Opening Remarks: John Eisenberg, M.D., M.B.A

The purpose of this National Summit on Medical Errors and Patient Safety Research was to set priorities for a national research agenda to address the issue of medical errors and patient safety. This issue has been recognized as one with a far-reaching impact, affecting consumers and health care professionals alike, both in the U.S. and abroad. In that sense, it is a significant public health problem and accordingly, it must be treated as one.

Dr. Eisenberg likened the problem of medical errors to an epidemic, and noted that we are currently in the first stage of understanding the epidemic. Research is necessary to understand the magnitude of the problem, its causes, and its burden on people, which will provide information crucial to developing a cure. Similar to the wars that have been waged on diseases such as cancer and heart disease, the war on medical errors will start with research, which must later be translated into high-quality and safe medical care for all.

The Institute of Medicine (IOM) report, released in November of 1999, estimated that 44,000- 94,000 Americans die each year as a result of medical errors, and the annual cost attributable to medical errors is $29 billion in additional health care burdens. If money can be invested in appropriate research, the payoff will be twofold: saving money and, most importantly, saving lives.

Soon after the release of the IOM report, the Quality Interagency Coordination Task Force (QuIC) was charged by the President to develop a Federal response to the IOM report by coordinating all Federal agencies with an interest in quality health care to explore Federal actions to address the problem. In its report to the President, Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and their Impact, the QuIC, among other recommendations, proposed to convene several national summits and expert meetings to review research needs related to patient safety and to develop a responsive national research agenda.

The National Summit brought together users of research, funders of research, and researchers themselves in a forum where needs were examined and actions were recommended. The funders at the Summit represented broad-based coalitions of organizations interested in investing in research, including:

• Self-funded and private health care systems (Department of Defense, Department of Veterans Affairs, Premier Health Care Systems, Commonwealth Fund, Kaiser Family Foundation, Robert Wood Johnson Foundation, California Health Foundation, Grantmakers in Health, National Patient Safety Foundation, Jewish Healthcare Foundation).
• Private and public purchasers (Aetna U.S. Healthcare, Health Care Financing Administration).
• Public health agencies (Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention).
• International representation from New Zealand, Britain, and Australia.

The users at the Summit represented five areas: consumers and purchasers; broad- based system approaches; particular system issues; reporting issues and learning approaches; and state coalitions and public policy advocates.

Dr. Eisenberg recognized that reducing medical errors and enhancing patient safety will require a long-term investment and international commitment. He also emphasized that improving patient safety is not just an issue that reflects the Federal government, private sector, or the US alone. It is an international problem that will require a cooperative, unified, and diversified approach to ensure that every patient receives the highest quality medical care possible.

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Panel 1: Consumers and Purchasers

The purpose of hearing from consumers and purchasers was to highlight the very real impact of errors on patients and their families, as well as on those who purchase care on their behalf, and to better understand this group's research needs.

Susan Sheridan, Consumer, Boise, ID

Mrs. Sheridan testified that from a consumer's perspective, the health care system is uncoordinated, confusing, and potentially dangerous. From her own experience with medical errors suffered by both her son and husband, she raised a number of issues related to medical treatment and the health care system. She cited the need for consumers to be empowered, informed, and involved in their health care, and for regulatory agencies to be responsive to consumers' needs to make for a more user-friendly system. Mrs. Sheridan proposed research in five areas:

• To examine how to restore ethics to the American medical system.
• To identify in retrospect what deaths and injuries could have been prevented by mandatory hospital policies and procedures.
• To establish a system for monitoring, evaluating, and assessing health care.
• To identify the role of consumers in relation to the role of regulatory agencies.
• Specifically, to examine how consumers are informed of their responsibilities to report medical errors, and whether regulating agencies understand their own responsibilities to address such reports.
• To define the ethical responsibility and accountability of hospitals to patients who are victims of medical errors.

