| Testimony of Donald Berwick, M.D.
Member Committee on the Quality of Health Care in America Institute of Medicine before the Subcommittee on Health of the Committee on Veteran's Affairs and the Subcommittee on Health and the Environment and the Subcommittee on Oversight and Investigations of the Committee on Commerce U.S. House of Representatives February 9, 2000 Good morning, Mr Chairman and distinguished members of the three Subcommittees. My name is Donald M. Berwick. I am a pediatrician and President and CEO of a non-profit education and research organization called the Institute for Healthcare Improvement, and also Clinical Professor of Pediatrics and Health Care Policy at the Harvard Medical School. For the past two years, I have served on the Institute of Medicine's Committee on Quality of Care in America, which is the group that issued the report on patient safety, To Err Is Human. The patient safety report is the first in a series. The Institute of Medicine Committee on Quality of Care in America is continuing its work, and will this year issue several further reports and recommendations on how to address serious deficiencies in the quality of care. We chose to report on improving safety first, because it seems so fundamental and urgent. I must say that I hope our future reports will get as much attention as this one has. In the next few minutes, I would like to summarize the findings of the IOM Committee, and then to point out specific implications for Federal action. Our report has six key findings, First, we find that American health care is unacceptably unsafe today. Between three and four percent of hospital patients are harmed by the care that is supposed to help them. Out of every 100 hospitalized patients, seven are exposed to a serious medication error that either harms them or could have harmed them. We estimate that between 44,000 and 98,000 Americans die in hospitals each year as a result of errors in their care. If the actual number is 44,000, this is the eighth leading cause of death in America. If it is 98,000, errors are the fourth leading cause of death. We note that almost all the information on safety that we have is about hospitals; we know far too little about other areas of care, like nursing homes, home health care, office based care, ambulatory surgery, and so on. Our Committee suspects that hazards in these areas are also common. Second, we find that errors and threats to patient safety are generally not due to flaws like carelessness or incompetence in individual doctors, nurses, and other workers. People don't want to make errors, and they try hard not to. The vast majority of errors in medical care -- perhaps 95% to 98% -- are what we call "systems errors," by which we mean that they are characteristics of the equipment, procedures, job designs, communication systems, and so on that support safe work, or ought to. Put another way, if we simply fired every health care worker who was involved in errors, and substituted a new person, our future error rates would not change at all. Blame won't help. Only system changes can help. One implication of a systems view of error is that responsibility for safety lies with the people who organize and run those systems -- executives, clinical leaders, Boards of Trustees. It is they, and not the individual doctors and nurses, who can do the most to make patients safer. Third, our report finds that we can do something about safety. There is a long history of great scientific research on causes of errors and ways to prevent them. Other industries rely on these sciences -- human factors engineering, human psychology, industrial engineering, and others -- to make their systems safer. Health care has not done so. Our Committee believes that, if we get smart about using what we know about safe designs, we can make patients much safer immediately. If we go further, and organize the right research on safe designs for health care, we can drive hazards to even lower levels. As a national target, we suggest for starters that we aim for a 50% reduction in patient injuries from health care over the next five years. Fourth, we find that improving safety will require cultural change in health care. To reduce errors, health care needs to know about and discuss its own errors. Today, we generally don't do that. We have good research that shows that doctors, nurses, and others in health care are frightened to reveal the errors they see and know about, whether patients are harmed or not. As a result, many health care organizations sincerely believe their error rates to be far lower than they actually are. The problem has been driven underground because people are afraid to talk about it, and therefore health care has trouble learning about hazards and preventing them. Contrast that with the aviation industry, which has made a serious effort to create a culture of safety, in which reporting errors is rewarded. The voluntary Aviation Safety Reporting System, run by NASA for the FAA, collects over 30,000 reports a year from pilots, air traffic controllers, and others. The people making these reports know that they will not be punished in any way for revealing problems, and, in fact, if there was no criminal activity or serious injury, the very act of reporting protects them legally from possible prosecution or punishment. We still have plane crashes, but aviation is 10 to 20 times safer today that a few decades ago, because it has information on its hazards. Our Committee recommends widespread use of blame-free reporting systems, much