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Background and Methodology

This report on patient safety is part of a larger study examining the quality of health care in America. The Quality of Health Care in America project was initiated by the Institute of Medicine in June 1998, with the charge of developing a strategy that will result in a threshold improvement in quality over the next ten years. Specifically, the committee is charged with the following tasks:

• review and synthesis of findings in the literature pertaining to the quality of care provided in the health care system;

• development of a communications strategy for raising the awareness of the general public and key stakeholders of quality-of-care concerns and opportunities for improvement;

• articulation of a policy framework that will provide positive incentives to improve quality and foster accountability;

• identification of key characteristics and factors that enable or encourage providers, health care organizations, health plans, and communities to continuously improve the quality of care; and

• development of a research agenda in areas of continued uncertainty.

A growing body of rigorous research has documented serious and widespread quality problems in American medicine. The burden of harm con-



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A Background and Methodology T his report on patient safety is part of a larger study examining the quality of health care in America. The Quality of Health Care in America project was initiated by the Institute of Medicine in June 1998, with the charge of developing a strategy that will result in a threshold improvement in quality over the next ten years. Specifically, the committee is charged with the following tasks: • review and synthesis of findings in the literature pertaining to the quality of care provided in the health care system; • development of a communications strategy for raising the awareness of the general public and key stakeholders of quality-of-care concerns and opportunities for improvement; • articulation of a policy framework that will provide positive incen- tives to improve quality and foster accountability; • identification of key characteristics and factors that enable or encour- age providers, health care organizations, health plans, and communities to continuously improve the quality of care; and • development of a research agenda in areas of continued uncertainty. A growing body of rigorous research has documented serious and wide- spread quality problems in American medicine. The burden of harm con- 205

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206 TO ERR IS HUMAN veyed by the collective impact of all of our health care quality problems requires the urgent attention of all stakeholders—the health professions, health policy makers, consumer advocates, and purchasers of care. The chal- lenge is to bring the full potential benefit of effective health care to all Ameri- cans while avoiding unnecessary and harmful interventions and eliminating preventable complications of care. Meeting this challenge demands a readi- ness to think in radically new ways about how to deliver health care services and how to assess and improve their quality. Yet neither business leaders, medical leaders, policy makers, nor the public has a clear picture about whether different forms of financing and delivery of care have affected the quality of care and how best to structure financing, oversight, and delivery of care to improve quality. The methods used for this study included a review of available litera- ture, a commissioned paper, public testimony, a telephone survey, and input from targeted groups on specific issues. A review of the literature relied on published articles focusing on areas of quality, medical errors, patient safety, aviation safety, worker safety, and pharmaceutical safety. Working papers and web sites were also consulted, generally provided by organizations in- volved in patient safety, accreditation, and existing error reporting systems. A paper was commissioned on the legal issues raised in protecting data and reporters in error reporting systems that are external to a health care organization. This paper was completed for the committee by Randall Bovbjerg, J.D., and David Shapiro, M.D., J.D. It formed the basis for Chap- ter 6 of this report. The content of this report was discussed at seven meetings of two differ- ent subcommittees. It was on the agenda at four meetings of the Subcom- mittee on Creating an External Environment for Quality and three meetings of the Subcommittee on Creating the 21st Century Health System. It was also on the agenda at three meetings of the Committee on Quality of Health Care in America. The public testimony provided follows: Subcommittee on Creating an External Environment for Quality November 2, 1998 Martin Hatlie, National Patient Safety Foundation Michael Cohen, Institute for Safe Medication Practices Ronald Goldman, Veterans Health Administration

