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CHAPTER 1

The Global Evolution of Continuous Quality Improvement: From Japanese Manufacturing to Global Health Services William A. Sollecito and Julie K. Johnson

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C

We are here to make another world.

—W. Edwards Deming

ontinuous quality improvement (CQI) comes in a variety of shapes, colors, and sizes and has been

referred to by many names. It is an example of the evolutionary process that started with industrial applications, primarily in Japan, and has now spread throughout the world, affecting many economic sectors, including health care. In this introductory chapter, we define CQI, trace its history and adaptation to health care, and consider its ongoing evolution. References to subsequent chapters and a previously published volume of case studies (McLaughlin, Johnson, & Sollecito, 2012) provide greater detail and illustrations of CQI approaches and successes as applied to health care.

Despite the evolution and significant progress in the adoption of CQI theory, methods, and applications, the need for greater efforts in quality improvement in health care continues unabated. For example, a major study from 2010 encompassing more than 2,300 admissions in 10 North Carolina hospitals demonstrated that much more needs be done to improve the quality and safety in U.S. hospitals, and it may have implications for health care globally. It found that “patient harms,” including preventable medical errors and other patient safety measures, remained common with little evidence of improvement during the 6-year study period from 2002 to 2007 (Landrigan et al., 2010). In recent years, there has been substantial progress in the greater diffusion of

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CQI in health care in certain sectors. For example, there has been broader institutionalization of CQI in public health in the United States, much of which can be attributed to the broader application of accreditation requirements; this is described in Chapters 11 and 12. Great progress has also been seen in the broader adoption of CQI in resource-poor countries, as documented in Chapter 13. However, with greater complexity in health care comes greater challenges; for example, greater uses of technology bring benefits and risks, as described in Chapter 4, and more widespread applications of evidence-based interventions do not necessarily provide improved outcomes (Wandersman, Alia, Cook, Hsu, & Ramaswamy, 2016). As a result, the challenge of how to cross the quality chasm (Institute of Medicine [IOM], 2001) in health care clearly remains, and our goal in this text is to help to shed light on the scope of the problem and potential solutions.

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▶ Definitions

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Quality in Health Care The exact definition of quality in health care varies somewhat for the various sectors of health care. The World Health Organization (WHO) provides a broad- based definition that encompasses global health care as:

“the extent to which health care services provided to individuals and patient populations improve desired health outcomes. In order to achieve this, health care must be safe, effective, timely, efficient, equitable and people-centered.”

Safe. Delivering health care that minimizes risks and harm to service users, including avoiding preventable injuries and reducing medical errors.

Effective. Providing services based on scientific knowledge and evidence-based guidelines.

Timely. Reducing delays in providing and receiving health care.

Efficient. Delivering health care in a manner that maximizes resource use and avoids waste.

Equitable. Delivering health care that does not differ in quality according to personal characteristics such as gender, race, ethnicity, geographical location, or socioeconomic status.

People-centered. Providing care that takes into account the preferences and aspirations of individual service users and the culture of their community (World Health Organization, 2017).

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Quality Assurance Quality assurance (QA) is closely related to, and sometimes confused with, CQI. QA focuses on conformance quality, which is defined as “conforming to specifications; having a product or service that meets predefined standards” (McLaughlin & Kaluzny, 2006, p. 37). QA is sometimes the primary goal of accreditation processes, for example in the 1980s and 90s hospital accreditation by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) now known as The Joint Commission (TJC) was primarily focused on meeting predefined standards (i.e., QA). More recently, especially in public health, accreditation is intended to promote CQI (see Chapters 11 and 12). QA is sometimes included in broader CQI initiatives as a way of defining baseline care, as an interim goal or as part of the process definition, but CQI is much broader in its goals than QA.

A related concept that should be mentioned briefly is quality control (QC), which was widely used in the early development of procedures to ensure industrial product quality. Various definitions can be found for this term (Spath & Kelly, 2017), and in some cases, QC is confused with QA. It is our experience that QC is synonymous with inspection of products or other process outputs with the goal of determining which products should be rejected and/or reworked, often accompanied by counting the number of “defects.” The role and weaknesses of inspection (in comparison to CQI) are further discussed by Ross (2014) as part of the evolutionary development of CQI.

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Continuous Quality Improvement (CQI) A succinct but accurate definition of CQI in health care is: “the combined efforts of everyone—health care professionals, patients and their families, researchers, payers, planners and educators—to make changes that will lead to better patient outcomes (health), better system performance (care) and better professional development (learning)” (Batalden & Davidoff, 2007, p. 2).

To expand on that definition, for example to include public health, and describe how this term has led to a broad movement, we provide a bit of history. What was originally called total quality management (TQM) in the manufacturing industry evolved into CQI as it was applied to health care administrative and clinical processes. Over time, the term continued to evolve, and now the same concepts and activities are referred to as quality improvement or quality management, or even sometimes simply as improvement, as in the Model for Improvement (Langley et al., 2009). Except when we refer to specific historical examples, the terms CQI and QI will be used primarily throughout this text.