Robert Meenan, M.D., M.P.H., M.B.A., The Arthritis Foundation

Dr. Meenan emphasized that future research programs on medical errors should be designed with a balanced and comprehensive approach that recognizes the importance of chronic diseases, outpatient care, and alternative medical therapies. He highlighted four research areas that are important to people with chronic conditions:

• Research should not exclusively focus on fatal diseases, but should also consider chronic illnesses (e.g., arthritis) that reduce quality of life and impose economic burdens at both the personal and societal levels.
• Research should not overemphasize issues of inpatient care. Given the substantially larger number of patients who are treated in outpatient settings than in hospitals, the cumulative burden of outpatient errors is significantly greater.
• Research should not focus exclusively on errors of medications and surgery. People with chronic illnesses are treated with many other modalities of therapy (e.g., alternative medicine) whose safety must also be considered.
• Research should not exclusively focus on errors of commission (i.e., errors of execution and/or planning), but also consider errors of omission, which have an enormous cumulative impact on health care outcomes.

Steve Wetzell, Buyer's Health Care Action Group, Minnesota, Leapfrog Group Steering Committee

Mr. Wetzell's testimony focused on the business case for employers to advance the cause of patient safety, and on the effectiveness of purchasers in driving patient safety improvements. He noted that as the current market stands, there are no incentives for providers to focus on such important issues. He recommended that research be centered on:

• Determining if there is a business case for purchasers to be interested in investing in and advancing the patient safety issue. The first component of this research question is the extent to which errors impact on employee health, productivity, and absenteeism, as well as the cost of health benefits. The second component is how safety in ambulatory settings can be measured and incorporated into purchasing strategies, and how purchasers can change their purchasing practices to reduce errors in outpatient settings.
• Determining the effectiveness of purchaser efforts in driving improvements in patient safety.
• Identifying incentives (e.g., positive or negative, financial or non-financial) that can drive health care providers to improve the quality of health care they deliver.
• Finding out how to engage consumers to make them more informed decision-makers in their own health care, so they can have the tools and knowledge to protect their interests in the marketplace.
• Comprehensively and systematically reviewing the evidence for enhancing hospital safety.
• Developing guidance for purchasers to improve outpatient safety in ambulatory care settings.

Mary Jane England, M.D., Washington Business Group on Health

Dr. England proposed a research agenda to focus on assisting employers in understanding how they can help reduce outpatient medication errors. She recommended the exploration of three specific areas:

• The safety of ambulatory medications, specifically to determine the magnitude of the problem in terms of total costs of medication errors and inefficiencies, as well as morbidities resulting from such errors.
• The development of employer-based demonstration projects to provide employers with a standardized approach to using existing quality data to improve medication safety in ambulatory care.
• An examination of the effectiveness of different interventions to improve ambulatory medication safety.

Gregg Lehman, Ph.D., National Business Coalition on Health

Dr. Lehman's testimony focused on provider payment strategies, and how purchasers can assist consumers. He recommended four areas of research:

• Research to identify whether health plans currently have safety measures built into credentialing and contracting standards, and whether employer coalitions currently request health plans to report on the existence of safety and medical error reporting systems.
• Research to determine whether managed care poses special safety issues, and to identify such issues if they exist. Research to determine how purchasers can assist consumers in identifying unsafe providers.
• Research to determine what, if any, economic incentives or provider payment strategies work best to discourage errors and reward safety.

Question and Answer Session

The following additional areas for research focus were discussed:

• Exploring how standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) could become more proactive than reactive.
• Determining how accrediting organizations can play a more consultative role by identifying best practices in the field and sharing that information with other institutions.
• Developing outcomes information in relation to consumers and employees. Accrediting agencies could learn from other industries and the processes they have in place to reduce Occupational Safety and Health Administration (OSHA) infractions and other kinds of safety issues in the workplace.
• Studying how to make consumers aware of their responsibility to review accrediting agencies' systems or doctors.
• Studying whether after the introduction of computerized physician order entry systems, savings offset any additional costs (i.e., make a business case).
• Studying how computerized physician order entry systems can reduce adverse events, and studying such a system's impact on productivity and patient outcomes.
• Determining how much error can be avoided by giving patients more information, with a particular focus on the patient health record, and examining whether an employee, after receiving the information, is able to have the capacity to affect practitioners' behaviors to reduce the incidence of medical errors.
• Documenting how efforts by organizations, physicians' groups, and hospitals that invest in improving decision support systems have helped reduce adverse patient consequences.
• Identifying the elements of a safe system (e.g., electronic patient medical record) and searching for health systems that contain those elements as an approach to identifying best practices for further study.
• Compiling a compendium of all the evidence-based research already available into a checklist to which employers can respond.

