Journal:Strategies for laboratory professionals to drive laboratory stewardship

Full article title	Strategies for laboratory professionals to drive laboratory stewardship
Journal	Practical Laboratory Medicine
Author(s)	White, Terra, E.; Wong, Wesley B.; Janowiak, Diane; Hilborne, Lee H.
Author affiliation(s)	Quest Diagnostics, hc1, University of California - Los Angeles
Primary contact	terra dot e dot white at questdiagnostics dot com
Year published	2021
Volume and issue	26
Article #	e00249
DOI	10.1016/j.plabm.2021.e00249
ISSN	2352-5517
Distribution license	Creative Commons Attribution 4.0 International
Website	https://www.sciencedirect.com/science/article/pii/S2352551721000494
Download	https://www.sciencedirect.com/science/article/pii/S2352551721000494/pdfft (PDF)

Abstract

Appropriate laboratory testing is critical in today's healthcare environment that aims to improve patient care while reducing cost. In recent years, laboratory stewardship has emerged as a strategy for assuring quality in laboratory medicine with the goal of providing the right test for the right patient at the right time. Implementing a laboratory stewardship program now presents a valuable opportunity for laboratory professionals to exercise leadership within health systems and to drive change toward realizing aims in healthcare. The proposed framework for program implementation includes five key elements: 1) a clear vision and organizational alignment; 2) appropriate skills for program execution and management; 3) resources to support the program; 4) incentives to motivate participation; and, 5) a plan of action that articulates program objectives and metrics. This framework builds upon principles of change management, with emphasis on engagement with clinical and administrative stakeholders and the use of clinical data as the basis for change. These strategies enable laboratory professionals to cultivate organizational support for improving laboratory use and take a leading role in providing high-quality patient care.

Keywords: clinical laboratory, laboratory stewardship, quality of health care, change management, patient care, leadership

Introduction

Establishing the correct diagnosis is fundamental to the appropriate treatment of patients, making laboratory testing and other diagnostic services (e.g., radiology) critical to the overall practice of medicine. Some suggest that up to 70% of medical decisions are based, in part, on laboratory findings. While the specific percentage may be debatable, there is no question that laboratory diagnostics are central for medical practice today. The coronavirus disease 2019 (COVID-19) pandemic highlighted the critical role that the nation's laboratories and laboratory professionals play in assuring quality healthcare, well beyond just the pandemic response. Healthcare leaders repeatedly acknowledged the importance of laboratory testing for COVID-19 patient management to, for example, assess symptomatic patients, identify emerging variants, and perform effective contact tracing. Laboratory medicine is also central to the worlds' public health response to COVID-19.

Laboratory testing is typically one of the highest volume medical activities in a health system. Despite their major role in driving clinical decision-making, laboratory diagnostics are highly variable and filled with opportunities to increase appropriate testing while reducing waste. Annual cost estimates in the U.S. for low-value screening, testing, or procedures range from $17.2 billion to $27.9 billion. Excessive diagnostic testing can also increase patient risk while not improving diagnostic certainty. Achieving the aims of higher quality and lower cost depends on the laboratory community taking a central role in improving effective test utilization.

Over the last century, pathologists and laboratory professionals honed their craft while simultaneously expanding tools available to screen, diagnose, treat, and manage patients. The laboratorian historically focused quality efforts on a test's analytic quality. While analytic quality is necessary for appropriate care, it is not sufficient; effective test utilization requires clear medical justification to support the need for a particular test with an understanding of how the results will contribute to guiding patient management. This discussion focuses on the evolution of effective test utilization and implementation of laboratory stewardship as a laboratory leadership strategy to assure effective test use.