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207 APPENDIX A January 29, 1999 Charles Billings, M.D., Ohio State University (designer of the Aviation Safety Reporting System) June 15, 1999 Tim Cuerdon, Health Care Financing Administration Margaret VanAmringe, Joint Commission on Accreditation of Health Care Organizations Marge Keyes, Agency for Healthcare Research and Quality Joint Meeting of Both Subcommittees June 16, 1999 Kenneth Kizer, M.D., Undersecretary of Health, Veterans Health Administration A short telephone survey was conducted between February 24 and May 5, 1999 of a number of states having error reporting systems that affect hos- pitals. The list of states was obtained from the Joint Commission on Ac- creditation of Healthcare Organizations. A nonrepresentative sample was chosen to obtain additional information on their programs, focusing mainly on the largest states. The respondent was the individual at the state health department with administrative responsibility over the reporting program. Information was collected on the definition of a reportable event, which organizations submit reports, the number of reports submitted in the most recent year available, the year the reporting program was implemented, who has access to the information reported, and what is done with the informa- tion obtained (e.g., organization follow-up on specific events, compilation of data and trending over time). All respondents were given an opportunity to review the information on their states and make any corrections or clarifi- cations. Finally, input was obtained through two group meetings with specific key audiences. The first meeting was a 90-minute discussion held on August 2, 1999, at the 12th Annual Conference of the National Academy for State Health Policy in Cincinnati, Ohio. This meeting was attended by 19 people, all of whom had responsibilities associated with quality-of-care issues, some related to state error reporting programs. Open discussion was held on roles that states can play in ensuring adequate oversight of quality-of-care and patient safety, and what would be helpful to the states to increase their ef- forts in safety oversight. The second meeting was a one-day roundtable discussion held on Sep-

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208 TO ERR IS HUMAN tember 9, 1999, with health professionals active in their professional societ- ies and associations through support from The Commonwealth Fund. This meeting was attended by 14 people representing medicine, nursing, and pharmacy. This open discussion covered issues related to the extent to which the health and medical community is aware of quality and safety concerns, specific actions that professional societies and groups can take to improve patient safety, and barriers that impede these actions from moving forward. OTHER IOM WORK ON QUALITY This quality initiative represents a continuing IOM interest in quality of health care. Several other quality-of-care projects have been undertaken in recent years. America’s Health in Transition: Protecting and Improving the Quality of Health and Health Care (IOM-wide special initiative) The Special Initiative on Health Care Quality was created in 1996 to examine how to maintain and improve the health and well-being of the popu- lation and the quality of care that the public receives as the health care sys- tem restructures. This special initiative is evaluating quality assessment and improvement tools and their uses, and promoting the application of appro- priate tools at all levels of health care, in all organizations, for the entire population. The initiative will also inform consumers, policy makers, pro- viders, and others of key opportunities and obstacles to achieving better health outcomes for individuals and populations, and will provide them with information and tools to enable them to make better decisions and choices about health and health care. National Roundtable on Health Care Quality The National Roundtable on Health Care Quality was created to exam- ine continual changes in health care and the implications of these changes for the quality of health and health care in this nation. The Roundtable con- vened nationally prominent representatives of the private and public sectors (regional, state, and federal); academia; patients; and the health media to analyze unfolding issues concerning health care quality. This initiative pro- duced three reports: The Urgent Need to Improve Health Care Quality, Mea-

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209 APPENDIX A suring the Quality of Health Care, and Collaboration Among Competing Man- aged Care Organizations for Quality Improvement. Ensuring the Quality of Cancer Care The National Cancer Policy Board undertook a comprehensive review of the quality of cancer care provided in the United States. The report, pub- lished in June 1999, delineates essential elements needed to improve quality in cancer care. The report provides an overview of the present cancer care system, moving from detection and early treatment to care at the end of life. Major obstacles impeding patient access to quality cancer care are identi- fied. The report offers a model of an ideal cancer care delivery system and provides examples of the problems that limit early detection, accurate diag- nosis, optimal treatment, and responsive supportive care. Recommendations to improve the quality of cancer care are offered for consideration by Con- gress, public and private health care purchasers, individual consumers, pro- viders and researchers. Improving Quality in Long-Term Care The Committee on Improving Quality in Long-Term Care was convened to examine the means for assessing, overseeing, and improving the quality of long-term care in different settings and the practical and policy challenges of achieving a consistent quality of care regardless of where care is received. This study built on a 1986 report, Improving the Quality of Care in Nursing Homes, which initiated changes that significantly altered where long-term care is received and by whom. The most recent study examines the full range of long-term care settings and services, including nursing homes, assisted living facilities, and community-based home health care.