Panel 2: Broad-Based System Approaches

Recognizing that medical errors are the fault of systems and not of individuals, the purpose of hearing from this panel was to identify how improving patient safety can be a health care system-wide endeavor. It was generally accepted that reducing and preventing medical errors and improving the overall safety of the health care system will demand the collaboration and participation of all stakeholders. Some of the common themes raised by this panel were: confidentiality and protection, human factors, organizational/cultural issues, reporting systems, use of technology, and training of providers.

Gordon Sprenger, American Hospital Association

Mr. Sprenger emphasized that efforts to improve patient safety will be most effective if they are implemented across the entire health care system and in all clinical settings, including hospitals, nursing homes, and physicians' offices. He recognized that reducing errors will require the design and implementation of error-resistant systems, and proposed that there be:

• Research to study how to change the traditional culture of health care to one that encourages learning from failures. Research can identify what critical factors make for a more open learning environment and what regulatory and legislative changes are necessary for creating such an environment.
• Research to examine effective risk management strategies and safety practices from other high-risk fields, with a special focus on how to tailor these models to the health care environment.
• Research to build an evidence base for current safety practices in health care, with a focus on how they can yield safer systems.
• Research on human factors issues to help explain why errors occur and how systems should be organized to minimize errors.
• Research to identify the most useful technology for reducing medical errors, and to identify areas in which the industry should make an investment in such technology.
• Research to close the gap between knowledge and practice, with a special focus on communication in health care settings.
Research to study medical errors and patient safety in ambulatory care settings.

Saul Weingart, M.D., Ph.D., Harvard Executive Session on Medical Error and Patient Safety

Dr. Weingart outlined a research agenda calling for the study of patient safety innovation at the organizational level. He emphasized that medical errors must be studied at the level of deficiencies in the organizational process in order to arrive at solutions. In view of that, he proposed six research focal points:

• Collecting case studies of cutting-edge innovators in patient safety and identifying what factors allow for their success (e.g., organizational context, leader attributes, market conditions).
• Exploring new models for the dissemination of innovation designed to promote improvements in patient safety.
• Examining the cost and effectiveness for technological solutions to the medical errors problem, and also the limits of such solutions.
• Studying the impact of fiscal austerity on safety, with a special focus on the effect of high patient-to-nurse ratios on error, the relationship between competing markets for health care and hospitals' safety concerns, and whether safe organizations also deliver better (and more cost-effective) care.
• Examining the feasibility of establishing multi-site research laboratories for testing novel drug-delivery systems, reporting systems, order-entry systems, and other processes designed to improve patient safety.
• Developing a standardized instrument for measuring the effect of patient safety improvements, for the purpose of reporting to the public.

Robert Crane, Kaiser Permanente Institute for Health Care Policy

Mr. Crane proposed research that would combine both qualitative and quantitative approaches and would look across institutions and aggregations of data, providing opportunities for interdisciplinary collaboration to improve patient safety (which, he noted, will require assurances of confidentiality). He identified five areas of potential research and recognized their inter-relatedness, providing an opportunity to integrate them into broader studies:

