CHAPTER 1 - Continuous Quality Improvement in the Clinical Laboratory: Evolution of the Concept and Tools for Implementation

Oct 26, 2026

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Continuous Quality Improvement (QI) in the clinical laboratory is presented through an evolution of concepts, patient-safety concerns, and practical implementation tools. The chapter frames QI as system- and process-centered, explaining how poorly designed systems drive inefficiency and negative outcomes. It reviews historic foundations, including Donabedian’s quality domains and metrics (structure, process, outcome) and the Institute of Medicine’s six quality domains. Shewhart, Deming, and Juran influences are used to introduce control charts and the PDSA/PDCA learning cycle, including statistical variation concepts and control versus uncontrolled processes.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Introduction and Evolution of the Continuous Quality Improvement Concept

Historic Perspective

Shewhart, Deming, and Juran Foundations

Control charts and statistical process control

Variation: assignable/common causes

PDSA (Plan–Do–Study–Act) learning and improvement cycle

CHAPTER 1 Continuous Quality Improvement in the Clinical Laboratory: Evolution of the Concept and Tools for Implementation Vijayalakshmi Padmanabhan, MD, MPH, FCAP Introduction and Evolution of the Continuous Quality Improvement Concept The past few decades have seen a change in perception in the health care system and among the public of patient safety, quality, and cost of healthcare. Regardless of whether their position is laboratory director, manager, or a trainee, patient safety and quality improvement (QI) are terms that the reader will need to be familiar with and use in daily practice. This chapter is an introduction to the world of quality and patient safety; hopefully, with this introduction, the reader can more confidently embark on the process of QI. This chapter focuses on approaches to QI and how to apply the principles of QI in the laboratory. A basic tenet is that“every system is perfectly designed to achieve the results it achieves.”1 Poorly designed systems generate inefficiency and waste, poor health care quality, and negative health outcomes. The emphasis of QI should be on systems and processes of care instead of the individual laboratorian. To achieve better laboratory quality we must change the system. Historic Perspective QI methods were first applied to health care in the United States in the early 20th century in the form of professional licensing and standards-based external evaluations of hospitals and medical schools.2,3 Avedis Donabedian, a mid-20th century academic physician with a special interest in public health and healthcare quality, is considered by many to be one of the founders of the contemporary health care quality movement.4 Donabedian describes 7 pillars of quality in medicine: Efficacy, Efficiency, Optimality, Acceptability, Legitimacy, Equity, and Cost. To measure these goals, he described three types of metrics for evaluating quality in health care, the domains of quality of care: structure, process, and outcome. Structure includes the environment in which care is provided; the facilities, equipment, services, and manpower available for care; the qualifications, skills, and experience of the healthcare professionals; and other characteristics of the hospital or system providing care. The process consists of the activities and steps involved and the sequence of these steps when patients receive health care. For the laboratory, process refers to how the specimen is moved into, through, and 1 Chapter 1 out of the system, which equates to the preanalytical, analytic and postanalytic steps in the process of a laboratory test. Process measures of quality can be developed and monitored around any of these steps. After this groundbreaking work, a body advising the government on issues regarding social, economic, and political aspects of health care and medicine evolved, and the Institute of Medicine (IOM) was founded in 1970.5 To Err is Human brought the patient safety perspective in healthcare to the forefront.6 Six domains of healthcare quality were described by the IOM in 2001 in thereport “Crossing the Quality Chasm.”7 These domains include safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness. For example, laboratories generally aim to be efficient without waste and timely with reports. The exact indicators to measure in a QI plan can be determined using the frameworks of the Donabedian triad and the IOM’s quality domains. Local priorities, local patterns of practice, ease of access to data, and resources required to collect, analyze, and display data, etc., will also play a role in determining the measures that are established. Shewhart, Deming, and Juran are often considered to be the three founders ofthe QI movement.8,9 Two of Shewhart’s contributions continue to influence the daily work of quality: control charts and the Plan–Do–Study–Act (PDSA) cycle.10 The Shewhart cycle or Shewhart learning and improvement cycle combines managemen

FAQs

What is the role of the PDSA (or PDCA) cycle in the QI movement?

The chapter presents the cycle as a learning and improvement framework in which management policy and procedures are repeatedly evaluated, supporting continuous improvement through iterative planning, action, and study/check of results.

Oct 26, 2026

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