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A Comprehensive Approach to Improving Patient Safety

This report proposes a comprehensive approach reducing medical for errors and improving patient safety. The approach employs market and regulatory strategies, public and private strategies, and strategies that are implemented inside health care organizations as well as in their external environment. To achieve a threshold improvement in patient safety, all of these strategies must be employed in a balanced and complementary fashion.

This introductory chapter first discusses patient safety within the overall context of improving quality. The objective of the Quality of Health Care in America Project is to lay out a strategy for achieving a threshold improvement in quality over the coming decade. Patient safety is one of three domains of quality concerns. A general model of how the external environment influences health care organizations to improve different domains of quality is presented and the model is then discussed as it applies to patient safety, the focus of this first report of the Quality of Health Care in America Committee. Second, the chapter provides a roadmap to the remainder of the report by briefly describing the chapters that follow.



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1 A Comprehensive Approach to Improving Patient Safety T his report proposes a comprehensive approach for reducing medical errors and improving patient safety. The approach employs market and regulatory strategies, public and private strategies, and strategies that are implemented inside health care organizations as well as in their ex- ternal environment. To achieve a threshold improvement in patient safety, all of these strategies must be employed in a balanced and complementary fashion. This introductory chapter first discusses patient safety within the overall context of improving quality. The objective of the Quality of Health Care in America Project is to lay out a strategy for achieving a threshold improve- ment in quality over the coming decade. Patient safety is one of three do- mains of quality concerns. A general model of how the external environment influences health care organizations to improve different domains of quality is presented and the model is then discussed as it applies to patient safety, the focus of this first report of the Quality of Health Care in America Com- mittee. Second, the chapter provides a roadmap to the remainder of the report by briefly describing the chapters that follow. 17

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18 TO ERR IS HUMAN PATIENT SAFETY: A CRITICAL COMPONENT OF QUALITY A general model of the influence of the environment on quality, as shown in Figure 1.1, contains two primary dimensions. The first dimension identifies domains of quality. These include: safe care, practice that is con- sistent with current medical knowledge and customization. The second di- mension identifies forces in the external environment that can drive quality improvement in the delivery system. These have been grouped into two broad categories: regulatory/legislative activities, and economic and other incentives. Safety, the first domain of quality, refers to “freedom from accidental injury.” This definition is stated from the patient’s perspective. As discussed in chapter 2 of this report, health care is not as safe as it should be. The second domain refers to the provision of services in a manner that is consistent with current medical knowledge and best practices. Currently, Economic and Other Incentives EXTERNAL DRIVERS Regulation and Legislation DOMAINS OF QUALITY (Care Processes) Practice Consistent with Safe Customization Current Medical Knowledge External Drivers: Two categories of factors that can influence quality improvement—regulation and legislation, and economic and other incentives such as actions by purchasers and consumers or professional and community values. Safe: Freedom from accidental injury. Requires a larger role for regulation and oversight authority. Practice Consistent with Current Medical Knowledge: Best practices, incorporating evidence- based medicine. Customization: Meeting customer-specific values and expectations. Requires a larger role for creative, continuous improvement and innovation within organizations and marketplace reward. FIGURE 1.1 A general model of the influence of the external environment on quality.