• Research to synthesize current knowledge of best clinical practices and to evaluate those practices in order to facilitate the subsequent creation and implementation of successful practices. Such research could employ large integrated data systems (currently in place in many health care organizations) to find and study antecedent conditions of errors and high-risk situations that would signal a greater than usual rate of errors or adverse events in a specific practice.
• Research to study human factors and incorporate the information into reengineering specific processes for improving patient safety. Human factors issues include: what human factors lead to error, how knowledge of human factors can improve the effectiveness of error prevention strategies, and what the impact of training and team factors is on safety in hospital settings.
• Research to evaluate and validate the efficacy and cost-effectiveness of new technology designed to improve health care quality and safety, in order to help organizations prioritize their investments in such technology. In addition, research is needed to study how technology actually creates opportunities for new types of errors to occur.
• Research to evaluate existing medical errors reporting systems (e.g., State mandatory reporting systems) to determine their impact on the improvement of patient safety. Research is also needed to identify factors that underlie the success of such systems, with an emphasis on how causes of errors were translated into system changes for safety improvement.
• Research to identify the cultural factors at the health care team level that are needed to transform the current culture of blame. A standardized set of patient safety-oriented questions or a survey instrument could be developed for this purpose to allow for comparison across institutions.

Dale Bratzler, D.O., American Health Quality Association

Dr. Bratzler emphasized that a research agenda on patient safety must include studies identifying the most effective methods for facilitating changes in caregiving processes. To that end, he proposed two broad areas of research:

• Research to examine the best methods for identifying opportunities for clinical quality improvement. Specifically, the research needs to determine how much data is necessary to identify meaningful opportunities for improvement, and to examine the effect of mandatory reporting on successful identification of such opportunities.
• Research to examine the best methods for facilitating quality improvement efforts by practitioners and providers. Specifically, the research needs to identify best strategies for disseminating information about quality improvement to providers and practitioners. The effectiveness of error reduction efforts as they relate to facility attributes (e.g., size, location, affiliation with a larger organization) also needs to be examined. Finally, the research should study the ability of existing Peer Review Organizations (PROs) to serve as catalysts for quality improvement with health care providers and practitioners.

David Woods, Ph.D., Human Factors and Ergonomics Society

Dr. Woods' testimony placed a heavy emphasis on the need to create a useful partnership between the health care industry and the field of human factors engineering. Research in the human factors field, with a focus on underlying mechanisms and behavioral patterns, can provide a convincing basis for changing the system. He asserted that research must be done:

• To consider building a research agenda as an interdisciplinary partnership between the human performance specialties and various medical specialties. The health care industry can benefit from studying the formal and informal organizational basis of the successes of the safety program of the National Aviation and Space Administration (NASA).
• To develop and test interventions for reducing problems arising from breakdowns in human performance.
• To identify the sources of complexity that contribute to human performance problems in operating complex systems, to understand the strategies used for coping with complexity, and to devise better ways of helping people cope with complexity.
• To study the user-centered design of computer systems in other high-risk industries, and to create demonstration projects for user-centered design of information technology to ensure that benefits are gained while error-inducing designs are avoided.
• To understand the impact of new advances in the technology of "connectivity" (i.e., Internet, telecommunications) on the practice of medicine, and to direct these new advances to enhance patient safety.
• To examine how new technologies will affect roles, judgement, and coordination, which will reveal side effects that could create new systemic complexities.

Robert Wears, M.D., M.S., MedTeams Consortium

Recently, there has been a successful demonstration of the effectiveness of teamwork in emergency medicine and a growing availability of health care simulators. As a result of this, Dr. Wears proposed that further research should be conducted in four specific areas:

• Research to expand the use of patient simulators from a single practitioner focus to a team focus.
• Research to use simulators to identify appropriate team structures best suited to different settings of care.
• Research to investigate the use of simulation to reinforce, retrain, and refresh technical skills together with teamwork skills.
• Research to study the establishment of medical simulation centers of excellence.

Question and Answer Session

The following additional areas for research focus were discussed:

• Examining strategies for disseminating information across a health care "system" that is actually very fragmented.
• Identifying effective ways to translate what is already known into practice. Understanding how new technology will affect the current concept of teamwork (i.e., "computer-supported cooperative work").
• International examination of confidentiality protections given to health care providers, and whether such protections make a difference in error improvement.
• Hospitals and medical associations should work with their members to develop the need for research. Associations have the ability to bring together various parties and to engage them in the research process, so they remain vested in the research findings.
• Using large data sets to study errors in omission and commission. This endeavor will be greatly enhanced by the development of an electronic medical record by a number of organizations.

