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MAY 24, 2001

Good morning, Mr. Chairman and members of the Committee. I am honored to appear before you today to discuss the important issue of reducing medical errors and improving the safety of the health care services that Americans receive.

I would like to commend you, Mr. Chairman, and your colleagues for the role that you have played in helping to focus attention on this issue and for your commitment to finding solutions to what is by any estimate one of the leading public health challenges that we face today. Your leadership in this area has constituted a vital service to the Nation and will be critical as we move forward in this endeavor.

For the most part, the findings described in the Institute of Medicine=s (IOM) landmark November 1999 report, To Err is Human: Building a Safer Health System, are no longer front-page news. But the findings are no less serious, and they present no less of a challenge for all of us who care deeply about the quality of our Nation=s health care system and the lives of the people who are affected when mistakes occur.

Another report released by the IOM in March 2001, Crossing the Quality Chasm: A New Health System for the 21st Century, has served as a reminder of what the 1999 errors report made clear. A wide gap exists in the quality of care people receive and the quality of care that we as a Nation are capable of providing. And, most troubling of all, too many people in the United States are harmed or lose their lives as a result of the health care services that they receive.

While the statistics are familiar, they bear repeating: according to the IOM report, between 44,000 and 98,000 Americans die each year as a result of medical errors, making them the 8th leading cause of death in the United States. More people die from medical errors than from automobile accidents, breast cancer, or AIDS. Further, the report suggests that medical errors result in approximately $29 billion in excess health care expenditures and lost productivity each year.

While there has been some debate about the numbers in the errors report, I think we can all agree that no matter whether it is 44,000, or 98,000, or some other number B it is too many. I think we would also agree that these errors are not solely the fault of individual doctors, nurses, and other clinicians. I believe that our health care workforce is comprised of the most talented and dedicated professionals in the world. Rather, these errors are the result of systems of care that are not adequately designed to prevent errors and their consequences.

As a result, this is not an issue that individual doctors, nurses, and other clinicians can fix by themselves. In fact, it is not an issue that any one group alone can fix B whether it is the Congress, the Administration, the States, oversight organizations, health professional groups, large purchasers of health care services, or patients themselves. We will only arrive at a solution if all of us who have a stake in the system agree to tackle medical errors together.

I want to assure you, Mr. Chairman and members of the Committee, that this Administration stands ready to do its part and is committed to continue working with you and others to address this issue. The IOM errors report provided a number of important recommendations that we have taken into consideration in deciding what the Administration and the Department of Health and Human Services, in particular, should be doing in this area.

Those recommendations addressed what can be done to improve safety at the clinical level, where care is provided, and they also addressed what we who are responsible for setting the policies and regulations governing the health care system can do to improve health care safety. In particular, the report highlighted the need to establish a national focus to create leadership, research, and tools to enhance the knowledge base about safety; to identify and learn from medical errors through mandatory and voluntary reporting systems; to raise standards and expectations for improvements in safety through the actions of oversight bodies, group purchasers, and professional organizations; and to implement safe practices at the delivery level.

Since the IOM errors report was issued, there have been broad discussions about what steps need to be taken, and policy makers and industry leaders have agreed that more research is needed to help us expand our understanding about when and how errors occur. We need to evaluate what is most effective in reporting about errors and specific interventions to improve patient safety, as well as what kinds of activities will best support these interventions. It is also essential that there be close collaboration among all of the interested public- and private-sector groups, the States, and the many Federal agencies involved in patient safety activities.

Effective solutions will be the ones that are based on changes in systems B not just individuals. I believe that the first step is to facilitate the collection and analysis of information that will help providers and others learn from the safety problems identified so that they are not repeated. As noted in the IOM errors report, the second step is ensuring that the members of the public receive the information they need about the safety of the health care system, and that those organizations with oversight responsibilities receive the information that they can use to carry out their designated functions.

Further, it is critically important to find ways to encourage the implementation of what we know from research will improve patient safety practices in hospitals, clinics, nursing homes, doctors= offices, and other settings. To achieve this goal, it is critical for all of these organizations to develop their own internal processes and activities for addressing their particular safety problems. Only organizations in which providers and staff are freely able to review, analyze, and discuss the specific factors that prevent patients from getting the safest and best possible care in their institutions will be able to identify opportunities to change their system to remedy the problems.

Reducing medical errors and improving patient safety is not simply about what doctors, nurses, and other clinicians do or don=t do when they treat patients. Reducing medical errors and improving patient safety is about all of us who have a role to play exercising commitment and leadership in this area, and in the case of patients, helping them to take an active role, too.

