In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Clinical Laboratory Management Apply the principles of management in a clinical setting with this vital guide Clinical Laboratory Management, Third Edition, edited by an esteemed team of professionals under the guidance of editor-in-chief Lynne S. Garcia, is a comprehensive and essential reference for managing the complexities of the modern clinical laboratory. This newly updated and reorganized edition addresses the fast-changing landscape of laboratory management, presenting both foundational insights and innovative strategies. Topics covered include: an introduction to the basics of clinical laboratory management, the regulatory landscape, and evolving practices in the modern healthcare environment the essence of managerial leadership, with insights into employee needs and motivation, effective communication, and personnel management, including the lack of qualified position applicants, burnout, and more financial management, budgeting, and strategic planning, including outreach up-to-date resources for laboratory coding, reimbursement, and compliance, reflecting current requirements, standards, and challenges benchmarking methods to define and measure success the importance of test utilization and clinical relevance future trends in pathology and laboratory science, including developments in test systems, human resources and workforce development, and future directions in laboratory instrumentation and information technology an entirely new section devoted to pandemic planning, collaboration, and response, lessons learned from COVID-19, and a look towards the future of laboratory preparedness This indispensable edition of Clinical Laboratory Management not only meets the needs of today’s clinical laboratories but anticipates the future, making it a must-have resource for laboratory professionals, managers, and students. Get your copy today, and equip yourself with the tools, strategies, and insights to excel in the complex and ever-changing world of the clinical laboratory.
Establishing and maintaining laboratory quality standards are essential to generate reliable results to support clinical and public health actions. The Laboratory Quality Standardspresent a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. This book also outlines mechanism to implement them. This book will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requirements set with the ultimate objective to comply with ISO 15189 in a logical and step-by-step manner.
Forensic science has come a long way in the past ten years. It is much more in-depth and much broader in scope, and the information gleaned from any evidence yields so much more information than it had in the past because of incredible advances in analytic instruments and crucial procedures at both the crime scene and in the lab. Many practices have gone digital, a concept not even fathomed ten years ago. And from the first collection of evidence to its lab analysis and interpretation to its final presentation in court, ethics has become an overriding guiding principle. That’s why this new edition of this classic handbook is indispensable. The Forensic Laboratory Handbook Procedures and Practice includes thirteen new chapters written by real-life practitioners who are experts in the field. It covers the tried and true topics of fingerprints, trace evidence, chemistry, biology, explosives and arson, forensic anthropology, forensic pathology, forensic documents, firearms and toolmarks. This text also addresses an array of new topics including accreditation, certification, ethics, and how insects and bugs can assist in determining many facts including a margin of time of death. In the attempt to offer a complete and comprehensive analysis The Forensic Laboratory Handbook Procedures and Practice also includes a chapter discussing the design of a laboratory. In addition, each chapter contains educational requirements needed for the discipline it covers. Complete with questions at the end of each chapter, brief author bios and real crime scene photos, this text has risen to greet the many new challenges and issues that face today’s forensic crime practitioners.
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Digital Forensic Processing and Procedures: Meeting the Requirements of ISO 17020, ISO 17025, ISO 27001 and Best Practice Requirements, Second Edition provides a one-stop shop for a set of procedures that meet international best practices and standards for handling digital evidence during its complete lifecycle. The book includes procedures, forms and software, providing anyone who handles digital evidence with a guide to proper procedures throughout chain of custody--from incident response straight through to analysis in the lab. This book addresses the whole lifecycle of digital evidence. - Provides a step-by-step guide on designing, building and using a digital forensic lab - Addresses all recent developments in the field - Includes international standards and best practices
Physiological Tests for Elite Athletes, Second Edition, presents the most current protocols used for assessing high-level athletes. Based on the insight and experience of sport scientists who work closely with elite athletes to optimize sporting success, this comprehensive guide offers the how and why of both general and sport-specific physiological testing procedures. Readers will learn to use these tests to identify the strengths and weaknesses of athletes, monitor progress, provide feedback, and enhance performance their athletes’ potential. Physiological Tests for Elite Athletes, Second Edition, guides readers in ensuring precision and reliability of testing procedures in the field or lab; correctly preparing athletes before testing; and accurately collecting, handling, and analyzing data. It leads readers through general testing concepts and athlete monitoring tools for determining anaerobic capacity, neuromuscular power, blood lactate thresholds, and VO2max. It also presents principles and protocols for common lab- and field-based assessments of body composition, agility, strength and power, and perceptual and decision-making capabilities. Reproducible forms throughout the book assist readers with data collection and preparticipation screening. After reviewing general protocols, this unique text takes a sport-specific look at the most effective tests and their applications in enhancing the performance of elite athletes. Protocols for 18 internationally recognized sports are introduced, and for each sport a rationale for the tests, lists of necessary equipment, and detailed testing procedures are provided. Normative data collected from athletes competing at national and international levels serve as excellent reference points for measuring elite athletes. New to the second edition are sport-specific assessments for Australian football, BMX cycling, rugby, sprint kayaking, high-performance walking, and indoor and beach volleyball. The second edition of Physiological Tests for Elite Athletes also features other enhancements, including extensive updates to normative data and reference material as well as several new chapters. New information on data collection and handling covers approaches for analyzing data from the physiological monitoring of individual athletes and for groups of athletes in team sports. Revised chapters on environmental physiology provide current insights regarding altitude training and training in heat and humidity. Discussions of the scientific basis of various strategies for athlete recovery in both training and competition enable readers to make sound decisions in employing those strategies to help their athletes optimally recover. For exercise physiologists, coaches, and exercise physiology students, Physiological Tests for Elite Athletes, Second Edition, is the essential guide to the most effective assessment protocols available. Using the precise and proven protocols in this authoritative resource, exercise physiologists can acquire detailed information to assist athletes’ preparation.
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
This book explains how SaaS works and lists and describes many common misconceptions and pitfalls that laboratories have about implementing Quality Management Systems (QMS). By walking the reader through all ISO 15189 Standards and describing each in detail, we can show how to implement them in common sense and meaningful ways. This book demonstrates to clinical laboratories how to combine the rigor of international standards with the inherent benefits of contemporary cloud-based software systems so that they can involve the entire laboratory in making quality a shared habit.
