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September 10, 2002
Good morning, Madam Chairwoman and members of the Subcommittee. I am honored to appear before you today to discuss ways the Federal government can help reduce medical errors and improve the safety of the health care services that Americans receive.
In the last few years the Department of Health and Human Services (HHS) has developed a coordinated set of initiatives to identify and reduce threats to patient safety and improve the quality of patient care. While these initiatives are important, they are only a beginning.
President Bush and I recognize that significant progress will only be achieved when the talents and energies of health professionals are fully engaged in improving the quality of care. We have been heartened by the recent emergence of several notable private sector patient safety initiatives. But much more needs to be done -- and can be done -- to eliminate the barriers that discourage health care providers from participating, voluntarily and enthusiastically, in local and regional patient safety and quality improvement efforts.
The main barrier, of course, is the fear professionals have that if they report some event or some condition that is less than perfect, their report will be used to stir up litigation rather than the fix the problem. They need assurances that if they report, the information will be used constructively, not destructively. The President made this point explicitly in his speech at the Medical College of Wisconsin, in Milwaukee, when he said, "We actually have a system that penalizes doctors for trying to prevent errors and avoid complications in patient care," because when they discuss information about patient care they put themselves, or others, at risk of a lawsuit. As the President said, "This doesn't make much sense. These good faith efforts do not deserve the punishment of a lawsuit." He called on Congress to remedy this situation.
I am pleased to say that the legislation this Committee is considering represents the change in direction that the President called for and that is essential to improving quality of care in this country. It will take us away from the blame game played after there has been an injury and will set us on the more productive path of working together to improve the system and to prevent adverse events from occurring in the first place, by encouraging a culture of learning and constant quality improvement in our health care system.
The vast majority of doctors, nurses, and other health care professionals are dedicated, conscientious people who work long hours under very difficult circumstances. They are there when we need them. They would be a critical part of our front-line defense in the event of a bio-terrorism attack. They are heroes. And we should recognize this, to them and to ourselves. We should support, not attack them.
Health professionals are not opposed to quality improvement. Just the opposite; they embrace it. We should support their efforts to improve quality. But it must be real and meaningful quality improvement, done in a supportive and cooperative way. The legislation this Committee proposes meets these important principles.
Madam Chairwoman, your legislation provides the types of protections that the President believes are essential to foster the development and institutionalization of quality improvement efforts in our health care system. I commend you, and your colleagues, for your leadership in developing, and, we hope, moving this important legislation.
The Patient Safety Challenge
The Institute of Medicine=s (IOM) landmark 1999 report, To Err is Human, alerted the nation to the patient safety challenge in ways that prior studies had not. The IOM estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors, making them the eighth leading cause of death in the United States. More people die from medical errors than from automobile accidents, breast cancer, or AIDS. While there has been subsequent debate about the actual number of deaths, it is clear that the rate of medical errors is unacceptably high.
I would like to highlight four of the IOM conclusions that are particularly relevant to today=s hearing. First, the elimination of medical errors will not be accomplished by attempting to identify and discipline the Abad apples@. The IOM report concludes that errors are not solely the fault of individual doctors, nurses, and other clinicians; they are often Aa failure in the process of delivering care in a complex delivery system.@ System failures result from a complex interaction of people, technology, work processes, and working conditions, but few health care providers have expertise in the identification and analysis of contributors to system failures.
Second, the IOM report cautions that if a patient experiences an adverse event during the process of care, this does not necessarily mean that a medical error has occurred. Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself. We should not equate problem outcomes with bad practice, but, rather, we should strive to differentiate one from the other.
Third, the IOM concluded that much can be learned from the analysis of errors--from errors that result in serious patient injury or death as well as from errors that result in little or no patient injury, but which, when aggregated, can help identify patterns of system failures. To foster such analyses, the IOM urged health care organizations to implement non-punitive systems for reporting and analyzing errors within their organizations and encouraged the development of voluntary reporting systems.