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19 A COMPREHENSIVE APPROACH TO IMPROVING PATIENT SAFETY there is a great deal of variability in medical practice and, oftentimes, a lack of adherence to medical standards based on scientific evidence.1 The third domain exemplifies the ability to meet customer-specific val- ues and expectations, permitting the greatest responsiveness to individual values and preferences and maximum personalization or customization of care. Strong policy directives are difficult to implement in this area because of the variety of individual needs and preferences. Previous work by the IOM categorized quality problems into misuse (avoidable complications that prevent patients from receiving full potential benefit of a service), overuse (potential for harm from the provision of a service exceeds the possible benefit) and underuse (failure to provide a ser- vice that would have produced a favorable outcome for the patient).2 Within this framework, issues of misuse are most likely to be addressed under safety concerns. Issues of overuse and underuse are most likely to be addressed under the domain of practice consistent with current medical knowledge. Activities in the external environment are grouped under two general categories: (1) regulation and legislative action and (2) economic and other incentives (or barriers). Regulation and legislation include any form of pub- lic policy or legal influence, such as licensing or the liability system. Eco- nomic and other incentives constitute a broad category that includes the collective and individual actions of purchasers and consumers, the norms and values of health professionals, and the social values of the nation and local communities. Regulation and legislative action can influence quality in health care or- ganizations in two ways. First, it can empower the chief executive officer and governance of health care organizations to take action internally to im- prove quality. It provides a call to action from the external environment that requires a response inside the organization, and lack of an appropriate re- sponse generally results in certain sanctions. Second, it requires all health care organizations to make minimum investments in systems for quality, thus creating a more level playing field throughout the industry. It should also be noted, however, that regulation and legislation can also create disincentives for quality, such as lax or conflicting standards. Marketplace incentives direct the values, culture, and priorities of health care organizations and reward performance beyond the minimum. One way this can happen is by purchasers and consumers requesting and using infor- mation to direct their business to the best organizations and providers in a community. Both public and private purchasers can be a strong influence, although public purchasers (especially the Health Care Financing Adminis-

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20 TO ERR IS HUMAN tration) are perceived as a potentially stronger force because of the size of the population they cover as a single purchaser and also because of the addi- tional demands they can bring through conditions of participation and other oversight responsibilities. In health care, efforts to make comparative per- formance data available in the public domain to assist purchasers and con- sumers in identifying high quality providers are just starting to emerge through activities such as the Health Plan Employer Data and Information Set (HEDIS) of the National Committee for Quality Assurance (NCQA) and the Consumer Assessment of Health Plans (CAHPs) survey from the Agency for Healthcare Research and Quality (AHRQ). Although purchasing activities are a major component of the market- place, health care is not driven by only economic factors. Incentives come from other directions as well, including the norms, values and standards of health professionals and social values of communities. Professional groups, such as medical societies, specialty groups and associations, play a role in defining norms and standards of practice, and setting expectations and val- ues, beginning with training and education and continuing into practice. Such standards and values not only influence the members of a profession, but also the expectations of consumers and others. Additionally, health pro- fessionals and health care organizations are expected to respond to social demands, such as caring for the uninsured or working collaboratively to improve health status in local communities. Media, advocacy, and others also influence organizational and professional behavior, but do so indirectly, often working through other parties that have direct influence, such as pur- chasers and consumers. Activities in the external environment interact with each other in vari- ous ways for the different domains of quality. As noted by the curve in Fig- ure 1.1, the committee believes regulation and legislation play a particularly important role in assuring a basic level of safety for everyone using the health system. Economic, professional and other incentives can, and should, rein- force that priority. On the other hand, the customization of care to meet individual needs and preferences is more driven by economic and other in- centives, with regulation and legislation potentially playing a supportive or enabling role. Encouraging practice consistent with current medical knowl- edge is reflected as a joint responsibility. The committee believes that a basic level of safety should be assured for all who use the health system and a strong regulatory component is critical to accomplishing this goal. In most industries, ensuring safety is a traditional role of public policy, enforced through regulation. A regulatory authority

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21 A COMPREHENSIVE APPROACH TO IMPROVING PATIENT SAFETY generally defines minimum levels of capability or expected performance. Through some type of monitoring mechanism (e.g., surveillance system, complaint or reporting system, inspections), problems can be identified and corrective action taken to maintain the minimum levels of performance. However, the committee recognizes that regulation alone will not be sufficient for achieving a significant improvement in patient safety. Careful alignment of regulatory, economic, professional and other incentives in the external environment is critical if significant improvements in safety are to occur. In developing its recommendations, the committee sought a careful balance between the regulatory/legislative influences and the influence of economic and other incentives. The precise balance that will prove most successful in achieving safety improvements is unknown. Ongoing evalua- tion should assess whether the proper balance has been achieved relative to safety or if refinement is needed. The committee’s strategy for improving patient safety is for the external environment to create sufficient pressure to make errors so costly in terms of ability to conduct business in the marketplace, market share and reputation that the organization must take action. The cost should be high enough that organizations and professionals invest the attention and resources necessary to improve safety. Such external pressures are virtually absent in health care today. The actions of regulatory bodies, group purchasers, consumers and professional groups are all critical to achieving this goal. At the same time, investments in an adequate knowledge base and tools to improve safety are also important to assist health care organizations in responding to this chal- lenge. ORGANIZATION OF THE REPORT Following is a brief description of each of the remaining chapters in the report. As a whole, these chapters lay out a rationale for taking strong ac- tions to improve patient safety; a comprehensive strategy for leveraging the actions of regulators, purchasers, consumers, and professionals; and a plan to bolster the knowledge base and tools necessary to improve patient safety. Chapter 2 of this report, Errors in Health Care: A Leading Cause of Death and Injury, reviews the literature on errors to assess current under- standing of the magnitude of the problem and identifies a number of issues that inhibit attention to patient safety. A general lack of information on and awareness of errors in health care by purchasers and consumers makes it impossible for them to demand better care. The culture of medicine creates