There are many current HHS programs to achieve these aims and the President=s budget request of $72 million for HHS for medical errors and patient safety -- an increase of $15 million over FY 2001 -- will strengthen these current activities.

What are our current activities? To build the research base about when and how errors occur, the Agency for Healthcare Research and Quality (AHRQ) is presently investing its FY 2001 appropriation of $50 million for new patient safety research. This research will support large demonstrations in states, health care systems, and networks to test reporting strategies and patient safety interventions; help develop and test the use of appropriate technologies to reduce medical errors, such as hand-held electronic medication systems; and increase our understanding of how the environment of care affects the ability of providers to improve safety.

The Centers for Disease Control and Prevention (CDC) is pursuing a number of patient safety initiatives, including the National Electronic Disease Surveillance System (NEDSS). NEDSS will electronically link data collected by private-sector health care organizations and public health departments. It can serve as a model for how to increase efficiency, volume, accuracy, completeness and timeliness of reporting and exchanging information. In FY 2000, CDC provided funding for 14 States to develop NEDSS systems. CDC has also provided funding for 32 States and three large metropolitan areas to assess their current health information systems and to determine how they can implement NEDSS specifications and standards. The FY 2002 Budget includes an increase of $2 million for CDC to collect more information on hospital acquired infections.

The Food and Drug Administration (FDA) also has several initiatives underway to improve patient safety. For example, the FY 2002 Budget includes an increase of $10 million for the FDA to improve and respond to data collected on adverse events. FDA is working to improve labeling and packaging standards to reduce the chances of clinicians confusing drugs with similar names, making dosage errors, and in causing adverse interactions between drugs. In addition, the FDA is requiring all registered blood establishments to report any event associated with biologics, including blood, blood components and source plasma that represents a deviation in manufacturing. FDA has also been piloting a program to educate and encourage hospital personnel to accurately identify and report injuries, deaths and close calls associated with medical products.

Further, as you are aware, the Health Care Financing Administration (HCFA) already contracts with the Peer Review Organizations (PROs) in each State to improve the quality of care and reduce errors through the collegial dissemination of best practices. However, HCFA is also developing the Medicare Patient Safety Monitoring System (MPSMS) to assure the public that rates of hospital adverse events are being scrutinized.

There are also a number of activities underway to help foster greater collaboration between Federal agencies, and between the Federal government and the public- and private-sectors. Several weeks ago, I announced the formation of a new Patient Safety Task Force within HHS. The Task Force, which is comprised of AHRQ, CDC, the FDA, and HCFA, will coordinate an effort to improve existing HHS systems to collect data on patient safety. Working closely with the States and private-sector partners, the Task Force will identify how these existing systems can be more user-friendly , and reduce the burden of data reporting on providers and others, and improve the value of the information that is collected.

I also want to note that HHS spearheads the existing Quality Interagency Coordination (QuIC) Task Force. As you know, QuIC is coordinating the overall Federal response to the IOM=s report on medical errors. In particular, within the last year, the QuIC has held a national summit to set the agenda on patient safety research; initiated a breakthrough series with the Institute for Healthcare Improvement to foster improvements in high-risk settings in health care facilities that the Federal government manages; and helped produce materials for dissemination to the public on steps that people can take to prevent medical errors from happening to them.

The Department has also established a number of partnerships with the private sector. AHRQ and HCFA are both involved in working with the National Forum for Healthcare Quality Measurement and Reporting (Quality Forum), which has broad participation from all parts of the health care system, including national, State, regional, and local groups representing public and private purchasers, employers, health care professionals, and others. We are partnering with the Quality Forum and its members to identify where the research most strongly supports specific evidence-based interventions that will improve patient safety. Also, HCFA is collaborating with the Leapfrog Group, an alliance of large employers concerned with improving health care quality, to develop initiatives to improve safety through the use of these large employers= leverage as health care purchasers.

As I mentioned, the President has requested $72 million for HHS for medical errors and patient safety in the budget he has sent to Congress. With these additional resources, we can expand on the work already stated and enhance our health infrastructure to improve patient safety.

In particular, the Budget includes an increase of $3 million, or six percent, for AHRQ to strengthen the current systems. I believe the improved data collection system that the HHS Patient Safety Task Force is pursuing is vital. These systems for learning must be distinguished from systems for public accountability. We clearly need both. Just as the health care industry needs to know what changes will best prevent medical mistakes, the public expects and has a right to receive information demonstrating that the health care delivery system is as safe as possible. The system under development by the Patient Safety Task Force is a system for learning. It will be based on data collected from existing reporting requirements, to be used by health care providers and leaders of the health care facilities to change the way that care is provided.