Fourth, the IOM concluded that health care providers need to be assured that if they report errors that are necessary to detect system problems, these reports will be used for that purpose in a culture of safety rather than unproductively as grist for the litigation mill. As the IOM report reminds us:
Patient safety is also hindered through the liability system and the threat of malpractice, which discourages the disclosure of errors. The discoverability of data under legal proceedings encourages silence about errors committed or observed. Most errors and safety issues go undetected and unreported, both externally and within health care organizations.
The failure to report errors hampers quality improvement efforts and threatens the quality of care for us. It also blocks our best efforts to improve the quality of health care information systems. If providers are reluctant to keep track of the information required to improve the quality and safety of health care delivery for fear of lawsuits, health care providers will continue to lag behind in electronic information systems, despite all our work to develop effective standards and support for 21st century medical information systems. The IOM urged Congress to guaranty the confidentiality of data related to patient safety and quality improvement.
Proposed Substitute for HR 4889
Madam Chairwoman, the Administration supports your efforts to pass your proposed substitute for HR 4889, and enact legislation to remove the liability barriers to improving quality and safety of health care during this session of Congress. Your proposal appropriately responds to the IOM recommendations and advances the Administration=s goal of facilitating health care professionals' ability to improve the quality of our health care.
The proposal assures doctors and other health professionals that if they report information to expert Patient Safety Organizations (PSOs), that information will be used for patient quality improvement efforts and will be kept confidential. This will encourage them to report, and will greatly increase the amount of data available for analysis by experts. Because the PSOs will receive information about more than one hospital and about more than one doctor, they will be able to detect patterns of good and bad practices that might not otherwise be noticeable on a single provider basis. They will be able to provide recommendations to local providers about system changes that the providers would not have been able to develop on their own. These new Patient Safety Organizations will promote collaboration and cooperation among providers on a regional basis. They will be proactive.
The legislation recognizes that new ways of addressing quality are needed. If we have too many deaths and injuries from medical care now, the current system-based on finding fault with individual providers-must not be working. The bill changes the focus along the lines outlined by the President, and sets the new direction he identified. There are four important elements of the bill that start us down a new and better path.
First, the legislation focuses on system improvement. Rather than focusing on finding individual "bad actors," it recognizes the fact that health care is delivered a part of a system. No person, not even a doctor, is perfect. But by looking at the system in which care is delivered, we can provide protection against human frailties. The role of the individual provider is critical, but systems can help providers, give them more information, and warn them about possible mistakes. The legislation will help identify system failures by enabling PSOs to examine a wide range and large number of providers. It will make it easier to bring information about how the system works, rather than reviewing the practices of one doctor or even one hospital. It will be able to gather information from a broad range of providers and see how the system works.
Second, the legislation is forward looking and proactive. The Patient Safety Organizations will be able to examine processes and look at outcomes at various institutions, and make suggestions for improvements. Rather than focusing only on adverse events that have occurred, they will proactively identify better ways of delivering care.
Third, it is pragmatic. It takes the common sense approach that the way to improve quality is to identify problems and make improvements. Instead of playing the blame game and litigating against our doctors for particular events that may or may not represent malpractice, the legislation recognizes the importance of preventing the adverse event from occurring in the first place.
It recognizes that more must be done to improve quality and safety. The Administration fully supports effective enforcement programs based on available data to identify "bad actors" and remove them from medical practice. Information from medical records and other existing data sources will continue to be available for plaintiffs who are injured negligently as a result of medical errors. What is desperately needed, however, is new information to help prevent errors in the first place. And that is what this bill will provide.
Finally, the bill recognizes the value of local and private quality efforts. We cannot improve quality by imposing solutions from Washington. There is often no one right way, and if there were, Washington might be the last to know about it. The best way to improve quality is to integrate it in the thoughts and processes and habits of the people who actually deliver care. Doctors and hospitals will be able to work together with local Patient Safety Organizations to identify problems and experiment with different ways of improving care.
Current HHS Activities
Madam Chairwoman, your bill also complements existing HHS patient safety activities and, in turn, will help to guide our ongoing technical assistance to private sector initiatives, including the new Patient Safety Organizations.
One of my major management initiatives at HHS has been to foster better coordination and integration of related activities that cross agency lines so that we can speak as Aone Department.@ And we are here today as one Department, with the Centers for Medicare and Medicaid Services joining the Agency for Healthcare Research and Quality in supporting this legislation.