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22 TO ERR IS HUMAN an expectation of perfection and attributes errors to carelessness or incom- petence. Liability concerns discourage the surfacing of errors and communi- cation about how to correct them. The lack of explicit and consistent stan- dards for patient safety creates gaps in licensing and accreditation and lets health care organizations function without some of the basic safety systems in place. The lack of any agency or organization with primary responsibility for patient safety prevents the dissemination of any cohesive message about patient safety. Given the gaps in the external environment, it should come as no surprise that the health care delivery system is not as responsive as it could be to concerns about patient safety. The external environment is not creating any requirement or demand for the delivery system to reduce medi- cal errors and improve the safety of patients. Chapter 3, Why Do Errors Happen?, offers a discussion of several con- cepts in patient safety, including a number of definitions for terms used throughout this report. The chapter describes leading theory on why acci- dents happen and the types of errors that occur. It also explores why some systems are safer than others and the contribution of human factors prin- ciples to designing safer systems. Chapters 4 through 8 of the report lay out a set of actions that the exter- nal environment can take to increase attention by the delivery system to issues of patient safety. They also identify a set of actions that the delivery system can pursue in response. The combination of proposed strategies seeks to build a national focus on patient safety, make more and better informa- tion available, set explicit standards for patient safety, and identify how health care organizations can put safety systems into practice. Chapter 4, Building Leadership and Knowledge to Improve Patient Safety, discusses the need for a focal point for patient safety. The lack of a clear focal point makes it difficult to define priorities, call for action where needed, or produce a consistent message about safety. Other high-risk in- dustries can identify an agency or organization with accountability for moni- toring and communicating about safety problems. No such focal point ex- ists in health care. The chapter discusses the role of national leadership to set aims and to track progress over time in achieving these aims, the need to develop and fund a safety agenda, and approaches for improving dissemina- tion and outreach about safety to the marketplace and to regulators and policy makers. Chapter 5, Error Reporting Systems, discusses reporting systems as one means for obtaining information about medical errors. A number of public and private reporting systems currently exist, some focused on very specific

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23 A COMPREHENSIVE APPROACH TO IMPROVING PATIENT SAFETY issues, such as medications, and others are more broad based. However, collecting reports on errors is only part of the picture. Analyzing and using the information is how improvements can occur. This chapter discusses the role and purpose of error reporting systems, how to maximize the availabil- ity and use of reports, and the contribution of existing reporting systems. Chapter 6, Protecting Voluntary Error Reporting Systems from Legal Discovery, identifies the legal constraints on protecting data submitted to voluntary reporting systems. Health care organizations are concerned that sharing information about medical errors will expose them to litigation. The unwillingness to share such information means that errors remain hidden and the same errors may be repeated in different organizations. The chapter discusses the legal and practical options available for protecting data to let providers and health care organizations more openly discuss issues related to medical error and patient safety so that errors can be prevented before they result in serious harm or death. Chapter 7, Setting Performance Standards and Expectations for Safety, discusses the need for explicit and consistent standards for patient safety. Such standards not only define minimum expected levels of performance, but also set expectations for purchasers and consumers. The roles of licens- ing and accrediting bodies are discussed relative to standards for health care organizations, professionals, and drugs and medical devices. The roles of purchasers and professional groups in setting expectations are also dis- cussed. Chapter 8, Creating Safety Systems in Health Care Organizations, dis- cusses actions within the delivery system to improve patient safety. The goal for improving patient safety is to affect the delivery of care. Health care organizations have to make certain that systems are in place to ensure pa- tient safety, but they also have to build in mechanisms for learning about safety concerns and for continuous improvement. The chapter discusses the importance of an organizational commitment to safety and the need to in- corporate safety principles into operational processes. Before proceeding further, it is useful to identify what this report is not. Three distinct issues that have been raised during various discussions on patient safety are not addressed here. First, the committee recognizes that a major force for improving patient safety is intrinsic motivation, that is, it is driven by the values and attitudes of health professionals and health care organizations. This report, however, focuses primarily on the external envi- ronment and the policy and market strategies that can be employed to en- courage actions by health professionals and health care organizations. It is