Evolution of quality in laboratory medicine

The pursuit of laboratory medicine quality improvement will shortly celebrate its one-hundredth anniversary. In 1922, a group of 39 physicians came together to form what is now known as the American Society for Clinical Pathology (ASCP), now the largest professional organization of pathologists and laboratory professionals in the world. The goal of the ASCP was to “achieve greater scientific proficiency in clinical pathology [meaning here the practice of pathology in the clinical setting, including both anatomical and clinical pathology], and to maintain the status of clinical pathologists on an equal plane with other specialists.” ASCP recognized the contributions and importance of both quality people and quality processes to assuring reliable laboratory results. As such, ASCP was instrumental in creating the American Board of Pathology (1935) to certify pathologists and the Board of Registry (now the Board of Certification) to certify laboratory professionals (1928). ASCP, under the guidance of past president F. William Sunderman, created an inter-laboratory quality control program, now recognized as the College of American Pathologists’ Proficiency Testing Program.

The evolution of quality in pathology and laboratory medicine paralleled that of medicine generally. In 1910, Abraham Flexner issued his landmark report that fundamentally restructured medical education in the U.S., a structure still used today. Training moved from a relatively unstructured generalist model to focus on scientific methods with considerably greater rigor. All medical disciplines reexamined their roles in medical education, delivery of healthcare, and patient centricity; pathology and laboratory medicine was no exception.

In addition to increased technical rigor, attention grew over the ensuing decades to focus on greater evaluation and understanding of the appropriateness (to assess overuse) and necessity (to assess underuse) of medical services. A series of landmark interdisciplinary studies conducted at the RAND Corporation in the 1980s and 1990s highlighted clinical variation in practice and advocated for more explicit criteria to guide diagnosis and treatment. These and other studies served as the basis for more rigorous assessment of clinical evidence, evaluation of practice against that evidence, examination of individual care practices against recognized best practices, and ultimately structuring of payment models to align reimbursement incentives with appropriateness.

Over the past four decades, the discipline of medical quality assessment and improvement has evolved, both scientifically and culturally. Quality control became quality assessment and improvement, and quality improvement became performance improvement. What we recognized originally as performance improvement took a major shift at the turn of the century when the Institute of Medicine published their landmark book To Err Is Human: Building a Safer Health System. This publication and the subsequent publication, Crossing the Quality Chasm: A New Health System for the 21st Century, refocused the dialogue from quality to patient safety. The study and improvement of quality has seen many names over the years; recognizing the goal as patient safety focused attention on what matters most to patients, their safety when seeking care from healthcare systems that exist to reduce the burden of disease and improve outcomes of care.

Patient safety continues to be a primary focus both within healthcare institutions and clinical laboratories. Five decades ago, the laboratory medicine community recognized that laboratory quality depended not only on the analytic quality of the laboratory, but also on the steps that lead up to testing and those that follow. Laboratory quality experts, including the Centers for Disease Control and Prevention, coined the phrase “Total Testing Process,” which encompasses all aspects of testing from the pre-analytical phase starting with formulation of the clinical question that a laboratory test seeks to answer through to the post-analytical phase where the result is reported, acted upon, and impacts patient outcomes. Studies suggest that the majority (65%–70%) of laboratory errors occur in the preanalytical phase, before the specimen ever reaches the laboratory. Another 15%–20% occur in the postanalytical phase. The fewest errors actually occur in the analytic phase of the total testing process, that part of the total testing process most under the laboratory's direct control.

Emergence of laboratory stewardship

Laboratory stewardship programs focus primarily on aspects of laboratory practice that offer the greatest opportunity to improve patient care, particularly including the pre- and post-analytical components of the total testing process. As such, they now receive increased attention in the overall approach to optimize laboratory services. Stewardship programs challenge laboratory professionals to reach outside their analytic “comfort zone,” recognizing that the greatest opportunity to impact the value of laboratory testing comes from engaging external colleagues to focus on pre- and post-analytic components. Accordingly, laboratorians are strongly encouraged to further develop their existing relationships with clinical partners by engaging in conversations on what constitutes optimal patient care for achieving desired clinical outcomes and reduced diagnostic errors.