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Panel 3: Particular System Issues

This panel focused on very targeted areas that contribute to the research agenda on medical errors and patient safety: medication errors, hospital staffing, medical devices, and end-of-life care.

Michael Cohen, F.A.S.H.P., Institute for Safe Medication Practices

Dr. Cohen's testimony focused on why widely known and effective medication error reduction strategies have not been adopted, and on how to structure a nationwide communication initiative on medication error prevention. He suggested that research be done to identify:

• The current level to which known medication error reduction strategies have been adopted.
• Barriers that have led to the failure to adopt widely known medication error reduction strategies.
• The most effective ways to structure and fund a comprehensive nationwide communication initiative, taking advantage of current knowledge about medication error prevention to provide crucial information directly to all health care participants.

Patricia Underwood, American Nurses Association

Ms. Underwood's testimony focused on the relationship between working conditions in health care settings and patient safety. She suggested the following as priority areas: Research to evaluate the occurrence of medical errors in relation to the following variables:

• Patient-nurse ratio, severity of illness, mortality/morbidity rates, and length of stay.
• Research to examine the relationship between continuous hours worked by health care professionals and their ability to work safely and without errors.
• Research to evaluate the relationship between work environment and patient safety by assessing the following trends: work-related staff illness and injury rates, overtime rates, staff satisfaction levels, flexibility of human resources policies and benefits packages, use of supplemental staffing, and compliance with Federal, State, and local regulations.
• Research to compare the efficacy in reducing medical errors of institutions that have enhanced monitoring and reporting systems versus institutions where continuous quality improvement principles have been implemented as part of the organization's culture.

Mark Bruley, Emergency Care Research Institute

Mr. Bruley noted that while most medical errors have many causes, there are three constants in any accident: the medical device or technology, the procedure, and the resulting injury. He proposed a research agenda focusing on the interactions of these constants by addressing three key areas:

• Defining the extent to which medical devices contribute to medical errors, with a special focus on the technology-intensive medical specialties.
• Identifying what safety features or engineering controls (including those based on human factors research) can be employed to minimize the likelihood of medical errors.
• Determining whether the frequency and severity of device-related errors justifies the development of broader reporting and prevention interventions.

Joanne Lynn, M.D., M.A., M.S., RAND Center to Improve Care of the Dying and Americans for Better Care of the Dying

The end-of-life patient population is a very important target of safety research because they have more contact with the health care system (and are therefore at greater risk for error), and they are also physiologically more vulnerable to medication errors and other lapses in patient safety than healthier patients. Dr. Lynn identified five priority areas for research focusing on vulnerable populations:

• Research to examine alternative conceptual models for the current definition of "cause of death," and to determine when medical errors (that are part of a chain of causation leading to death) should be counted as a cause of death.
• Research to examine the magnified effects of routine errors on the vulnerable patient population in comparison to their effects on the more robust general patient population.
• Research to examine the effectiveness of subjecting errors of non-treatment or mistreatment of common end-of-life symptoms (e.g., pain, depression) to the same kinds of systems engineering, accountability, and national goal-setting that is being proposed for medication errors.
• Research to examine how provider and public health organizations can arrange services in a way that will provide efficient, sustainable, reliable, and safe care for the end-of-life population.
• Research to determine whether emergency hospitalizations of patients at the end of life should be considered potentially preventable adverse events and therefore significant risk factors.

Question and Answer Session

The following additional areas for research focus were discussed:

• Research must take a whole-system approach, and not just a provider-focused approach, to find a lasting solution.
• Research should examine the financial distress of hospitals and how it impacts on medical errors, with a special focus on staffing patterns.
• Research should identify the best components of other industries' safety efforts (e.g., aviation industry), and can also examine the adaptation and application of other industries' models to health care.

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