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24 TO ERR IS HUMAN hoped that actions in the external environment will lead to implementation of a specific set of actions within health care organizations. Although some health care organizations are already implementing the recommended ac- tions absent any incentives from the external environment, the external en- vironment can motivate a broader response. Second, worker safety is often linked with patient safety. If workers are safer in their jobs, patients will be safer also. Sometimes, the actions needed to improve patient safety are ones that would also improve worker safety. Procedures for avoiding needlesticks or limiting long work hours are aimed at protecting workers but can also protect patients. Thus, although worker safety is not the focus of this report, the committee believes that creating a safe environment for patients will go a long way in addressing issues of worker safety as well. The third issue is that of access to care. This report is focused on making the delivery of care safer for patients who have access to and are using the health care system. Safe care is an important part of quality care. Although safe care does not guarantee quality, it is a necessary prerequisite for the delivery of high-quality care. However, the committee also recognizes the relationship that exists between access and quality. When someone needs medical care, the worst quality is no care at all. Access continues to be threatened in today’s health care marketplace. For many people the lack of insurance creates a significant barrier to access. The uninsured typically use fewer services than the insured, are more likely to report having cost and access problems, and are less likely to believe that they receive excellent care.3 However, access is not just a concern of the uninsured. Even people with insurance are growing uneasy about their ac- cess to care. Employers are reducing coverage for workers and their depen- dents.4 Inadequate coverage compromises access and creates inequities be- tween those who have complete coverage and full access and those who have partial coverage and partial access. Insufficient coverage also creates concerns about the affordability of care, either because services are not cov- ered at all or because significant out-of-pocket payments, such as copayments and deductibles, are involved. Although financial burden is a significant barrier to access, other factors interfere as well, such as poor transportation, language, and cultural barriers.5 When access to care is threatened, the ability to make a threshold change in quality is also threatened. Although it is not being addressed in this re- port, those dealing with overall quality concerns will also have to consider problems of access.

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25 A COMPREHENSIVE APPROACH TO IMPROVING PATIENT SAFETY REFERENCES 1. Chassin, Mark R.; Galvin, Robert W.; and the National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality. JAMA. 280(11):1000– 1005, 1998. See also: Advisory Commission on Consumer Protection and Quality in the Health Care Industry. Quality First: Better Health Care for All Americans. U.S. Depart- ment of Health and Human Services. 1998. 2. Chassin, Mark R.; Galvin, Robert W.; and the National Roundtable on Health Care Quality. The Urgent Need to Improve Health Care Quality. JAMA. 280(11):1000– 1005, 1998. 3. Berk, Marc L., and Schur, Claudia L. Measuring Access to Care: Improving Infor- mation for Policymakers. Health Affairs. 17(1):180–186, 1998. Also, Donelan, Karen; Blendon, Robert J.; Schoen, Cathy, et al. The Cost of Health System Change: Public Discontent in Five Nations. Health Affairs. 18(3):206–216, 1999. 4. Kronick, Richard, and Gilmer, Todd. Explaining the Decline in Health Insurance Coverage, 1979–1995. Health Affairs. 18(2):30–47, 1999. 5. Institute of Medicine. Access to Health Care in America. Michael Millman, ed. Washington, D.C.: National Academy Press, 1993.