We will operate this new data collection system on the basis on a number of key goals and priorities B ones that the Patient Safety Task Force has identified. We believe that it is critically important to encourage reporting of errors. For instance, we do not believe that information on error rates by hospital or by individual physician would encourage these providers to come forward. In fact, doing so would actually prevent the collection of fair and reliable information, and we believe that making this information public would actually discourage reporting.

Providers should be encouraged to come forward with information about their medical mistakes, problems, and Anear misses@ that they have encountered, as part of the Department=s efforts and of organizational and local efforts to increase patient safety. The Department's goal, and the goal of safety initiatives more generally, should be to reduce medical mistakes, not punish people for what has happened in the past. For that reason, confidentiality of the data collected is essential.

We do think that information from this system should to be made available to the public, but only after a thorough analysis of the data. Information should be available about what types of errors occur most frequently; what specific actions providers are taking to reduce those errors; what types of programs are associated with lower rates of injury for patients; what individuals and family members can do to reduce their risk of harm; and what public agencies or oversight bodies can do to assist.

Second, we believe that we must ensure that reporting to our database does not increase the potential for liability or disciplinary action. This does not mean that patients will have less access to the information currently available about their condition or the care that they received. However, it does mean that strong confidentiality and peer review protections should be extended to cover those people who come forward to submit reports about patient safety problems. These protections should cover not only information submitted to our database, but should also extend to data, analyses, and reports developed as part of organizational and local programs and initiatives to improve patient safety and quality. These initiatives by individual organizations and collaborative groups will play an important role in determining whether the Department=s findings will actually affect the care provided at specific institutions, which have very diverse circumstances and opportunities for improving safety. In addition, these protections should be applied to the Federal agencies taking part in the systems and the contractors and others involved. While HHS has some peer review protections in place as a result of agencies= authorizing legislation, only you, Mr. Chairman, and your colleagues on the Committee and in Congress can create the kind of peer review protections that are needed B protections that can stretch across all of the States and health care systems involved.

We are also committed to reducing the burden on providers, the States, and others that must now submit data to multiple agencies, in many different formats on each individual event that occurs. Simply put, systems need to make it easy for front-line doctors, nurses, managers, and others to help us capture the data we all need to improve patient safety. We owe it to those people who provide health care services each and every day B many of them life-saving interventions B to lessen their paperwork and administrative tasks.

As important as peer review protections are, we think it is equally important to protect patients= privacy. All patients can be sure that the privacy of their information would be maintained. Current laws that govern the use of data by our agencies require that this information remain confidential.

Lastly, we believe that our new patient safety data collection system should facilitate quick, short-turnaround analyses, as well as longer-term research. We have a critical need to know how we can improve safety now, as well as a need for evaluation research that examines the effectiveness of various approaches to reducing errors over time. Our new data collection system will make it possible to do both. We have to ensure that the data collected is converted into information that providers can and will use. Our goal is not to collect data for the sake of collecting data.

In addition to using data to improve safety, we will use the data collected in these systems to put together the National Quality Report that AHRQ was charged with producing when its reauthorization legislation was passed in December 1999. This report will provide a clear, easily understood picture of the quality and safety of health care in America and to highlight areas where improvement is needed. We believe the public will best be served by annual reports like this one that will provide people with research-based information about the safety of the Nation=s health care system.

Other efforts to communicate with the public about medical errors and patient will be required to meet this need. Research and demonstration projects that will be conducted by AHRQ can help further inform those efforts. The research and demonstration projects being carried out will help us to understand what kinds of information people would find most useful, and how and when to provide it to them.

Mr. Chairman, in closing let me say that there is a great need for a system with strong peer review protections in place that will shield doctors, nurses, and others from reprisals or other actions against them if they come forward with information about errors and patient safety problems. We also need to take steps to ensure that medical data collected for such purposes will always remain private.

We will make sure useful information that will make a difference in the quality and safety of the health care services Americans receive is disseminated to all Americans and all health care providers.

Finally, I want to reiterate that top quality health care is a hallmark for America, and this Administration is committed to patient safety and a reduction of medical errors. Improving patient safety will require the concerted involvement of all that care about these issues. The keys to moving forward are an emphasis on collaboration, research to develop evidence about how to design and implement safer systems of care, the collection of data that yield the information that we need to improve safety, and the development of reliable information that the public can use.

I look forward to answering any questions that you may have. Thank you.

Last revised: May 30, 2001