In health care, a broader definition of CQI and its components is this: CQI is a structured organizational process for involving personnel in planning and executing a continuous flow of improvements to provide quality health care that meets or exceeds expectations. CQI usually involves a common set of characteristics, which include the following:

■   A link to key elements of the organization’s strategic plan

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■   A quality council made up of the institution’s top leadership

■   Training programs for personnel ■   Mechanisms for selecting improvement

opportunities ■   Formation of process improvement teams ■   Staff support for process analysis and redesign ■   Personnel policies that motivate and support staff

participation in process improvement ■   Application of the most current and rigorous

techniques of the scientific method and statistical process control

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Institutional Improvement Under its various labels, CQI is both an approach or perspective and a set of activities applied at various times to one or more of the four broad types of performance improvement initiatives undertaken within a given institution:

1. Localized improvement efforts 2. Organizational learning 3. Process reengineering 4. Evidence-based practice and management

Localized improvement occurs when an ad hoc team is developed to look at a specific process problem or opportunity. Organizational learning occurs when this process is documented and results in the development of policies and procedures, which are then implemented. Examples include the development of protocols, procedures, clinical pathways, and so on. Process reengineering occurs when a major investment blends internal and external resources to make changes, often including the development of information systems, which radically impact key organizational processes. Evidence-based practice and management involve the selection of best health and management practices; these are determined by examination of the professional literature and consideration of internal experience, and more recently, especially in public health, accreditation requirements. The lines of demarcation between these four initiatives are not clear because performance improvement can occur across a continuum of project size, impact, content, external

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consultant involvement, and departure from existing norms.

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Societal Learning In recent years, the emphasis on quality has increased at the societal level. The Institute of Medicine (IOM) (now called the U.S. National Academy of Medicine) has issued a number of reports critical of the quality of care and the variability of both quality and cost across the country (IOM, 2000, 2001). This concern has increased with mounting evidence of the societal cost of poor- quality care in both lives and dollars (Brennan et al., 2004). It builds on the pioneering work of Phillip Crosby (1979), who provided a focus on the role of cost in quality initiatives that is quite relevant today. Crosby’s writings emphasize developing an estimate of the cost of nonconformance, also called the cost of quality. Developing this estimate involves identifying and assigning values to all of the unnecessary costs associated with waste and wasted effort when work is not done correctly the first time. This includes the costs of identifying errors, correcting them, and making up for the customer dissatisfaction that results. Estimates of the cost of poor quality range from 20–40% of the total costs of the industry, a range widely accepted by hospital administrators and other health care experts.

This view leads naturally to a broadening of the definition of quality by introducing the concept of adding value, in addition to ensuring the highest quality of care, implying greater accountability and a cost benefit to enhance the decision-making and evaluation aspects of CQI initiatives. This concept has seen a resurgence in recent years as national health plans, for example in the United States and the United Kingdom, look to minimize

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cost and increase value while providing the highest quality of care. For example, several leading experts propose refocusing on quality and accountability simultaneously, noting that “improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care” (Berwick, Nolan, & Whittington, 2008, p. 759). These same sentiments are echoed by Robert Brook of the RAND Corporation, who proposes that the future of CQI in health care requires a focus on the concept of value, with consideration of both cost and quality (Brook, 2010).

Most recently, a large-scale reinforcement of these concepts in the United States is found in the goals of the Affordable Care Act (ACA), which jointly emphasizes improvements to access, quality of care, and cost reduction. Although some progress can be attributed to the ACA for example, in regard to lowering hospital acquired infections and readmissions—achievement of its long-term goals is still a work in progress (Blumenthal, Abrams, & Nuzum, 2015; Somander, 2015). These concepts are discussed in greater detail throughout this book, particularly in the final chapter (Chapter 14). Concerns about linking quality and value are not limited to the United States; similar evidence and concerns have been reported from the United Kingdom, Canada, Australia, and New Zealand (Baker et al., 2004; Davis et al., 2002; Kable, Gibbard, & Spigelman, 2002). This emphasis has played out in studies, commissions, and reports as well as the efforts of regulatory

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organizations to institutionalize quality through their standards and certification processes. As you will see throughout this book, concern for quality and cost is a matter of public policy.

Professional Responsibility Health care as a whole is often likened to a cottage industry with overtones of a medieval craft guild, with a bias toward treatment rather than prevention and a monopoly of access to and implementation of technical knowledge. This system reached its zenith in the mid- 20th century and has been under pressure ever since (McLaughlin & Kaluzny, 2002; Rastegar, 2004; Schlesinger, 2002; Starr, 1982). It is reinforced by the concept of professionalism, by which service providers are assumed to have exclusive access to knowledge and competence and, therefore, take full responsibility for self-regulation and for quality. However, much of the public policy debate has centered on the weaknesses of the professional system in improving quality of care. Critics point to excessive professional autonomy; protectionist guild practices, such as secrecy, restricted entry, and scapegoating; lack of capital accumulation for modernization; and economic self-interest as major problems. As we will see, all of these issues impinge on the search for improved quality. However, we cannot ignore the role of professional development as a potential engine of quality improvement, despite the popular emphasis on institutional improvement and societal learning. This, too, will be addressed in subsequent chapters.

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