Rationale for the Fiscal Year 2001 HCQO Request

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Performance Budget Submission for Congressional Justification

Rationale for the Fiscal Year 2001 HCQO Request

The fiscal year 2001 Request provides $41,295,000 for three new priorities and three continuing priorities which will be carried out through the Research on Health Costs, Quality and Outcomes activity. The new priorities are:

Priority 1—Enhancing Patient Safety: $20,000,000 (includes $5,000,000 for Informatics)
Priority 2—Informatics: $ 5,000,000
Priority 3—Improving Worker Health: $10,000,000

The continuing priorities are:

Priority 4—The National Quality Report: $ 2,295,000 (also see MEPS section)
Priority 5—Improving Clinical Prevention: $ 2,000,000
Priority 6—Building Capacity: $ 2,000,000

Priority 1—Enhancing Patient Safety ($20,000,000)

Background

The recent Institute of Medicine (IOM) report, To Err is Human, alerted the Nation that errors occur too frequently in the care of patients. It estimated that between 44,000 and 98,000 people die each year due to medical errors, and that more are harmed. The report notes that this means errors cause more deaths annually than breast cancer and auto accidents. In addition to this extraordinary human toll, medical errors result in annual costs of $17 billion to $29 billion in the United States.

In 1993, medication errors are estimated to have caused 7,000 deaths, compared to 6,000 deaths from workplace injuries.

Deaths due to preventable adverse events are estimated to exceed the deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516).

The IOM recognized that errors are part of the larger health care quality agenda, which includes efforts to ensure that people are given the care that has been shown to be most effective in addressing their health problems. The IOM also recognized that safety does not reside in a person, device or department but emerges from the interactions of components of a system. Errors are systems problems, which cannot be resolved by eliminating "bad" clinicians. The IOM report concluded that many errors can be avoided, or their potentially harmful effects on patients minimized, if we can learn enough from the errors that occur to understand how to redesign the processes and systems of care to be safer. The process would be similar to that in the auto industry, which has provided the public with safer cars through analyses of crash information.

Medical errors are "...the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (e.g., error of planning)."

—Institute of Medicine, 1999

While many sectors of the health care industry are eager to respond to the IOM's dramatic call for action, providers, payers, accreditors and other oversight organizations, and consumers are unsure what steps they can take that will achieve the substantial improvements in the safety of the health care delivery system that the American public deserves. As noted in the IOM report, their actions will be most effective if informed by analyses of databases that can help to identify the underlying causes of errors.

This research will lead to the development of tools and strategies for reducing errors or mitigating their impact, which in turn can be investigated for their effectiveness and applicability in other aspects of the health delivery system, and the information and tools disseminated broadly to encourage their appropriate use. Although there is much to learn from efforts in other industries such as aviation, manufacturing, and banking, it is clear that a substantial body of research will be required to facilitate errors prevention in health care.

"Creating an information infrastructure and building a better evidence base for patient safety are critical to taking a more strategic approach to reducing errors and improving patient safety."

—Institute of Medicine, 1999

The Agency for Healthcare Research and Quality (AHRQ) is a natural focal point for a national effort to enhance patient safety. AHRQ (then the Agency for Health Care Policy and Research) funded the landmark research by Professors Lucian Leape and David Bates that first brought national attention to the issue of medical errors. Subsequent studies sponsored by the Agency have focused on the detection of medication errors, investigation of diagnostic inaccuracies, the relationship between nurse staffing and adverse events, computerized adverse drug event monitoring, and computer-assisted decisionmaking tools to mitigate errors and improve safety.

Research finding: Leape and Bates tested software that allows doctors to enter their medication orders, including dosage, route and frequency, directly on computer terminals, thereby eliminating handwritten orders. The system also alerts doctors when an order contains a possible error, such as a potential drug interaction or allergic reaction by the patient.

In the hospital that was studied, the researchers found that the software decreased the rate of serious "nonintercepted" errors—mistakes that could have or did cause an adverse drug event and which were not caught before reaching the patient—by more than half. The new software is estimated to save the hospital between $5 million and $10 million annually, even after accounting for development, start-up and maintenance costs.

The Agency is also well positioned to coordinate a comprehensive and sustained effort to reduce medical errors among Federal departments and agencies through the Quality Interagency Coordination (QuIC) Task Force, as well as by integrating public-sector efforts with those of the private sector through collaborative work with the National Quality Forum, National Patient Safety Foundation, and other entities working on this agenda. Under its newly signed reauthorization, which transformed the AHCPR into AHRQ, the Agency has the authority to conduct and support research on reducing medical errors and improving patient safety.

