Point-of-Care Testing: Performance Improvement and Evidence-Based Outcomes PDF

Preface

Why? This is the question that many find themselves asking regarding the performance of laboratory testing at the site of patient care (point-of-care testing, POCT). While clinicians can argue the need for faster turnaround time of results, decreased sample requirements, and convenience to patient care, there is little in the peer-reviewed literature that actually demonstrates improved patient outcomes as a direct result of implementing POCT. POCT popularity is on the rise, and every day additional devices with wider menus and enhanced features are being introduced to the market. However, much of this testing is being adopted without critical investigation of its limitations or imPOCT on patient care. Only after careful assessment have clinicians found the imPOCT of overutilization. While some testing may be vital and important to patient care, other testing is unnecessary and duplicative of services already being delivered in an institution. In light of increasing healthcare pressure for financial and resource management, the amount of labor that is required to ensure quality testing under current regulatory guidelines requires those testing practices to be questioned.

Yet, laboratorians and POCT coordinators implement testing and take on the demands of supervising and managing the testing process, without questioning the need or benefit of moving the test onto the medical unit. Technologists often feel intimidated and claim that it is not within their purview to question the demands of a clinician. However, it is essential that the laboratorian develop the skills not only to question the need for implementing new technologies, but also to reassess the continued need for delivery of current, ongoing POCT.

Medical technologists, pathologists, and even physicians are hesitant to question the patient care practices of other clinicians, partially due to their lack of knowledge of the entire patient situation and partially because there is poor evidence to support their reason to question an ongoing practice. Many clinicians think that if the practice has always been done this way and no one has ever been harmed, why make waves? Surely there must be something else that needs more urgent attention.

Unfortunately, many of these misconceptions arise from the lack of appreciation for what is required to maintain the testing process in a quality manner. POCT certainly has the potential to provide a faster result, but whether that faster result translates into improved patient care is another question. POCT without quality assurance can generate misleading results, to the patient's detriment and increased overall cost of care. Additionally, POCT reagents are more expensive than core laboratory reagents on a unit basis, and labor costs are often higher because the test requires the focused attention of nursing and medical staff that are higher paid due to their patient contact responsibilities. Common sense dictates that such increased expenditures should be balanced by increased benefits to the system somewhere, whether directly to the patient or in staff convenience, scheduling, or time management.

POCT thus presents a dilemma that has only recently been realized: that a fast result may not necessarily be a better result. The risks to the patient have been appearing in the literature both as a result of failure to comply with regulatory requirements and due to a general lack of staff awareness for testing nuances. Clinicians are so used to getting "quality" results from a core laboratory that they translate that quality to POCT. As long as a device gives a result, that result is assumed to be correct and comparable to the core test with which the clinician is familiar. POCT, however, is a different methodology and can present accuracy and precision differences that may imPOCT some patient populations. POCT is thus not universally interchangeable with the core laboratory test, and many of those situations are not recognized until the test is adopted into clinical practice.

The peer literature has falsely promoted this equivalence of core and POCT, as the bulk of POCT studies concern technical performance and laboratory correlations, not patient outcomes. As long as a similar result is obtained, POCT is assumed to generate the same or better outcomes than the core laboratory test because the result is available faster. Actual outcomes are rarely examined, and even more rarely followed up after implementation. Whether a faster result is really a better result thus defines the current dilemma facing laboratorians. While we may not be able to deliver a test any faster in a core laboratory given current technology limitations, POCT may not necessarily be the universal solution to clinical turnaround time, patient complaints, and other clinical problems. Integration is the key. POCT is worthless without also changing clinical management and preparing the staff to act on the result in a timely, clinically useful manner.

This book thus presents a critical look at the field of POCT and the literary evidence supporting its imPOCT on patient outcome. The first half of the book explores the principles and theory of POCT, quality issues, evidence-based medicine, the role of perfonnance improvement in the development of effective testing, practice guidelines, and critical pathways of care. The second half of the book focuses on individual tests and published literature to support improved patient outcomes from the use of POCT. I would hope that the reader would acquire an appreciation of the evidence-based perspective and foundation of available literature in order to address the appropriate questions of patient benefit and clinical utility to physicians demanding POCT. Moreover, laboratory staff should gain the confidence to address utilization issues on an equal basis with physicians, since physicians are as concerned about patient care as laboratorians but may not be aware or have thought about whether their patients are actually achieving the predicted benefits. This book should provide the foundation for developing evidence-based point-of-care and for building clinicians' understanding of the role of POCT in patient care.

To address a potential criticism, this book is neither anti-POCT nor proPOCT. It is pro-clinically useful testing as based on available, published evidence. This evidence should consist of randomized controlled trials demonstrating patient benefit in a convincing number of patients. Demanding evidence in the fonn of well-designed trials is not unreasonable and is also aligned with the current trends of peer-reviewed publications. Many publishers have adopted the recent CONSORT (Consolidated Standards of Reporting Trials) guidelines, and are currently assessing the publication potential of submitted studies by comparison to these standards.

This is indeed the era of evidence-based medicine. As the laboratory, nursing, and clinical departments experience greater staffing shortages, there will be increased pressure to implement POCT to obtain a result while the patient is being seen. There will also be increased need to justify the resources required to maintain POCT. We should be prepared to answer questions about clinical necessity, analytical methodology, and how the result will alter patient management.

This book is thus a tool to the understanding of available evidence-based literature and, more importantly, what studies need to be conducted to optimize the utilization of POCT. I hope you enjoy this book and find it as interesting to read as it was for me to construct. Indeed, many of the contributors claimed to have learned a considerable amount in the process of writing their chapters. I hope that you will find as much insight in reflecting on your own POCT practices.

This book is dedicated to my family (Denise, Ashley and Jacqueline) for the time they have allowed me to complete this work and to my parents (Barbara and Isaac) for their support and inspiration. Credit is also due the medical staff and laboratory professionals who have brought me their numerous POCT issues over the years. Most importantly, I want to thank Linda Hadley for her administrative assistance and the POCT staff at Baystate Medical Center (Dr. Carol Rauch, Dr. Deb Morsi, Mark Provost, Claudia Chiapuzzi, and Cathy Bartholomew) and the Johns Hopkins Medical Institutions (Sandra Humbertson, Karen Dyer and Juanita Stem) for their advice in developing an evidence-based POCT philosophy and realization of that philosophy in practice.