer, or AIDS ( IOM, To Err is Human). In order to reduce medical errors, programs must first identify the underlying causative factors so that they can be understood, and then implement effective preventive strategies. Unfortunately, most healthcare systems and regulators have not modified their tactics to focus on prevention. The systematic problems that are associated with medical errors and close calls persist; namely the belief that accountability systems and punishment are the primary and most effective means to achieve improvement in patient safety. While accountability systems play an important role in health care organizations, they cannot do all things. Albert Einstein once observed, "Insanity: doing the same thing over and over again and expecting different results." This is where we seem to currently find many individuals and organizations in their quest for patient safety improvement. Put another way - the health care system punishes providers without giving them the tools to improve patient safety.
An over-reliance on punitive accountability systems is a major stumbling block to improvement because it does not encourage identification of potential problems and provides disincentives for reporting. This state of events is not peculiar to healthcare and has been encountered by other industries. Aviation recognized that further improvement in safety could not be achieved by putting in place yet another accountability system. Instead they introduced a system whose purpose was learning, whose goal was prevention not punishment, and most importantly was viewed as both beneficial and non-punitive by the end-users or those from whom reports are sought. Today in medicine there is no dearth of accountability systems but there is a scarcity of systems that are viewed as non-punitive reporting systems.
To address these needs the VA developed and continues to implement an innovative systems approach to prevent harm to patients within VA's 163 medical centers. VA recognized that individual human behavior is seldom the basic reason for medical adverse events - adverse events are usually due to the complex interaction of known and unforeseen vulnerabilities in health care delivery. Innovations were necessary, since no one had ever instituted a comprehensive systems-oriented safety program for large medical organizations. VA combined lessons from industrial settings such as aviation and nuclear power with the theory and body of knowledge from human factors and safety engineering to fashion systems that would better contribute to prevention of unintended harm to patients. (Human factors engineering was cited by the 1999 IOM report as the discipline most often overlooked by health care when designing safety systems.)
VA implemented nationwide internal and external reporting systems that supplement the many accountability systems we already had. The new systems' sole purpose was for organizational learning. They were constructed to encourage maximal reporting of even close calls and potential problems with non-punitive methods. This was essential because without the ability to identify system vulnerabilities and to analyze their root causes for common systematic problems our ability to achieve meaningful and sustainable patient safety improvement is limited. One method VA employed to better understand how to make these systems optimally function was to first do some surveys and focus groups of both VA and external healthcare workers to better understand their concerns and the characteristics that would help make our program effective. One point that was clear concerned the issue of punitive measures. Specifically, health care providers' view of punitive actions extended beyond typical administrative punishment to include factors such as shame, embarrassment, and professional reputation. Protection from these factors, was essential if we were to receive any reports from which we could then learn and proceed to undertake improvement and prevention efforts. This information convincingly demonstrated that confidentiality is pivotal to assuring the non-punitive intent and potential of your learning system to the personnel from which you wish to receive reports.
The importance of confidentiality has been shown in many safety systems ranging from military aviation safety programs to the NASA - Aviation Safety Reporting System ( ASRS). The ASRS program and its success have been cited in numerous venues including the IOM Report 'To Err Is Human.' For more than 25 years, the ASRS has handled over 500,000 reports without compromising the confidentiality of its reporters. Maintaining this level of trust has been essential to allowing the ASRS to identify problems and systems vulnerabilities that were subsequently dealt with, which otherwise might have resulted in catastrophic events. There are also examples of other aviation safety systems patterned after the ASRS, such as the one in New Zealand, that were initially successful until they divulged the identity of a user resulting in the cessation of reporting and effectively the end of their system. In fact, after the passage of several years they tried to re-establish their system but failed to do so due to their inability to ensure that confidentiality would be maintained. This experience demonstrates that once trust is violated it can be extremely difficult or impossible to restore. Ultimately, public safety suffers because problems cannot be identified early and corrected.
Confidentiality is the common element that enables a safety system to be effective. It is important to recognize that making patient safety information confidential does not deprive any of the pre-existing internal or external accountability systems of information that they require. The two systems are mutually independent, that is, data reported and developed in the course of a patient safety activity is in addition to, separate, and apart from events identified to oversight reports. Voluntary reports on close calls and other problems would not otherwise exist were it not for a confidential system. Currently, the statutory protection for this type of information varies from state to state and does not permit the confidential and privileged sharing of information across state borders. Confidentiality for patient safety information, if uniformly available, will facilitate the sharing of information between institutions in a particular locale as well as on a national basis. Without it, the fear of shame, embarrassment, and other punitive measures stands in the way of dissemination of information that will improve the quality and safety of health care and benefit patients everywhere.
Experience in the VA system has shown that reporting of events and especially close calls increased dramatically after clear definitions were enacted as to what constituted a confidential patient safety issue. This has resulted in the identification and mitigation of system vulnerabilities not just within the VA system but globally. Without confidentiality the same results could not have been achieved.
Interest in improving patient safety is at an all time high. Very early, VA identified improved patient safety as a high priority. Our systems now serve as benchmarks to be emulated by others. We are proud of our accomplishments, however, there are numerous other methods and approaches that are currently in use, being developed, or are being contemplated. As more experience and data emerge from these activities it will be possible to identify safe practices that can be universally applied for patients' benefit. Uniform, unambiguous, and assured confidentiality of patient safety information is essential for these efforts to flourish. We must approach patient safety in a way that emphasizes and celebrates prevention, not punishment.
Thank you for the opportunity to appear before the committee. I will be pleased to respond to your questions.