New initiatives to reduce errors in health care and enhance patient safety will build upon recent Agency commitments to research in this area. Last year, AHRQ awarded four extramural grants to establish Centers for Education and Research on Therapeutics (CERTs). These university-based centers will conduct research and educate medical practitioners and other decisionmakers concerning the benefits, risks and effectiveness of new uses, existing uses or combined uses of therapeutics—drugs, biologics and medical devices. This year, the Agency is supporting a research grant examining medical errors in nursing homes. AHRQ also recently released an RFA calling for extramural research focused on testing the effectiveness of the transfer and application of evidence-based and effective practices to improve patient safety by reducing preventable medical errors that are frequent and cause serious harm.

AHRQ is also providing ongoing support for a project being carried out by the private-sector National Patient Safety Foundation that identifies and aggregates information on funding agencies and organizations and topics of research on medical errors and patient safety in both the public and private sectors. These existing research initiatives, however, do not meet the ambitious research agenda described in the IOM report, which suggested a substantial role for the Agency in leading the Nation's efforts to understand and use information about errors to improve safety. AHRQ plans to collect data on medical errors and support the analysis of those data to create knowledge about what errors are occurring and what methods are most effective in reducing those errors. These activities will also include serving a coordinating and convening role with QuIC partners. These activities would be in addition to the Agency's current quality measurement and improvement activities.

Development of a Substantial Research Initiative on Patient Safety at AHRQ

AHRQ proposes a broad research initiative spanning the full pipeline of research that will further the Nation's understanding of when, how and under what circumstances errors occur, identify the causes of errors, develop the tools, data and researchers needed to foster a national strategy to improve patient safety, and work with public and private partners to apply evidence-based approaches to the improvement of patient safety. The research and training efforts proposed will ensure that efforts for enhancing patient safety will move beyond just describing and defining the problem to providing the knowledge and tools that will be required to address the patient safety challenge. The goal of this research initiative is to provide an evidence base for the Nation's approaches to enhancing patient safety.

Given the potentially explosive nature of medical errors and the need for action along many fronts (research, training, quality improvement, reporting systems, education and regulation), this initiative will begin with extensive consultation with external stakeholders. This will help to focus the Agency's activities on those that complement private- and public-sector actions. Indeed, AHRQ will build on its successful experience in other initiatives to serve as the science partner to organizations with responsibilities for clinical care delivery, oversight or regulation. Specific activities will be designed to meet the priorities developed by a national meeting on research on medical errors and other stakeholder meetings with public- and private-sector entities interested in patient safety, to ensure that the research agenda is user-driven.

This research agenda-setting conference will bring together researchers, data collection entities, and users of the research in order to review the current state of the patient safety research field, to learn from its lessons about programs and policies to translate the research into practice and policy, and to set priorities for research. Key partners in this effort will include other Federal agencies in the Quality Interagency Coordination Task Force, hospitals and nursing home associations, medical specialty societies, nursing and other health professional organizations, managed care organizations, purchasing coalitions, Joint Commission for Accreditation of Healthcare Organizations (JCAHO), the National Committee for Quality Assurance (NCQA), the National Quality Forum, and the American Accreditation HealthCare/Commission (formerly known as URAC).

Fundamental Research on Medical Errors—$5,000,000

There are major gaps in the Nation's understanding of patient safety, such as the types of medical errors, the factors associated with their occurrence, and their prevalence in settings other than acute care hospitals. There are also important gaps in knowledge about how the level of errors is affected by systems differences (staff reporting relationships, the flow of charts and data, sign-off procedures for medication) or organizational culture and leadership. It is likely that patient safety problems in nursing homes, ambulatory care facilities and patients' homes are common, preventable and fundamentally different from those in the hospital setting. This knowledge is essential if effective prevention strategies to prevent errors and to increase patient safety are to be developed and implemented.

In addition, the Agency's investment in fundamental research will focus in three areas described below. The Agency will expand two existing programs, in particular. The Evidence-based Practice Centers will be asked to report on the best practices in errors reduction using lessons from health care as well as other industries. The newly established Centers for Education and Research on Therapeutics program is supporting additional research on medication errors and determine new and effective approaches to improve patient safety.