I am delighted to report that patient safety is an exemplary model of inter-agency coordination. We have created a Patient Safety Task Force that brings together three agencies with regulatory and data collection responsibilities--the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Food and Drug Administration--and our lead research agency on patient safety, the Agency for Healthcare Research and Quality. An important goal of the Task Force is to simplify the reporting of patient safety data to HHS agencies. The current system is unnecessarily burdensome. The same adverse event often needs to be reported in different ways on separate forms to different HHS components, and those who report the data never learn whether it was useful.
The Patient Safety Task Force will replace this cumbersome system in two ways. At the front end, it is creating a single computer interface and standardizing the required information so that those who are required to report this information will only have to enter the data once and will only be asked to report data that will be helpful for patient safety analyses; the computer systems will then route the information to the appropriate HHS components. At the back end, the Task Force wants to ensure that we close the Areporting loop@ by ensuring that the data are integrated and analyzed and that the non-identifiable data maintained by AHRQ and the results of its research can be searched in real time by those reporting the data. Patient safety improvement can only be a true public-private sector collaboration if those who report information also benefit from its analysis. Our experience in streamlining the reporting and analysis of data will be helpful as AHRQ provides technical assistance to the Patient Safety Organizations created by your bill.
Let me now turn to specific initiatives at these agencies. With $55 million in dedicated funding in FY 2002 and a request of $60 million for FY 2003, AHRQ is now the leading funder of patient safety research in the world. Its current research portfolio includes 5 large initiatives, including support for 24 demonstration projects related to the collection, analysis, and use of patient safety data; 22 projects developing and testing state-of-the-art clinical informatics applications; 8 projects related to working conditions (such as fatigue, stress, and sleep deprivation); 23 projects fostering innovative approaches to improving patient safety; and 7 projects to develop, demonstrate, and evaluate new approaches to improving provider education related to patient safety. In addition, AHRQ will soon receive a report from the IOM on structured approaches for reporting patient safety data. That report, and the ongoing results of these and future research projects, will be shared with Patient Safety Organizations as they become operational.
AHRQ=s FY 2003 budget submission requests $2 million to launch a Patient Safety Improvement Corps, experts who will work with State health departments and health care institutions to expand State and local capacity to use existing knowledge to identify and eliminate threats to patient safety. In recognition of the dearth of expertise in patient safety analysis, AHRQ will work with Patient Safety Organizations in the development of the Corps and will work to leverage existing Federal expertise across the government to ensure that these private sector initiatives can become operational as soon as possible.
As you can see, AHRQ is well positioned to carry out its proposed statutory role as a "science partner" for Patient Safety Organizations. AHRQ sees the potential for tremendous synergy between the activities of Patient Safety Organizations and its ongoing national research. Moreover, the agency has already seen tremendous public and private sector interest - from States, health care institutions, health plans, and providers -- in participating in such initiatives, if only protections of the type proposed in this bill can be provided for patient safety data. As a result, this legislation will greatly enhance AHRQ's ability to carry out its patient safety mission.
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 2003 budget request and the 2002 enacted level include $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 2003 budget includes an increase of $5 million above the $17 million provided in FY 2002 for the FDA to improve the collection and analysis of adverse event data, and to ensure that response to findings is timely and well communicated. FDA is working to improve labeling and packaging standards to reduce the chances of clinicians confusing drugs with similar names or making dosage errors, both of which can lead to adverse interactions between drugs. In addition, for biological products the FDA is requiring all establishments to report any event associated with biologics that were distributed by the manufacturer, including blood, blood components, and source plasma, that represents a deviation in manufacturing. FDA is also piloting a program of active collaboration with community medical programs to collect information about product safety that will supplement information from spontaneous reporting systems. And the FDA is developing a regulation to reduce drug administration errors by having bar coding technology apply to the administration of drugs.