like ASRS, by organizations and, where helpful, others. This would be a major change from the status quo. But, we think, voluntary reporting systems are not enough. We find widespread distrust by the public in the lack of transparency of the health care system today. The public thinks we are hiding our flaws from them, and, in some ways, we are. To improve public trust, we make a fifth recommendation -- that all health care organizations should be required to report to state officials some forms of patient injury -- a limited number of serious sentinel events, such as unexpected deaths, wrong-side surgery, and deaths from medication errors. In fact, we think that about 22 states have some form of mandatory reporting already, but these state systems at the moment lack consistency in definitions and reporting methods, and therefore we have a lot of trouble learning from the reports. In addition, few states have invested anything like the needed resources in analyzing the reports they get. The aviation system assigns highly experienced pilots to reviewing those 30,000 reports, and that is why ASRS can learn so much. We are not recommending a large Federal bureaucracy. We recommend only that the Federal government establish some standards for mandatory reports of sentinel events to states. We also do not think that mandatory reports should identify individual doctors and nurses; these would be reports by organizations to states that events have occurred and what is being done about them. We know that our recommendation for mandatory reporting is controversial. If we overdo it, then a severe mandatory system could chill the development of the more important voluntary systems. On the other hand, we do not think that a voluntary system, alone, is sufficiently responsive to the public's concerns about accountability. We need to find the right balance between a system for learning -- which has to be voluntary -- and a system for public accountability -- which has to have mandatory elements. Our sixth recommendation is for a research, development, and communication center -- a National Center for Patient Safety -- to accelerate our learning and spread of good ideas about improving safety. We don't have anything like that now, and, as a result, we have neither an organized national research agenda nor an easy way to let hospitals and health care systems learn about how to get safer. Aviation has the NASA-Ames center, which includes some of the best research in the world on aviation safety. Our Committee recommends an initially modest investment -- $35 million -- in such a Center, and our initial suggestion is that the Agency for Health Care Research and Quality may be a good home for it. To summarize our findings, especially with regard to helpful Federal actions, we recommend: 1. A firm national commitment to improving patient safety dramatically and promptly; 2. Funding of a National Center for Patient Safety at an initial level of $35 million per year; 3. Federal standards for minimum content and format for mandatory reporting of a very limited number of sentinel events by organizations to states; 4. Extension of peer review protections to voluntary error reporting systems developed by health care organizations; 5. Annual reports by the Agency for Health Care Research and Quality on the state of patient safety in America, to track our progress. I would like to make two final personal comments that go beyond the findings of the IOM Committee. First, discussions of mandatory reporting have focused largely on the need for reports by organizations to state agencies. I think there is an additional mandatory reporting issue that the IOM did not address, but that is equally important; namely, the requirement that organizations inform patients and families of serious injuries and errors in their care. Most people in health care would regard this as an ethical duty, but, in fact, we do not have evidence that this happens routinely. I think we need to promise and assure that this happens. The Veterans Health Administration does have such a mandatory standard, and I think it ought to be a model for us all. Second, the IOM Committee did not have the time or resources to explore the knotty problem of malpractice liability and tort reform. Many in health care say that the threat of malpractice suits makes secrecy necessary, and keeps organizations and individuals from talk openly about errors. To some extent, this is simply an excuse to avoid tackling the problem of safety; I know that because there are now many organizations that have begun to change their internal cultures without any change in the tort system. On the other hand, I believe strongly that movement toward a no-fault malpractice litigation system would help increase safety-oriented activity immediately. Furthermore, if we really believe that most patient injuries come from systems, not individual people, then we ought to fix the responsibility where it belongs: with health care organizations and enterprises. I have been working on quality of care issues for over two decades, but I have never before seen such a tremendous opportunity for improvement as we now have due to public attention to the issue of patient safety. If we act promptly and with courage, literally millions of future patients will be saved the pain and risk of injury from errors in their care. Thank you for this opportunity to testify. I would like my statement put in to the record. I would be happy to answer any questions the Committee may have. Back to Witness List |