The Scope and Impact of Medical Errors. While knowledge about the epidemiology of medical errors has grown over the last 10 years, many questions remain. The research that does exist about errors in health care largely examines adverse drug events in hospital settings. AHRQ will sponsor research to determine the prevalence and impact of medical errors in other settings, such as ambulatory clinics, as well as hospital, home health, and other long-term care settings. Some of the research questions outlined by the IOM and to be addressed in this initiative include:

The impact of various management practices on the risk of errors.
The degree to which medical errors affect different populations, notably the elderly, children, minority and disabled individuals.
The types and causes of errors among different clinical specialties (e.g., intensive care) and sites of care (nursing homes, etc.).

The Root Causes of Medical Errors. Knowing when and where medical errors occur is just a first step. Research must then determine why errors occur and what system or other changes can prevent them. Learning from extensive work in other fields, the Agency will sponsor health services research to uncover the human, educational and system factors that produce errors. This research will build the critical of knowledge needed to prevent errors, beginning with the identification of key errors and an analysis of the factors underlying them, followed by an evaluation of strategies that can be applied to successfully reduce errors, such as computer applications for improving patient safety.

Research on Reporting Systems. Establishing reporting systems, both mandatory and voluntary, that capture the full scope of the challenge of errors is a central recommendation of the IOM report. There is growing expertise in reporting systems in health care and other industries. At least one-third of States have some form of adverse-event reporting systems. However, the IOM study found that these systems are generally used to investigate specific events and are less successful at using the data to identify broad trends and to identify where improvements could be achieved. Also, little is known about alternative approaches to implementing reporting systems, ideal characteristics of reporting systems, what can be learned from such systems, or the impact of State programs on health and safety.

AHRQ will work closely with States to convene and share information and expertise and will fund studies to determine the most effective approaches. The health care sector also has much to learn from other domains of human enterprise, such as manufacturing, aviation and banking, where error prevention programs and research have been longstanding. For example, the aviation industry has the Aviation Safety Reporting System (ASRS), which systematically collects information on errors averted and committed. AHRQ will foster knowledge transfer from these other industries. These studies could include:

Identifying critical components for reporting systems.
Demonstration programs for reporting.
Evaluations of existing State mandatory reporting systems to determine what information they collect, how it is used, and whether it would be feasible to integrate all or some of the data across the State systems to broaden information on errors.
The development of techniques for the analysis and dissemination of patient safety data and the impact of reporting.
Studies to explore how well different reporting-system models (voluntary and mandatory). achieve the goals of enhancing accountability in the health care system and assisting the health care system in learning how to avoid errors or to minimize their impact on patients.

Strengthening the Nation's Ability to Improve Patient Safety—$4,000,000

Just as important as the knowledge about medical errors are the methods, tools, databases and trained professionals needed to support a national effort to improve patient safety. Following on the success of the Evidence-based Practice Centers and the CERTs, AHRQ will fund patient safety "Centers of Research Excellence." These centers will address the range of patient safety issues, including the full range of sites of care (e.g., nursing homes and ambulatory care facilities), the populations affected (e.g., elderly, institutionalized, and children) and cross-cutting research (e.g., diagnostic accuracy, computer and other technology applications, and human factors analysis).

New Tools to Measure and Improve Patient Safety. AHRQ is the Federal government's lead Agency for the development, testing and dissemination of measures of health care quality. Quality measures are a critical tool used by providers, systems and policymakers to understand the nature of quality problems, report on them, and institute quality improvement strategies. AHRQ will build on its existing portfolio of quality measurement activities to develop tools and methods to measure and improve patient safety. To focus its funding in this area, AHRQ will work closely with the National Quality Forum and other private-sector efforts on core measures for patient safety, as called for by the IOM report.

Developing the Data to Understand the Dimensions of Patient Safety. The Agency also has experience through the Healthcare Cost and Utilization Project (HCUP), working in partnership with States and provider organizations, to create national databases for research and reporting purposes while preserving confidentiality of data at both the patient and provider level. The Agency also has sponsored the development of tools and measures, such as HCUP Quality Indicators, which providers can use to identify, quantify, and benchmark hospital errors.

In fiscal year 2001, AHRQ will work with States and other partners to begin to develop a database of information on adverse events. This database will protect the confidentiality of the providers, institutions and patients involved and will be used by researchers to study trends and patterns in adverse events. The data will also be made available to local improvement agencies to facilitate comparisons with peer organizations and other States and to target quality improvement strategies. The database will not set standards but will instead provide a vehicle to assemble and analyze existing data from the States and private sector. In addition, the Agency will provide technical assistance to State and private-sector entities collecting, analyzing and disseminating patient safety data.