Further, as you are aware, the Centers for Medicare and Medicaid Services (CMS) already contracts with Quality Improvement Organizations (QIOs), formerly known as Peer Review Organizations (PROs), in each State to improve the quality of care and reduce errors through the collegial dissemination of best practices. They are accomplishing this in a number of ways, most of which are specified in our contract with the QIO. For example, CMS and the QIOs are working to improve clinical health outcomes of Medicare Beneficiaries and to prevent clinical disorders in a variety of health care settings. For instance, QIOs work with nursing homes in their states using the publicly reported Minimum Data Sets quality of care measures developed by CMS. QIOs also provide information to Medicare beneficiaries and their families, which can be used for selecting nursing homes, improving nursing home care, and obtaining a better understanding about nursing home care. Likewise, QIOs are working with home health agencies in their states, using the publicly reported OASIS quality of care measures developed by CMS. As with nursing homes, the QIOs provide information to Medicare beneficiaries and their families. QIOs also are continuing work with hospitals to reduce medication and other system failures related to acute myocardial infarction, heart failure, and pneumonia, and are adding a new clinical area focus, the prevention of surgical infection. The QIOs also focus some of their efforts on Critical Access Hospitals. Furthermore, in physician offices, QIOs are continuing work in the areas of care for chronic diseases like diabetes and preventative services like mammography and adult immunizations for flu and pneumonia. In addition to these various clinical settings, QIOs are focusing on different populations. They will continue work to eliminate health disparities between certain medically underserved populations and the general population. We also have added rural beneficiaries to the list of the groups eligible for theseprojects. And QIOs will continue work to ensure that Medicare+Choice Organizations are part of CMS' overall efforts to improve health outcomes and enrollee satisfaction for beneficiaries enrolled in a Medicare+Choice Organization.
In addition to clinical quality improvement, QIOs are helping to improve patient safety and health through helpful information and effective communication. The QIOs play an active role in communicating publicly reported nursing home and home health agency quality of care measures; and provide assistance to providers and beneficiaries in their states in interpreting and using this information. Additionally, through coordination with JCAHO, the QIOs are assisting hospitals in their states in developing the infrastructure and tools to permit electronic self-reporting of quality of care measures. The QIOs also are continuing to conduct those communication activities required by law, such as preparing an annual report and providing beneficiary and provider information. Additionally, QIOs are establishing a Consumer Advisory Council to advise them regarding consumer-oriented activities.
QIOs are also dedicated to improving beneficiary safety through Medicare beneficiary protection activities. The QIOs continue to provide review and beneficiary complaint responses as required by law and regulations. Additionally, the QIOs have implemented a new element of the beneficiary complaint response program utilizing the mediation process to supplement the more formal complaint review procedures. Moreover, a Payment Error Prevention Program has been revamped and included in the QIOs statement of work. Under the Hospital Payment Monitoring Review Program, the QIOs will continue to review medical records for coding and medical necessity in order to estimate national and statewide payment error rates for inpatient PPS services. Finally, CMS uses special studies to direct the QIOs to perform work or special projects that are not identified in the other tasks, but fall within the scope of our contract with them.
Patient Safety Coordination Beyond the Department
Madam Chairwoman, I also want to note that my interest in improving the coordination of patient safety activities extends beyond my own Department. I recognize that other Departments have a strong interest and activities in patient safety, and it is critical that we not work at cross purposes. We are using the existing Quality Interagency Coordination (QuIC) Task Force, which includes all Departments, agencies, and entities with an interest in improving the quality of patient care, to coordinate the overall Federal response to the IOM=s report on medical errors. 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.
We are also working with other nations to leverage our resources and share our knowledge. On October 10, 2001, the Secretary of State for Health in the United Kingdom (UK), Alan Milburn, and I signed a cooperative agreement to support collaborative activities in quality improvement and patient safety. Already there have been positive activities between the United States (US) and the UK in the areas of adverse event reporting and patient safety research. We are working closely with the newly formed National Patient Safety Agency (NPSA) in the UK to standardize reporting formats and coordinate our research agendas. As I speak, UK and US patient safety researchers are meeting today to explore common research methods for patient safety.
Madam Chairwoman, I look forward to working with you on this legislation and would like to convey, once again, the President=s appreciation for your leadership in this area. I would be happy to answer any questions that you may have. Thank you.
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Last revised: September 12, 2002