Part II
Establishing Comprehensive Patient Safety Programs

This part of the report begins by providing an overview of the components of a patient safety program (Chapter 5). It then reviews in more detail adverse event analysis (Chapter 6) and near-miss analysis (Chapter 7).

ESTABLISHMENT OF COMPREHENSIVE PATIENT SAFETY PROGRAMS

Traditionally, adverse event reporting systems have focused on past events, logging serious events and facilitating root-cause analysis and the formulation of system improvements. While submitting and analyzing patient safety–related reports of past events is extremely important, insufficient attention has been paid to improving patient safety by preventing adverse events from occurring in the first place. Patient safety considerations are integral to each clinical decision and surveillance. Thus, the committee believes patient safety cannot be considered separately from the delivery of quality care. Chapter 5 outlines the components of a comprehensive patient safety program implemented within a culture of safety. To facilitate the implementation of such a program, a strong patient safety research agenda is needed.

Recommendation 5. All health care settings should establish comprehensive patient safety programs operated by trained personnel within a culture of safety. These programs should encompass (1) case find-



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Patient Safety: Achieving a New Standard for Care Part II Establishing Comprehensive Patient Safety Programs This part of the report begins by providing an overview of the components of a patient safety program (Chapter 5). It then reviews in more detail adverse event analysis (Chapter 6) and near-miss analysis (Chapter 7). ESTABLISHMENT OF COMPREHENSIVE PATIENT SAFETY PROGRAMS Traditionally, adverse event reporting systems have focused on past events, logging serious events and facilitating root-cause analysis and the formulation of system improvements. While submitting and analyzing patient safety–related reports of past events is extremely important, insufficient attention has been paid to improving patient safety by preventing adverse events from occurring in the first place. Patient safety considerations are integral to each clinical decision and surveillance. Thus, the committee believes patient safety cannot be considered separately from the delivery of quality care. Chapter 5 outlines the components of a comprehensive patient safety program implemented within a culture of safety. To facilitate the implementation of such a program, a strong patient safety research agenda is needed. Recommendation 5. All health care settings should establish comprehensive patient safety programs operated by trained personnel within a culture of safety. These programs should encompass (1) case find-

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Patient Safety: Achieving a New Standard for Care ing—identifying system failures, (2) analysis—understanding the factors that contribute to system failures, and (3) system redesign—making improvements in care processes to prevent errors in the future. Patient safety programs should invite the participation of patients and their families and be responsive to their inquiries. Recommendation 6. The federal government should pursue a robust applied research agenda on patient safety, focused on enhancing knowledge, developing tools, and disseminating results to maximize the impact of patient safety systems. AHRQ should play a lead role in coordinating this research agenda among federal agencies (e.g., the National Library of Medicine) and the private sector. The research agenda should include the following: Knowledge generation High-risk patients—Identify patients at risk for medication errors, nosocomial infections, falls, and other high-risk events. Near-miss incidents—Test the causal continuum assumption (that near misses and adverse events are causally related), develop and test a recovery taxonomy, and extend the current individual human error/recovery models to team-based errors and recoveries. Hazard analysis—Assess the validity and efficiency of integrating retrospective techniques (e.g., incident analysis) with prospective techniques. High-yield activities—Study the cost/benefit of various approaches to patient safety, including analysis of reporting systems for near misses and adverse events. Patient roles—Study the role of patients in the prevention, early detection, and mitigation of harm due to errors. Tool development Early detection capabilities—Develop and evaluate various methods for employing data-driven triggers to detect adverse drug events, nosocomial infections, and other high-risk events (e.g., patient falls, decubitus ulcers, complications of blood product transfusions). Prevention capabilities—Develop and evaluate point-of-care decision support to prevent errors of omission or commission. Data mining techniques—Identify and develop data mining techniques to enhance learning from regional and national patient safety databases. Apply natural language processing techniques to facilitate the extraction of patient safety–related concepts from text documents and incident reports.

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Patient Safety: Achieving a New Standard for Care Dissemination—Deploy knowledge and tools to clinicians and patients. ADVERSE EVENT ANALYSIS The Institute of Medicine’s (IOM) report To Err Is Human: Building a Safer Health System report (Institute of Medicine, 2000) boosted existing patient safety initiatives and stimulated new ones. Today in the United States, there are many types of patient safety reporting systems in operation or under development at the federal, state, and private-sector levels. Overseas, Australia (Australian Council for Safety and Quality in Health Care, 2001; Runciman and Moller, 2001) and the United Kingdom (National Patient Safety Agency, 2001) are implementing nationwide patient safety reporting systems. The federal government operates patient safety reporting systems as part of its role of performing regulatory oversight of the health care industry and as part of its caregiver role through the Veterans Health Administration and the Department of Defense. Many states operate reporting systems as part of their regulatory oversight role of health care providers. In addition, many health care institutions operate patient safety systems for internal quality improvement purposes, and a few private-sector organizations operate such systems on a national basis. Appendix C provides summaries of a sampling of major U.S. patient safety reporting systems. The aim of adverse event analysis is to identify ways to improve the delivery of health care through the analysis of adverse events. Accomplishing this objective involves defining the adverse events to investigate, establishing methods for the detection of such events, and identifying the data needed for analysis purposes. The functional requirements of adverse event analysis systems and the implications for data standards are examined in Chapter 6. NEAR-MISS ANALYSIS Current patient safety reporting systems are nearly always focused on adverse events and usually neglect near-misses (sometimes called “close calls”). Of the patient safety reporting systems currently operational in the United States, only a small proportion collect and analyze information on near misses (see Appendix C). None of the reporting systems used for federal regulatory oversight include near misses as reportable events. Of the 21 states mandating patient safety reporting systems, only Pennsylvania and

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Patient Safety: Achieving a New Standard for Care Kansas collect near-miss information (Rosenthal, 2003). Private-sector reporting systems are much more likely to collect information on near misses. The committee believes that near-miss reporting and analysis systems should be fostered. Near misses are often precursors of adverse events, and analysis of their root causes can provide important insights into how to prevent adverse events from happening. In addition, near misses involve some planned or unplanned recovery procedures. These responses to system breakdowns are a key element of learning from near misses. Identifying what recovery procedures work in practice helps in developing better care delivery systems. The functional requirements of near-miss analysis systems and the implications for data standards are examined in Chapter 7. REFERENCES Australian Council for Safety and Quality in Health Care. 2001. Safety in Numbers: A Technical Options Paper for a National Approach to the Use of Data for Safer Health Care (Work in Progress). Online. Available: http://sq.netspeed.com.au/articles/Publications/numbers.pdf [accessed March 4, 2002]. Institute of Medicine. 2000. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press. National Patient Safety Agency, Department of Health, United Kingdom. 2001. Doing Less Harm (Version 1.0a). Online. Available: http://www.npsa.org.uk/admin/publications/docs/draft.pdf [accessed April 16, 2002]. Rosenthal, J. 2003. State Reporting Systems Collecting Information on Near Misses. Personal communication to Institute of Medicine’s Committee on Data Standards for Patient Safety. Runciman, W. B., and J. Moller. 2001. Iatrogenic Injury in Australia. Adelaide, Australia: Australian Patient Safety Foundation, Inc.