Developing the Talent to Investigate and Improve Patient Safety. The investigation of errors and their remedies will require the application of knowledge from fields not usually associated with health care research, including human factors research and industrial engineering. Investments must be made in developing skilled professionals who are capable of performing this research, tool development, and dissemination of knowledge and tools. AHRQ will expand its successful training programs to support individuals and institutions to train investigators in the methods and tools for research and evaluation of adverse events. As part of their training experiences, these researchers will have opportunities to work directly with States, reporting systems, and providers, thus also extending the technical expertise available to States to build and enhance their reporting systems and quality improvement strategies. The Agency will collaborate with national professional societies to integrate up-to-date and evidence-based information into professional education efforts.

Improving Patient Safety—$11,000,000

Demonstrations and Development of Community-based Laboratories. Despite the substantial gaps in our understanding about medical errors, there are some settings where enough is known to begin to fund efforts to replicate, and/or expand to a larger scale, interventions that have been shown to effectively reduce the morbidity and mortality attributable to medical errors. The Agency will fund evaluations of traditional efforts (e.g., incident reports) versus newer approaches (root cause analysis and systems approaches), as well as the design and testing of model approaches by clinicians, health systems, purchasers and others to reduce errors in both clinical and managerial systems. Systems found to be effective will be widely disseminated using a broad array of strategies, such as industry conferences, Web-based information sources and newsletters, and articles in trade press.

In addition, the Agency will support the creation of community-based laboratories through professional societies, primary care networks, integrated service delivery networks, and others. Community-based laboratories are clinical health care delivery settings where researchers can test models, collect data on patient safety, and apply new tools and approaches. Because they are not traditional university-based research organizations, community-based laboratories provide the added value that their findings will be instantly generalizable across settings. These laboratories will bring together the best of research on improving patient safety and will foster the testing and application of tools and approaches from other industries to reduce errors in the health care sector. Models found to be effective will also be widely disseminated.

The Role of Computers in Reducing Medical Errors. Health information technology holds the potential to dramatically reduce the rate of medical errors. For example, physician-order entry systems have been shown to be effective in reducing mistakes due to misinterpretation of handwriting. These systems also have allowed clinicians to receive immediate feedback about potential drug interactions with other medications that the patient is taking. Past research sponsored by the Agency has shown that computer applications can reduce the occurrence of adverse drug events, assist the appropriate timing of medications, provide automated reminders to alert providers in real time to medication interactions, and embed decision-support systems that can improve compliance with evidence-based protocols. In fiscal year 2001, AHRQ will support a $10 million initiative examining the role of computers in improving care, of which $5 million will be dedicated to the role of computers in improving patient safety. See the Informatics section for details.

Development of Public and Private Partnerships to Disseminate Effective Strategies. A key component of any national effort to improve patient safety is collaboration with all the stakeholders and relevant actors; this approach has been integrated throughout the Agency's proposed strategy for improving patient safety. In addition, the IOM recognized that communication of information on and knowledge of patient safety and medical errors is critical, yet there are few objective sources of the latest information on patient safety.

The Agency will therefore develop and pilot an online clearinghouse to serve as this objective source of the latest information on patient safety. A feature of the planned clearinghouse will be to maximize the use of the interactive nature of the Internet, creating opportunities for distance learning and initiating online forums, such as a "National Morbidity & Mortality Conference" of selected cases to promote quality improvement. Patient and provider information will be kept confidential in the presentation of these cases, but the causes and potential remedies for the errors will be emphasized. The Agency will work closely with existing public and private organizations, such as the National Quality Forum, educational and accrediting entities, purchasers, and quality-oversight organizations in the development of this communication strategy.

Another important target audience for information on patient safety and medical errors are State officials in the executive and legislative branches. In March 2000, the Agency will be sponsoring a workshop for senior State health officials entitled "What States Can Do To Improve Patient Safety and Reduce Medical Errors," as part of AHRQ's User Liaison Program (ULP). The ULP translates, synthesizes and disseminates health services research findings into easily understandable and usable formats, to State, local and Federal policymakers through interactive workshops and technical assistance. The ULP provides an important vehicle through which the evolving research on patient safety can be translated into action. AHRQ will expand the ULP and other activities with State and local officials to assure that relevant and timely research findings and information on effective approaches to patient safety are widely available.

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