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 consistent with current medical knowledge and customization. The second dimension 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.

Figure 1.1

A general model of the influence of the external environment on quality.

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, 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 values 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 service 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 public policy or legal influence, such as licensing or the liability system. Economic 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 organizations in two ways. First, it can empower the chief executive officer and governance of health care organizations to take action internally to improve quality. It provides a call to action from the external environment that requires a response inside the organization, and lack of an appropriate response 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 information 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 Administration) 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 additional demands they can bring through conditions of participation and other oversight responsibilities. In health care, efforts to make comparative performance data available in the public domain to assist purchasers and consumers 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 marketplace, 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 values, 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 professionals 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 purchasers and consumers.

Activities in the external environment interact with each other in various ways for the different domains of quality. As noted by the curve in Figure 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, reinforce that priority. On the other hand, the customization of care to meet individual needs and preferences is more driven by economic and other incentives, with regulation and legislation potentially playing a supportive or enabling role. Encouraging practice consistent with current medical knowledge 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 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 evaluation 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 challenge.

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 actions 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 understanding 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 an expectation of perfection and attributes errors to carelessness or incompetence. Liability concerns discourage the surfacing of errors and communication about how to correct them. The lack of explicit and consistent standards 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 medical errors and improve the safety of patients.

Chapter 3, Why Do Errors Happen?, offers a discussion of several concepts in patient safety, including a number of definitions for terms used throughout this report. The chapter describes leading theory on why accidents happen and the types of errors that occur. It also explores why some systems are safer than others and the contribution of human factors principles to designing safer systems.

Chapters 4 through 8 of the report lay out a set of actions that the external 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 information 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 industries can identify an agency or organization with accountability for monitoring and communicating about safety problems. No such focal point exists 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 dissemination 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 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 availability 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 licensing 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 discussed.

Chapter 8, Creating Safety Systems in Health Care Organizations, discusses 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 patient 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 incorporate 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 environment and the policy and market strategies that can be employed to encourage actions by health professionals and health care organizations. It is 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 actions absent any incentives from the external environment, the external environment 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 needle sticks 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 access to care. Employers are reducing coverage for workers and their dependents. ⁴ Inadequate coverage compromises access and creates inequities between 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 covered 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 report, those dealing with overall quality concerns will also have to consider problems of access.

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. Department of Health and Human Services. 1998. [PubMed: 9749483]

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. [PubMed: 9749483]

3.

Berk, Marc L., and Schur, Claudia L. Measuring Access to Care: Improving Information 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. [PubMed: 10091430]

5.

Institute of Medicine. Access to Health Care in America. Michael Millman, editor. , ed. Washington, D.C.: National Academy Press, 1993. [PubMed: 25144064]