The holistic approach of laboratory stewardship to enhance laboratory value aligns with broad healthcare aims. Over the past few decades, healthcare leaders articulated and refined a “triple aim” that includes the key goals of better patient experience, better population health, and lower cost. An additional aim, the well-being of the care team, was added later. Laboratory stewardship supports each of these goals: optimal laboratory testing that avoids over- or undertesting improves the patient experience; reduced care variation improves population health; prevention of unnecessary test orders (and associated downstream care) lowers healthcare costs; and streamlined clinical decision support improves clinician practice satisfaction. In addition to these healthcare goals, laboratory stewardship also acknowledges the operational aspects of laboratory medicine, including risk management and reasonable payment from third party payers for medically necessary services.

Opportunities to improve laboratory services exist in every organization. Some of these opportunities may be unique to a specific organization, while many are common across multiple healthcare systems. When challenges to quality patient care are common, specialty societies, payers, consortia of health systems, and others will articulate those issues and promulgate guidelines, recommendations, payment policies, and other programs to close these common gaps. When developed by these healthcare stakeholders, strategies for optimal care are usually specific, explicit, and based on published evidence. Published guidelines and recommendations from trusted organizations are a good starting place for examination of internal practices because they are defensible, recognized by internal stakeholders, and frequently already tied to performance incentives. Many measures are either laboratory medicine–specific or include laboratory diagnostics metrics to measure performance (e.g., percent of patients with diabetes who are regularly evaluated for glucose control).

The Healthcare Effectiveness Data and Information Set (HEDIS) and the Choosing Wisely campaign are examples of integrated efforts to identify measures that improve quality of patient care, including laboratory services. HEDIS began in the 1990s and is now one of the most widely adopted tools for improving organizational performance. This set of metrics is developed by the National Committee for Quality Assurance (NCQA) and is used by health plans and medical groups to evaluate clinician performance against accepted metrics. Provider incentives are frequently tied to performance on accepted HEDIS measures.

The Choosing Wisely campaign was initiated by the American Board of Internal Medicine (ABIM) Foundation in 2012 to promote conversations among physicians, patients, and other healthcare stakeholders on appropriate patient care. In 2013, the ASCP joined Choosing Wisely to start conversation on the appropriate utilization of medical tests and procedures that sometimes provide little or no benefit and, in some cases, cause harm to patients. A multiyear initiative, the Choosing Wisely campaign provides resources for patients and physicians to engage in these important conversations that help patients choose care that is supported by evidence, not duplicative of other tests and procedures already received, free from harm, and truly appropriate. Choosing Wisely pulls together recommendations from many specialty societies based on published, peer-reviewed evidence. These recommendations, in addition to those published separately by medical specialty societies, are good sources to use when identifying or justifying specific performance improvement projects supported by laboratory stewardship initiatives.

National medical societies such as the ASCP that joined the Choosing Wisely campaign initially identified five tests or procedures often used in their specialty whose use, at least in some situations, should be reconsidered. Numerous Choosing Wisely guidelines that focus on laboratory medicine topics now exist, being submitted by laboratory societies (e.g., ASCP, the American Association of Blood Banks, the American Society for Clinical Laboratory Science, the American Society for Microbiology) and by specialty societies that use laboratory tests (e.g., American College of Obstetricians and Gynecologists, American Academy of Family Physicians). For example, in August 2019 the American Academy of Pediatrics recommended not testing for Lyme disease as a cause of musculoskeletal symptoms without an exposure history or appropriate exam findings. They noted: “The musculoskeletal manifestations of Lyme disease include brief attacks of arthralgia with early disseminated Lyme and/or intermittent or persistent episodes of arthritis in one or a few large joints, with predilection for the knee, in late disease. Lyme testing in the absence of these features and without appropriate exposure from living in or traveling to a Lyme endemic area increases the likelihood of false positive results and may lead to unnecessary follow-up and therapy. Diffuse arthralgias, myalgias, or fibromyalgia alone are not criteria for musculoskeletal Lyme disease.”

Notes

This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added.